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ORTHODONTIC RETENTION: A PROSPECTIVE

EVALUATION OF STABILITY, PERIODONTAL


OUTCOMES AND ADHERENCE

Dalya Al Moghrabi

A thesis submitted for the degree of Doctor of Philosophy


Centre for Oral Bioengineering
Barts and The London School of Medicine and Dentistry
Queen Mary University of London
2019

STATEMENT OF ORIGINALITY

I, Dalya Al Moghrabi, confirm that the research included within this thesis is
my own work or that where it has been carried out in collaboration with, or
supported by others, that this is duly acknowledged and my contribution
indicated. Previously published material is acknowledged.
I attest that I have exercised reasonable care to ensure that the work is
original, and does not to the best of my knowledge break any UK law,
infringe any third party’s copyright or other Intellectual Property Right, or
contain any confidential material.
I accept that the College has the right to use plagiarism detection software to
check the electronic version of the thesis.

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I confirm that this thesis has not been previously submitted for the award of a
degree by this or any other university.
The copyright of this thesis rests with the author and no quotation from it or
information derived from it may be published without the prior written consent
of the author.

Signed: .................................................
Date: .....................................................

ABSTRACT

Aims:
To systematically review the evidence concerning the effects of orthodontic
retention and adherence to wear of removable appliances and adjuncts; to
evaluate stability and periodontal outcomes with retention and factors
influencing retainer wear; and to develop and evaluate novel means of
improving adherence.
Methods:
1. Two systematic reviews were performed.
2. A four-year follow-up of a randomised controlled trial (RCT) involving
either fixed or thermoplastic retainers (TPR) was undertaken (n= 42).
3. Factors influencing removable retainer wear, retainer-related tweets and
preferences concerning bespoke mobile applications were assessed using
qualitative methods (n= 15 interviews; n= 827 tweets).
4. Qualitative findings informed the development of the ‘My Retainers’
application, and its effectiveness at three-month follow-up was assessed
in a clinical trial involving 84 participants.
Results:
1. There was limited high-quality evidence to endorse the use of one type of
orthodontic retainer in relation to periodontal health, and suboptimal
adherence was typical of removable orthodontic appliances.

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2. Higher levels of irregularity (1.64mm) were observed in the TPR group
(P= 0.02; 95% confidence interval [CI]: 0.30, 2.98mm) with no significant
difference in terms of the periodontal outcomes.
3. Six influencers of adherence to removable retainer wear were identified.
This was corroborated by the negative experiences in relation to the
orthodontic retainers being commonly shared on Twitter. A mechanism of
communication, responsive reminders and access to useful information
were recommended for inclusion in the mobile application.
4. Median wear time was slightly higher in the intervention group; however,
this difference (0.91 hours/day) was not statistically significant (P= 0.56;
95% CI: -2.19, 4.01) with no significant difference in terms of the
periodontal outcomes.
Conclusions:
1. High-quality research is needed to elucidate outcomes related to
orthodontic retainers, and to develop and evaluate methods to improve
adherence with removable appliances.
2. Fixed retention offers superior stability outcomes when compared to TPRs
in the long term with similar periodontal outcomes.
3. Adherence to retainer wear is multi-faceted with extraneous factors
influencing wear time. Most of the publicly-available tweets portrayed
retainer wear in a negative light.
4. Provision of the bespoke ‘My Retainers’ application did not lead to an
improvement in adherence in the short term with further refinement and
research required.

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TABLE OF CONTENTS
STATEMENT OF ORIGINALITY....................................................................2
ABSTRACT.....................................................................................................3
LIST OF TABLES...........................................................................................8
LIST OF FIGURES.......................................................................................10
LIST OF APPENDICES................................................................................12
LIST OF ABBREVIATIONS.........................................................................13
ACKNOWLEDGEMENTS............................................................................14
CHAPTER 1. INTRODUCTION....................................................................16
CHAPTER 2. LITERATURE REVIEW.........................................................18
2.1 Post-Treatment Dental Changes..........................................18
2.2 Orthodontic Retainers..........................................................18
2.2.1 Effectiveness of orthodontic retainers......................................18
2.2.2 Retention and periodontal health.............................................20
2.2.3 Patient-reported outcomes and quality of life with orthodontic ... .
retainers..................................................................................26
2.3 Adherence to Removable Orthodontic Appliance Wear....27
2.3.1 Estimating levels of adherence to removable appliance wear in .
orthodontics.............................................................................28
2.3.2 Adherence to removable orthodontic retainer wear.................30
2.3.3 Factors influencing adherence to orthodontic retainer wear....31
2.3.4 Approaches to improve adherence to removable appliance and .
adjunct wear in orthodontics....................................................34
2.4 The Use of Bespoke Mobile Applications and Social Media ..
in Orthodontic Research........................................................... 36
2.4.1 Mobile applications and social media: Non-interventional ...........
orthodontic studies..................................................................37
2.4.2 Mobile applications and social media: Interventional orthodontic
studies.....................................................................................38
2.5 Qualitative Research in Orthodontics.................................43
CHAPTER 3. AIMS, OBJECTIVES AND OVERVIEW OF METHODOLOGY
......................................................................................................................46
3.1 Aims.......................................................................................46
3.2 Objectives..............................................................................46
3.3 Overview of Methodology.....................................................47
CHAPTER 4. THE EFFECTS OF FIXED AND REMOVABLE ........................
ORTHODONTIC RETAINERS: A SYSTEMATIC REVIEW.........................48
4.1 Background and Aims..........................................................48
4.2 Methods.................................................................................48
4.3 Results...................................................................................50
4.4 Discussion.............................................................................75
4.5 Conclusions..........................................................................78
CHAPTER 5. ADHERENCE TO REMOVABLE ORTHODONTIC
APPLIANCES AND ADJUNCTS WEAR: A SYSTEMATIC REVIEW AND
META-ANALYSIS........................................................................................79
5.1 Background and Aims..........................................................79
5.2 Methods.................................................................................79
5.3 Results...................................................................................82
5.4 Discussion.............................................................................98

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5.5 Conclusions.........................................................................102
CHAPTER 6. THE EFFECTS OF FIXED VERSUS REMOVABLE
ORTHODONTIC RETAINERS ON STABILITY AND PERIODONTAL
HEALTH: FOUR-YEAR FOLLOW-UP OF A RANDOMISED CONTROLLED
TRIAL..........................................................................................................103
6.1 Background and Aims........................................................103
6.2 Methods...............................................................................103
6.3 Results.................................................................................109
6.4 Discussion...........................................................................116
6.5 Conclusions.........................................................................121
CHAPTER 7. FACTORS INFLUENCING ADHERENCE WITH
THERMOPLASTIC RETAINERS: A QUALITATIVE STUDY....................122
7.1 Background and Aim..........................................................122
7.2 Methods...............................................................................122
7.3 Results.................................................................................123
7.4 Discussion...........................................................................133
7.5 Conclusions.........................................................................135
CHAPTER 8. WHAT ARE PEOPLE TWEETING ABOUT ORTHODONTIC
RETENTION: A CROSS-SECTIONAL CONTENT ANALYSIS................136
8.1 Background and Aim..........................................................136
8.2 Methods...............................................................................136
8.3 Results.................................................................................139
8.4 Discussion...........................................................................144
8.5 Conclusions.........................................................................148
CHAPTER 9. DEVELOPMENT OF ‘MY RETAINERS’ MOBILE
APPLICATION: TRIANGULATION OF TWO QUALITATIVE METHODS 149
9.1 Background and Aim..........................................................149
9.2 Methods...............................................................................149
9.3 Results.................................................................................151
9.4 Discussion...........................................................................162
9.5 Conclusions.........................................................................164
CHAPTER 10. EVALUATION OF THE EFFECTIVENESS OF ‘MY
RETAINERS’ MOBILE APPLICATION IN IMPROVING ADHERENCE
WITH .................................................................................................................
THERMOPLASTIC RETAINERS: A RANDOMISED CONTROLLED TRIAL
....................................................................................................................165
10.1 Background and Aims......................................................165
10.2 Methods.............................................................................165
10.3 Results...............................................................................173
10.4 Discussion.........................................................................180
10.5 Conclusions.......................................................................186
CHAPTER 11. OVERALL CONCLUSIONS...............................................187
RECOMMENDATIONS FOR FUTURE RESEARCH DIRECTIONS.........189
REFERENCES............................................................................................191
APPENDICES.............................................................................................222

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LIST OF TABLES
Table 1. Summary of randomised controlled trials involving involving the
assessment of stability outcomes in removable retainers. ...........................
19

Table 2. Summary of studies involving the assessment of periodontal


outcomes with fixed versus comparison to removable retainers. .................
24

Table 3. Factors influencing adherence to removable orthodontic retainer


wear. ............................................................................................................ 33

Table 4. Summary of randomised controlled trials involving the use of mobile


applications and social media in orthodontic patients. .................................
40 Table 5. Characteristics of included trials (n= 24). .......................................
52

Table 6. Periodontal indices used and tooth surfaces scored in the included
studies. ........................................................................................................ 62

Table 7. Periodontal outcomes (plaque and gingival indices) including the


follow-up periods. .........................................................................................
65

Table 8. Periodontal outcomes (calculus, bleeding on probing and probing


depth) including the follow-up periods. .........................................................

66 Table 9. Survival and failure rates of fixed and removable

retainers. ........... 70

Table 10. Patient-reported outcomes and cost-effectiveness. .....................


74

Table 11. Baseline characteristics of the included studies. ..........................


84

Table 12. Adherence levels with various orthodontic regimens. ..................


90

Table 13. Factors influencing adherence levels. ..........................................


97

Table 14. Periodontal outcomes recorded. ................................................


106

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Table 15. Baseline characteristics overall and in both groups. ..................
111

Table 16. Stability outcomes in fixed and removable retainer groups. .......
113

Table 17. Periodontal outcomes in the fixed and removable retainer groups.
................................................................................................................... 115

Table 18. Periodontal outcomes in the labial and lingual surfaces in both
treatment groups. .......................................................................................

115 Table 19. Participant characteristics (n=

15). ............................................. 124

Table 20. Main themes, with definitions and a relevant representative tweet.
................................................................................................................... 138

Table 21. Impact of orthodontic retainers on daily activities and social life.
142 Table 22. Facilitators and barriers relating to bespoke mobile application
use.
................................................................................................................... 152

Table 23. Recommendation and implementation of the mobile application


features, content and design. .....................................................................

153 Table 24. Integration of findings from the Twitter study. ............................

161

Table 25. Baseline characteristics of the sample (n= 84)........................... 174

Table 26. Thermoplastic retainer failures during the study. .......................


175

Table 27. Data pertaining to retainer wear, stability and periodontal outcomes
in both treatment groups. Data presented as median (interquartile range).
177

Table 28. Median regression on the impact of objective wear on stability and
periodontal outcomes accounting for baseline data. ..................................
178 Table 29. Responses concerning experiences during retention. ...............
179

Table 30. Percentage of correct responses concerning levels of knowledge


related to orthodontic retainers. ................................................................. 179

Table 31. Experience and knowledge outcomes in treatment groups (exact

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Mann-Whitney U test). ............................................................................... 180

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LIST OF FIGURES
Figure 1. Mixed-methods design. .................................................................
47

Figure 2. PRISMA flowchart of the included studies (n= 16). .......................


51

Figure 3. Risk of bias for included randomised controlled trials. Low risk of
bias (green); unclear risk of bias (yellow); high risk of bias (red) (n= 18). ....
59

Figure 4. Newcastle-Ottawa Scale scores for non-randomised studies (n= 6).


..................................................................................................................... 60

Figure 5. Forest plot presenting the risk of failure of mandibular stainless


steel fixed retainers bonded from canine to canine. .....................................
72

Figure 6. Forest plot presenting the risk of failure of mandibular stainless


steel fixed retainers bonded to canines only. ...............................................
72 Figure 7. PRISMA flowchart of the included studies (n=
11) ........................ 83

Figure 8. Risk of bias for the included randomised controlled trials: Low risk
of bias (green); unclear risk of bias (yellow); high risk of bias (red) (n= 2). ..
88

Figure 9. Methodological quality of the included mixed-methods study


(Veeroo et al., 2014). ................................................................................... 89

Figure 10. Forest plot presenting the mean difference in objectivelymeasured


adherence levels in relation to stipulated duration of wear. ......... 93

Figure 11. Forest plot presenting the mean difference in objectivelymeasured


adherence levels in relation to self-reported wear time. .............. 94 Figure
12. Study flow diagram. .................................................................. 110

Figure 13. Factors influencing adherence to thermoplastic retainer wear. .


125

Figure 14. Flow diagram of the included tweets. ........................................


139

Figure 15. Frequency of tweets within each main theme. ..........................


139

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Figure 16. Distribution of tweets within each theme and sub-theme. .........
141

Figure 17. Facilitators and barriers to retainer wear. ..................................


142

Figure 18. Stages followed to develop the mobile application features,


content and design. ....................................................................................
150

Figure 19. Screenshot of the calendar tool in ‘My Retainers’ mobile


application. .................................................................................................
155

Figure 20. Screenshot of the frequently-asked questions section in ‘My


Retainers’ mobile application. .................................................................... 155
Figure 21. Mobile application features mapped to theoretical constructs and
the expected outcomes. .............................................................................

160 Figure 22. Retainer wear chart...................................................................

168

Figure 23. Laboratory procedures followed to integrate the TheraMon ® micro-


electronic sensor within the thermoplastic retainer. ...................................

170 Figure 24. CONSORT diagram showing the flow of

participants. .............. 175

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LIST OF APPENDICES
Appendix 1. List of published articles .........................................................
222

Appendix 2. MEDLINE search via OVID (1946 to 31 st of October, 2015) ..


223

Appendix 3. MEDLINE search via OVID (1946 to 1 st week of May, 2016) .


224

Appendix 4. Risk of bias assessment in non-randomised studies using


(ROBINS-I) tool ..........................................................................................
225

Appendix 5. Ethical approval for the follow-up RCT and the one-to-one
interviews ................................................................................................... 242

Appendix 6. Information sheet for the follow-up RCT and the one-to-one
interviews ................................................................................................... 244

Appendix 7. Consent form for the follow-up RCT and the one-to-one
interviews ................................................................................................... 246

Appendix 8. Topic guide ............................................................................ 247

Appendix 9. Content of ‘My Retainers’ mobile application .........................


249

Appendix 10. Ethical approval for the mobile application RCT...................


260

Appendix 11. European Orthodontic Society grant application letter .........


265

Appendix 12. Information sheets for the mobile application RCT ..............
266

Appendix 13. Consent forms for the mobile application RCT .....................
278

Appendix 14. Questionnaire to assess knowledge and experiences related to


retainer wear ..............................................................................................
281

Appendix 15. Additional data from the experience and knowledge


questionnaire not included in the inferential analysis .................................
283

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LIST OF ABBREVIATIONS

BOP Bleeding on probing


CAL Clinical attachment level
CI Confidence interval
ES Effect size
F Female
FA Fixed appliances
FAQ Frequently-asked questions
FR Fixed retainer
GI Gingival index
h/d Hours/day
HG Headgear
ICC Intraclass correlation coefficient
ICW Inter-canine width
IMW Inter-molar width
IQR Interquartile range
LII Little’s irregularity index
M Male
mm Millimetre
MMAT Mixed Methods Appraisal Tool
Mn Mandibular
mo Months
Mx Maxillary
n Number
n/a Not applicable
NHS National Health Service
NI No information
NS Not significant
OB Overbite
OH Oral hygiene
OJ Overjet
PAR Peer Assessment Rating
PI Plaque index
RCT Randomised controlled trial

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ROBINS-I tool Risk of Bias in Non-Randomised Studies of Interventions
tool
SD Standard deviation
SS Stainless steel
TPR Thermoplastic retainer
VFR Vacuum-formed retainer
w Week(s)
y Year(s)
ACKNOWLEDGEMENTS

I would like to express my profound gratitude to my primary supervisor


Professor Padhraig Fleming, who went above and beyond his role as an
academic mentor. I have been extremely fortunate to work closely with such
a distinguished and eminent researcher, clinician and teacher. Having a
knowledgeable supervisor who is open to new ideas, has encouraged me to
utilise a variety of research approaches; including systematic reviews,
randomised controlled trials and qualitative methods. I enormously
appreciate Professor Fleming’s timely, constructive and insightful feedback.
His compassion, enthusiasm and positive energy have been contagious, and
I aspire to emulate his authentic and impeccable work. I immensely
appreciate his role in making this experience smooth, rich and memorable.

This project would not have been possible without the support of many
others. I would like to thank Professor Ama Johal and Professor Nikolaos
Donos for their guidance. I am grateful to Fiorella Beatriz Colonio Salazar
and Cecilia Gonzales Marin for their advice and support. I would like to
recognise the contributions of Professor Nikolaos Pandis, who undertook the
statistical analysis; Kieran McLaughlin, who provided the dental lab work and
Niamh O’Rourke, who completed the first phase of the initial randomised
controlled trial. I am also grateful to UCL Health Creatives for their technical
assistance in developing the mobile application. I would like to thank all the
participants who took part in the project, as well as the nurses and
postgraduate students at the Royal London Hospital who helped with the
recruitment. I would like to extend my sincere gratitude to my colleagues and

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friends. Special thanks to Aliki Tsichlaki for her support and with whom I
have shared many special moments during this journey.

My sincere thanks to the Saudi Arabian Cultural Bureau in the United


Kingdom and for Princess Nourah bint Abdulrahman University for
generously funding my PhD. They have made a considerable investment in
young Saudi academics and have had a pivotal role in my career. I would
also like to thank the European Orthodontic Society for partially funding the
project.
I dedicate this work to my doting father Hassan and to the soul of my mother
Majida. I am forever grateful to my father for his endless care and love. He
cultivated in me a strong passion for education ever since I was a child. His
unwavering belief in me, his prayers and words of encouragement have
always sparked energy in me. Finally, my warmest gratitude goes to my
dearest sisters, Nouran and Nouf. I immensely appreciate their love and
support. Their encouraging and kind words have always elated and
empowered me. No amount of thanks will suffice.

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CHAPTER 1

CHAPTER 1. INTRODUCTION

As far back as 1934, Oppenheim suggested that ‘Retention is the most


difficult problem in orthodontia; in fact it is the problem’ (Oppenheim, 1934).
More than 80 years later, this issue remains unresolved (Littlewood et al.,
2016). According to Little et al. (1988), 90% of treated cases were shown to
have experienced post-treatment dental changes in the form of mandibular
incisor crowding at a 20-year follow-up. Maintaining teeth in their corrected
position following orthodontics is achieved using fixed or removable
retainers.

A recent Cochrane review concluded that there are voids in the literature with
no evidence of superiority for fixed over removable retainers or vice versa in
terms of their effectiveness, and limited evidence concerning associated
harms, long-term implications and patient satisfaction (Littlewood et al.,
2016). Removable orthodontic retainers continue to be popular despite the
availability of fixed retainers. The continued use of removable components
can be attributed to the relative simplicity of fabrication and adjustment, low
cost and reduced chair-side time. Fixed retainers place a higher premium on
optimal oral hygiene and, although breakages of both removable and fixed
orthodontic retainers are frequent, fracture of fixed retainers is considerably
more common at least in the short term (Hichens et al., 2007; Pandis et al.,
2013).

The recommended duration of retainer wear has long been a dilemma in


orthodontics; there is now a widespread acceptance of a prolonged, and
indeed indefinite retention, implying that it may be a lifelong experience
(Valiathan and Hughes, 2010). There is, however, no previous prospective
clinical study assessing the stability of treatment involving passive removable
orthodontic retainers over a period in excess of two years. In addition, in view
of the potential burden of sustained retainer wear and the possible harm
associated with prolonged use of retention to the periodontium, it is important

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CHAPTER 2

that a more holistic assessment of benefits, harms and experiences


associated with prolonged use of orthodontic retainers is undertaken.

CHAPTER 1

Understanding patient values, experiences and preferences is a vital cog in


evidence-based practice (Sackett et al., 1996). Positive patient experiences
are particularly important during retention to ensure optimal levels of
adherence. However, in the orthodontic literature, experiences and quality of
life during retention have been captured almost exclusively using
questionnaires (Störmann and Ehmer, 2002; Hichens et al., 2007; Kumar
and Bansal, 2011; Pratt et al., 2011b; Scribante et al., 2011; Jaderberg et al.,
2012; Sawhney, 2014; Forde et al., 2018). Although qualitative research is
becoming increasingly ingrained within dentistry (Stewart et al., 2008), it has
not been used in exploring patient experiences with orthodontics retainers.

There is a lack of long-term prospective research assessing levels of


adherence to removable retainers; notwithstanding this, there is an
appreciation that prolonged adherence with retainers is limited. Moreover,
there is a dearth of research evaluating the utility of interventions
underpinned by key behavioural change theories to enhance wear time
associated with removable orthodontic retainers (Gross et al., 1991;
Ackerman and Thornton, 2011; Hyun et al., 2015; Lin et al., 2015). It is
therefore important to develop and evaluate novel approaches based on
relevant behavioural change theories to ensure optimum levels of adherence
to removable appliance wear, especially in the long term.
CHAPTER 2. LITERATURE REVIEW

2.1 Post-Treatment Dental Changes

Orthodontic retention has been described as, ‘The holding of teeth following
orthodontic treatment in the treated position for the period of time necessary
for the maintenance of the result’ (Moyers, 1973). Furthermore, relapse has

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been defined as, ‘The return, following correction, of features of the original
malocclusion’ (British Standards Institution, 1983). More broadly,
posttreatment dental changes refer to both alteration in tooth position due to
relapse as well as other reasons such as age-related change (Mitchell,
2013). The premium on retention stems from findings from long-term
retrospective studies, in which a degree of post-treatment dental change in
the mandibular anterior region, in particular, was almost uniformly observed
(Little et al., 1988). Post-treatment dental changes following orthodontic
treatment can reduce patient satisfaction, and lead to compromised
outcomes and increased cost burden associated with re-treatment (Kearney
et al., 2016). Retention is therefore necessary following orthodontic treatment
to allow for reorganisation of the periodontal ligament and gingival fibres, to
permit neuromuscular adaptation, to maintain unstable tooth position, and to
mitigate against agerelated changes (Horowitz and Hixon, 1969; Blake and
Bibby, 1998).

2.2 Orthodontic Retainers

2.2.1 Effectiveness of orthodontic retainers

Orthodontic retainers are prescribed routinely following orthodontic


treatment. Little is known about the differences between the types of
retainers in terms of their effectiveness in maintaining orthodontic treatment
outcomes, especially in the long term. Notwithstanding this, few long-term
prospective studies have involved a comparison of the effectiveness of fixed
and removable retainers.

A number of randomised controlled trials (RCTs) have involved comparison


of the different types of removable orthodontic retainers (Table 1). Vacuum-

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CHAPTER 2

formed retainer (VFR) was observed to be superior to Hawley retainer in


relation to preservation of labial segment alignment (Rowland et al., 2007).
Additionally, full-time wear of removable retainers does not seem to offer any
improvement in alignment when compared to part-time wear (Gill et al.,
2007; Shawesh et al., 2009; Thickett and Power, 2009).

Table 1. Summary of randomised controlled trials involving involving


the assessment of stability outcomes in removable retainers.
Wear (parttime/full- Follow-up
Study Retainer type Findings
time) period
Rohaya et al. TPR Full-time for 1 w 9 mo TPR more effective
(2006) followed by in preventing
parttime rotational relapse
Hawley retainer Full-time for 3 mo
followed by
parttime
Gill et al. (2007) TPR Full-time 6 mo LII, ICW, IMW, OJ
and OB: NS
Part-time
Rowland et al. TPR Full-time for 1 w 6 mo - LII: TPR
(2007) followed by more effective
parttime - OJ, OB, tooth
rotation, ICW and
Hawley retainer Full-time for 3 mo
IMW: NS
followed by
parttime
Shawesh et al. Hawley retainer Full-time for 6 mo 1y LII: NS
(2009) followed by
parttime
Part-time
Thickett and TPR Full-time for 3 mo 1y - LII, ICW, IMW,
Power (2009) followed by arch length, OJ
parttime and PAR scores:
Part-time NS - OB: more
change in part-time
group
Kumar and TPR and Mn 33 Full-time for the 6 mo Higher PAR scores,
Bansal (2011) FR first 6 mo followed and LII in Begg
Begg retainer by part-time retainer group but
and Mn 3-3 FR not clinically
significant
Moslemzadeh et Hawley retainer No information 6 mo Stability outcomes
al. (2018) based on American
TPR 1mm in Board of
thickness Orthodontics
TPR 1.5mm in objective grading
thickness system: NS
Kaya et al. (2019) TPR Full-time for 6 mo 1y LII, ICW, IMW, arch
followed by length, OJ and OB:
Hawley retainer

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CHAPTER 2

parttime NS
FR: fixed retainer; ICW: inter-canine width; IMW: inter-molar width; LII: Little’s irregularity
index; mm: millimetres; Mn: mandibular; mo: months; NS: not significant; OB: overbite; OJ:
overjet; PAR: Peer Assessment Rating; TPR: thermoplastic retainer; w: week; y: year(s).
In an RCT conducted by Edman Tynelius et al. (2010; 2013; 2015), fixed
retainers, prefabricated positioners and inter-dental enamel reduction of
mandibular anterior teeth led to no significant difference in the irregularity of
the incisors, inter-canine and inter-molar widths and arch length at one-, two-
and five- year follow-up. Furthermore, in a three-year follow-up study, both
intact fixed and removable retainers were equally effective in maintaining
mandibular incisor alignment (Artun et al., 1997). However, patients who had
retainer breakage or loss exhibited more dental relapse than patients who
had intact retainers. Another RCT involved a comparison between a lingual
fixed retainer combined with a nights-only Hawley retainer and VFRs
prescribed for full-time wear (Xu et al., 2011). Similar stability of mandibular
incisor alignment was noted at a one-year follow-up (Xu et al., 2011).
However, it should be noted that the sample size in both studies (Artun et al.,
1997; Xu et al., 2011) was inadequate in all treatment groups, and data
concerning adherence to removable retainer wear were not reported.

Preservation of the dental alignment in the mandibular labial segment was


observed to be superior with fixed retainers than VFRs at one (Forde et al.,
2018) and two years post-treatment (McDermott et al., 2008). O'Rourke et al.
(2016) reported on a comparison of the effectiveness of VFRs and fixed
retainers in the mandibular arch 18 months post-treatment. No differences
were observed between these two types of retainers in maintaining the
alignment of the mandibular labial segment, inter-canine and inter-molar
widths and arch length. However, no previous prospective study assessing
the stability of treatment involving mandibular fixed retainers in comparison
to VFRs over a period in excess of two years has been undertaken.

2.2.2 Retention and periodontal health

The lack of any high-quality evidence concerning the implications of both


fixed and removable retainers on periodontal health was identified in a recent

19
CHAPTER 2

Cochrane review (Littlewood et al., 2016). The understanding of the


periodontal effects of prolonged fixed retention is mainly based on
retrospective research, which is likely to be prone to selection bias,
particularly as fixed retainers are more likely to be prescribed as a method of
retention in patients exhibiting good oral hygiene. Furthermore, retrospective
studies are susceptible to sampling bias in which adherent patients with
regular recall regimens are more likely to be included in the analysis, thereby
obscuring any potential effects.

A variety of periodontal measures are in use in clinical periodontal trials


(Hujoel, 2004). Dental calculus acts as a nidus for continuous plaque
accumulation (Newman et al., 2011), which plays a role in the aetiology of
gingivitis and the possible progression to periodontal disease characterised
by clinical attachment loss. Furthermore, probing pocket depths in excess of
3mm are inaccessible for adequate plaque control; the former is, therefore,
an important outcome measure. Clinical attachment level is a validated
surrogate measure and is predictive of tooth loss (Hujoel et al., 1999; Gilbert
et al., 2002). Additionally, the absence of bleeding on probing is a reliable
indicator of periodontal stability (Lang et al., 1990). Gingival recession may
pose an aesthetic issue, can lead to dental hypersensitivity which in turn
predispose to root caries. Full-mouth bleeding scores of more than or equal
to 30% and residual probing depth of 6mm or more after active periodontal
therapy are risk factors for tooth loss (Matuliene et al., 2008). As such, a
range of periodontal outcomes are used in order to provide a holistic
evaluation of treatment effects.

The prolonged effects of fixed retainers on periodontal health were assessed


retrospectively in three studies (Pandis et al., 2007; Booth et al., 2008; Levin
et al., 2008). Fixed retainers did not lead to adverse effects on gingival health
in patients with fixed retainers at 20-year follow-up (Booth et al., 2008).
Plaque and gingival indices scores and bone levels did not differ significantly
in patients who had fixed retainers over a prolonged (9-11 years) in
comparison to a shorter period (no longer than six months) (Pandis et al.,

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CHAPTER 2

2007). However, prolonged retention with fixed retainers was associated with
more significant calculus deposits, marginal gingival recession and probing
depth (Pandis et al., 2007). Higher plaque index scores and bleeding on
probing were observed in patients with fixed retainers in comparison to
controls with no significant difference in probing depth at a mean period of
four years post-treatment (Levin et al., 2008). However, no distinction was
made between maxillary and mandibular measurements (Levin et al., 2008).

The prolonged presence of fixed retainers was not reported to be associated


with clinically significant gingival recession in three studies (Pandis et al.,
2007; Levin et al., 2008; Renkema et al., 2013). In the long term, only a small
number of patients exhibited gingival recession in the mandibular dental
arch, mainly on the labial surfaces (Pandis et al., 2007). Due to the remote
location of the gingival recession, the authors concluded that recession could
not be explained by the fixed retainers (Pandis et al., 2007). Another
retrospective study observed no difference in the severity of gingival
recession based on dental cast measurements for patients with mandibular
fixed retainers bonded to six teeth or bonded to canines, in isolation, two to
five years post-treatment (Renkema et al., 2013). However, gingival
recession was only measured on the labial surfaces of the mandibular
anterior teeth in this study. A further limitation of this study was that gingival
recession was recorded as a binary outcome (more or less than 1mm) with
no account given to its severity. Higher levels of lingual gingival recession
were observed in patients with fixed retainers compared to those with no
fixed retention (Levin et al., 2008). However, the mean difference did not
exceed 0.2mm, and was therefore not clinically significant. While removable
retainers are used routinely following active orthodontic treatment, their
effects in respect of gingival recession has not been assessed within clinical
trials. Therefore, further research with more detailed periodontal assessment
would allow a greater understanding of the effect of different retainer types
on periodontal health.

21
CHAPTER 2

The effects of fixed in comparison to removable orthodontic retainers on


periodontal health have been evaluated in a limited number of prospective
studies (Table 2). Although thermoplastic retainers (TPRs) are commonly
prescribed as orthodontic retainers, only two published studies have involved
periodontal assessment with these in comparison with fixed retainers (Xu et
al., 2011; Storey et al., 2018). In a 12-month follow-up, higher calculus index
scores were observed with fixed retainers compared to VFRs (Xu et al.,
2011). The main limitation of the previous study was that the periodontal
assessment was confined to calculus scores. Furthermore, patients in the
fixed retainer group were instructed to wear an additional removable retainer
at night, making it difficult to distinguish between the effects of the different
types of retainers. In a recently published RCT involving fixed retention and
VFRs, no clinically significant difference was observed in the levels of the
gingival and plaque and calculus scores at one-year follow-up (Storey et al.,
2018). With regard to periodontal outcomes with mandibular Hawley
retainers in comparison to mandibular stainless steel fixed retainers, no
significant difference was observed at three-year follow-up (Artun et al.,
1997). Plaque, calculus and gingival indices scores reduced at three-year
follow-up in relation to the lingual aspect of the mandibular anterior teeth with
Hawley retainers (Artun et al., 1997). However, gingival index scores were
shown to increase on the buccal surfaces of maxillary and mandibular
anterior teeth in patients wearing Hawley retainers in one study at six-month
follow-up (Heier et al., 1997). However, the sample size in the Hawley
retainer group was small (n= 14) in both studies (Artun et al., 1997; Heier et
al., 1997), with no data on patient adherence to retainer wear.

Relatively few RCTs have involved a comparative assessment of periodontal


outcomes with different removable retainers. At a six-month follow-up,

significantly higher levels of plaque and calculus were observed with VFRs in
comparison with Hawley retainers (Manzon et al., 2018). In terms of levels of
gingival inflammation, no significant difference was observed between the
groups over a similar follow-up period (Manzon et al., 2018; Moslemzadeh et
al., 2018).

22
CHAPTER 2

It is, therefore, clear that the prolonged effect of orthodontic retention on


periodontal health has not been adequately addressed in prospective
research (Artun et al., 1997; Heier et al., 1997). As such, there is a lack of
RCTs involving a comparative assessment of the effects of prolonged fixed
and removable retention on the periodontal health.

23
CHAPTER 2

Table 2. Summary of studies involving the assessment of periodontal outcomes with fixed versus comparison to removable
retainers.
Retention Periodontal Index/Measurement
Study Study design Retainer design
period outcome(s) appraoch/Scale
Artun Retrospective Range: 1 y - 0.032” Plain FR (canines only) Plaque Silness and Löe (1964)
(1984) study and 2 mo to - 0.032” Spiral wire FR (canines only) Gingival inflammation Löe and Silness (1963)
8 y and 7 mo - 0.0195” Spiral wire FR
Calculus Ramfjord (1959)
- No retainer
- Removable retainer Loss of attachment Ramfjord (1959)
Probing depth mm
Artun et al. Prospective 3y - 0.032” Plain FR (canines only) Plaque Silness and Löe (1964)
(1997) cohort study - 0.032” Spiral wire FR (canines only) Gingival inflammation Löe and Silness (1963)
- 0.0205” Spiral wire FR
Calculus Ramfjord (1959)
- Removable retainer
Heier et al. Prospective 6 mo - 0.0175” Multistrand SS FR Plaque Turesky et al. (1970)
(1997) cohort study - Hawley retainer Gingival inflammation Lobene et al. (1986)
Calculus Volpe (1967)
Masaki Retrospective Minimum of - FR Probing depth mm
(2007) study 7 mo in - Hawley retainer Bleeding on probing Present/Absent
retention
Gingival recession mm
Millet et al. RCT 12 mo - 0.018” Multistrand FR Gingival bleeding NI
(2008) - VFR Pocket depth NI
Cerny et Retrospective Minimum of - FR Plaque 5-point ordinal scale
al. (2010) study 15 y in - Removable retainer Gingival inflammation
retention Calculus
Gingival recession
Rody Jr et Retrospective Minimum of - 0.028” Plain FR - Plaque Present/Absent
al. (2011) study 4 y in Hawley retainer Probing depth mm
retention - No retainer
Bleeding on probing Present/Absent

24
CHAPTER 2

Li et al. RCT 1y - VFR Calculus Greene and Vermillion (1960)


(2016) - 0.0195” Multistrand SS FR with Hawley
retainer
Rody Jr et Retrospective Minimum of - 0.028” Plain FR Plaque Present/Absent
al. (2016) study 6 mo in - 0.0195” Round braided wire - Gingival inflammation Present/Absent
retention Removable retainer
Bleeding on probing Present/Absent
Probing depth mm
Gingival recession mm
Mondal et Prospective 6 mo - FR Plaque Turesky et al. (1970)
al. (2017) cohort study - Removable retainer Calculus NI
Storey et RCT 1y - 0.0195” 3-stranded Twistflex SS FR Plaque Silness and Löe (1964)
al. (2018) - VFR Gingival inflammation Löe (1967)
Calculus Greene and Vermillion (1960)
FR: fixed retainer; mm: millimetres; mo: months; NI: no information; SS: stainless steel; VFR: vacuum-formed retainers; y: year(s).

25
CHAPTER 2

2.2.3 Patient-reported outcomes and quality of life with orthodontic


retainers

Patient-reported outcomes are important in providing information that can aid


in assessing the benefits and harms associated with orthodontic retainers, as
well as the impact of appliance wear on quality of life. Fixed retention has
variously been linked to altered speech, discomfort, tongue irritation,
hindrance of oral hygiene measures and impairment of aesthetics (Störmann
and Ehmer, 2002; Scribante et al., 2011; Sawhney, 2014). Failure to comply
with removable retention has been attributed to associated discomfort and
hassle (Wong and Freer, 2005; Pratt et al., 2011b), with embarrassment
related to speech and aesthetics also commonplace with removable
retainers (Hichens et al., 2007; Jaderberg et al., 2012; Forde et al., 2018).

In an RCT conducted in the UK, Hawley retainers caused embarrassment in


terms of speech and aesthetics in 17% of patients, compared to 7% in the
VFR group (Hichens et al., 2007). However, similar levels of discomfort were
observed in both groups. Although TPRs were considered aesthetically more
acceptable to patients in comparison to Begg retainers, the former was
associated with difficulty in eating (Kumar and Bansal, 2011). In all previous
studies, patient-reported outcomes in relation to orthodontic retainers were
assessed using questionnaires (Störmann and Ehmer, 2002; Hichens et al.,
2007; Kumar and Bansal, 2011; Pratt et al., 2011b; Scribante et al., 2011;
Jaderberg et al., 2012; Sawhney, 2014; Forde et al., 2018). Although
questionnaires provide measurable effects, they do not provide sufficient
depth and understanding of the implication of retainer-related experiences. In
particular, questionnaires may be based on the clinicians’ preconceptions,
which may result in relevant information being overlooked. A further limitation
was the risk of recall bias due to a lack of complete and accurate reporting of
relevant information at the time of the study. Moreover, the risk of response
bias exists whereby patients may try to please the clinician with their
responses.

27
CHAPTER 2

Surprisingly, given the likelihood of negative experience and social impacts


associated with orthodontic retainers, there is no validated instrument to
specifically evaluate the effect of retainer wear on quality of life. The
development of a validated questionnaire related to retention may provide a
more holistic tool to assess the physical, psychological, and social impacts of
retainer wear (Cunningham and Hunt 2001; Sischo et al., 2011). However,
the use of similar questionnaires in orthodontics is limited to the assessment
of quality of life in patients with dentofacial deformity (Cunningham et al.,
2000), hypodontia (Akram et al., 2011) and malocclusion (Patel et al., 2016).
Therefore, the development of validated instruments in future research is
essential in order to improve treatment process and outcomes (Sischo and
Broder, 2011).

Levels of speech impairment have been reported with removable retainers


using objective measures such as articulation and acoustic tests (Haydar et
al., 1996; Atik et al., 2016). However, unless complementary qualitative
studies are undertaken, the effect of retainers on quality of life and levels of
adherence will remain unclear. Inconveniences related to retainer wear
including maintenance requirements, cost of replacement and the need for
long-term commitment have been identified in a study involving one-to-one
interviews (Kearney et al., 2016). Limited information is available in relation
to facilitators of retainer wear. Some patients, however, regard adherence to
retainer wear as an ‘investment’ to maintain orthodontic treatment results
(Kearney et al., 2016). Therefore, there is a need for further studies
incorporating an in-depth investigation of patients’ experiences during the
retention phase that cannot be satisfactorily answered using quantitative
methods alone.

2.3 Adherence to Removable Orthodontic Appliance Wear

The terms ‘compliance’ and ‘adherence’ have been used interchangeably in


both the dental and orthodontic literature. Compliance has been defined as,
‘The extent to which the patient’s behaviour matches the prescriber’s
recommendations’ (Horne et al., 2005). Adherence represents, ‘The extent to

28
CHAPTER 2

which the patient’s behaviour matches agreed recommendations from the


prescriber’ (Horne et al., 2005). The terms differ in the underlying assumption
of the patient role. While compliance is associated with paternal
connotations, adherence implies a level of patient involvement and equal
partnership in adopting clinical recommendations (Horne et al., 2005).

Patient adherence to removable orthodontic appliance wear is integral to


successful treatment. For example, a direct relationship between adherence
levels with the van Beek appliance recorded using objective measures and
overjet reduction was reported in a prospective cohort study by Al-Kurwi et
al. (2017). However, adherence to removable orthodontic appliance wear is
known to be problematic. It has been suggested that just 8% of patients
comply with the prescribed duration of wear in a study focussing on
removable appliances (Schäfer et al., 2015). In further studies based on
micro-electronic sensors in headgear or Bionators, appliance wear for just
50% to 60% of the stipulated time was observed (Sahm et al., 1990a;
Brandão et al., 2006; Huanca Ghislanzoni et al., 2019). This was further
complicated by the fact that patients may over-report hours of wear up to
two-fold (Brandão et al., 2006; Bos et al., 2007). These issues risk possible
increase in the treatment duration (Skidmore et al., 2006), may mislead the
treating orthodontist and can cause unnecessary changes in the treatment
plan and compromised outcomes. There is, therefore, a premium on
optimising and indeed better predicting patient adherence to removable
appliance wear.

2.3.1 Estimating levels of adherence to removable appliance wear in


orthodontics

Orthodontists are now capable of objectively monitoring patient adherence


with removable appliances using indwelling micro-electronic sensors
ensuring the veracity of the estimates of appliance wear that would otherwise
be overestimated (Schott et al., 2016). Gauging adherence by subjective
measures including patient reports may be of dubious value (Brandão et al.,

29
CHAPTER 2

2006; Bos et al., 2007). Thus, unless wear time is objectively-measured, the
true figure cannot be known with any degree of certainty. There are relatively
few examples of micro-electronic sensors within dentistry with devices such
as TheraMon® having the advantage of its relatively small size permitting
more subtle housing within an orthodontic appliance over alternatives such
as the Smart Retainer® microelectronic sensor (Schott and Goz, 2010b).
Therefore, a slight increase in the bulk of the retainers is required to allow for
their integration. Unlike the Smart Retainer ®, TheraMon® microelectronic
sensor software can also detect manipulation attempts by the patient
(Schäfer et al., 2015).

TheraMon® microelectronic sensors are not without their disadvantages, both


in respect of the reliability of objective data and the longevity of the sensor. A
mean under-recording of 4% was reported in an in vivo study including
TheraMon® microelectronic sensors over a period of seven days (Brierley et
al., 2017). Moreover, variation related to location was also observed (Brierley
et al., 2017). The reported mean difference between actual and recorded
wear time was 1.2 hours per day in the maxilla, and 0.8 hours per day in the
mandible, indicating acceptable accuracy of TheraMon ® microelectronic
sensors (Brierley et al., 2017). Furthermore, two in vitro studies involved
testing the accuracy of TheraMon® sensor using thermostatic water baths
(Schott and Goz, 2010b; Kirshenblatt et al., 2018). The recorded
measurements were reported to be precise in 55.6% (Schott and Goz,
2010b) and 81% (Kirshenblatt et al., 2018) of the total number of days.
However, the mean discrepancy did not exceed ten minutes (Schott and
Goz, 2010b) and
3.5 minutes (Kirshenblatt et al., 2018) in both studies. In terms of failure
rates, 14.5% of micro-electronic sensors integrated within removable
functional appliances required replacement within the first six months of
treatment (Parekh, 2016). There is, therefore, a need to augment objective
data with subjective reports. Furthermore, microelectronic sensors may also
have an impact on the appearance of the retainers. Positioning the
microelectronic sensor on the posterior buccal aspect of the retainers can

30
CHAPTER 2

help minimise this. Notwithstanding this, the acceptability to patients of


integrating a sensor within orthodontic appliances might be limited; however,
it has been shown that 75% of patients are accepting of these sensors
(Schott and Goz, 2010a).
2.3.2 Adherence to removable orthodontic retainer wear

Adherence to removable orthodontic retainer wear can have a meaningful


bearing on the maintenance of treatment outcomes in both the short and
long term. Several studies involving subjective measures of removable
retainer wear have highlighted the issue of suboptimal adherence in the short
term and up to two-year post-treatment (Hichens et al., 2007; Pratt et al.,
2011b; Lin et al., 2015). Subjective measures included adherence levels as
reported by patients, their parents or treating clinicians using questionnaires
or daily calendars. However, when self-reports were compared to objective
measures, over-reporting was exposed despite awareness of being
objectively-monitored (Schott et al., 2016). Therefore, reliance on subjective
measures alone to assess patient adherence to removable appliance wear
may be insufficient.

The use of indwelling micro-electronic sensors to assess objective


adherence to orthodontic retainer wear has been applied in relatively few
studies. Tsomos et al. (2014) reported that the actual wear of different
removable orthodontic retainers was 112% of the stipulated time. In this
cross-sectional study, the time at which the readings were recorded was not
standardised, with a wide observation period ranging from 55 to 318 days
(Tsomos et al., 2014). The sample was selected, at least one month after
supply of the retainer, based on the orthodontist’s impression of adherence
levels, which introduces the possibility of selection bias (Tsomos et al.,
2014). The findings of this study must be interpreted with caution, as patients
had to pay for the sensors which might explain the levels of adherence
(Tsomos et al., 2014). However, the sample included patients wearing VFRs
and different types removable appliances, and the data were not presented
separately (Tsomos et al., 2014). Furthermore, the number of patients

31
CHAPTER 2

wearing VFRs was small (n= 5) (Tsomos et al., 2014). In a prospective study
involving Hawley retainers and functional appliances, Schott et al. (2013),
reported wear rates of as high as 87% of the stipulated time. Participants
were selected for inclusion if they were considered suitable for a removable
retainer with a micro-electronic sensor as assessed by the orthodontist,
which introduces the possibility of selection bias. Although the follow-up
period was up to 15 months, drop-outs were not reported and the method of
dealing with missing data was not explained (Schott et al., 2013). This may
influence the results, as it can be assumed that adherent patients are likely
to attend their follow-up appointments, while those less adherent are more
likely to be lost to follow-up potentially introducing attrition bias.

The actual wear-time relative to stipulated wear ranged from 30% to 85% in
patients wearing Hawley retainers in the short term (Hyun et al., 2015).
However, the sample size was small in the treatment and control groups
(Hyun et al., 2015). It was shown that patients do not exceed a mean wear
time of 16 hours per day despite being asked to wear VFRs on a full-time
basis (Kourakou, 2016). Overall, however, limited assessment of treatment
outcomes, such as measures of stability and periodontal health, in relation to
objectively-assessed adherence to orthodontic retainer wear has been
undertaken in prospective research. There is, therefore, a need for
welldesigned prospective research in order to assess objective measures of
adherence especially in the long term.

2.3.3 Factors influencing adherence to orthodontic retainer wear

Several studies included assessment of factors relating to suboptimal


adherence levels with removable orthodontic retainers including age, gender,
time elapsed since debond, type of retainer and wear regimen, place of
treatment and type of health insurance (Table 3). Hawley retainers and VFRs
were both reported to cause some levels of discomfort and embarrassment
due to speech and aesthetics (Hichens et al., 2007; Pratt et al., 2011b;
Almuqbil and Banabilh, 2019). Inconveniences caused by appliance wear are

32
CHAPTER 2

likely to have an effect on wear time. This was reflected in the higher levels
of adherence to VFR wear in comparison to Hawley retainers, up to two
years post-debond (Hichens et al., 2007; Pratt et al., 2011b; Mirzakouchaki
et al., 2016). Furthermore, failure to wear retainers was attributed to simply
forgetting to wear them in 50% of patients (Lin et al., 2015). Requirement for
maintenance of removable retainers appears to be an important factor
related to continuation of wear (Pratt et al., 2011b; Lin et al., 2015). However,
it must be recognised that these studies were questionnaire-based and
included subjective measures of removable appliance wear (Hichens et al.,
2007; Pratt et al., 2011b; Lin et al., 2015; Almuqbil and Banabilh, 2019).

Patients’ attitudes towards their retainers, in terms of whether they regard


them as an ‘investment’ or a tedious commitment, appear to be important in
determining success (Kearney et al., 2016). Motives for wearing removable
functional appliances were linked to the ability to observe positive dental
changes, in addition to being continually encouraged by the dentist at
followup appointments (Čirgić et al., 2015). However, it would be intuitive to
expect facilitators of retainer wear to be different. This may relate to the
relatively passive function of orthodontic retainers in maintaining treatment
outcomes, and to the less frequent number of follow-up visits. There is,
therefore, a need for qualitative studies to understand facilitators and barriers
related to retainer wear.

33
CHAPTER 2

Table 3. Factors influencing adherence to removable orthodontic


retainer wear.
Retainer type/Wear
Study Age Gender Other factors
regimen
- - More adherence to VFR -
Hichens et al.

wear than Hawley


(2007)

retainers

NS NS Type of retainer: NS Time elapsed since


Pratt et al. Kacer et al.

debond: less adherence


(2010)

over time

Younger Females - < 2 years post - Patient


debond: more adherence understanding is important
(2011b)

patients more more


adherent adherent to VFR wear for adherence levels
than - > 2 years post - Time elapsed since
males debond: more adherence debond: less adherence
to Hawley retainer wear over time
NS NS - Place of treatment and
Schott et al.

type of health insurance:


(2013)

NS

NS except for NS - Hawley and Time elapsed since


Sawhney

maxillary thermoplastic retainers: debond: NS


(2014)

retainer worn NS
full-time: 17-20 - Full-time and part-
year-old more time:
adherent than NS
the rest of the
groups
Younger NS - -
Tsomos et al.

patients more
(2014)

adherent

NS NS - - Time elapsed since


Kourakou

debond: NS
(2016)

- Place of treatment:
NS
Junior school NS More adherence to VFR - Place of treatment,
Mirzakouchaki et al.

children more wear than Hawley living


adherent than retainers place: NS
(2016)

primary and - Patients treated by


high school orthodontists were more
children adherent than those
treated by students -
Patients with housewife
mothers more adherent
than those with employed
mothers

34
CHAPTER 2

NS: not significant; VFR: vacuum-formed retainers.

2.3.4 Approaches to improve adherence to removable appliance and


adjunct wear in orthodontics

In the orthodontic literature, relatively few studies have involved the


assessment of the effects of interventions to enhance wear time associated
with different orthodontic appliances. There is an acceptance that the
Hawthorne effect results in an increase in the number of hours of wear of
both headgear and removable retainers (Doruk et al., 2004; Brandão et al.,
2006; Ackerman and Thornton, 2011; Tsomos et al., 2014; Hyun et al.,
2015). The use of headgear calendars or conscious hypnosis were both
shown to be effective in increasing the duration of headgear wear in single
studies (Cureton et al., 1993b; Trakyali et al., 2008). Furthermore, the use of
a behavioural intervention (‘if-then’ planning) to address the potential
mismatch between intentions and actions in relation to intra-oral elastic wear
did not lead to a significant improvement in adherence levels (Veeroo et al.,
2014). Although the intervention was informed by participants in a qualitative
element of the study, its effectiveness was tested on a small sample (n= 12)
(Veeroo et al., 2014). Moreover, WhatsApp reminder messages were
postulated to improve adherence to elastic wear at three-month followup
(Leone et al., 2018). However, the study did not include an objective
measure of adherence, and assessment of adherence was based solely on
the observed improvement of buccal segment relationships.

In addition, the use of images to visualise consequences of poor removable


retainer wear in combination with verbal instructions and parental
involvement resulted in higher adherence levels in comparison to verbal
instructions alone or excluding the parents (Lin et al., 2015). However,
adherence levels were self-reported by the patients in this study (Lin et al.,
2015). Contingency contracting was effective in enhancing patient adherence
to orthodontic retainers (Gross et al., 1991). However, removable appliance
wear was subjectively-assessed based on parents’ reports. It is clear that

35
CHAPTER 2

relatively few interventions aiming to optimise appliance wear time have


been evaluated in well-designed prospective studies.
A number of relevant unpublished theses involving interventions aiming to
enhance adherence to orthodontic appliance wear using objective measures
have been conducted. The use of calendars and awareness of being
monitored did not significantly improve Hawley retainer wear (Goldenberg,
2016). However, the sample size was small, with inadequate reporting of the
randomisation and allocation concealment (Goldenberg, 2016). Furthermore,
the use of a reminder in the form of an alarm was reported to be more
effective than daily calendars or no reminder (Frilund and Widegren, 2015).
In the latter study, although the wear time was recorded using embedded
microelectronic sensors, the sample was heterogenous with participants
wearing both van Beek appliances and expansion plates designed to achieve
different treatment objectives. Furthermore, the number of participants within
each group was low (just 4-5 patients). Moreover, the use of a bespoke
mobile application did not result in a significant difference in adherence to
headgear wear in comparison to a control group (Clinton Muñoz, 2018). The
latter study was a short-term non-randomised trial with a small sample size
(Clinton Muñoz, 2018). A comprehensive description of the mobile
application and its functionality was reported allowing for replication in future
research; however, the process underpinning the development was
overlooked (Clinton Muñoz, 2018). Overall, these interventions appeared to
have some effect, although the actual hours of wear were less than that
stipulated in most studies.

Qualitative research complementary to clinical trials can provide an in-depth


insight into the interventions being assessed; nevertheless, its use in
orthodontic research has been limited. Furthermore, primary research is
needed to explore the effectiveness of other untested interventions in the
context of enhancement of adherence to removable appliance and the wear
of other adjuncts in orthodontics. For example, face-to-face interventions
such as motivational interviewing has shown promise in the medical literature
in relation to smoking cessation (Lindson et al., 2019), and substance use

36
CHAPTER 2

(Smedslund et al., 2011). However, its reported use in clinical dentistry and
orthodontics has been limited to the effect of motivational interviewing on oral
health-related behaviours and appointment attendance (Gao et al., 2014; Wu
et al., 2017; Rigau-Gay et al., 2018). Moreover, the utilisation of relevant
theories in the early stages of development to understand the method of
achieving the expected outcome is recommended In the Medical Research
Council framework (Craig et al., 2008). Behavioural change theories have
been integral to Internet-based interventions designed to promote health
behaviour change (Webb et al., 2010). However, the use of relevant theories
in dentistry has been limited to oral hygiene-related interventions (Renz et
al., 2007). There is a wide range of existing behaviour change theories such
as the Health Belief Model (Becker et al., 1978) and Social Cognitive Theory
(Bandura, 1991), making the selection of an appropriate theory to underpin
the development of a specific intervention challenging. However, better
understanding of factors influencing a specific behaviour is a prerequisite to
theory selection (Michie et al., 2014).

2.4 The Use of Bespoke Mobile Applications and Social


Media in Orthodontic Research

Daily Internet access is almost universal (86%) among adults in the UK


(Office for National Statistics, 2018). Users spend five hours a day on their
phones and check these devices an average of 85 times on a daily basis
(Andrews et al., 2015) with younger people regularly checking their mobile
phones while engaged in other activities (Walsh et al., 2008). The increased
use of mobile phones has raised the possibility of their use in the delivery of
health-related information and health management (Food and Drug
Administration, 2015), with 325,000 health-related mobile applications
available in 2017 (Research2Guidance, 2017). A total of 241 patient-centred
orthodontic mobile applications were developed in 2018, representing a
three-fold increase since 2014 (Siddiqui et al., 2019).

37
CHAPTER 2

Recent estimates have suggested that two-thirds of orthodontic patients use


social media (Stephens et al., 2013; Nelson et al., 2015) with documented
use in the context of sharing experiences and concerns related to orthodontic
treatment (Rachel Henzell et al., 2014; Noll et al., 2017). Therefore, social
media may offer valuable insight in relation to patients’ perceptions,
experiences and impact of treatment.
2.4.1 Mobile applications and social media: Non-interventional
orthodontic studies

The popularity of social media and ease of access to online shared data
have provided a rich resource to understand orthodontic patients’
experiences and concerns (Papadimitriou et al., 2019). The relevant
published studies were mainly focused on reporting use of social media and
assessment of the quality of information posted on different social media
platforms. Furthermore, an increasing number of orthodontic mobile
applications are developed each year (Siddiqui et al., 2019). Detailed
reporting of the processes underpinning their development allows for
replication in research and implementation in practice (Craig et al., 2008;
Glasziou et al., 2008).

Patients’ documented use of social media in the context of orthodontics has


encompassed the posting of videos on YouTube related to treatment;
comments concerning bullying in relation to malocclusion and fixed
appliances; and experiences with active appliances, aligners, hypodontia and
orthognathic surgery (Rachel Henzell et al., 2014; Chan et al., 2017; Noll et
al., 2017; Barber et al., 2018; Lena and Dindaroglu, 2018; Livas et al., 2018;
Watts et al., 2018; Papadimitriou et al., 2019). In terms of seeking
orthodonticrelated knowledge, surprisingly only 7-8% of prospective patients
considered using the Internet or social media to access relevant information,
although this data was likely slightly outmoded (Henzell et al., 2013;
Stephens et al., 2013). Social media content in relation to orthodontic
retainers has not previously been investigated.

38
CHAPTER 2

Assessment of the quality of information posted on different social media


platforms related to orthodontics has gained attention in recent years. The
perils of seeking online orthodontic information have been highlighted with
suboptimal quality of information provided in YouTube videos (Knösel and
Jung, 2011). This is important as patients increasingly seek medical
information online (Diaz et al., 2002), and may use this information for
selfdiagnosis and behavioural alteration. The latter may be particularly
influential for patients during retention as they may no longer be under the
supervision of an orthodontist.

Studies involving assessment of the effects of social media and bespoke


mobile applications often report some information pertaining to the content,
frequency and method of delivery (Table 4). However, transparent reporting
of the processes underpinning the development of bespoke mobile
applications or social media-based interventions is evidently being
overlooked in orthodontic research. Only two studies have provided
comprehensive reporting of the process followed in the development of a
mobile or tablet applications focusing on oral hygiene for orthodontic patients
(Meru, 2012; Scheerman et al., 2018). Providing sufficient details regarding
the interventions and the development process is important to facilitate
implementation (Craig et al., 2008; Glasziou et al., 2008).

2.4.2 Mobile applications and social media: Interventional


orthodontic studies

There has been an increasing interest in the use of bespoke mobile


applications and social media to improve orthodontic outcomes (Table 4).
Interactive reminders and educational messages through a mobile
application have proven effective in improving orthodontic appointment
attendance (Li et al., 2016). In another study, patients who shared photos of
their teeth and sent messages in a WhatsApp group moderated by the
researcher were reported to have improved oral hygiene levels (Zotti et al.,
2016). Additionally, active reminders through a bespoke mobile application
prompted improvement of oral hygiene in participants undergoing fixed

39
CHAPTER 2

orthodontic treatment (Alkadhi et al., 2017). In one study, superior short-term


treatment outcomes were reported in participants who received WhatsApp
reminder messages for elastic wear when compared to controls (Leone et
al., 2018). However, elastic wear was not objectively-assessed and Class II
buccal segment correction was used as a surrogate measure of adherence.
Therefore, it is possible that receiving an electronic reminder can serve as a
tool to optimise adherence to removable appliance wear.
In a qualitative study, participants advocated the use reminders through a
mobile application to facilitate adherence to removable functional appliances
(El-Huni et al., 2019). Receiving electronic reminders is a passive process
involving automatic notification when the electronic reminder is received.
Furthermore, depending on the content of the reminders, these approaches
offer the potential to motivate and educate on the importance of retainer
wear. Addressing patients’ needs by capturing their preferences can help to
make the intervention appealing and, therefore, potentially improve
outcomes.

The use of social media and mobile applications as an intervention


represents a promising method for delivery of orthodontic information.
However, the reported use of such an approach during the orthodontic
retention phase is limited.

40
CHAPTER 2

Table 4. Summary of randomised controlled trials involving the use of mobile applications and social media in orthodontic
patients.
Participants and Orthodontic Content of the Follow-up
Study Setting Treatment groups appliance Outcomes intervention Findings period
Al-Silwadi et n= 67 YouTube video and FA Knowledge Biweekly e-mails Greater levels of 6-8 w
al. (2015) verbal and written improvement included a link to a knowledge
Age ≥ 13 y information (n= 34) YouTube video improvement in the
concerning fixed intervention group
Control group (verbal and appliances and OH
Eastman Dental
written information) (n= maintenance
Hospital, UK
33)
Li et al. n= 224 (68 M, 156 F) WeChat group messages FA Duration of - Reminders and - Shorter duration of From initial
(2016) (n= 112; mean age: 17.6 treatment, educational treatment, improved treatment
Dental hospital and ± 0.8 y) attendance, OH messages and attendance and until debond
clinic in China and FA articles (1-2/w) less FA breakage in
Control group (n= 112; breakage - Included both the intervention
mean age: 18.7 ± 1 y) written text and group - OH levels:
photos NS
Zotti et al. n= 80 (34 M, 46 F) Moderated WhatsApp FA PI, GI, white Monthly sharing of - Lower scores of PI 1 y
(2016) group and OH-related spot lesions and smile photos and and GI in the
video tutorials (n= 40; caries weekly ranking intervention group -
mean age: 14.1 y) based on OH levels Lower incidence of
new white spot
Control group (n= 40; lesions and caries
mean age: 13.6 y) in the intervention
group
Alkadhi et n= 44 (19 M, 25 F) Reminders through a FA OH (PI and GI) Notification Greater reduction in 4 w
al. (2017) bespoke mobile messages (3/day) plaque and gingival
Riyadh College of application (n= 22; mean and educational scores in the

41
CHAPTER 2

Dentistry and age: 16.6 ± 3.2 y) video intervention group


Pharmacy, Saudi
Arabia Control group (n= 22;
mean age: 17.2 ± 5.2 y)
Samuelson n= 47 (19 M, 28 F) Powered toothbrush with FA Self-reported Tracking of - Self-reported 3 mo
(2017) a corresponding mobile adherence with toothbrushing adherence with
Age ≥ 12 y application connected via toothbrushing frequency and toothbrushing
Bluetooth (n= 15) advice, PI and duration advice was
Powered toothbrush (n= GI highest in the
Orthodontic 18) mobile application
Postgraduate Clinic at Manual toothbrush (n=
group - PI and GI:
the University of 14) NS
Alabama, USA
Leone et al. n= 42 (20 M, 22 F) WhatsApp reminder Intermaxillary Buccal segment Six privately-sent Greater buccal 3 mo
(2018) messages (n= 21; mean elastics correction messages (2/w) segment correction
Age range: 14-34 y age: 18.38 ± 6.16 y) in the intervention
group
Control group (n= 21;
mean age: 19.67 ± 6.75
y)
Erbe et al. n= 60 (30 M, 30 F) Interactive powered FA Plaque scores Reminders using Greater reduction in 6 w
(2019) toothbrush with a and duration of photos with plaque scores and
Mean age: 14.5 ± 1.2 corresponding mobile toothbrushing emphasis on increased time
application connected via increasing time spent in
y
Bluetooth (Oral-B mobile spent in toothbrushing
application v2.1; Procter toothbrushing in
Department of & Gamble) (n= 30; mean
areas of concern
Orthodontics and age: 14.5 ± 1.14 y)
Dentofacial
Orthopaedics, Manual toothbrush (n=
University Medical

42
CHAPTER 2

Centre of the 30; mean age: 14.5 ±


Johannes Gutenberg 1.27 y)
University, Germany

Scheerman n= 132 (59 M, 73 F) WhiteTeeth mobile FA - Plaque - Weekly - Greater 3 mo


et al. (2019) application (n= 67; mean scores and recording of the reduction in plaque
Orthodontic clinics in age: 13.2 ± 1.01 y) gingival amount of scores in the
bleeding - Self- disclosed plaque - intervention group
Netherlands
reported oral Personalised - Gingival
Control group (n= 65;
health feedback in the bleeding:
mean age: 13.5 ± 0.97 y) form of
behaviours NS
educational and/or - Self-reported
instructional oral health
videos behaviours: NS
- Setting “if-
then” plans and
daily reminders
Zotti et al. n= 60 (24 M, 36 F) Moderated WhatsApp Hawley Appointment Weekly sharing of Higher attendance 1y
(2019) group (n= 30; mean age: retainers attendance and photos of teeth and rate and lower
Mean age: 17.5 y 17.2 ± 1.03 y) change in the monthly ranking dental relapse in the
inter-canine based on levels of intervention group
Control group (n= 30; width participation
mean age: 17.8 ± 1.06 y)
F: female; FA: fixed appliances; GI: gingival index; M: male; mo: months; NS: not significant; OH: oral hygiene; PI: plaque index; w: week(s); y: year(s).

43
CHAPTER 2

2.5 Qualitative Research in Orthodontics

There has been an increasing recognition of the value of qualitative research


in dentistry, especially within dental public health stemming from the need to
understand patients’ behaviours, motives and impact of experiences related
to treatment (Stewart et al., 2008; Masood et al., 2011). Although quantitative
studies offer an objective measure of different outcomes, in some instances
explanation of such outcomes are only possible using qualitative methods.
Therefore, quantitative and qualitative methods are seen as complimentary
techniques (O'Cathain et al., 2013). Moreover, studies incorporating in-depth
understanding of patients’ experiences may provide a holistic assessment of
benefits and harms associated with orthodontic treatment.

The limited quantity of qualitative research in orthodontics was underlined in


a previous study which only identified 27 studies published over a ten-year
period (Almeida et al., 2018). The use of qualitative methodology in
orthodontics provided information in relation to the perceived benefits of
treatment together with the impact of fixed and removable appliances on
daily activities and social life (Mandall et al., 2006; McNair et al., 2006; Abed
Al Jawad et al., 2012; Rachel Henzell et al., 2014; Carter et al., 2015; Čirgić
et al., 2015; El-Huni et al., 2019). Furthermore, qualitative studies have been
used to elucidate methods of information seeking in prospective orthodontic
patients and motives for having orthodontic treatment (McNair et al., 2006;
Pabari et al., 2011; Prabakaran et al., 2012; Stephens et al., 2013). Negative
social effects, discomfort, embarrassment and inconveniences with
orthodontic retainers were reported in a number of qualitative and
mixedmethod studies (Bennett and Tulloch, 1999; Carter et al., 2015;
Kearney et al., 2016). However, further studies focusing on barriers and
facilitators of retainer wear on a daily basis are needed.

Factors influencing adherence levels in orthodontic patients has been


addressed in a limited number of qualitative studies. Trulsson et al. (2004)
based on interviews with 6-13 year-old orthodontic patients wearing

44
CHAPTER 2

headgear reported that age is an important factor influencing adherence


levels. Younger patients had less internal motivation for treatment and are
more influenced by their parents than older patients (Trulsson et al., 2004).
In the previous study, compliance referred to willingness of patients to
complete their treatment; however, this does not necessarily translate into
higher levels of headgear wear. Castellanos Giraldo et al. (2014) reported
that orthodontists’ knowledge and patient-clinician relationship in terms of
trust and communication were influential in compliance levels. However, the
study did not include a specific definition of patient compliance, and involved
both adherence to the clinicians’ advice and appointment attendance
(Castellanos Giraldo et al., 2014). Although the levels of adherence required
with both fixed and removable orthodontic appliances differ significantly, the
type of orthodontic treatment undertaken was not made clear (Castellanos
Giraldo et al., 2014). Furthermore, the study involved focus groups of 17
patients with diverse ages (11-18 years) (Castellanos Giraldo et al., 2014). It
was possible that older patients may have dominated the focus group
discussions, especially in view of the large number of participants. It is clear
that qualitative studies assessing factors influencing adherence levels in
particular are scarce; therefore, further qualitative research is needed.

Interestingly, findings from one qualitative study helped to inform the nature
of a novel intervention designed to optimise adherence levels with intra-oral
elastics (Veeroo et al., 2014). Furthermore, patient interviews were
conducted to inform the design and content of an orthognathic information
aid (Flett et al., 2014). Taking patient opinion into consideration in the
process of the development of tools such as DVD, mobile applications or
websites is likely to increase acceptability and usability. Qualitative research
aided the development of the Malocclusion Impact Questionnaire, used to
measure oral health-related quality of life of patients with malocclusion (Patel
et al., 2016). Furthermore, questionnaires to gather in-depth information
relating to the expectations of joint restorative-orthodontic treatment
(Gassem et al., 2016) and quality of life (Akram et al., 2011) in patients with
hypodontia were developed based on findings from qualitative research. In

45
CHAPTER 2

the orthodontic literature, qualitative research has also been used to aid in
the development of a patient decision aid for people considering fixed
orthodontic treatment (Marshman et al., 2016). As such, qualitative research
methods are becoming more established within orthodontics and their use in
the development of patient-informed interventions may have significant
application.

46
CHAPTER 3

CHAPTER 3. AIMS, OBJECTIVES AND OVERVIEW OF


METHODOLOGY

3.1 Aims

The overall aims of the present study were:


1. To evaluate the effectiveness, periodontal implications and adherence
levels associated with orthodontic retention.
2. To evaluate factors affecting adherence to removable thermoplastic
orthodontic retainer wear.
3. To develop and evaluate the effectiveness of a novel electronic
means of enhancing adherence to removable retainer wear.

3.2 Objectives

1. To systematically review the effect of fixed and removable orthodontic


retainers on periodontal health.
2. To systematically assess objective levels of adherence with various
removable orthodontic appliances and adjuncts, and to evaluate the
evidence concerning the effectiveness of approaches to improve
adherence.
3. To compare the stability of orthodontic treatment outcomes and
periodontal health in the medium-term (four years or more) with fixed
versus removable retainers.
4. To explore factors influencing removable retainer wear and
participants’ views in relation to possible bespoke electronic means of
enhancing retainer wear.
5. To describe the content of Twitter posts related to orthodontic
retainers.
6. To develop a novel patient-informed mobile application aimed to
enhance retainer wear.

47
CHAPTER 4
7. To evaluate the effectiveness of the developed mobile application on
adherence to thermoplastic retainer wear, stability, periodontal
outcomes, experiences and knowledge related to orthodontic
retainers.

CHAPTER 3

3.3 Overview of Methodology

Two comprehensive literature searches with no language restriction based


on a registered strategy were undertaken to systematically review the effect
of orthodontic retainers on periodontal health (Chapter 4), and levels of
objectively-assessed adherence to removable appliance wear (Chapter 5).
Participants who took part in a previous randomised controlled trial (RCT)
(O'Rourke et al., 2016) and were in at least four years following the removal
of active appliances were recalled with stability and periodontal outcomes
recorded (Chapter 6).

Factors influencing adherence to medium-term retention were explored in


oneto-one interviews involving a subset of participants using removable
retention (Chapter 7). Twitter posts related to retainers were also analysed
(Chapter 8) to inform the development of the electronic reminder (Chapter 9).
This information was combined with the participants’ preferences in relation
to the nature of a bespoke electronic reminder and concerning features,
content and design (Chapter 9). The effectiveness of the developed
electronic reminder in improving adherence to thermoplastic retainer wear
was assessed in an RCT (Chapter 10). The outline of the mixed-methods
design (Chapters 8-10) including both qualitative and quantitative methods is
presented in Figure 1.

48
Figure 1. Mixed-methods design.

CHAPTER 4. THE EFFECTS OF FIXED AND REMOVABLE


ORTHODONTIC RETAINERS: A SYSTEMATIC REVIEW

4.1 Background and Aims

Indefinite retention in the form of fixed or removable retainers is routinely


prescribed following orthodontic treatment. Therefore, it is imperative to
elucidate the benefits and potential harms associated with orthodontic
retainers. The primary aim of this systematic review was to assess of the
effects of orthodontic retainers on periodontal health. The secondary aims
were to assess the survival and failure rates of retainers, the impact of
orthodontic retainers on patient-reported outcomes and their
costeffectiveness (Appendix 1).

4.2 Methods

The protocol for this systematic review was registered on PROSPERO


(www.crd.york.ac.uk/prospero; CRD42015029169).

 Eligibility criteria
The following selection criteria were applied:
• Study design: randomised, non-randomised controlled clinical trials,
prospective cohort studies and case series (with a minimum sample
size of 20 patients) with minimum follow-up periods of six months.
• Participants: patients having had orthodontic treatment with fixed or
removable appliances followed by orthodontic retention.

49
CHAPTER 4
• Interventions: fixed retainers, removable retainers and interproximal
reduction.
• Outcome measures: periodontal outcomes, survival and failure rates
(including detachment of fixed retainers, breakage, retainer loss or the
need for replacement), patient-reported outcomes and
costeffectiveness measures.

50
CHAPTER 4

 Search strategy for identification of studies


The following databases were searched up to 31 st of October 2015 without
language restrictions: MEDLINE via OVID (Appendix 2), PubMed, the
Cochrane Central Register of Controlled Trials (CENTRAL), LILACS and
BBO databases. Unpublished trials were searched electronically using
ClinicalTrials.gov (www.clinicaltrials.gov), the National Research Register
(www.controlled-trials.com) and ProQuest Dissertation and Thesis database
(http://pqdtopen.proquest.com).

 Assessment of relevance, validity and data extraction


Full-texts of relevant abstracts were retrieved. Data were tabulated using
prepiloted data collection forms by two authors (DA, PSF). Data extracted
included: (1) study design; (2) sample: size, demographic and clinical
characteristics; (3) intervention: fixed retainers, removable retainers or
interproximal reduction; (4) follow-up period; (5) maxillary/mandibular arch;
and (6) outcomes (primary and secondary).

 Risk of bias (quality) assessment


For randomised controlled trials (RCTs) sequence generation, allocation
concealment, blinding of outcome assessors, incomplete outcome data,
selective reporting and other biases were assessed using the Cochrane
Collaboration’s Risk of Bias tool (Higgins et al., 2011). Any disagreement
was resolved by joint discussion (DA, PSF). Only studies at low or unclear
risk of bias overall were to be included in the meta-analysis. The
methodological quality of the included non-randomised studies was
assessed using the Newcastle-Ottawa Scale (Wells et al., 2001). Studies
adjudged to be of moderate or high methodological quality overall (more than
five stars) were to be included in the meta-analysis. The authors of the
included studies were contacted for clarification if required.

 Strategy for data synthesis


Clinical heterogeneity was assessed according to the treatment
interventions, wear regimen for removable retainers, measurement approach

51
CHAPTER 4

and location of the retainers. For periodontal outcomes, the index used and
surfaces examined were considered. Statistical heterogeneity was to be
assessed by inspecting a graphic display of the estimated treatment effects
from individual trials with associated 95% confidence intervals (CI).
Heterogeneity would be quantified using I-squared with values above 50%
indicative of moderate to high heterogeneity which might preclude meta-
analysis. A weighted treatment effect was to be calculated, and the results
for retainer failure were to be expressed as odds ratios. All statistical
analyses were undertaken using the Stata statistical software package
(version 12.1; StataCorp, College Station, Tex).

4.3 Results

 Study selection and characteristics


Twenty-four studies were identified, 18 RCTs and six prospective cohort
studies. Of these only 16 were deemed to be of high quality. Meta-analysis
was unfeasible due to considerable clinical heterogeneity and variations in
outcome measures. Mean failure risk for mandibular stainless steel fixed
retainers bonded from canine to canine was 0.29 (95% CI: 0.26, 0.33) and
for those bonded to canines only was 0.25 (95% CI: 0.16, 0.33). A
metaregression suggested that failure of fixed stainless steel mandibular
retainers was not directly related to the period elapsed since placement (P=
0.938).

Sixty-four considered potentially relevant to the review. Following retrieval of


the full-text articles, 36 studies were excluded. Overall, 24 studies met the
inclusion criteria (Figure 2). The study design, characteristics of participants,
comparison groups, follow-up period and the outcomes of the included
studies are presented in Table 5.

52
CHAPTER 4

Records identified through OVID Additional records identified


and PubMed databases search through other sources

Identification
(n= 379) (n= 538)

Records after duplicates removed


(n= 913)
Screening

Records screened Records excluded


(n= 913) (n= 849)

Full-text articles excluded


Full-text assessed for eligibility (n= 40):
(n= 64)
Irrelative outcomes (n= 22)
Eligibility


• Cross-sectional studies (n= 4)
• Retrospective studies (n= 4)
• Protocols (n= 4)
• <6 months follow-up (n= 3)
• Subjects did not undergo
orthodontic treatment (n= 2)
• No control group (n= 1)

Studies included in qualitative synthesis


(n= 24)
Included

Studies included in quantitative


synthesis
(n= 16)

Figure 2. PRISMA flowchart of the included studies (n= 16).

53
CHAPTER 4

Table 5. Characteristics of included trials (n= 24).


Wear Followup
Study Participants
Study Intervention/Comparison (parttime/full- period Dental arch Outcomes
Design (overall)
time)
Zachrisson Prospective n= 43 0.032" or 0.036" Blue Elgiloy FR - Mean: Mn anterior teeth Failure rate, calculus
(1977) cohort study bonded using a holding wire 15.7 mo accumulation
Overall age range: (canines only) (n= 22) Range:
14-17 y 0.032" or 0.036" Blue Elgiloy FR 12-30 mo
bonded using a steel ligature
(canines only) (n= 21)
Artun et al. Prospective n= 49 0.032" Plain FR (canines only) - 3y Mn anterior teeth LII, failure rate, plaque
(1997) cohort study (n= 11) index, calculus index,
0.032" Spiral wire FR (canines gingival index, probing
only) (n= 13) attachment level
0.0205" Spiral wire FR (n= 11)
Removable retainer (n= 14) Unclear
Heier et al. Prospective n= 36 0.0175” Multistrand SS FR (n= - 6 mo Mx and Mn Modified gingival index,
(1997) cohort study 22) anterior teeth bleeding on probing,
Overall mean age: plaque index, calculus
16.3 y Hawley retainer (n= 14) Unclear Mx and Mn index, gingival crevicular
dentition fluid flow
Overall age range:
12.8-21.1 y
Rose et al. RCT n= 20 (12 M, 8 F) 1mm Polyethylene woven ribbon - 24 mo Mn anterior teeth Patient acceptance and
(2002) FR (n= 10) preference, survival of
Overall mean age: 0.0175” Multistrand SS FR (n= retainers, amount of
calculus,
22.4 ± 9.7 y 10) demineralisation, caries
Störmann RCT n= 98 0.0195" Respond® FR (n= 30) - 24 mo Mn anterior teeth Bleeding on probing,

54
CHAPTER 4

and Ehmer 0.0215" Respond® FR (n= 36) plaque index, failure rate,
(2002) Overall age range: aesthetic problems,
13-17 y patient discomfort, LII,

Prefabricated FR (canines only) occlusal discrepancies,


(n= 32) ICW
Hichens et RCT n= 355 (350 Hawley retainer (n= 172) Full-time for 3 6 mo Mx and Mn Cost-effectiveness,
al. (2007) questionnaires mo followed by dentition patient satisfaction,
completed at 6 part-time for 3 failure rate, LII
mo) (155 M, 242 mo
F)* VFR (n= 183) Full-time for 1
week, followed
Overall mean age: by part-time
14 - 15 y
Al-Nimri et Prospective n= 62 (18 M, 44 F) 0.036" Round SS FR (canines - 21.31 Mn anterior teeth Plaque index, gingival
al. (2009) cohort study only) (n= 31; mean age: 20.23 ± mo index, retainer failure,
3.8 y) oral hygiene index,
0.015" Multistrand FR (n= 31; 19.35 Irregularity index
mean age: 19.97 ± 4.2 y) mo
Liu (2010) RCT n= 60 0.75mm Fibre-reinforced - 12 mo Mn anterior teeth Bleeding index, pocket
composite FR (n= 30) depth, failure rate
0.9mm Multistrand SS FR (n=
30)
Tacken et RCT n= 274 (135 M, Glass fibre-reinforced FR (500 - 24 mo Mx 2-2 and Mn Failure rate, modified
al. (2010) 139 F) unidirectional glass fibres) (n= anterior teeth gingival index, bleeding
45; mean age: 14.8 ± 1.3 y) on probing, plaque index
Overall mean age: Glass fibre-reinforced FR (1000
14 y unidirectional glass fibres) (n=
48; mean age: 14.6 ± 2.7 y)
0.0215" Coaxial FR (n= 91;

55
CHAPTER 4

mean age: 15 ± 1.3 y)


Untreated control (n= 90)
Scribante et RCT n= 34 (9 M, 25 F) 0.0175" Multistrand SS FR - 12 mo Mn anterior teeth Failure rate, patient
al. (2011) satisfaction of the
Overall mean age: Polyethylene fibre-reinforced aesthetic result
14.3 y resin composite FR

Ardeshna Prospective n= 56 (76 FRs) 0.53mm or 1.02mm - 24 mo Mx anterior teeth Survival and failure rates
(2011) cohort study Fibrereinforced thermoplastic FR (n= 2 retainers),
with polyethylene terephthalate Mn anterior teeth
glycol matrix resin (n= 21 retainers,
6 of them were
bonded to
canines only)
0.53mm or 1.02mm Mx anterior teeth
Fibrereinforced thermoplastic FR (n= 14 retainers),
with polycarbonate matrix resin Mn anterior teeth
(n= 39 retainers,
5 of them were
bonded canines
only)
Sun et al. RCT n= 111 Hawley retainer (n= 56) Full-time 12 mo Mx and Mn Survival and failure rates
(2011) dentition
Overall mean age:
14.7 y Thermoplastic retainers (n= 55) Full-time

Overall age range:


12-17 y

56
CHAPTER 4

Xu et al. RCT n= 40 (16 M, 29 F) VFR (n= 25) Full-time 12 mo Mx and Mn Overjet, overbite, ICW,
(2011) dentition IMW, LII, calculus index
Overall mean age: scores, breakage rate
13-16 y 0.0195" Multistrand SS FR with Part-time
Hawley retainer (n= 15)

Bazargani RCT n= 51 0.0195" Multistrand FR with - Mean: Mn anterior teeth Retainer failure, calculus
et al. (2012) twostep bonded resin adhesive 24.4 ± accumulation,
Overall mean age: (n= 25) 4.7 mo discoloration around
18.3 ± 1.3 y 0.0195" Multistrand FR with composite pads
nonresin adhesive (n= 26)

Bolla et al. RCT n= 85 (29 M, 56 F) Glass fibre-reinforced FR (n= 40; - 6y Mx 2-2 (n= 14 Bond failure and
(2012) mean age for M: 23.4 y, mean retainers) and Mn breakage of retainers
age for F: 20.2 y) anterior teeth (n=
34 retainers)
0.0175" Multistrand SS FR (n= Mx 2-2 (n= 18
45; mean age for M: 24.1 y, retainers) and Mn
mean age for F: 22.6 y) anterior teeth (n=
32 retainers)
Taner and Prospective n= 66 (14 M, 52 F) Direct bonding of 0.016" x 0.022" - 6 mo Mn anterior teeth Failure rate
Aksu (2012) cohort study multistrand SS dead soft wire FR
(n= 32; mean age: 15.96 ± 3.21
y)
Indirect bonding of 0.016" x
0.022" multistrand SS dead soft
wire FR (n= 34; mean age: 19.44
± 6.79 y)
Salehi et al. RCT n= 142 (59 M, 83 Polyethylene woven ribbon FR - 18 mo Mx and Mn Survival and failure rates
(2013) F) (n= 68; mean age: 18.1 ± 5.23 y) anterior teeth

57
CHAPTER 4

0.0175" Multistrand SS FR (n=


Overall age range: 74; mean age: 18.2 ± 4.81 y)
14-28 y
Pandis et al. RCT n= 220 (60 M, 160 0.022” Multistrand SS FR - Median: Mn anterior teeth Failure rate, adhesive
(2013) F) bonded with chemical-cured 2.19 y remnant index scores
composite (n= 110; median age: Range:
Overall median 16 y (IQR: 2)) 0.0033.64
age: 16 y (IQR: 2) 0.022” Multistrand SS FR y
bonded with light-cured
Overall age range: composite (n= 110; median age:
12-47 y 16 y (IQR: 2))
Edman RCT n= 75 (30 M, 45 F) Mx VFR and Mn 0.7mm spring Full-time for 2 24 mo Mx and Mn Cost effectiveness and
Tynelius et hard wire FR (canines only) (n= days followed dentition societal costs
al. (2014) Overall mean age: 25) by part-time for
14.3 ± 1.5 y 1 y. Every other
night in the 2nd y
Mx VFR and interproximal Full-time for 2
enamel reduction in the Mn days followed
anterior teeth (n= 25) by part-time for
1 y. Every other
night in the 2nd y
Prefabricated positioner (n= 25) Part-time for 1
y, followed by
every other
night in the 2nd y

Torkan et RCT n= 30 (10 M, 20 F) Fibre-reinforced resin composite - 6 mo Mx and Mn Plaque index, calculus
al. (2014) FR (n= 15; mean age: 16.2 ± 1.9 anterior teeth index, gingival index,
y) bleeding on probing,
0.0175” Multistrand SS FR (n= width of periodontal

58
CHAPTER 4

15; mean age: 15.7 ± 2.1 y ligament


Sfondrini et RCT n= 87 (35 M, 52 F) 0.5mm Silanised-treated glass - 12 mo Mn anterior teeth Bond adhesive failure
al. (2014) fibres-reinforced composite resin
Overall mean age: FR (n= 40)
24 y 0.0175" Multistrand SS FR (n=
47)
Overall age range:
14-62 y
Bovali et al. RCT n= 63 (28 M, 35 F) Direct bonding of 0.0215" - 6 mo Mn anterior teeth Failure rate, time to fit
(2014) multistrand SS FR (n= 31; mean retainers
Overall age range: age: 19.8 ± 6.5 y
12-38 y Indirect bonding of 0.0215"
multistrand SS FR (n= 32; mean
age: 17.2 ± 3.1 y)

Sobouti et RCT n= 128 (60 M, 68 Fibre-reinforced composite FR - 24 mo Mn anterior teeth Survival and failure rates
al. (2016) F) (n= 42; mean age: 18.5 ± 3.6 y)
0.0175” Flexible spiral wire FR
Overall mean age (n= 41; mean age: 18.4 ± 3.7 y)
18 ± 3.6 y
0.0009” Dead soft twisted wires
FR (n= 45; mean age: 17 ± 3.3
Overall age range:
y)
13-25 y

59
CHAPTER 4

O'Rourke et RCT n= 82 (23 M, 59 F) VFR (n= 40; mean age: 16.95 ± Full-time for 6 18 mo Mn dentition LII, ICW, IMW, arch
al. (2016) 2.02 y) mo, followed by length, failure rate
Overall mean age: part-time for 6
17.73 ± 3.52 y mo, then for
every other
night in the 2nd y
0.0175” SS coaxial FR (n= 42; -
mean age: 18.47 ± 4.41 y)

F: female; FR: fixed retainer; ICW: inter-canine width; IMW: inter-molar width; IQR: interquartile range; LII: Little’s irregularity index; M: male; Mn: mandibular;
mo: months; Mx: maxillary; RCT: randomised controlled trial; SS: stainless steel; VFR: vacuum-formed retainer; y: year(s). *Overall sample.

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CHAPTER 4

 Risk of bias within studies


The random sequence generation was adequately performed in 12 studies
(Störmann and Ehmer, 2002; Hichens et al., 2007; Sun et al., 2011;
Bazargani et al., 2012; Pandis et al., 2013; Salehi et al., 2013; Bovali et al.,
2014; Edman Tynelius et al., 2014; Sfondrini et al., 2014; Torkan et al., 2014;
O'Rourke et al., 2016; Sobouti et al., 2016). The assessor was adequately
blinded in six trials (Bazargani et al., 2012; Pandis et al., 2013; Bovali et al.,
2014; Edman Tynelius et al., 2014; Torkan et al., 2014; O'Rourke et al.,
2016). Overall, 11
RCTs were judged to be of low risk of bias (Figure 3) (Hichens et al., 2007;
Liu, 2010; Scribante et al., 2011; Bazargani et al., 2012; Pandis et al., 2013;
Salehi et al., 2013; Bovali et al., 2014; Edman Tynelius et al., 2014; Sfondrini
et al., 2014; Torkan et al., 2014; O'Rourke et al., 2016). All six prospective
cohort studies (Zachrisson, 1977; Artun et al., 1997; Heier et al., 1997;
AlNimri et al., 2009; Ardeshna, 2011; Taner and Aksu, 2012) (Figure 4) were
deemed to be of high quality in terms of sample selection, except for one
study (Al-Nimri et al., 2009) which did not demonstrate the absence of pre-
existing periodontal disease. Assessment of the outcome was deemed
satisfactory in all but two studies (Zachrisson, 1977; Artun et al., 1997).
Overall, five prospective cohort studies were judged to be of moderate to
high quality (Artun et al., 1997; Heier et al., 1997; Al-Nimri et al., 2009;
Ardeshna, 2011; Taner and Aksu, 2012).
Allocation concealment

Incomplete outcome
Blinding of outcome

Selective reporting
Random sequence

assessment

Overall risk
Other bias
generatio
n

data

61
CHAPTER 4

Störmann and Ehmer (2002) High

Torkan et al. (2014) Low

Sfondrini et al. (2014) Low

Hichens et al. (2007) Low

Bovali et al. (2014) Low

Liu (2010) Low

Scribante et al. (2011) Low

Bazargani et al. (2012) Low

Edman Tynelius et al. (2014) Low

Salehi et al. (2013) Low

Bolla et al. (2012) High

Tacken et al. (2010) High

Pandis et al. (2013) Low

Sun et al. (2011) High

Xu et al. (2011) High

Rose et al. (2002) High

O'Rourke et al. (2016) Low

Sobouti et al. (2016) High

Figure 3. Risk of bias for included randomised controlled trials. Low


risk of bias (green); unclear risk of bias (yellow); high risk of bias (red)
(n= 18).
Outcome
Selection

Comparability

Overall score

62
CHAPTER 4

★ ★ ★
Al-Nimri et al. (2009) ★ ★ ★ 7 stars

★ ★ ★ ★
Ardeshna (2011) ★ ★ ★ ★ 8 stars

★ ★ ★ ★
Taner and Aksu ★ ★ ★ ★ 8 stars
(2012)

★ ★ ★
★ ★ ★
Artun et al. (1997) ★ 7 stars

★ ★
★ ★ ★
Zachrisson (1977) 5 stars

★ ★ ★ ★
Heier et al. (1997) ★ ★ ★ ★ 8 stars

Figure 4. Newcastle-Ottawa Scale scores for non-randomised studies


(n= 6).

 Results of individual studies and additional analysis

Periodontal outcomes
Of the included trials, only seven trials assessed periodontal outcomes
(Tables 6-8) (Artun et al., 1997; Heier et al., 1997; Al-Nimri et al., 2009; Liu,
2010; Tacken et al., 2010; Bazargani et al., 2012; Torkan et al., 2014). Four
of these were RCTs (Liu, 2010; Tacken et al., 2010; Bazargani et al., 2012;
Torkan et al., 2014) and the other three were prospective cohort studies
(Artun et al., 1997; Heier et al., 1997; Al-Nimri et al., 2009). Two trials did not
report baseline scores (Al-Nimri et al., 2009; Bazargani et al., 2012), and
another two studies reported the periodontal outcome with no distinction

63
CHAPTER 4

made between maxillary and mandibular measurements (Heier et al., 1997;


Tacken et al., 2010).

No significant difference was observed between the mandibular stainless


steel fixed retainers bonded to anterior teeth and canines only in terms of
periodontal outcomes, at 12-month and three-year follow-up in two studies
(Artun et al., 1997; Al-Nimri et al., 2009). With regard to the periodontal
outcomes of mandibular Hawley retainers in comparison to mandibular
stainless steel fixed retainers, no significant difference was observed at a
three-year follow-up (Artun et al., 1997). When mandibular fibre-reinforced
composite was compared to mandibular stainless steel fixed retainers, no
significant difference in probing depth, bleeding on probing and calculus
scores at six-month follow-up was observed (Liu, 2010; Torkan et al., 2014).
Probing depth and bleeding on probing were further measured at a 12-month
follow-up, and showed no significant difference between the two groups (Liu,
2010). However, gingival and plaque indices scores were reported to be
higher in both maxillary and mandibular fibre-reinforced composite compared
to the stainless steel fixed retainers at a six-month follow-up (Torkan et al.,
2014). Very few overlapping studies were identified. As a consequence,
metaanalysis was therefore not possible in view of heterogeneity.

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CHAPTER 4

Table 6. Periodontal indices used and tooth surfaces scored in the included studies.

Periodontal
Study Intervention Index Dental Arch Teeth Tooth surfaces
outcomes

- 0.032" Plain FR (canines Plaque index 0 absence Mandible 3-3 Lingual, mesial, distal
only) 1 on probe
- 0.032" Spiral wire FR 2 visible
(canines only) 3 abundant
- 0.0205" Spiral wire FR Gingival index 0 absence Mandible 3-3 Lingual, mesial, distal
- Removable retainer 1 mild
2 moderate
Artun et 3 severe
al. (1997) Calculus index 0 absence Mandible 3-3 Lingual, mesial, distal
1 supragingival calculus not more than
1mm
2 moderate amount of supragingival or
subgingival calculus
3 abundance of supragingival and
subgingival calculus
Pocket depth Mean attachment loss Mandible 3-3 Lingual
- 0.0175” Multistrand SS FR Gingival index 0 absence Maxilla and 3-3 Labial, lingual,
- Hawley retainer 1 mild (localised) mandible interdental labial,
2 mild (generalised) interdental lingual
Heier et 3 moderate
al. (1997) 4 severe
Bleeding on 0 absence Maxilla and 3-3 Labial, lingual,
probing 1 point bleeding mandible interdental labial,
2 profuse interdental lingual

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CHAPTER 4

Plaque index Using disclosing Maxilla and 3-3 Labial, lingual


0 no plaque mandible
1 spots at the cervical margin
2 thin band at the cervical margin
3 gingival 1/3 4 gingival 2/3

5 > gingival 2/3

Calculus index 1 slight amount of calculus Maxilla and 3-3 Labial, lingual (3
2 moderate amount of calculus mandible sites/surface)
3 heavy calculus
4 very heavy calculus
- 0.036" Round SS FR Plaque index 0 absence Mandible 3-3 labial/lingual/mesial/distal
(canines only) 1 on probe
- 0.015" Multistrand FR 2 visible
3 abundant
Gingival index 0 absence Mandible 3-3 Labial and lingual
Al-Nimri et 1 mild
al. 2 moderate
(2009) 3 severe
Calculus - Part of oral hygiene index Maxilla and All teeth Labial and lingual
- Tooth with the highest score determine mandible except
the index score for the segment (6 mandibular
segments) labial
segment
- 0.75mm Fibre-reinforced Pocket depth Scores added together Mandible 3-3 Lingual (3 sites/tooth)
Liu (2010) composite FR Bleeding on Scores added together Mandible 3-3 Lingual (3 sites/tooth)
- 0.9mm Multistrand SS FR probing
Tacken et - Glass fibre-reinforced FR Gingival index 0 absence Unclear Unclear Unclear, 3 sites/tooth:
al. (2010) (500 unidirectional glass 1 mild mesial distal central

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CHAPTER 4

fibres) 2 moderate
- Glass fibre-reinforced FR 3 severe
(1000 unidirectional glass Bleeding on 0 no bleeding Unclear Unclear Unclear, 3 sites/tooth:
fibres)
probing 1 point bleeding mesial distal central
- 0.0215" Coaxial FR
2 abundant bleeding
- Untreated control
Plaque index Using disclosing Unclear Unclear Unclear, 3 sites/tooth:
0 no plaque mesial distal central
1 spots at the cervical margin
2 thin band at the cervical margin
3 gingival 1/3
4 gingival 2/3
5 > gingival 2/3
-0.0195" Multistrand FR with Calculus Present/Absent Mandible 3-3 Lingual
Bazargani two-step bonded resin
et al. adhesive
(2012) -0.0195" Multistrand FR with
non-resin adhesive
- Fibre-reinforced resin Plaque index Using disclosing Maxilla and 3-3 lingual
composite FR 0 absence mandible
- 0.0175” Multistrand SS FR 1 visible on the probe
2 visible
3 abundant
Calculus index 0 absence Maxilla and All teeth Unclear
Torkan et 1 up to 1/3 mandible
al. (2014) 2 up to 2/3
3 > 2/3
Gingival index 0 absence Maxilla and Unclear Lingual
1 mild mandible
2 moderate
3 severe
Bleeding on Present/Absent Maxilla and 3-3 Unclear

67
CHAPTER 4

probing mandible
FR: fixed retainer; SS: stainless steel.

Table 7. Periodontal outcomes (plaque and gingival indices) including the follow-up periods.
Study Intervention Plaque index (mean ± SD) Gingival index (mean ± SD)
Artun et al. 0.032" Plain FR (canines only) Baseline: 0.32 ± 0.2; 3 y: 0.06 ± 0.02 Baseline: 1.01 ± 0.1; 3 y: 0.66 ± 0.14
(1997) (n= 11)
0.032" Spiral FR (canines only) Baseline: 0.17 ± 0.08; 3 y: 0.10 ± 0.03 Baseline: 0.95 ± 0.07; 3 y: 0.49 ± 0.13
(n= 13)
0.0205" Spiral wire FR (n= 11) Baseline: 0.26 ± 0.2; 3 y: 0.13 ± 0.07 Baseline: 1.14 ± 0.07; 3 y: 0.39 ± 0.15
Removable retainer (n= 14) Baseline: 0.31 ± 0.11; 3 y: 0.13 ± 0.06 Baseline: 1.08 ± 0.07; 3 y: 0.77 ± 0.11
Heier et al. 0.0175” Multistrand SS FR (n= Baseline: 2.78; 6 mo: 3.03 Baseline: 0.79; 6 mo: 0.40
(1997) 22)
Hawley retainer (n= 14) Baseline: 2.78; 6 mo: 2.52 Baseline: 0.80; 6 mo: 0.74
Al-Nimri et 0.036" Round SS FR (canines After minimum of 12 mo: 1.02 ± 0.52 After minimum of 12 mo: 1.19 ± 0.44
al. (2009) only) (n= 31)
0.015" Multistrand FR (n= 31) After minimum of 12 mo: 1.21 ± 0.48 After minimum of 12 mo: 1.34 ± 0.39
Tacken et Glass fibre-reinforced FR (500 6 mo: 12 mo: 18 mo: 24 mo: 6 mo: 12 mo: 18 mo: 24 mo:
al. (2010) unidirectional glass fibres) (n= 1.88 ± 2.32 ± 2.25 ± 2.11 ± 1.20 ± 1.00 ± 1.28 ± 1.51 ±
45) 0.74 0.93 0.78 0.73 0.43 0.30 0.36 0.45
Glass fibre-reinforced FR (1000 6 mo: 12 mo: 18 mo: 24 mo: 6 mo: 12 mo: 18 mo: 24 mo:
unidirectional glass fibres) (n= 2.03 ± 2.12 ± 2.48 ± 2.18 ± 1.09 ± 1.09 ± 1.20 ± 1.55 ±
48) 0.84 0.77 0.69 0.79 0.46 0.34 0.33 0.37
0.0215" Coaxial FR (n= 91) 6 mo: 12 mo: 18 mo: 24 mo: 6 mo: 12 mo: 18 mo: 24 mo:
1.74 ± 2.09 ± 2.07 ± 2.14 ± 0.71 ± 0.61 ± 0.70 ± 0.98 ±

68
CHAPTER 4

0.92 0.82 0.76 0.78 0.29 0.29 0.27 0.54


Torkan et Fibre-reinforced composite resin Maxilla: median 0 (baseline), 1.66 (6 mo) Maxilla: median 0.5 (baseline), 1 (6 mo)
al. (2014) FR (n= 15) Mandible: median 0.91 (baseline), 2 (6 mo) Mandible: median 0.33 (baseline) 1 (6 mo)
0.0175” Multistrand SS FR (n= Maxilla: median 0.33 (baseline), 0.66 (6 mo) Maxilla: median 0 (baseline), 0.83 (6 mo)
15) Mandible: median 0.33 (baseline), 0.91 (6 mo) Mandible: median 0.16 (baseline), 0.41 (6 mo)
FR: fixed retainer; mo: months; SD: standard deviation; SS: stainless steel; y: years.

Table 8. Periodontal outcomes (calculus, bleeding on probing and probing depth) including the follow-up periods.
Probing depth
Study Intervention Calculus Bleeding on probing (mean ± SD)
(mean ± SD)
Artun et al. 0.032" Plain FR (canines only) (n= Mean percentage - Attachment loss at 3
(1997) 11) (baseline): 16.67 ± 8.03, y: 0.85 ± 0.55mm
3 y: 3.33 ± 2.22
0.032" Spiral FR (canines only) (n= Mean percentage Attachment loss at 3
13) (baseline): 8.64 ± 4.45, y: 0.63 ± 0.2mm
3 y: 3.09 ± 3.09
0.0205" Spiral wire FR (n= 11) Mean percentage Attachment loss at 3
(baseline): 17.36 ± 6.84, y: 0.62 ± 0.25mm
3 y: 17.36 ± 8.87
Removable retainer (n= 14) Mean percentage Attachment loss at 3
(baseline): 9.52 ± 5.45, y: 0.72 ± 0.33mm
3 y: 8.33 ± 5.61
Heier et al. 0.0175” Multistrand SS FR (n= 22) Mean (baseline and 6 Baseline: 0.32 6 -
(1997) mo): 0.20 mo: 0.23

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CHAPTER 4

Hawley retainer (n= 14) Mean (baseline): 0.05 Baseline: 0.34 6


Mean (6 mo): 0.06 mo: 0.22

Liu (2010) 0.75mm Fibre-reinforced composite - Baseline: 3.50 Baseline: 6.33mm


FR (n= 30) 6 mo: 10.17 6 mo: 8.51mm
12 mo: 11.12 12 mo: 9.24mm
0.9mm Multistrand SS FR (n= 30) Baseline: 3.67 Baseline: 5.92mm
6 mo: 8.89 6 mo: 8.08mm
12 mo: 9.24 12 mo: 8.92mm

Tacken et al. Glass fibre-reinforced FR (500 - 6 mo: 12 mo: 18 mo: 24 mo: -


(2010) unidirectional glass fibres) (n= 45) 0.72 ± 0.89 ± 0.82 ± 1.00 ±
0.22 0.19 0.23 0.35

Glass fibre-reinforced FR (1000 6 mo: 12 mo: 18 mo: 24 mo:


unidirectional glass fibres) (n= 48) 0.76 ± 0.81 ± 0.89 ± 1.06 ±
0.18 0.21 0.23 0.29
0.0215" Coaxial FR (n= 91) 6 mo: 12 mo: 18 mo: 24 mo:
0.46 ± 0.55 ± 0.57 ± 0.84 ±
0.18 0.19 0.21 0.38
Bazargani et 0.0195" Multistrand FR with twostep 4% (2 y) - -
al. (2012) bonded resin adhesive (n= 25)
0.0195" Multistrand FR with 31% (2 y)
nonresin adhesive (n= 26)
Torkan et al. Fibre-reinforced composite resin Maxilla: median 0 Maxilla: median 0.16 (baseline), 0.5 (6 -
(2014) fixed retainer (n= 15) (baseline and 6 mo) mo)
Mandible: median 0 Mandible: median 0 (baseline), 0.66 (6
mo)

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(baseline), 0.33 (6 mo)


0.0175” Multistrand SS FR (n= 15) Maxilla and mandible: Maxilla: median 0 (baseline), 0.5 (6 mo)
median 0 (baseline and 6 Mandible: median 0 (baseline) 0.33 (6
mo) mo)
FR: fixed retainer; mm: millimetres; mo: months; SD: standard deviation; SS: stainless steel; y: year(s).

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CHAPTER 4

In terms of the natural history of periodontal changes related to stainless


steel fixed retainers, plaque and gingival indices scores on the lingual
surfaces of mandibular anterior teeth increased from baseline to six months
follow-up, however this was not statistically significant (Torkan et al., 2014).
At a threeyear follow-up, plaque and gingival indices scores remained low
(Artun et al., 1997). No significant changes in the calculus index scores at
six-month (Torkan et al., 2014) and three-year follow-ups (Artun et al., 1997)
were observed in two studies. Bleeding on probing scores for the stainless
steel fixed retainer group increased at both six months (Liu, 2010; Torkan et
al., 2014) and 12 months (Liu, 2010) from baseline, although only one study
reported this to be statistically significant (Liu, 2010). Similar patterns were
observed for fixed fibre-reinforced composite retainers (Liu, 2010; Torkan et
al., 2014). Conversely, plaque, calculus and gingival indices scores were
reduced at a three-year follow-up in relation to the lingual surfaces of the
mandibular anterior teeth with Hawley retainers (Artun et al., 1997).
However, the gingival index scores were shown to increase on the buccal
surfaces of maxillary and mandibular anterior teeth in one study at six-month
follow-up (Heier et al., 1997).

Survival and failure rates of retainers


The survival rate of fixed retainers was reported over 12 to 24 months
(Ardeshna, 2011; Scribante et al., 2011; Salehi et al., 2013). In terms of
retainer material, one study reported that the fibre-reinforced thermoplastic
fixed retainer with a polyethylene terephthalate glycol matrix resin survived
significantly less than a fibre-reinforced thermoplastic fixed retainer with a
polycarbonate matrix resin (Ardeshna, 2011). Two other studies observed no
significant difference in the survival rate of multistrand stainless steel fixed
and aesthetic retainers made of polyethylene woven ribbon or polyethylene
fibrereinforced resin composite (Scribante et al., 2011; Salehi et al., 2013).
No statistical difference was observed in the survival rate between both
maxillary and mandibular fixed retainers (Ardeshna, 2011; Salehi et al.,
2013). Interestingly, in one study the survival rate of fibre-reinforced
thermoplastic fixed retainers was directly related to the thickness of the wire
and the number of teeth bonded (Ardeshna, 2011).

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CHAPTER 4

All the studies that involved mandibular stainless steel retainers reported
failures on a patient basis (Artun et al., 1997; Al-Nimri et al., 2009; Liu, 2010;
Scribante et al., 2011; Bazargani et al., 2012; Taner and Aksu, 2012; Pandis
et al., 2013; Salehi et al., 2013; Bovali et al., 2014; Edman Tynelius et al.,
2014; Sfondrini et al., 2014; O'Rourke et al., 2016), except for two studies in
which the failure was reported on a tooth basis (Scribante et al., 2011;
Sfondrini et al., 2014) (Table 9). The mean failure risk for mandibular
stainless steel fixed retainers bonded to canine to canine was 0.29 (95% CI:
0.26, 0.33) based on eight studies (n= 555) (Figure 5). The follow-up period
ranged from six to 36 months. Similarly, the failure risk for mandibular
stainless steel fixed retainers bonded to canines was 0.25 (95% CI: 0.16,
0.33) based on three studies (Artun et al., 1997; Al-Nimri et al., 2009; Edman
Tynelius et al., 2014) (n= 79) over a follow-up period of 12 to 36 months
(Figure 6). Considerable statistical heterogeneity was noted in both analyses
(I-squared= 89%) reflecting high levels of inconsistency and limited numbers
of events. A metaregression analysis shows that the follow-up period was not
a predictor of failure rate for mandibular stainless steel fixed retainers (P=
0.938).

One study reporting failure rates of mandibular Hawley retainers was unclear
regarding the stipulated duration of wear (Artun et al., 1997). However, two
studies reported around 12% failure over a period of six months and 14% at
a three-year follow-up (Artun et al., 1997; Hichens et al., 2007). Similarly, the
failure rate for maxillary vacuum-formed retainers (VFRs) was reported to be
10% over two years (Edman Tynelius et al., 2014), whereas a further study
reported a higher rate of 17% over six months (Hichens et al., 2007).
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CHAPTER 4

Table 9. Survival and failure rates of fixed and removable retainers.

Study Intervention Survival rate Failure rate

Artun et al. 0.032 " Plain FR (canines only ) - 1/11 (9.1%)


(1997) 0.032 " Spiral FR (canines only ) 4/13 (30.7%)
0.0205 " Spiral wire FR 3/11 (27.27%)
Removable retainer
2/14 (14.28%)
Hichens et al. Hawley retainer - 40/344 (11.6%)
(2007) 20/366 (17%)
VFR
Al-Nimri et al. 0.036" Round SS FR (canines only) - 4/31 (13%)
(2009) 9/31 (29%)
0.015" Multistrand FR
Liu (2010) 0.75mm Fibre-reinforced composite FR - 0/30 (0%)
0/30 (0%)
0.9mm Multistrand SS FR
Ardeshna 0.53mm or 1.02mm Fibre-reinforced thermoplastic FR with polyethylene Median: 2.97 mo 22/23 (95.6%)
(2011) terephthalate glycol matrix resin
0.53mm or 1.02mm Fibre-reinforced thermoplastic FR with polycarbonate Median: 11.37 mo 32/53 (60.3%)
matrix resin
Scribante et al. 0.0175" Multistrand SS FR - 23/102 bonded
(2011) teeth (23%)
Polyethylene fibre-reinforced resin composite FR 13/90 bonded teeth
(14%)
Bazargani et 0.0195" Multistrand FR with two-step bonded resin adhesive - 1/25 (4%)
al. (2012) 7/26 (27%)
0.0195" Multistrand FR with non-resin adhesive
Taner and Aksu Direct bonding 0.016" x 0.022" multistrand SS dead soft wire FR - 15/32 (46.8%)
(2012) 10/34 (29.4%)
Indirect bonding 0.016" x 0.022" multistrand SS dead soft wire FR
Pandis et al. 0.022” Multistrand SS FR bonded with chemical-cured composite - 47/110 (42.7%)
(2013) 55/110 (50%)
0.022” Multistrand SS FR bonded with light-cured composite

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CHAPTER 4

Salehi et al. Polyethylene woven ribbon FR Maxilla: mean 13.96 ± 4.53 34/68 in the maxilla
(2013) mo (50%), 29/68 in the
Mandible: mean 14.26 ± 4.70 mandible (42.6%)
mo
0.0175" Multistrand SS FR Maxilla: mean 15.34 ± 4.04 27/74 in the maxilla
mo (36.5%), 28/74 in
Mandible: mean 15.61 ± 3.61 the mandible
mo (37.8%)
Bovali et al. Direct bonding of 0.0215" multistrand SS FR - 7/29 (24.1%)
(2014) 10/31 (32.2%)
Indirect bonding of 0.0215" multistrand SS FR
Sfondrini et al. 0.5mm Silanised-treated glass fibres-reinforced composite resin FR - 27/240 bonded
(2014) teeth (11.25%)
0.0175" Multistrand SS FR - 50/282 bonded
teeth (17.73%)
Edman VFR in the maxilla and 0.7mm spring hard wire FR in the mandible - 2/24 (8.3%) VFR,
Tynelius et al. (canines only) 15/24 (62.5%) FR
(2014) 3/25 (12%)
VFR in the maxilla and interproximal enamel reduction in the mandibular
anterior teeth 0/25 (0%)

Prefabricated positioner
O'Rourke et al. VFR - -
(2016) 3/42 (7.14%)
0.0175” SS coaxial FR
FR: fixed retainer; mm: millimetres; mo: months; SS: stainless steel; VFR: vacuum-formed retainers.

71
CHAPTER 4

Figure 5. Forest plot presenting the risk of failure of mandibular


stainless steel fixed retainers bonded from canine to canine.
CI: confidence interval; ES: effect size.

Figure 6. Forest plot presenting the risk of failure of mandibular


stainless steel fixed retainers bonded to canines only.
CI: confidence interval; ES: effect size.
Patient-reported outcomes and cost-effectiveness

79
CHAPTER 4

Patient-reported outcomes were reported in two studies (Hichens et al.,


2007; Scribante et al., 2011) (Table 10). Removable retainers were reported
to be associated with discomfort, with those in the Hawley retainer group
reporting higher levels of embarrassment in terms of both speech and
aesthetics (Hichens et al., 2007). In terms of cost-effectiveness (Table 10),
VFRs were reported to be significantly more cost-effective than the Hawley
retainers within the National Health Service over a six-month retention period
(Hichens et al., 2007). One study, over two years, reported that interproximal
reduction as a retention method and positioners to be more cost-effective
than the mandibular stainless steel fixed retainers bonded to canines
(Edman Tynelius et al., 2014).

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CHAPTER 4

Table 10. Patient-reported outcomes and cost-effectiveness.


Patientreported
Study Intervention outcomes Cost-effectiveness

Hichens et al. (2007) Hawley retainer Embarrassment: Mean cost (per patient):
29/168 (17%) - to the NHS: €152 (€150.86,
Discomfort: €153.15)
109/168 (65%) - to the orthodontic practice: -€1.00
(-€1.78, -€0.22)
- to the patient: €11.63 (€9.67,
€13.59)
VFR Embarrassment: Mean cost (per patient):
13/182 (7%) - to the NHS: €122.02 (€120.84,
Discomfort: €123.21)
112/182 (62%) - to the orthodontic practice: €34.00
(-€34.57, -€33.34)
- to the patient: €6.92 (€5.29, €8.53)

0.0175" Mean: 8.24 ± -


Scribante et al. (2011)

Multistrand SS FR 1.39; median:


8.50; range:
4.50-10.0 (using
visual analogue
scale)
Polyethylene fibre- Mean: 9.73 ±
reinforced 0.42; median:
resin composite 10.00; range:
FR 9.00-10.0 (using
visual analogue
scale)
Mx VFR and Mn - Costs of Costs of
Edman Tynelius et al. (2014)

0.7mm spring hard scheduled unscheduled


wire FR appointments: appointments:
€12,425 €804

Mx VFR and Costs of Costs of


interproximal scheduled unscheduled
enamel reduction appointments: appointments:
in the Mn anterior €11,275 €303
teeth
Prefabricated Costs of Costs of
positioner scheduled unscheduled
appointments: appointments:
€10,500 none

FR: fixed retainer; Mn: mandibular: Mx: maxillary; NHS: National Health Service;
SS: stainless steel; VFR: vacuum-formed retainer.

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CHAPTER 4

4.4 Discussion

Based on the findings of this systematic review, there is a lack of evidence to


endorse the use of one type of orthodontic retainer based on their effect on
periodontal health, survival and failure rates, patient-reported outcomes and
cost-effectiveness. Largely, this finding can be attributed to a lack of
highquality, relevant research. In this respect, the results of the present
systematic review are in line with previous systematic reviews (Littlewood et
al., 2006; Westerlund et al., 2014; Littlewood et al., 2016). Interestingly, it
was observed that the failure of fixed stainless steel mandibular retainers
was not directly related to the duration of follow-up. This suggests that other
factors including the influence of operator technique and experience might
override the effects of retainer design or materials, although the follow-up did
not extend beyond three years in the present review.

Generally, relatively minor changes in the periodontal parameters were


reported; however, given that most studies did not incorporate an untreated
control, or indeed a control group without retention, it was unclear whether
these changes were attributable to the intervention or temporal changes, in
isolation. As such additional research including prospective cohort studies
with matched controls incorporating baseline assessment would be helpful in
providing a more conclusive information. It is worthy of mention, that the
current standard of care is to recommend bonded retention to preserve
orthodontic correction in those with a history of periodontal disease as these
patients are known to be particularly susceptible to post-treatment changes
(Sharpe et al., 1987; Johnston et al., 2008). It is therefore important that
there is greater clarity in relation to the compatibility of fixed retention with
periodontal health and indeed on variations that may facilitate maintenance
of optimal hygiene.

A minimum follow-up period of six months was set to distinguish between


gingival inflammation associated with fixed orthodontic treatment and
periodontal side-effects related to the orthodontic retainers (Zachrisson and

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CHAPTER 4

Zachrisson, 1972). Previous reviews have stipulated a minimum observation


period of three months (Littlewood et al., 2006; 2016) to two years
(Westerlund et al., 2014). However, a three-month period might be
insufficient to allow for the resolution of inflammatory changes related to the
presence of active appliances. Using a minimum of two-year observation
period risks omission of a considerable amount of relevant research.
Moreover, in this review just one study focusing on the periodontal outcomes
involved follow-up in excess of two years (Artun et al., 1997). It is therefore
clear that the prolonged effect of orthodontic retention on periodontal health
has not been adequately addressed in prospective research.

Intuitively, a significant difference in the patient-reported outcomes and


experiences could be expected with both fixed or removable retainers in view
of the differences in appearance, size and requirement for appliance wear.
Notwithstanding this, only two studies reported on satisfaction with the
appearance of retainers or on levels of associated embarrassment or
discomfort (Hichens et al., 2007; Scribante et al., 2011). This tendency for
researchers to concentrate on objective, often clinician-centred outcomes
has recently been documented both within orthodontics and general dental
research more broadly (Tsichlaki and O'Brien, 2014; Fleming et al., 2016).
Further studies incorporating patient-reported outcomes are therefore
necessary to provide a more holistic assessment of benefits, harms and
experiences associated with orthodontic retainers.

While the primary focus of this review was to compare the effectiveness of
retainer types, it was also possible to generate epidemiological data on the
risk of failure of fixed retainers based on the primary studies. Failure risk of
0.29 was observed for fixed wires bonded to the six anterior teeth and
approximately one-quarter of retainers bonded to mandibular canines only,
based on observation periods of six months to three years. This data
highlights that the risk of failure was considerable and that fixed retention
does not guarantee prolonged stability. Similar findings have been observed
in observational studies (Booth et al., 2008). The onus on realistic treatment

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planning with due consideration for placement of teeth into a zone of relative
stability therefore remains paramount (Lee, 1999).
Following the completion of the current systematic review, a number of
relevant RCTs have been published. In terms of periodontal outcomes, no
significant differences were observed between Hawley retainers and VFRs in
terms of gingival inflammation at a six-month follow-up (Manzon et al., 2018;
Moslemzadeh et al., 2018). However, patients wearing VFRs exhibited
higher levels of plaque and calculus over a similar follow-up period (Manzon
et al., 2018). Furthermore, one RCT involved a comparative assessment of
mandibular fixed retainers and VFRs with superior periodontal outcomes in
the latter group (Storey et al., 2018); however, significant differences were
observed for plaque and calculus scores only (Storey et al., 2018). It was
unclear as to whether this would result in periodontal breakdown over a
longer period of follow-up. In terms of failure rates, significantly more
breakages were reported with VFRs when compared to Hawley retainers
(Manzon et al., 2018), although the reported failure rates were lower
compared to those observed in a separate trial involving fixed retainers
(Forde et al., 2018). Furthermore, significantly less breakage was reported
with an Essix-type retainer of 1mm thickness when compared to 0.75mm
thickness over a one-year period (Zhu et al., 2017). In terms of patient
reported-outcomes, Essix-type retainers were associated with more
discomfort than fixed retainers (Forde et al., 2018), but less when compared
to Hawley retainers (Manzon et al., 2018).

Attempts were made to identify all trials meeting the inclusion criteria in the
current review with no restrictions based on either the publication date or
language. Furthermore, both prospective cohort studies and RCTs were
included. Cohort studies were included, in particular, to permit assessment of
the periodontal outcomes as they are more likely to involve more prolonged
periods of follow-up, which may be necessary to reveal the extent of any
prolonged periodontal effects. Meta-analysis was not undertaken in view of
the clinical heterogeneity between the limited number of included studies,
which made statistical pooling inappropriate in relation to periodontal health,

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survival and failure rates, patient-reported outcomes and cost-effectiveness.


This inability to undertake meta-analysis is common to many orthodontic
systematic reviews with meta-analysis reported in just 27% of 157 reviews
over a 14-year period with a median of just four studies for those that did
incorporate meta-analysis (Koletsi et al., 2015). The onus on producing
highquality primary research studies in orthodontics remains.

4.5 Conclusions

There is a lack of high-quality evidence to endorse the use of one type of


orthodontic retainer based on their effect on periodontal health, risk of failure,
patient-reported outcomes and cost-effectiveness. Further well-designed
prospective studies are therefore required to provide further definitive
information in relation to the benefits and potential harms of prolonged
retention.

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CHAPTER 5

CHAPTER 5. ADHERENCE TO REMOVABLE


ORTHODONTIC APPLIANCES AND ADJUNCTS WEAR: A
SYSTEMATIC REVIEW AND META-ANALYSIS

5.1 Background and Aims

Adherence to wearing of removable orthodontic components may have a key


influence on the efficiency and indeed success or failure of orthodontics in
the short and long term. However, there is a lack of consensus regarding the
anticipated wear associated with removable adjuncts and indeed how this
relates to reported wear durations. The primary aim of this review was,
therefore, to assess the levels of adherence to the wearing of various
removable orthodontic appliances and adjuncts. Secondary aims were to
assess the effectiveness of the interventions used to improve adherence
levels, to explore patient experiences with interventions to enhance
adherence to wearing these removable adjuncts and to identify factors
affecting cooperation (Appendix 1).

5.2 Methods

 Protocol and registration


The protocol for this systematic review was prospectively registered on
PROSPERO (www.crd.york.ac.uk/prospero; CRD42016036059).

 Eligibility criteria
The following inclusion/exclusion criteria were applied:
1. Study design:
- Quantitative studies: randomised, non-randomised controlled
clinical trials, prospective cohort studies and case series
(minimum sample size of 20 patients) incorporating objective
data on adherence levels.
- Qualitative studies exploring patients’ views and experiences of
removable orthodontic appliances or adjuncts and/or the

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interventions used to improve adherence levels (including


barriers and facilitators affecting wear of the appliance).
- Mixed methods studies in which quantitative or qualitative
components meet the above criteria.
2. Participants: patients of any age treated with headgear, protraction
facemask, chin-cup, removable appliances, removable retainers or
fixed appliances with the use of intra-oral elastics as adjuncts.
3. Interventions and comparators: orthodontic interventions including
headgear, protraction facemask, chin-cup, removable appliances,
removable retainers or fixed appliances with the use of intra-oral
elastics as adjuncts. The use of means of improving adherence levels
was also to be assessed.
4. Outcome measures:
- Primary outcomes included adherence levels with orthodontic
regimens (hours per day of wear or percentage of
recommended wear) in relation both to stipulated and patient-
reported levels of wear.
- Secondary outcomes were the impact of interventions used to
improve adherence levels and delineation of patient
experiences and factors influencing adherence with wear
regimens.

 Information sources, search strategy, and study selection


The following electronic databases were searched from inception to May
2016 without language restrictions: MEDLINE via OVID using specific search
terms (Appendix 3), PubMed, the Cochrane Central Register of Controlled
Trials (CENTRAL), Web of Science Core Collection, and LILACS and BBO
databases. Unpublished clinical trials were accessed electronically using the
following online portals: ClinicalTrials.gov (www.clinicaltrials.gov), the
National Research Register (www.controlled-trials.com), and ProQuest
Dissertation and Thesis database (http://pqdtopen.proquest.com). Citation
tracking and searching of reference lists of the included studies was

87
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performed to identify relevant research. The authors of the included studies


were contacted via email if additional information was required.
 Risk of bias/quality assessment in individual studies
Following identification and retrieval of relevant abstracts, two authors (DA,
PSF) independently identified studies that met the inclusion/exclusion criteria
and assessed their quality. Reconciliation of disagreement followed joint
discussion (DA, PSF). The quality of randomised controlled trials (RCTs) was
assessed using the Cochrane Collaboration’s Risk of Bias tool (Higgins et al.,
2011) with only studies at low or unclear risk of bias to be included in the
metaanalysis. The following domains were considered: sequence generation,
allocation concealment, blinding of outcome assessors, incomplete outcome
data, selective reporting, and other biases. The quality of non-randomised
clinical trials was assessed using the Risk of Bias in Non-Randomised
Studies of Interventions (ROBINS-I) tool (Sterne et al., 2016), with studies of
low or unclear risk of bias to be included in the meta-analyses. The following
domains were assessed: bias due to confounding, selection bias, bias in
classification of intervention, bias due to missing data, bias in measurement
of the outcomes, and selective reporting. The quality of mixed-methods
studies was assessed using the Mixed Methods Appraisal Tool (MMAT)
(Pluye et al., 2009), with a threshold score of 50% for inclusion assessing
qualitative and quantitative aspects, as well as mixed-methods. The quality
of the included studies was assessed independently by two authors (DA,
PSF), with disagreements resolved by joint discussion.

 Data items and collection


Data from the included studies was abstracted using pre-piloted data
collection forms. Data extraction included: (1) study design and setting; (2)
characteristics of participants; (3) appliance type and objective measure
used; (4) treatment interventions; (5) stipulated wear time; (6) duration of the
study and treatment phase; (7) objective and self-reported wear time; (8)
patient awareness of the presence of the micro-electronic sensor or timer; (9)
treatment cost; and (10) factors influencing adherence levels.

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 Summary measures and approach to synthesis


Clinical heterogeneity in relation to the type of orthodontic appliance or
adjunct was considered prior to comparisons. Statistical heterogeneity was
investigated by examining a graphical display of the estimated adherence
levels in conjunction with 95% confidence intervals (CI). Statistical
heterogeneity was quantified using the I-squared statistic. A weighted
estimate of objective adherence level for different orthodontic appliances in
relation to stipulated wear time and relative to self-reported levels was
calculated from the included studies. Data from qualitative studies were to be
synthesised thematically (Thomas and Harden, 2008), followed by
integration of quantitative and qualitative results.

 Risk of bias across studies


In order to identify any publication bias, standard funnel plots and contoured
enhanced funnel plots were to be drawn if sufficient number of included
studies were identified (more than ten studies).

 Additional analysis
Meta-regression was undertaken to assess the relative effects of appliance
type on adherence levels (extra-oral vs. intra-oral appliances). All statistical
analyses were undertaken using the Stata statistical software package
(version 12.1; StataCorp, College Station, Tex).

5.3 Results

 Study selection and characteristics


Electronic databases search yielded 4263 records; an additional six records
were identified from hand searching. Following exclusion of 190 duplicates,
4079 titles and abstracts were scanned to identify relevant studies by two
authors (DA, PSF). Eighty full-text articles (74 from electronic searches) were
obtained and evaluated. Fifty-six full-texts were excluded, with 24 meeting
the selection criteria; of these, two were RCTs (Hyun et al., 2015; Arreghini

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et al., 2017), 21 were prospective cohort studies (Clemmer and Hayes, 1979;
Sahm et al., 1990a, 1990b; Bartsch et al., 1993; Cureton et al., 1993a,
1993b; Cole, 2002; Doruk et al., 2004; Ağar et al., 2005; Brandão et al.,
2006; Bos et al., 2007; Trakyali et al., 2009; Kawala et al., 2013; Pauls et al.,
2013; Schott et al., 2013; Schott et al., 2014; Schott and Ludwig, 2014a,
2014b; Tsomos et al., 2014; Schäfer et al., 2015; Schott et al., 2016), and
one had a mixedmethods design (Veeroo et al., 2014) (Figure 7). The study
design, patient characteristics, appliance type and interventions within the
included studies are summarised in Table 11.

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CHAPTER 5

Records identified from


Records identified from hand
electronic database formal
search
search
Identification
(n= 6)
(n= 4263)

Total number of records (n= 4269) Duplicates (n= 190)

Records screened Records excluded (n= 3999)


(n= 4079)
Screening

Full-text assessed for eligibility Full-text articles excluded


(n= 80) (n= 56):

• Duration of wear not


Eligibility

verified using objective


reading/measurement (n=
32)
• Review articles (n= 4)
• Irrelevant outcomes (n= 7)
• Sample < 20 participants
(n= 5)
• Adherence data not fully
presented (n= 5)
• In vitro studies (n= 3)

Studies included in qualitative synthesis


(n= 24)
Included

Studies included in quantitative synthesis


(n= 11)

Figure 7. PRISMA flowchart of the included studies (n= 11)

91
CHAPTER 5

Table 11. Baseline characteristics of the included studies.


Stipulated Study Subjective Awareness
Participants and Objective Treatment
Study Design Appliance/Adjunct Intervention wear time duration/Treatment recording of being
Setting measure (h/d) cost
phase of wear monitored
Prospective n= 20 (11 M, 9 F) Cervical pull HG Aledyne Timer®, n/a 12-14 Up to 6-9 weeks No No Unclear
cohort study Mean age: 13.8 y
Clemmer and Hayes

Aledyne Co., Los


Age range: 11-17 Altos, Calif
y
(1979)

Saint Louis
University
Department of
Orthodontics
Prospective n= 28 (10 M, 18 Cervical pull HG Fabricated from 12 Up to 3 mo, with Yes No Unclear
al. (1993a)
Curetonet

cohort study F) commercial wrist minimum of 3 mo of


Age: > 10 y watch HG wear

U.S. Army dental


facility With calendar
Cureton et al.

(n= 14; 7 M, 7
(1993b)

F)
Without
calendar (n=
14; 3 M, 11 F)
Prospective n= 77 (40 M, 37 Bionator Fabricated from n/a 15 Mean: 3.9 mo (initial No Unclear Unclear
Bartsch et al.

cohort study F) commercial wrist and advanced


(1993)

Mean age: 10.2 ± watch stages of treatment)


1.51 y

Würzburg
Orthodontic
Department
Prospective n= 16 (8 M, 8 F) Cervical pull HG Compliance n/a 10-12 Up to 6 mo, with Yes Unclear Unclear
(2002)
Cole

cohort study Mean age: 12.7 y Science System®, minimum of 3 mo of


Ortho Kinetics, HG wear
Vista, Calif

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Prospective n= 21 (10 M, 11 HG Compliance Patients were 14 First 3 mo of HG Yes Patients Unclear


Brandão et al. (2006) cohort study F) Science System® informed wear were
Mean age: 14.8 y and Affirm smart about the informed at
Age range: 11- headgear monitor of HG T1
19.5 y modules®, Ortho wear at T1
Kinetics, Vista,
Calif
Graduate clinic at
the Federal
University of
Paraná in Brazil
Prospective n= 56 (19 M, 37 Cervical pull HG Thermonchron i- n/a 12 Up to 29 days (initial Yes No Unclear
Bos et al. (2007)

cohort study F) Button®, Maxim and advanced stages


Mean age: 12.89 Integrated of treatment)
± 2.16 y Products,
Age range: 10-22 Sunnyvale, Calif
y

Department of
Orthodontics,
Academic Centre
for Dentistry,
Amsterdam
Prospective n= 30 (16 M, 14 Cervical pull HG Compliance Conscious 16 Up to 6 mo Yes No Statefunded
Trakyali et al. (2008)

cohort study F) Science System®, hypnosis


Ortho Kinetics, motivation
Vista, Calif group and HG
timetables (n=
15; mean age
10.78 ±
1.06 y)
Verbal
motivation
group and HG
timetables (n=
15; mean age
10.07 ±
1.09 y)

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Prospective n= 28 (16 M, 12 Mx removable TheraMon® n/a 15 First 6 mo of No Unclear Unclear


Schott et al. (2014) cohort study F) appliance Sensor, appliance wear
Mean age: 10.6 ± Handelsagentur
2.2 y Gschladt,
Age range: Hargelsberg,
7.717.4 y Austria or
Forestadent,
Pforzheim,
Germany
Mixedmethods Semi-structured Intra-oral elastics Number of used Intervention Full-time First visit following Yes Unclear Unclear
Veeroo et al. (2014)

study interviews: elastics group (‘ifthen’ (changed commencement of (duration in


n= 14 (5 M, 9 F) planning) (n= twice elastic wear hours)
Age range: 15-16 6) daily)
y
Control group
RCT: n= 12 (5 M, (n= 6)
7 F)
Age range: 13-16
y

Orthodontic
departments in
Aylesbury and
Amersham, UK
RCT n= 18 (7 M, 11 F) Mx Hawley retainer SMART® Micro- Group 1: 19 12 weeks No Yes Unclear
Hyun et al. (2015)

(cross-over Mean age: 15.44 electronic sensor, aware about


study) ± 1.38 y Great Lakes being
Orthodontics, monitored
Buffalo, New York from the start
University of of the study
Buffalo (n= 8)
Orthodontic Clinic
Group 2: At T1
aware about
being
monitored at
T1 (n= 10)

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Prospective n= 141 (88 M, 53 Mx removable TheraMon® n/a 15 First 3 mo of No Unclear Statutory


Schäfer et al. (2015) cohort study F) appliance (n= 70) Sensor, appliance wear health
Mean age: 10.95 Handelsagentur insurance
± 1.87 y Gschladt, (n= 98)
Age range: 7-15 y Functional appliance Hargelsberg,
(standard activator or Austria or Private
Private practice Class III activator) Forestadent, health
and University (n= 71) Pforzheim, insurance
Hospital Germany (n= 43)

Prospective n= 109 (54 M, 55 Mx removable TheraMon® n/a Mean: First follow- up Yes Yes Unclear
Schott et al. (2016)

cohort F) appliance (n= 33) Sensor, 15.1 ± 0.9 appointment


study Mean age: 12.3 ± Functional appliance Handelsagentur Mean:
2.9 y (bite-jumping Gschladt, 15.2 ± 0.5
Age range: 6-20 y appliance or standard Hargelsberg,
activator) Austria or
Private practice (n= 34) Forestadent,
and University Modified Hawley Pforzheim, Mean:
Hospital retainer (n= 42) Germany 13.4 ± 2.7
F: female; h/d: hours/day; HG: headgear; M: male; mo: months; Mx: maxillary; n/a: not applicable; RCT: randomised controlled trial; y: years.

95
CHAPTER 5

 Risk of bias within studies


The methodological quality of the RCTs is presented in Figure 8. Hyun et al.
(2015) had an overall score of unclear risk of bias, due to lack of description
of the allocation concealment and outcome assessment. The other clinical
trial was considered to be at high risk of bias, due to attrition bias, selective
reporting, and lack of clarity on the method used to deal with missing data
(Arreghini et al., 2017). Using the ROBINS-I tool for assessing risk of bias in
prospective cohort studies, eight studies were deemed of an overall serious
risk of bias (Appendix 4). Bias due to confounding was observed in five
studies (Kawala et al., 2013; Pauls et al., 2013; Schott and Ludwig, 2014a,
2014b; Tsomos et al., 2014), due to failure to consider the variability of the
appliances assessed. Three studies suffered from serious bias in the
selection of the reported outcomes (Ağar et al., 2005; Pauls et al., 2013;
Schott et al., 2013), another two studies had bias due to high drop-outs
(Doruk et al., 2004; Ağar et al., 2005), and one study had selection bias
(Schott et al., 2013). One mixedmethods study scored more than 50% using
the MMAT (Veeroo et al., 2014) (Figure 9).
Allocation concealment

Otherthreats to validity
Incomplete outcome
Blinding of outcome

Selective reporting
Random sequence

assessment

Overall risk
generation

data
Hyun et al. (2015) Unclear

Arreghini et al. (2017) High

Figure 8. Risk of bias for the included randomised controlled trials: Low
risk of bias (green); unclear risk of bias (yellow); high risk of bias (red)
(n= 2).

88
CHAPTER 5

Qualitative section Quantitative Mixed-methods


section section
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3

          
Figure 9. Methodological quality of the included mixed-methods study (Veeroo
et al., 2014).

 Results of individual studies, meta-analysis, and additional analysis

Levels of objectively-measured adherence with various removable orthodontic


adjuncts
The mean duration of objectively-measured wear was considerably lower
than stipulated wear time among all appliance types in the included studies
(Table 12) with a mean discrepancy of 5.81 hours/day (95% CI: 4.98, 6.64) in
relation to headgear based on six studies involving 171 participants
(Clemmer and Hayes, 1979; Cureton et al., 1993a; Cole, 2002; Brandão et
al., 2006; Bos et al., 2007; Trakyali et al., 2008) (Figure 10). In view of the
overlap of the sample within three studies (Sahm et al., 1990a, 1990b;
Bartsch et al., 1993), the most representative of these was selected (Bartsch
et al., 1993). In relation to functional appliances, the corresponding
discrepancy between verified and stipulated wear time was 5.71 hours/day
(95% CI: 4.98, 6.45) (Figure 10). Smaller discrepancies were observed for
maxillary removable appliances (3.53 hours/day; 95% CI: 2.06, 5.00) and
Hawley retainers (4.58 hours/day; 95% CI: 3.21, 5.95) (Figure 10).
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CHAPTER 5

Table 12. Adherence levels with various orthodontic regimens.


Actual wear Self-reported Subjective wear
Stipulated Objective wear
time relative to wear time time relative to Additional
Study Appliance Study groups wear time time (mean in
stipulated wear (mean in h/d ± actual wear comments
(h/d) h/d ± SD)
time SD) time
Cervical - 12-14 7.43 57.2% - - -
and Hayes
Clemmer

pull HG
(1979)

Cervical With calendar (n= 12 7.9 65.8% 11.36 143.8% Orthodontists


pull HG 14) overestimated HG
wear by 60%
(1993
a;

Orthodontic
1993b)

residents:
Curetonet al.

Without calendar 5.3 44.2% 10.88 205.3% overestimated HG


(n= 14) wear by 71%
Dental assistants:
overestimated
HG wear by 73%
Bionator - 15 8.7 58.0% - - -
Bartsch

(1993)
et al.

Cervical - 10-12 6.78 52.1% 8.89 131.1% -


(2002)
Cole

pull HG

HG T1: Unaware of 14 T1: 5.6 ± 4.4 T1: 56.7 ± 13.6 ± 2.6 242.9 ± 19.1% -
Brandão

(2006)

presence of timer 45.0%*


et al.

(n= 21)

T2: Aware of the T2: 7.0 ± 5.4 T2: 62.8 ±


presence of timer 52.5%*
(n= 21)

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Cervical - 12 5.58 ± 4.39 46.5 ± 78.7% 11.02 ± 3.77 197.5 ± 34.2% Wear time as
Bos et al. (2007)
pull HG estimated by
orthodontists: mean
9.52 ± 3.59 h/d Wear
time as estimated by
parents: mean 11.12
± 3.97 h/d

Cervical Conscious 16 3 mo: 13.75 ± 3 mo: 85.9 ± 3 mo: 18.51 ± 3 mo: 134.6 ± -
Trakyali et al. (2008)

pull HG hypnosis 5.29 38.5% 2.96 16.0%


motivation group 6 mo: 12.13 ± 6 mo: 75.8 ± 6 mo: 17.97 ± 6 mo: 148.1 ±
and HG timetables 4.49 37.0% 3.80 21.1%
(n= 15)
Verbal motivation 3 mo: 8.92 ± 3 mo: 55.75 ± 3 mo: 14.55 ± 3 mo: 163.1 ±
group and HG 3.41 38.2% 3.69 25.4%
timetables (n= 6 mo: 9.68 ± 6 mo: 60.5 ± 6 mo: 16.29 ± 6 mo: 168.3 ±
15) 4.43 45.8% 4.09 25.1%
Mx - 15 T1 (55 ± 11 T1: 85.3 ± - - -
Schott et al. (2014)

removable days): n= 29.7%


appliance 28, 12.8 ±
3.8
T2 (57 ± 13 T2: 88.7 ±
days): n= 29.3%
26, 13.3 ±
3.9
T3 (58 ± 7 T3: 84.7 ±
days): n= 37.8%
13, 12.7 ±
4.8
Intra-oral Intervention group Full-time - 77.0%† Median: 20 h/d - -
Veeroo et
al. (2014)

elastics (‘if-then’ planning) (changed


(n= 6) twice daily)
Control group (n= 49.5%† Median: 19 h/d
6)

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Mx Hawley Group 1: aware 19 T1: 16.3 ± 4.39 T1: 85.8 ± - - -

Hyun et al. (2015)


retainer about being 26.9%
monitored from the
T2: 15.6 ± 4.77 T2: 82.1 ±
start of the study
30.6%
(n= 8)
Group 2: aware T1: 10.6 ± 5.36 T1: 55.8 ±
about being 50.6%
monitored at T1 T2: 11.1 ± 6.08 T2: 58.4 ±
(n= 10) 54.8%
Functional - 15 Median: 9.5 h/d 63.3% - - -
Schäfer et al.

appliance (IQR: 4.6)


(2015)

Mx - 15 Median: 10.1 67.3%


removable h/d (IQR: 4.3)
appliance
Mx - Mean ± SD: 11.9 ± 3.0 78.8 ± 25.2% 12.0 ± 3.0 100.8 ± 25% Wear time as
Schott et al. (2016)

removable 15.1 ± 0.9 estimated by


appliance orthodontists: mean
11.6 ± 2.7 h/d
Functional Mean ± SD: 10.2 ± 3.3 67.1 ± 32.3% 12.2 ± 3.6 119.6 ± 29.5% Wear time as
appliance 15.2 ± 0.5 estimated by
orthodontists: mean
11.0 ± 3.5 h/d
Modified Mean ± 9.0 ± 4.9 67.2 ± 54.4% 10.1 ± 3.8 112.2 ± 37.6% Wear time as
Hawley SD:13.4 ± 2.7 estimated by
retainer orthodontists: mean
9.4 ± 3.4 h/d
h/d: hours/day; HG: Headgear; IQR: interquartile range; mo: months; Mx: maxillary; SD: standard deviation.
*Based on percentage data presented.

Based on elastics returned vs. projected number.

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Figure 10. Forest plot presenting the mean difference in


objectivelymeasured adherence levels in relation to stipulated duration
of wear.
CI: Confidence interval.
*Median value was used, since the mean was not presented.

A Monte Carlo permutation test was undertaken to explore the possible


effect of appliance type on adherence levels. Although the adherence levels
with headgear were lower than other intra-oral appliances, meta-regression
suggested that the level of adherence was not directly related to the type of
the appliance (P= 0.21).

Objectively-measured adherence levels compared to self-reported wear


with removable orthodontic adjuncts
Self-reported wear time was consistently higher than objectively-measured
wear time in all types of appliances (Table 12). The mean difference between
objective and self-reported adherence levels with headgear wear was
calculated from five studies (Cureton et al., 1993a; Cole, 2002; Brandão et
al., 2006; Bos et al., 2007; Trakyali et al., 2008), with self-reported wear was

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observed to be 5.02 hours/day (95% CI: 3.64, 6.40) higher than the
objectivelymeasured wear (Figure 11; Table 12). Over-reporting was
somewhat lower in a study focusing on intra-oral appliances (Schott et al.,
2016) (Figure 11; Table 12). Self-reported wear time approximated stipulated
wear time more closely, with the difference not exceeding three hours (Table
12).

Figure 11. Forest plot presenting the mean difference in


objectivelymeasured adherence levels in relation to self-reported wear
time.
CI: Confidence interval.

Impact of interventions used to improve adherence levels


The effectiveness of the different interventions in improving adherence levels
was identified in five studies (Cureton et al., 1993b; Brandão et al., 2006;
Trakyali et al., 2008; Veeroo et al., 2014; Hyun et al., 2015) (Table 12). A
slight increase in adherence to both the headgear and Hawley retainers wear
when patients were aware of monitoring was reported in two studies

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(Brandão et al., 2006; Hyun et al., 2015). The use of headgear calendars or
conscious hypnosis were both shown to be effective in increasing the
duration of headgear wear in single studies (Cureton et al., 1993b; Trakyali
et al., 2008). Furthermore, the use of a behavioural intervention (‘if-then’
planning) to address the potential mismatch between intentions and actions
in intra-oral elastic wear did not lead to a significant improvement in the
adherence levels (Veeroo et al., 2014). However, although these
interventions appeared to have some effect, the objectively-assessed
adherence level was less than that stipulated in all of these studies (Cureton
et al., 1993b; Brandão et al., 2006; Trakyali et al., 2008; Veeroo et al., 2014;
Hyun et al., 2015).

Factors affecting adherence levels and patient experiences


Several studies considered factors that may affect adherence levels
including age, gender, phase of treatment, and patient motivation and
attitudes (Table 13). Younger age groups were reported to be more adherent
than older individuals in five studies (Sahm et al., 1990b; Cureton et al.,
1993a; Brandão et al., 2006; Bos et al., 2007; Schäfer et al., 2015).
However, no relationship between the adherence levels and age was noted
in two studies (Clemmer and Hayes, 1979; Bartsch et al., 1993). Three
studies observed that females were more adherent (Clemmer and Hayes,
1979; Sahm et al., 1990b; Schäfer et al., 2015), however, this was not
corroborated in the remaining studies (Bartsch et al., 1993; Cureton et al.,
1993a; Brandão et al., 2006). Adherence level was also reported to be better
in the early stages of treatment in a number of studies (Sahm et al., 1990b;
Bartsch et al., 1993; Bos et al., 2007). In isolated studies, patient motivation
and attitudes towards the orthodontic treatment were reflected in the
adherence levels, although limited data were reported in this respect
(Clemmer and Hayes, 1979; Bartsch et al., 1993). Only one mixed-methods
study involving semi-structured interviews explored barriers to adherence to
intra-oral elastics wear (Veeroo et al., 2014); thematic synthesis was
therefore not undertaken, thus precluding the integration of the quantitative
and qualitative data.

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 Risk of bias across studies


Tests for publication bias were not undertaken as no more than six studies
were included in an individual meta-analysis.

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Table 13. Factors influencing adherence levels.


Study Age/Gender Other factors
Age: no linear relationship between age School performance: adherent patients
Clemmer and Hayes and adherence levels. showed better school performance.
Gender: females more adherent. Self-perception of malocclusion:
adherent patients evaluated their
(1979)

malocclusion as severe. Attitude


towards orthodontic treatment:
adherent patients showed better
attitudes towards orthodontic
treatment.
Age: youngest patients more adherent Treatment stage: patients in the early
Sahm et al.

than the rest of the groups. stages of treatment more adherent.


(1990b)

< 11 y: mean 8.87 h/d < 3 mo: mean 8.29 h/d


12-13 y: mean 6.81 h/d 4-12 mo: mean 7.24 h/d
> 13 y: mean: 6.97 h/d > 12 mo: mean 5.76 h/d
Gender: females more adherent.
M: mean 7.38 h/d
F: mean 7.95 h/d
Age: youngest patients more adherent -
Cureton et al. (1993a)

than the rest of the groups. 10-12 y (n=


6): mean 8.3 ± 3.1 h/d
12-14 y (n= 9): mean 7.1 ± 3.9 h/d
14-16 y (n= 10): mean 5.4 ± 2.8 h/d
> 16 y (n= 3): mean 5.6 ± 2.2 h/d
Gender: males more adherent.
M: (n= 10): mean 7.3 ± 3.1 h/d
F: (n= 18): mean 6.2 ± 3.5 h/d
Age: no linear relationship between age Treatment stage: patients in the early
Bartsch et al. (1993)

and adherence levels. stages of treatment more adherent.


Parents role: parental control, interest
Gender: no effect of gender on and supervision correlated positively with
adherence levels. patient adherence.
Role of peers: social motivation from
peers correlated positively with patient
adherence.
School performance: adherent patients
reported high need for achievement at
school.
Motivation to seek orthodontic
treatment: both internal motivation and
parental involvement beneficial.
Orthodontist-patient relationship:
adherent patients more satisfied with
clinical atmosphere and time spent.
Number of complaints: adherent
patients reported less complaints about
their appliance.

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Age: younger patients more adherent -

Brandão et al. (2006)


particularly in early stages of treatment. ≤
14 y (n= 7), median at T1: 10.06 h/d, at
T2: 7.63 h/d
> 14 y (n= 10), median at T1: 8.62 h/d, at
T2: 11.34 h/d
Gender: males more adherent
particularly in early stages of treatment.

Age: younger patients more adherent. Treatment stage: patients in early


Bos et al.

< 13 y (n= 26): mean 9.38 ± 3.59 h/d stages of treatment more adherent. < 8
(2007)

≥ 13 y (n= 30): mean 6.08 ± 4.06 h/d mo (n= 26): mean 7.53 ± 4.74 h/d
≥ 8 mo (n= 30): mean 3.89 ± 3.30 h/d

Age: youngest patients more adherent Insurance type: higher adherence


Schäfer et al.

than older groups. levels in patients with private insurance.


(2015)

7-9 y (n= 34): median 12.1 h/d - statutory health insurance (n= 98):
10-12 y (n= 72): median 9.8 h/d median 9.6 h/d
13-15 y (n= 35): median 8.5 h/d - private health insurance (n= 43):
Gender: females more adherent. median 11.4 h/d
M (n= 88): median 9.3 h/d
F (n= 53): median 10.6 h/d
F: female; h/d: hours/day; M: male; mo: months; y: years.

5.4 Discussion

This systematic review builds on previous primary research confirming


suboptimal levels of adherence to a variety of removable orthodontic
adjuncts, although limited difference in objective adherence levels between
appliance variants and adjuncts was noted. Moreover, a significant
discrepancy between the objective and subjective reports was confirmed
using indwelling devices. Techniques directed at improving adherence have
promise but require further evaluation in high-level research. Furthermore,
there is a lack of clinical trials investigating their effectiveness coupled with a
dearth of in-depth qualitative information exploring patients’ experiences,
barriers and facilitators related to wear.

Overall, adherence to intra-oral appliance wear was slightly better than with
the extra-oral appliances; however, the difference between appliances was
not statistically significant. This lack of difference was mirrored by the
objective findings from clinical research alluding to similar changes in terms
of correction of Class II and Class III malocclusions with both intra- and
extra- oral removable appliances (Tulloch et al., 1997a; Seehra et al., 2012).

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Furthermore, similar levels of impairment of oral health-related quality of life


during treatment have been attributed to intra- and extra- oral removable
appliances (Kadkhoda et al., 2011). However, the decision to treat with
intraoral or extra-oral appliances, for example in Class II malocclusion, also
hinges on extraneous factors, such as the nature of the deformity and
aetiology of the condition. Notwithstanding this, an appreciation of the
predicted level of adherence with either approach is valuable.

The overall discrepancy between the stipulated and recorded wear durations
was significant being of the order of five hours with most appliances. In most
of the studies headgear wear was recommended for 12-14 hours/day and
functional appliances were prescribed for 15 hours daily. These primary
studies generally did not equate appliance wear duration with the outcome of
treatment on an individual basis. However, one study focusing on removable
appliance, reported improved treatment outcomes with higher adherence
levels (Schott et al., 2014). It would be intuitive to expect that reduced or
sporadic daily wear would translate either into failure or extension of
treatment. There is, for example, an acceptance that an incident force for six
hours daily is necessary to induce tooth movement (Proffit, 1978); however,
the corresponding threshold levels for orthopaedic change with functional
appliances or facemask therapy remain unclear. An RCT reported a mean
treatment duration of 11.2 months with the removable Twin blocks, whereas
the mean treatment time with the fixed Herbst appliance was 5.81 months in
order to achieve a similar outcome, indicating that increased wear was likely
to have a profound effect (O'Brien et al., 2003). Similarly, with the fixed Twin
Blocks, Read et al. (2004) reported a mean treatment duration of 5.1 months
to achieve overjet reduction. Conversely, Tulloch et al. (1997b) did not
observe an association between reported wear and the treatment response.
Furthermore, in a prospective analysis focusing on removable functional
appliances, Tsomos et al. (2014) reported wear for less than nine hours per
day despite 14 hours being prescribed during the active treatment phase.
However, when instructed to wear the appliance eight hours daily during the
retention phase, this level was actually exceeded. As such, further research

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concerning the optimal recommended wear regimen is required. A range of


other approaches geared at optimising adherence levels was identified in the
included studies. The use of headgear calendars (Cureton et al., 1993b),
known monitoring (Brandão et al., 2006; Hyun et al., 2015), conscious
hypnosis (Trakyali et al., 2008), and behavioural intervention (Veeroo et al.,
2014) all showed a degree of promise but require further evaluation in
highlevel research.

The problem of over-reporting of appliance wear has been exposed in the


present review with a consistent exaggeration of wear of the order of five to
six hours daily. Over-reporting was evident despite awareness of being
objectively-monitored in some instances (Schott et al., 2016). This finding
may relate to recall bias, especially if self-reported wear was recorded
retrospectively on follow-up visits (Cureton et al., 1993b; Bos et al., 2007;
Schott et al., 2016), rather than with daily recording using calendars or charts
(Cureton et al., 1993b; Cole, 2002; Brandão et al., 2006; Trakyali et al.,
2008). However, it is more likely that over-reporting of appliance wear may
stem from a response bias in an effort to please the clinician and avoid any
negative comments or judgement. It is therefore likely that forging optimal
trust and orthodontist-patient relationships may ensure that more realistic
reports of appliance wear are forthcoming (Bartsch et al., 1993; Čirgić et al.,
2015), although little information in this respect was obtained in the present
review. The reasons for suboptimal adherence levels remain unclear;
however, this may stem from impacts of the adjuncts including discomfort
(Lin et al., 2015) allied to social effects such as embarrassment with intra-
oral elastics (Veeroo et al., 2014), removable retainers (Hichens et al., 2007),
headgear and functional appliances (Kadkhoda et al., 2011). Furthermore,
technical issues associated with the use of some auxiliaries including intra-
oral elastics may arise (Veeroo et al., 2014). These issues and methods of
mitigating these problems require further evaluation in future primary
research.

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A range of factors other than the recommended wear regimen may have a
bearing on adherence levels (Fleming et al., 2007). Among these are age,
gender and treatment stage. Specifically, in the present review younger
patients tended to respond best. However, all of the included studies were
undertaken predominantly on adolescents. As such, adherence level among
adults was not considered; it is generally accepted, however, that adults are
less inclined to comply with adjuncts such as headgear or removable intra-
oral appliances. As removable appliances and headgears are mainly used in
adolescent patients, varying degrees of adherence levels are to be expected
from juveniles who may not necessarily engage with operators, or may not
entirely understand the implications of treatment. Treatment may therefore
be motivated externally by parents, peers or clinicians (Bartsch et al., 1993;
Čirgić et al., 2015). The onus on effective means of increasing adherence
levels in adolescents is clear. Adherence levels also appear to reduce
throughout treatment (Sahm et al., 1990b; Brandão et al., 2006; Bos et al.,
2007), although the follow-up period in the included studies did not exceed
six months. This highlights the need for further research with longer follow-up
periods; this is particularly true for removable retainer wear which entails an
onus on prolonged adherence to mitigate any post-treatment change related
both to relapse and maturational effects (Horowitz and Hixon, 1969).

The present review incorporated both randomised and non-randomised


studies. Non-randomised studies have a greater inherent risk of bias (Pandis
et al., 2014); however, as the primary aim was to address epidemiological
questions relating to wear rates allied to discrepancies between the reported
and observed wear, this was appropriate. Notwithstanding this, a number of
the included studies did have methodological shortcomings. Moreover, there
is a pressing need for robust prospective research addressing the potential
value of novel means of enhancing adherence levels in orthodontics as few
interventional studies on approaches to enhance wear were identified. This
mirrors many orthodontic systematic reviews with over 70% devoid of
metaanalysis overall (Koletsi et al., 2015). The advent of more reliable

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methods of objectively measuring removable appliance wear, however, may


ensure that further meaningful research in this area is forthcoming.

Following completion of this systematic review, a number of relevant studies


have been published. In a prospective study, the use of a mobile application
including educational content, reminders and a calendar tool did not
significantly improve the objectively-assessed headgear wear time (Clinton
Muñoz, 2018). However, the sample size in the previous study was small (n=
26), with only 11 participants receiving the intervention (Clinton Muñoz,
2018). Additionally, the baseline characteristics were significantly different
between the groups due to a lack of randomisation (Clinton Muñoz, 2018). In
another prospective study, the mean actual wear of headgear was reported
to be 5.6 hours less than that stipulated over an eight-month observation
period despite the participants’ awareness of being monitored (Huanca
Ghislanzoni et al., 2019). In the present systematic review, factors
influencing headgear wear were identified as mainly age, gender, treatment
stages, and attitudes and motives. Interestingly, recent research has
highlighted the effect of the force magnitude on adherence to headgear wear
(Talvitie et al., 2019). This is likely related to heightened levels of discomfort
(Fleming et al., 2018). In a recently published prospective study, the actual
wear time of removable functional appliance was less than or equal to 15
hours per day in approximately half of the participants, despite full-time
prescription (Charavet et al., 2019). Moreover, in another RCT involving Twin
Blocks, the actual wear time was 12 hours in the full-time group and eight
hours daily in the prescribed part-time group (Parekh et al., 2019). A related
qualitative study involving a subset of these participants exposed how the
participants wearing functional appliances regarded them as highly onerous
with a negative impact on quality of life and daily activities (El-Huni et al.,
2018). These findings are generally in keeping with those identified in the
review.

5.5 Conclusions

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On the basis of the present review it appears that adherence to removable


orthodontic appliances is suboptimal with patients wearing appliances
considerably less than stipulated and routinely over-reporting the duration of
wear. There is a need for further prospective research evaluating the
effectiveness of interventions to improve adherence to wearing of orthodontic
adjuncts and exploring patient experiences of removable devices and
appliances.

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CHAPTER 6. THE EFFECTS OF FIXED VERSUS


REMOVABLE ORTHODONTIC RETAINERS ON
STABILITY AND PERIODONTAL HEALTH: FOUR-YEAR
FOLLOW-UP OF A RANDOMISED CONTROLLED TRIAL

6.1 Background and Aims

Prolonged and indeed indefinite retention is routinely prescribed following


orthodontic treatment. Notwithstanding this, there is a dearth of prolonged,
prospective evaluation concerning the relative effectiveness and potential
harms associated with both fixed and removable retention (Littlewood et al.,
2016). Therefore, the primary aim of this study was to compare the stability
of orthodontic outcomes with fixed and removable retainers over a period of
at least four years. The secondary aim was to investigate periodontal
outcomes with fixed versus removable retainers over this period (Appendix
1).

The null hypothesis assessed in the current study was that stability and
periodontal outcomes are similar with use of fixed and removable orthodontic
retainers.

6.2 Methods

 Ethical approval, participants, eligibility criteria and setting


A follow-up was undertaken on a randomised controlled trial (RCT)
conducted at the Institute of Dentistry, Queen Mary University of London,
which had involved assessment of stability up to 18 months post-treatment
(O'Rourke et al., 2016). Ethical approval for a major amendment was
obtained (10/H0713/57, Bloomsbury Research Ethics Committee; Appendix
5) and all participants who participated in the previous clinical trial were
contacted for possible inclusion at least 48 months following the withdrawal
of active appliances with an appointment arranged at their convenience.

 Sample size

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The initial sample size was calculated based on previous research (Rowland
et al., 2007), although a higher level of attrition was to be expected after a
more prolonged follow-up. A total of 72 participants (36 in each group) was
required with a power of 90% to detect a difference of 0.5mm at the 0.05
level of statistical significance. To compensate for a drop-out rate of at least
15%, the final number enrolled in the trial was 82 participants at the outset
(O'Rourke et al., 2016).

 Randomisation and allocation concealment


In the previous RCT, 82 participants were randomly allocated by
computergenerated random allocation with allocation concealed from the
treating clinician using an opaque, sealed envelope system (O'Rourke et al.,
2016).

 Interventions
Participants received either a mandibular thermoplastic retainer (TPR) (Essix
Ace® Plastic 0.75mm in thickness, (DENTSPLY)) or fixed retainer (0.0175”
coaxial archwire; Ortho-Care, Shipley, UK) bonded with Transbond TM LR
composite material (3M Unitek, UK). Those in the removable retainer group
were instructed to wear the mandibular TPR on a full-time basis for the first
six months, nights only for the second six months, and alternate nights from
12 to 18 months following removal of active appliances. Thereafter,
intermittent nights-only wear (one to two nights weekly) was recommended.
Of the 82 participants included in the previous RCT, data were obtained from
48 at the 18-month follow-up (O'Rourke et al., 2016).

 Outcomes
The primary outcome was mandibular Little’s irregularity index (Little, 1975).
The following secondary outcomes were assessed:
- Allied stability outcomes including the inter-canine and inter-molar
widths and extraction space opening.

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- Periodontal outcomes including gingival inflammation, calculus and


plaque levels, clinical attachment level (CAL) and bleeding on
probing.
 Standardised procedures and data collection
An information sheet (Appendix 6) was provided to those participants willing
to participate at a minimum of 48-month follow-up following removal of active
appliances, and oral and written consent (Appendix 7) was obtained.
Participants were advised not to visit their dentist for dental prophylaxis for
one month prior to their appointment with those taking medications known to
have an effect on gingival health excluded from the periodontal assessment.
Five clinical measures of periodontal health were scored in the following
sequence: gingival inflammation (Lobene et al., 1986), followed by plaque
levels (Turesky et al., 1970), CAL, bleeding on probing and calculus levels
(Greene and Vermillion, 1960) (Table 14). Periodontal measurements were
recorded for the labial and lingual surfaces of mandibular canines, central
and lateral incisors. Each tooth surface was divided into thirds using vertical
lines based on the morphology and position of the dental papilla to
demarcate mesial, mid and distal surfaces. The periodontal measures were
scored clinically by one researcher (DA).

An impression of the mandibular arch was taken for all participants using
hydrophilic vinyl polysiloxane (Virtual®, Ivoclar Vivadent AG, Schaan,
Liechtenstein). The impression was then cast in hard (Type III gypsum)
stone.

The status of the fixed retainer in addition to the history of retainer repair and
previous breakage were recorded in the fixed retainer group. All participants
were asked about frequency, duration, type of toothbrushing and the time
elapsed since the last visit to the dentist. Patients wearing mandibular TPR
were also asked to complete a retainer wear chart. The self-reported
adherence levels were categorised as follows:
• Adherent: reported wear of retainers was as advised.

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• Partially-adherent: retainer wear instructions were not followed


precisely.
• Non-adherent: not wearing retainers.

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Table 14. Periodontal outcomes recorded.


Teeth and
Outcomes
Index/Method Scoring system surfaces Additional information
measure
examined
Modified gingival 0: healthy Mandibular 3-3 Assessed by direct visualisation without
index (Lobene et 1: mild inflammation (partial stimulation with a periodontal probe
al., 1986) unit) Labial and lingual
Modified
2: mild inflammation (entire surfaces (6
gingival index
unit) scores/tooth)
3: moderate inflammation
4: severe inflammation
Part of the oral 0: no calculus Mandibular 3-3 -
hygiene index 1: calculus covering up to 1/3
(Greene and of the tooth surface Labial and lingual
Vermillion, 1960) 2: calculus covering up to 2/3 surfaces (6
of the tooth surface and/or scores/tooth)
Calculus
separate flecks of
index subgingival calculus
3: calculus covering more than
2/3 of the tooth surface
and/or a continuous band of
subgingival calculus
Modified 0: no plaque Mandibular 3-3 Liquid disclosing solution (PlaqsearchTM,
QuigleyHein plaque 1: separate flecks of plaque at TePe®, Malmö, Sweden) was applied
index the cervical margin of the Labial and lingual using a swab pressed against each
(Turesky et al., tooth surfaces (6 papilla, followed by 10 millilitres water
Plaque index 1970) 2: thin continuous band of scores/tooth) rinsing
plaque (up to 1mm) at the
cervical margin of the tooth 3:
band of plaque wider than 1mm
covering less than 1/3 of the
crown of the tooth

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4: plaque covering at least


1/3 but less than 2/3 of the
crown of the tooth
5: plaque covering 2/3 or more
of the crown of the tooth
Measurement in - Mandibular 3-3 Measured to the nearest 0.5mm from the
Clinical millimetres cemento-enamel junction to the base of
attachment Labial and lingual gingival sulcus using a Williams probe
level surfaces (6 (Hu‐Friedy, Chicago, IL, USA)
scores/tooth)
- Present/Absent Mandibular 3-3 Maximum waiting time of 15 seconds
Bleeding on
Labial and lingual
probing
surfaces (6
scores/tooth)
Labial frenal - Attached - -
attachment Superficial
Gingival - Thick Labial to Based on probe visibility
biotype Thin mandibular 3-3

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 Study model measurements


Orthodontic stability was based chiefly on the irregularity of the mandibular
incisors using Little’s irregularity index to assign a cumulative score for the
contact point displacement in the mandibular inter-canine region (Little,
1975). Allied measurements including the inter-canine and inter-molar
widths, arch length and extraction space opening were also recorded,
adopting the same technique used in the previous study (O'Rourke et al.,
2016).

The lingual surfaces of the mandibular labial segment were obscured on the
study models using prosthetic dental wax (Ribbon Wax, Metrodent,
Huddersfield, UK) to ensure assessor blindness. Measurements were
performed by one researcher (DA) using a digital caliper (150mm DIN 862,
ABSOLUTE Digimatic caliper, model 500-191U; Mitutoyo, Andover,
Hampshire, UK) with a resolution of ± 0.01mm.

 Calibration
Inter-examiner and intra-examiner reliability of clinical and of study model
measurements were tested by assessing agreement between repeat
measurements. For stability outcomes, intra-examiner reliability was
performed on ten randomly selected study models four weeks after the initial
measurement. Inter-examiner reliability (DA, NO’R) was performed on ten
randomly selected study models with excellent agreement for intra-examiner
(intraclass correlation coefficient (ICC): 0.97) and inter-examiner (ICC: 0.92)
reliability. As the examiner (DA) was an orthodontist, familiarisation with the
measurement of periodontal outcomes was required; and therefore facilitated
by completion of an online course with oversight from a specialist in
Periodontology (CGM) prior to recruitment. Intra-examiner reliability for
scoring the modified gingival index and plaque scoring was assessed by
repeating measurements on ten intra-oral photographs at a four-week
interval (Turesky et al., 1970; Lobene et al., 1986). Repeated measurement
was performed on ten healthy volunteers 30 minutes apart to assess
repeatability of measurement of calculus scores and CAL. Differences

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between the repeated measurements relating to mean modified gingival


index, mean plaque and calculus scores, and mean CAL per tooth were
assessed using intraclass correlation. Excellent agreement was observed
(ICC: 0.94 to 0.97) for intra-examiner reliability.

 Statistical analysis
As the data were not normally distributed, median regression was used to
compare the effectiveness of the two types of retainers on orthodontic
stability accounting for baseline differences between the groups. Similarly,
the median difference between the fixed and removable retainers in terms of
gingival inflammation, calculus and plaque levels, CAL and bleeding on
probing was assessed using a Mann-Whitney U test. A subgroup analysis
was performed to compare the median difference in the periodontal
outcomes between the fixed and removable groups on the labial and lingual
surfaces independently. If any significant differences were identified in
relation to gingival inflammation plaque or calculus scores, probing depth or
bleeding on probing, median regression analysis was to be used to assess
the influence of age, gender, brushing frequency and duration, and type of
retainer on the outcome. A similar model was to be used to evaluate the
effect of retainer type on the CAL values. The level of statistical significance
in all analyses was set to 0.05 with all analyses undertaken using the Stata
statistical software package (version
14.1; StataCorp, College Station, Tex).

6.3 Results

Eighty-two participants were enrolled in the original RCT (O'Rourke et al.,


2016). Of these, 48 attended at 18-month follow-up (T3). At the four-year
follow-up (T4), 42 participants returned- 21 per group (Figure 12). Groups
were well-matched in terms of age, gender and treatment protocol with the
majority being females and 43% and 48% having extraction-based treatment
in the fixed and removable groups, respectively (Table 15). In terms of fixed
retainer integrity, all (100%) were in place at recall, although n= 3 (14%)

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were partially detached and n= 2 (10%) had history of repair. In the


removable retainer group, reported non-adherence levels increased from 0%
over the initial six months to 19% from 6-12 months, 52% in the second year
and 67% thereafter.

Figure 12. Study flow diagram.


Table 15. Baseline characteristics overall and in both groups.
Overall
FR group TPR group
sample
n= 21 n= 21
n= 42
Mean age in years ± SD 21.15 ± 2.41 21.54 ± 3.06 20.77 ± 1.49
Males n= 10 n= 18 n= 7
Gender
Females n= 32 n= 18 n= 14
Mean years in retention ± SD 4.16 ± 0.35 4.09 ± 0.25 4.23 ± 0.42
Treatment Extraction n= 19 n= 9 n= 10
protocol Non-extraction n= 23 n= 12 n= 11

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Type of Manual n= 37 n= 18 n= 19
toothbrush Electric n= 5 n= 3 n= 2
Daily Once n= 7 n= 6 n= 1
toothbrushing
Twice n= 35 n= 15 n= 20
frequency
< 1 minute n= 1 n= 0 n= 1
Time spent in
1-2 minutes n= 29 n= 14 n= 15
toothbrushing
> 2 minutes n= 12 n= 7 n= 5
None n= 23 n= 13 n= 10
Use of other Dental floss n= 10 n= 4 n= 6
oral hygiene
measures Interdental brush n= 3 n= 2 n= 1
Toothpick n= 9 n= 4 n= 5
< 6 months n= 10 n= 5 n= 5
Last visit to 6 months - < 1 year n= 5 n= 3 n= 2
the dentist 1-2 years n= 12 n= 9 n= 3
> 2 years n= 15 n= 4 n= 11
Smokers n= 4 n= 3 n= 1
Gingival Thick n= 17 n= 7 n= 10
biotype Thin n= 24 n= 14 n= 10
Fraenal Low n= 41 n= 21 n= 20
attachment High n= 1 n= 0 n= 1
FR: fixed retainer; SD: standard deviation; TPR: thermoplastic retainer.

 Orthodontic stability with fixed versus removable retention


In terms of the irregularity of the mandibular anterior segment, data from 42
participants were analysed (Table 16). Some degree of relapse occurred in
both treatment groups at the four-year follow-up with median increases in the
degree of irregularity of 0.85mm and 2.37mm in both the fixed and
removable retainer groups, respectively. After adjusting for confounders, the
median between-groups difference was 1.64mm higher in those wearing
TPRs (P= 0.02; 95% CI: 0.30, 2.98mm). No statistical difference was
observed between the treatment groups in terms of inter-canine (P= 0.52;
95% CI: -1.07, 0.55) and inter-molar widths (P= 0.55; 95% CI: -1.72, 0.93),
arch length (P= 0.99; 95% CI: -1.15, 1.14) and extraction space opening (P=
0.84; 95% CI: -1.54,

1.86).

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 Periodontal outcomes
For the modified gingival index, score 3 was the most frequent in both fixed
(55.4%) and removable (52.6%) retainer groups at the four-year follow-up. In
relation to the plaque index, score 4 was most frequently observed in both
fixed (31.3%) and removable retainer groups (27.7%). When calculus was
present, score 2 was the most common score in both groups (18.9% in fixed,
17.6% in removable). However, around two thirds of tooth surfaces were free
of calculus in both fixed and removable retainer groups.

No statistical difference in relation to periodontal parameters was observed


between the fixed and removable retainer groups (Table 17). In particular,
the median scores for the modified gingival index were slightly lower in the
fixed retainer group (P= 0.76). However, the median plaque levels (P= 0.27)
and CAL (P= 0.23) were slightly higher in the fixed group, although this was
not of statistical significance. When periodontal outcomes for the lingual
surfaces of the mandibular anterior segment in the fixed and removable
groups were compared, no significant difference was observed (P> 0.05)
(Table 18). Similar findings were observed in relation to the labial surfaces
(Table 18).

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Table 16. Stability outcomes in fixed and removable retainer groups.


Outcome Number of Time Statistical FR TPR
Coefficient† 95% CI P-value
measures participants point measures group* group

FR group: n= 21 T0 Median 0.25 0.42


IQR 0.47 0.84
Little’s TPR group: n= 21 T4 Median 1.23 3.16
irregularity 1.64 0.30, 2.98 0.02
index IQR 1.27 2.74
T4-T0 Median 0.85 2.37
IQR 0.91 2.26
FR group: n= 21 T0 Median 26.9 26.77
IQR 1.89 2.29
TPR group: n= 21 T4 Median 26.74 25.62
Intercanine
-0.26 -1.07, 0.55 0.52
width IQR 1.84 2.51
T4-T0 Median -0.28 -0.52
IQR 0.88 1.6
FR group: n= 21 T0 Median 42.8 41.77
IQR 3.96 4.03
TPR group: n= 19 T4 Median 42.23 42.66
Inter-molar
-0.40 -1.72, 0.93 0.55
width IQR 5.82 4.93
T4-T0 Median 0.15 -0.42
IQR 2.08 2.09
FR group: n= 21 T0 Median 24.45 25.84
Arch
IQR 3.83 7.04 -0.01 -1.15, 1.14 0.99
length TPR group: n= 19 T4 Median 22.15 20.81
IQR 2.96 8.33
T4-T0 Median -3.63 -3.78
IQR 0.59 2.1

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FR group: n= 9 T0 Median 0 0
IQR 0.19 0
Extraction TPR group: n= 10 T4 Median 1.37 1.65
site 0.16 -1.54, 1.86 0.84
opening IQR 0.72 1.57
T4-T0 Median 1.23 1.65
IQR 1.14 2.13
CI: confidence interval; FR: fixed retainer; IQR: interquartile range; TPR: thermoplastic retainer.
*Reference group.

Effect of treatment group on the outcome variables at T4.
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Table 17. Periodontal outcomes in the fixed and removable retainer


groups.
Outcome Statistical
FR group (n= 21) TPR group (n= 21) P-value
measures measures
Modified gingival Median 2.5 3
0.76
index IQR 3 3
Median 3.5 3

Plaque index 0.27


IQR 1 2

Median 0 0

Calculus index 0.19


IQR 1 1

Median 2 1.5

CAL (mm) 0.23


IQR 1 1

Bleeding on Median 1 1
0.87
probing IQR 2 2
CAL: clinical attachment level; FR: fixed retainer; IQR: interquartile range; mm:
millimetres; TPR: thermoplastic retainer.

Table 18. Periodontal outcomes in the labial and lingual surfaces in


both treatment groups.
Labial surfaces Lingual surfaces
Outcome Statistical
Pvalue Pvalue
measures measures TPR TPR
FR group group FR group group
Modified Median 1.5 2 3 3
gingival 0.20 0.38
IQR 3 3 1.5 3
index
Plaque Median 3 3 3.5 3
0.60 0.29
index IQR 2.5 2 1 2

Calculus Median 0 0 1 1
0.67 0.19
index IQR 0 0 1.5 2
Median 2 2 2 1.5

CAL (mm) 0.65 0.22


IQR 1 1 1 1

Bleeding Median 0 0 1 1
on 0.80 0.61
IQR 2 2 2 2
probing
CAL: clinical attachment level; FR: fixed retainer; IQR: interquartile range; mm:
millimetres; TPR: thermoplastic retainer.

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6.4 Discussion

Based on the findings of this four-year follow-up study, fixed retainers appear
to be more effective in preserving mandibular anterior segment alignment in
comparison with TPRs with in excess of 1.6mm less irregularity observed in
the previous group, although some deterioration was observed in both
groups. Given that subjects were randomly allocated to the retainer type,
irrespective of the baseline oral hygiene levels and previous periodontal
condition, it appears that fixed retention offers the potential benefit of an
improved preservation of alignment in the long term without significantly
increasing the risk of periodontal deterioration relative to the removable
retainers. It is important to note, however, that periodontal conditions cannot
be considered healthy in either group, with significant gingival inflammation
and elevated plaque levels a common finding which highlights the premium
on periodontal maintenance following orthodontics.

There are relatively few RCTs that have involved a comparison of the
effectiveness of fixed and TPRs (Xu et al., 2011; O'Rourke et al., 2016;
Forde et al., 2018). One of these involved a comparison between a lingual
fixed retainer combined with nights-only Hawley retainer and vacuum-formed
retainers (VFRs) prescribed for full-time wear (Xu et al., 2011). Similar
stability of the mandibular incisor alignment was noted at the one-year follow-
up (Xu et al., 2011). However, this study risked attrition bias due to the high
levels of drop-out with a small sample size. Similarly, in the earlier report of
the present study, O'Rourke et al. (2016) alluded to a lack of significant
between-groups difference in relation to the mandibular anterior segment
stability after 18 months. A recently published RCT involving a comparison of
fixed retainers and TPRs prescribed for nights-only wear also reported
comparable levels of relapse in the maxillary arch with a marginally greater
change (Little’s irregularity index: 0.92mm) in the mandibular arch at 12-
month follow-up (Forde et al., 2018). The findings from the present study

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imply that the benefit of fixed retention may well become more apparent
following more prolonged periods of retention mitigating against both
unstable tooth positioning and also against maturational change, while
declining levels of removable retainer wear may predispose to change. It
would therefore be intuitive to expect that further changes might take place in
the removable retainer group in the long term, amplifying the between-
groups difference in the longer term.

The observation of waning removable retainer wear over time is


unsurprising; moreover, it is likely that the suboptimal levels of wear claimed
in the present sample, with 67% non-adherent more than two years into the
retention phase, represents an overestimate of co-operation. It is accepted
that adherence to removable orthodontic component wear during active
treatment is limited with patients routinely failing to reach stipulated levels of
wear (Chapter 5). The expectation that patients might wear removable
retainers many years subsequent to treatment may therefore be somewhat
optimistic, particularly when the majority of this period is often not routinely
monitored by the treating clinician (Pratt et al., 2011a). It therefore appears
that novel means of enhancing adherence with retention regimens, including
approaches not directly reliant on patient-clinician contact, require further
refinement. These may include web-based or electronic methods such as
providing accessible and high-quality online information, promoting positive
behaviours on social media platforms, or the use of electronic reminders in
the form of e-mails or mobile applications.

A previous RCT has involved periodontal assessment of patients wearing


VFRs (Xu et al., 2011). In a 12-month follow-up, higher calculus index scores
were associated with fixed retainers compared to VFRs (Xu et al., 2011),
although periodontal assessment in the latter was confined to calculus
scores, in isolation. Furthermore, patients in the fixed retainer group were
instructed to wear an additional removable retainer at night, making it difficult
to distinguish between the effects of different types of retainers. In the
present study, participants with bonded wires were not prescribed any

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supplementary wear of removable retainers, ensuring that the impact of


retainer type both on stability and periodontal outcomes could be clearly
elucidated.

Participants in the present study were previously randomised into different


retainer groups, ensuring that all groups were likely to be similar with respect
to potential confounders including oral hygiene levels, although levels of
hygiene were suboptimal overall. This continued to be borne out in the
present follow-up. In particular, randomisation is likely to minimise selection
bias, particularly as fixed retainers are more likely to be reserved for those
patients exhibiting good oral hygiene. Observer bias was minimised in the
assessment of stability by obscuring the lingual surfaces of the teeth on the
study models; however, blinding was not feasible in the assessment of
periodontal outcomes, as this was measured clinically. Stability was
assessed in the mandibular arch as instability tends to be more salient in the
mandibular anterior region both due to treatment-induced and physiological
changes (Little et al., 1988). As such, more significant between-groups
differences may be apparent in the mandibular dental arch; nevertheless,
maxillary fixed retainers are similarly likely to be associated with optimal
stability. Notwithstanding this, the failure rate for maxillary retainers tends to
be slightly higher in view of occlusal and masticatory forces (Tacken et al.,
2010), potentially diluting any associated advantage. Stability was assessed
directly from study models using Little’s irregularity index (Little, 1975); this is
the most accepted approach to assessing stability. However, it fails to
account for vertical displacements, reciprocal rotations, angulation and
inclination changes. Based on lay and professional opinion, however,
horizontal displacements are consistently scored as the most salient feature
and this is reflected in Little’s scores (Kearney et al., 2016). In addition, one
should be mindful of inadvertent complications such as localised change in
torque, which are particularly prone to arise with fixed retainers in the long
term (Katsaros et al., 2007; Renkema et al., 2011). However, these
complications were not apparent in the present sample, although this may
reflect the relatively small sample size.

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In relation to the periodontal assessment, both an overall evaluation and


analysis of labial and lingual surfaces, in isolation, were included. The latter
ensured that the effect of plaque accumulation adjacent to bonded wires on
the lingual surfaces would not be diluted. In keeping with previous research
focusing on Hawley retainer to six-month follow-up (Heier et al., 1997),
whereby gingival index scores were increased on the labial surfaces of
maxillary and mandibular anterior teeth, minor changes were also observed
with the TPRs in the present study. The plaque scores present in both
groups were relatively high with median plaque index scores of 3 to 3.5,
being approximately 0.5 units higher than the mean plaque scores observed
on the lingual surfaces of the mandibular incisors with fixed and Hawley
retainers over a six-month period (Heier et al., 1997). A recently published
RCT, involved a comparison between fixed and VFRs in the mandibular
labial segment with no significant differences reported in gingival and
calculus indices at one-year follow-up; however, fixed retainers were
associated with significantly higher plaque scores (Storey et al., 2018).
However, the difference in plaque scores was not adjudged to be of clinical
significance (Storey et al., 2018). The difference between fixed and
removable retainers in terms of plaque and calculus levels was observed to
be substantial in another study (Mondal et al., 2017). However, there was
very limited information provided regarding the interventions, methods and
analysis undertaken, limiting the applicability of these findings (Mondal et al.,
2017).

A number of periodontal outcomes were assessed in the present study


potentially risking false positive outcomes in view of the high number of
statistical tests; however, these were all pre-specified and statistically
significant findings were not observed. This multitude of outcomes suggests
that refinement of outcomes within periodontology and general dental
research would be timely (Innes et al., 2016). Furthermore, the challenge of
selecting suitable outcomes is complicated by both the inherent subjectivity
of the available scoring systems (Hefti and Preshaw, 2012) and the lack of

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agreement in terms of the periodontal scoring systems to be used. The latter


was reflected in the heterogeneity of the periodontal indices in studies
concerning orthodontic retainers (Chapter 4). The Modified Gingival Index
was used as it is more sensitive to the extent of gingival inflammation in mild
cases in comparison to the Gingival Index developed by
Löe and Silness (1963). Additionally, the Gingival Index (Löe and Silness,
1963) is potentially invasive as a periodontal probe is used for examination,
rendering it difficult to assess the repeatability of the gingival scores and to
evaluate the volume of dental plaque, as the latter can also disturb the
integrity of the plaque biofilm (Hefti and Preshaw, 2012). In the present
study, the Modified Quigley-Hein Plaque Index (Turesky et al., 1970) was
used as it is more sensitive to smaller amounts of dental plaque in the
gingival third than the original Plaque Index (Silness and Löe, 1964). For
calculus scores, the index developed by Greene and Vermillion (1960) was
used as it distinguishes between supragingival and subgingival calculus.

The present study was limited by a relatively small sample size potentially
reducing the statistical power and risking false negative results; however,
significant findings were observed for the main outcome. Moreover, drop-out
was significant over the four-year period, although the final sample of 42 was
just six less than that obtained 2.5 years previously (O'Rourke et al., 2016).
However, drop-out rates were balanced between the groups and the main
reason for failure to attend was logistical, ensuring that missing data
occurred at random and therefore the risk of attrition bias was minimised.
Notwithstanding this, the challenge of recruiting and retaining a sufficiently
large sample to an orthodontic retention study is clear. Future research
evaluating the effectiveness of long-term approaches to orthodontic retention
should therefore be mindful of this issue. Furthermore, as this study was
conducted at a single, university-based centre, the findings are applicable to
patients with similar characteristics and may not be generalisable to other
settings and patient groups. Baseline periodontal assessment would have
facilitated a clearer understanding of the adverse changes occurring over the
retention period; however, patients with a history of periodontal disease were

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excluded at baseline (O'Rourke et al., 2016). Finally, an untreated control


group would have helped to ascertain whether the periodontal change
beyond that characteristic of maturation was associated with the four-year
retention period. However, recruitment of an age-matched, untreated control
with similar occlusal characteristics over a prolonged period could not be
justified from an ethical standpoint. Moreover, the magnitude of attachment
loss observed was small indicating that minimal effect could be attributed to
either retention regimen.

6.5 Conclusions

Fixed retainers may be more effective in retaining mandibular anterior


segment alignment compared to TPRs at four-year follow-up, although some
changes occurred in both groups. Both fixed and removable retainers were
associated with similar levels of gingival inflammation and poor oral hygiene.
On the basis of the present study, it therefore appears that fixed retainers
may be the approach of choice to maintain alignment of the mandibular
anterior teeth in the long term, but there is a clear need for optimal oral
hygiene before, during and after orthodontic treatment to avoid increased
levels of gingival inflammation.

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CHAPTER 7. FACTORS INFLUENCING ADHERENCE


WITH THERMOPLASTIC RETAINERS: A QUALITATIVE
STUDY

7.1 Background and Aim

Detailed analysis to provide a depth of understanding concerning


retainerrelated experiences from the patients’ perspective has not previously
been undertaken. The aim of this study was therefore to explore factors
influencing removable retainer wear over a minimum of four years giving an
in-depth understanding of patient perspectives over the medium-term
(Appendix 1).

7.2 Methods

Ethical approval for a major amendment was obtained (10/H0713/57,


Bloomsbury Research Ethics Committee; Appendix 5). A criterion-based
purposive sample of participants wearing thermoplastic retainers was
recruited from a previous randomised controlled trial (Chapter 6), including
both males and females and reflecting a variety of adherence levels.
Recruitment continued until data saturation was achieved. Participants
attending a four-year follow-up research appointment were provided with a
patient information sheet (Appendix 6) and invited to take part in the
interviews, and oral and written consent (Appendix 7) was obtained. The
interviews were undertaken in a non-clinical area at the Institute of Dentistry,
Queen Mary University of London.

A topic guide was developed and piloted based on professional opinion (DA,
FCS and PSF) (Appendix 8). The topic guide was adapted throughout the
study based on the participants’ responses. The interviews involved
discussions about the different phases of treatment following a chronological
order from appliance debond, retainer fit visit, and the different phases of
retention including experiences of full- followed by night- time wear for long

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term. Questions pertaining to the understanding of retainers, facilitators and


barriers to retainer wear, the process of seeking information during retention
phase, opinion about follow-up appointments and being discharged were
also asked. Furthermore, questions pertaining to the use of electronic
reminders designed to enhance retainer wear were asked (Chapter 9).
Prompts were used to facilitate an in-depth understanding of responses
(Ritchie et al., 2013). Relevant demographic and clinical data were obtained.
Subjective data concerning duration of retainer wear were recorded during
the interview.

The interviews were conducted by an orthodontic PhD student (DA), who


undertook formal qualitative research training prior to commencing the study.
The first three interviews were undertaken in the presence of a qualitative
researcher (FCS). The participants were informed about the interviewer’s
research and clinical roles prior to the interview. Interviews were
audiorecorded and transcribed verbatim, and lasted between 45 and 101
minutes. Transcription commenced directly after the interview using a
transcription service, and data were anonymised for analysis. The interviewer
(DA) reviewed the accuracy of all transcripts prior to the analysis stage. Field
notes were taken and were referred to during data analysis.

Data were analysed by two authors (DA, FCS) using NVivo TM qualitative data
analysis software (QSR international Pty Ltd, Australia, Version 11) following
the Framework Methodology involving: familiarisation, identification of
thematic framework, indexing, charting, mapping and interpretation (Ritchie
et al., 2013). Two researchers (DA, FCS) cross-checked the emergent
themes in parallel with data interpretation to ensure validity of the findings.
Any disagreements were resolved by joint discussion (DA, FCS and PSF).

7.3 Results

 Participant characteristics

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A total of 15 participants wearing thermoplastic retainers ( p1-p15) were


interviewed, including ten females (F) and five males (M) ranging from 19 to
30 years (Table 19). The average years in retention was 4.8 (range: 4-5.6
years). Six refused to take part in the interviews due to time commitment.
The number of participants was sufficient to achieve data saturation. Self-
reported levels of adherence to retainer wear ranged from few weeks (w),
months (mo), years (y) to adherent throughout.

Table 19. Participant characteristics (n= 15).

Participant Self-reported adherence to TPR


Gender Age (y)
number wear throughout retention phase

1 M 22.5 Adherent up to 1 y
2 F 19.6 Adherent up to 2 y
3 F 21.7 Adherent up to 2 y
4 M 20.5 Adherent up to 6 mo
5 F 21 Adherent throughout
6 F 23.1 Adherent up to 7 mo
7 F 21.7 Adherent up to 6 mo
8 F 30.2 Adherent up to 6 mo
9 M 20.5 Adherent up to 2 w
10 M 20.4 Adherent up to 1 y
11 M 20.2 Adherent throughout
12 F 19.8 Adherent up to 2 mo
13 F 19.6 Adherent up to 6 w
14 F 19.8 Adherent throughout
15 F 24.7 Adherent up to 2 mo
F: female; M: male; mo: months; TPR: thermoplastic retainer; w: weeks; y: year(s).

 Effect of time and age


Six main themes influencing retainer wear were modified mainly by the time
elapsed since debond and the participant age (Figure 13). Generally, retainer
wear fluctuates and typically wanes over time, in some cases ceasing
altogether. Initially, participants were motivated as a result of excitement
about the orthodontic treatment outcomes as they were eager to maintain
this with ‘short-term satisfaction’ being linked to a novelty effect. However,
motivation appears to diminish over time as inconveniences and pragmatic

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issues related to orthodontic retainers take hold. The follow-up appointments


typically reduce over time and ultimately cease, partly explaining the
associated reduction in adherence. After several months, most participants
went through a phase of questioning the need to wear the retainers often
making independent decisions to taper or cease wear. If any post-treatment
changes arose, selfmanagement and prescription were reported.
Nevertheless, participants also referenced occasions in which they improved
relaying the factors that prompted this. When reflecting on their experiences,
participants repeatedly referred to their immaturity at the start of retention as
a barrier to retainer wear.

Figure 13. Factors influencing adherence to thermoplastic retainer wear.

 Theme 1. Beliefs concerning retention


Retainers were considered important in maintaining post-treatment outcomes
being synonymous with feeling ‘secured’ and likened to a ‘safety net’.
Retainer wear was seen as a manifestation of a ‘perfectionist’ and a

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reflection of taking care of oneself. However, some confusion arose when


poor adherence did not necessarily result in any noticeable post-treatment
dental changes leading participants to question the importance of retainer
wear.
‘[A friend] has stopped wearing the retainers, and their teeth hasn't
really changed as much. I started thinking that maybe it's not that big
of a deal to stop wearing them.’ (M- Adherent up to 1 y P1)
Questioning the need for the retainers stemmed from their passivity in the
maintenance of post-treatment outcomes. However, their importance became
appreciated once dental changes were noticed stimulating attempts to
correct post-treatment changes. Furthermore, retainers were not perceived
as a continuation of treatment in all cases, with debond symbolising the end
of treatment.
‘You don't really see what it's doing because your teeth are straight
and the retainers are just a cover. It's only once the damage has been
done.’
(M- Adherent up to 6 moP4)
‘I was strict with myself, but then later on I was just a bit like “The
treatment's already done. I don't need to continue.”’ (F- Adherent up to
2 moP15)

Patients’ beliefs about their predisposition to the post-treatment changes


dictated the adherence levels. For some, feeling at lesser risk created a
barrier to retainer wear. For example, having particularly (1) long duration of
orthodontic treatment resulted in questioning the need to wear the retainers.
(2) The mild nature of pre-treatment malocclusion made some participants
feel less susceptible to post-treatment dental changes. Participants justified
the reduction in adherence over time as (3) the time elapsed since debond
increased. Following debond, participants felt greater susceptibility to
posttreatment dental changes, resulting in high adherence levels to allow
teeth ‘to settle’. However, after a period of time, the perceived need for the
retainers diminished resulting in poorer adherence.

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‘After one year, your teeth have become more fixed in that position, so
they are less likely to move.’ (F- Adherent up to 2 y P2)

The long-term requirement for retainers was viewed as an unrealistic


‘commitment’ by participants. The length of retainer wear was linked to a
certain age in which dental aesthetics may be a lesser priority. Furthermore,
the inability to remember the details of the recommendations made in terms
of duration and length of retainer wear was evident.
‘Once you've reached that stage where you don't really care how
people see you anymore, then why are you going to carry on wearing
your retainers?’ (M- Adherent up to 6 moP4)

 Theme 2. Perceived negative impact of post-treatment changes


Post-treatment dental changes were associated with a number of negative
connotations. Reluctance to undergo orthodontic retreatment due to pain and
impaired smile aesthetics was a motive for wearing retainers. Financial
burden associated with fixed orthodontic retreatment was also a stimulus for
retainer wear.

Participants were eager to prevent post-treatment dental changes when


reflecting on their previous experiences with fixed appliances. Jeopardising
orthodontic treatment outcomes was regarded as a devaluation of time and
commitment previously invested in prolonged orthodontic treatment. The
adherence early in the retention phase appears to reflect the investment
involved.
‘Four years' worth of braces treatment that I cannot let go down the
drain and one surgery… I didn't wear braces to my prom for no
reason.’
(F- Adherent throughoutP5)

 Theme 3. Effect on quality of life


The negative effects of retainers on quality of life seem to inhibit retainer
wear despite participants expressing the desire to be adherent. Negative

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experiences were related to physical and social impacts with perceived


burden on the participants’ lives. In relation to physical impact, pain markedly
constrained retainer wear, particularly after a period of non-adherence due to
hassle or forgetfulness, where participants reported experiencing numbness
and discomfort. However, for some participants, retainer tightness prompted
increase or resumption of retainer wear.
‘When I didn't wear it one time, my teeth were tight. So I was like, “I
need to make sure that I wear it afterwards.” That just gave me the
push that I need to wear it.’ (M- Adherent throughout P11)

Participants’ response to pain varied with some open to tolerating pain to


allow dental settling. However, in extreme cases, increased burden due to
pain led to a choice being made to completely stop retainer wear.
‘It hurts but I don't really mind because I know it’s going to keep my
teeth straight.’ (F- Adherent up to 2YP2)
‘I gradually stopped wearing them, so when I put them back on, they
really hurt. And then, I'd be less likely to wear it. Until I just stopped
wearing it.’ (F- Adherent up to 2 moP15)

During retainer wear, participants felt conscious of having ‘something


foreign’, an ‘extra layer’ and ‘extra heaviness’ on their teeth. Others
expressed the feeling of ‘lack of freedom’ during retainer wear. In terms of
appearance, although retainers are subtle, concerns were raised in this
respect. Participants referenced occasions where retainer wear during the
day caused embarrassment, impaired speech and had negative effects on
social activities. ‘When I took it out, I've heard “That's nasty” because they've
seen like a whole string of [saliva]. No matter how much you try to hide it,
you can't.’ (F- Adherent throughout P5)
‘Sometimes you'll miss a snack because you don't want to take it out
in front of people. You'd just rather eat at home.’ (F- Adherent
throughoutP5)

 Theme 4. Self-directed wear

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At the start of the retention phase, participants expressed intentions to wear


retainers due to high motivation and excitement in relation to recent
orthodontic treatment outcomes. However, participants perceived maintaining
a habit of retainer wear on regular basis as a ‘chore’, ‘time consuming’ and a
‘constant effort’. Maintaining the habit of retainer wear was challenging due to
forgetfulness or laziness in some instances. A strategy of linking retainer
wear to toothbrushing time to overcome forgetfulness was described. The
response of participants after missing a few days of retainer wear varied; in
some, it culminated in longer period of non-adherence but others
compensated with improved retainer wear thereafter.
‘Just thinking, “What's one day?” But then when you keep doing it, it's
not just one day anymore. It's a week that's gone by that you haven't
worn it a single day.’ (F- Adherent up to 6 w P13)
‘If I forgot to wear it for four hours, I'll keep it in for four hours extra
because I knew that I didn't wear it the day before.’ (F- Adherent up to
7 moP6)

As participants were in long-term retention, those who were non-adherent felt


that it would be challenging to set a habit to wear the retainers at this stage,
with the importance of setting habits early in the retention phase expressed.
Furthermore, participants alluded to the required hours and duration of wear
being an additional challenge in the long term.
‘When I can't meet that unrealistic standard, I just give up.’ (F-
Adherent up to 2 moP15)

Taking an active role in the retention phase was evident in terms of


selfdiagnosis, self-prescription, and making uninformed choices without
seeking professional advice. Participants attributed this to lack of follow-up
appointments and supervision, as well as immaturity. Independent decisions
in the form of self-prescription, and self-management of post-treatment dental
changes were reported:
‘I didn't think that I really needed to wear it [retainer] as often as they
said, so I just went my own way… That was my own personal

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decision. I didn't need to consult them because it was my retainers,


my teeth… I don't think it's normal for you to contact your orthodontist
to tell them how you are using the retainers.’ (F- Adherent up to 2 y P2)

Although cessation of retainer wear was an independent decision in many


instances, some participants reported not being conscious of the implications
of this due to their age and immaturity:
‘I was young, If I was ten years older then I would be a lot more aware
of it..’ (F- Adherent up to 2 yP3)
‘I was a kid. I was lazy, I just took it with the flow. But now, I'm much
more a planner.’ (M- Adherent up to 1 yP10)
 Theme 5. Network support
The importance of parental and peer support was widely discussed by
participants with regular referencing of parental advice about retainer wear;
however, this did not necessarily translate into optimal wear.
‘My Mum pushed me to wear the retainers. She said that I would have
to listen to the doctor and I'm like “Okay, I'll wear them”. But, I just
couldn't... I felt like it wasn't helping me in any way.’ (F- Adherent up to
2 moP12)

Peers and past patient experiences were quite powerful in raising awareness
about the importance of retainers. For example, knowing a friend who
experienced post-treatment dental changes because of poor adherence was
a motivator to retainer wear. Seeking non-expert advice was reported from
sources such as friends, and from patients’ online posts (YouTube videos
and online forums). Past patient experiences seemed to resonate more than
professional advice:
‘I would ask my friends about how often they wore their retainers to
see if maybe I should be wearing them more.’ (F- Adherent up to 2
yP2) ‘It was people my age showing you how to clean them and that's
what really attracted me, rather than seeing a professional video with
a dentist.’ (F- Adherent up to 7 moP6)

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Having friends who adhered to retainer wear made it socially more


acceptable to participants. However, in some instances, unfavourable
comparisons were made with peers, which served as a barrier to retainer
wear. Furthermore, being the only one wearing retainers was perceived as
problematic.
‘Many of them [friends] came off their retainers a lot quicker than I did.
And they said “Oh, nothing would happen, It doesn't matter”... And
their teeth hasn't moved as much. So I started thinking maybe it's not
that big of a deal to stop wearing them.’ (M- Adherent up to 1 y P1)
‘I was the first one to wear them in school so it was really unusual. If I
saw someone wearing them, I would've been okay.’ (F- Adherent up
to
2 moP12)

In terms of patient-clinician relationship, participants expressed trust in the


advice provided and adhering to professional recommendation was given as
a reason to wear retainers. Furthermore, participants saw dentists as an
authoritative figure reporting a sense of obligation or duty towards the
treating clinician:
‘It would have a bit more of a personal connection, because he's the
one that put your braces on, you'd feel more likely to put the retainers
on… You don't want to disappoint them.’ (M- Adherent up to 1 y P10)

In terms of communication with the treating clinician, some participants felt


unable to articulate their concerns, needs and preferences to their dentist in
view of their age, change of clinician, and infrequent follow-up appointments.
‘I was a child… I wasn't as vocal to speaking out about what the problems
are. If I had retainers now, I would be more opened to discussing it.’ (F-
Adherent throughoutP5)
‘The appointments were so far and few between... I don't feel like I
ever had a relationship with the dentist.’ (F- Adherent up to 2 mo P15)

Participants valued the importance of follow-up appointments and linked this


to the need to persevere with retainer wear. The lack of follow-up

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appointments was cited as a reason for cessation of wear in some.


Furthermore, participants highlighted the importance of follow-up
appointments in sharing concerns with the clinician, consolidating their
knowledge of retainer wear and asserting the importance of retainers. At
follow-up appointments, participants described wanting their clinician to show
empathy, be friendly but also professional. Being discharged was viewed
negatively, with participants described themselves as ‘on their own’ without
professional input.
‘I didn't have any more appointments. So, I just wore it for one year
and then stopped completely.’ (M- Adherent up to 1 y P10)
‘It [a concern about retainers] wasn't something that I could speak to
my dentist. Because I had no appointment, I had to Google it.’ (F-
Adherent throughoutP14)
‘If I was to have my old dentist, I would have taken it [retainer wear] on
board… He was so serious about it and had so much authority in my
eyes. I took his words literally. The way he said it, it was words of
encouragement but words of firmness.’ (F- Adherent up to 7 mo P6)

Participants emphasised the importance of being informed about retainers


from the start of the treatment in order to be prepared for the retention phase.
One participant described being anxious prior to the fit of the retainer
expecting it to be a ‘big head brace’. Participants felt that verbal
communication was inadequate and must be supplemented with illustration
of consequences of poor retention. Seeing photos of real patients was
perceived as ‘evidence’, ‘confirmation’ and would ‘strike home’.
‘Even when my doctor gave me a booklet about retainers, I just read
the first page… No one's bothered to read long booklets. You want
video clips.’ (F- Adherent up to 2 moP12)

 Theme 6. Pragmatic issues


Maintenance requirements including the limited durability and ease of loss
due to size and transparency of the thermoplastic retainers were both
considered barriers to retainer wear especially in the long term. Incidents of

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retainer loss or breakage after a period of wear marked the end-point of the
retention phase in many instances. Furthermore, participants reported
challenges in terms of cleaning the retainers especially in accessing the
fitting surface of teeth. ‘Given one pair and being told that it is supposed to
last for life is very impractical. Perhaps two pairs, like one pair and then a
spare one. If anything happens, they have a back-up.’ (F- Adherent up to 6
moP7)

Inaccessibility to retainers also appeared to influence retainer wear with


participants wearing the retainers typically if they were at home. However,
change of setting complicates access with holidays and outdoor activities
being associated with suboptimal wear. Visually seeing the retainer acted as
a direct aide memoir to remind patients to wear the retainers in many
instances, although this did not necessarily result in a decision to wear the
retainers.
‘I had a school trip and I just left it [retainers] at home. I didn't want the
extra responsibility if I lost them...’ (M- Adherent up to 1 y P10)

7.4 Discussion

This is the first study to explore patients’ perspectives on factors influencing


removable retainer wear allowing an in-depth understanding of their
experiences. A number of previously underreported issues related to
prolonged retention were identified, for example, self-directed wear, reticence
to share concerns with treating clinicians, negative influence of peers,
negative beliefs, and unmet needs in terms of follow-up appointments and
information provision.

Orthodontic retainers are theoretically a lifelong experience and are


prescribed routinely following orthodontic treatment; however, relatively few
studies have considered patient-reported outcomes in long-term retention
(Pratt et al., 2011b). Furthermore, most studies measure outcomes relevant
to the patient experiences using questionnaires, risking failure to capture an

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in-depth response. Patients’ experiences assessed in previous prospective


studies primarily involved aspects related to discomfort, embarrassment,
speech impairment and aesthetics (Hichens et al., 2007; Forde et al., 2018).

The qualitative approach assisted in understanding the patients’ behaviours,


motives and impact of experiences related to treatment. Although quantitative
studies offer an objective measure of the different outcomes, in some
instances explanation of such outcomes are only possible using qualitative
methods. Therefore, the current study was undertaken on a subset of the
sample included in a previous randomised controlled trial (Chapter 6).

Findings from a previous qualitative study have helped to inform the nature of
a novel intervention designed to optimise adherence to intra-oral elastic wear
(Veeroo et al., 2014). Similarly, results from this study can be utilised when
developing interventions aiming to enhance retainer wear, support patients
and addressing their needs. Themes identified from the current study could
be incorporated into measures of retainer impact on the quality of life and
overall experience. Moreover, participants reported a preference for visual
aids in information provision to allow better understanding of retainers and
their importance. This reinforces previous work whereby visual images were
used to highlight the consequences of poor adherence to Hawley retainer
wear (Lin et al., 2015). The latter in combination with verbal instructions and
parental involvement resulted in higher adherence levels in comparison to
verbal instructions alone (Lin et al., 2015). Relatively few (8%) of prospective
patients reported searching for online information related to their orthodontic
treatment in a previous UK-based study (Stephens et al., 2013). However, as
patients in long-term retention invariably lack formal follow-ups, more
frequent use of the Internet-based resources to access relevant information
from non-professional sources would be intuitive (Chapter 8). This also
corroborates recent reports of patients sharing experiences and concerns
about orthodontic retainers on social media (Chapter 8), and was reflected in
the frequent referencing of use of YouTube videos and other social media
sites in the present study.

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Participants included in this study were in prolonged retention and treated in


a hospital setting by postgraduates in which patients are followed-up for up to
a year post-debond. As such, the present findings may not be applicable to
other settings. The recommended duration of retainer wear in this study was
fulltime for the first six months, followed by part-time (nights-only wear). This
approach was chosen as the initial clinical trial (O'Rourke et al., 2016) was
designed to evaluate the comparative effectiveness of this wear protocol
versus fixed retention. This regimen was in line with previous research (Atack
et al., 2007); notwithstanding this, nights-only wear from the outset may be
equally effective (Littlewood et al., 2016) and might risk less degradation and
breakage of the vacuum-formed retainers. Furthermore, participants’ views
may be potentially altered by response bias, especially given that
interviewees were aware of the focus of the research. Notwithstanding this,
the interviewer used non-leading questions and was not the treating clinician,
potentially allowing participants to express their experiences more candidly.
However, as the interviewer was an orthodontist, potential biased responses
may stem from their preconceptions regarding the research topic. This was
mitigated by the involvement of a qualitative researcher and by group
discussions between the research team members during both the data
collection and analysis phases of the study.

7.5 Conclusions

Six key influencers of adherence to removable orthodontic retainer wear


were identified. These include; beliefs concerning retention, perceived
negative impact of post-treatment dental changes, effect on quality of life,
self-directed wear, network support and pragmatic issues. The findings of this
study highlight the need to develop interventions to improve the patient
journey in the retention phase. Approaches to improving adherence should
account for these while also being responsive to time following the removal of
active appliances and patient age.

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CHAPTER 8. WHAT ARE PEOPLE TWEETING ABOUT


ORTHODONTIC RETENTION: A CROSS-SECTIONAL
CONTENT ANALYSIS

8.1 Background and Aim

Twitter is a popular online social networking website established in 2006.


Twitter users can post and re-post tweets and follow other users enabling
social communication and networking. It is seen as a safe space in which
users can share real-time experiences with nearly one quarter of
orthodontists and orthodontic patients using it (Nelson et al., 2015). Data
derived from Twitter, however, has gained little attention within the
orthodontic literature. Removable retention is known to be reliant on optimal
adherence and influence by peer support. However, no studies have
evaluated Twitter content in relation to orthodontic retainers.

The aim of this cross-sectional study was therefore to describe the content of
Twitter posts related to orthodontic retainers (Appendix 1). The findings from
this study were used to inform the development of a bespoke mobile
application (Chapter 9).

8.2 Methods

Tweets were prospectively collected from publicly-available posts on Twitter


(www.twitter.com) using a bespoke social media monitoring tool
(https://www.brand24.com). The search was limited to original English
language tweets. Tweets containing the keywords ‘retainer OR retainers’
were collected over a period of three weeks (October 13 th to November 2nd,
2016). This search yielded 6,900 tweets; these were exported and randomly
ordered using Excel (Microsoft, Redmond, Wash), with 10% randomly
selected (n= 690). This number was anticipated to be sufficient to obtain
thematic saturation based on previous research (Heaivilin et al., 2011).
Thereafter, a follow-up search, in which tweets were collected over a one-

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month period (December 2016) was undertaken to ensure no new themes


emerged from the data, using the following keywords: ‘retainers AND dentist’
or ‘retainers AND orthodontist’. The later search yielded 137 tweets, and
were all to be included in the analysis. The exported data included the tweet,
date and time of posting, and the number of followers. Tweets were excluded
if the content was unclear, not in English, irrelevant to orthodontic retainers
or a duplicate. Pilot coding was undertaken on a subset of tweets (n= 70) by
two authors (DA, PSF) to agree on themes. Reconciliation of disagreement
followed joint discussion and an initial coding guide was agreed upon. If a
link was provided in the tweet, it was investigated in order to better
understand the content. Each tweet was categorised according to its content;
in certain scenarios, tweets were categorised under multiple themes. In order
to classify the tweeter into patient or professional, the public profile was
checked as required.

 Content analysis
The data were categorised under initial themes (Table 20). When a new
theme emerged, the list of themes was reviewed iteratively, refined and
retested against the data. Frequencies of tweets within each theme and sub-
theme were subsequently determined.

Table 20. Main themes, with definitions and a relevant representative


tweet.
Representative tweets
Main themes Definitions
(paraphrased)
Indicates retainer wear status, ‘I just realised I’ve been
consequences of poor forgetting to sleep with my
Adherence
adherence, barriers or retainers in... for the last three
facilitators. years’
Illustrates the effects of ‘The dentist told me I need to
retainers on daily activities or start wearing my retainers...
Impact
social life. can’t wait to look nerdy with
ugly lisps’
Refers to the care needed to ‘Flossing with wired retainers is
Maintenance maintain or avoid the loss of hard. I should be paid for this. I
orthodontic retainers. made my dentist so much

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money’
Concerns the ease or difficulty ‘When your orthodontist says
in dealing with or accessing you can start wearing your
Patientclinician clinicians, or describes the retainers part-time only, but
relationship quality of communication you’ve already been doing that’
between patients and
clinicians.
Any tweet related to retainer ‘I feel so good for having worn
Positive
wear expressed in a positive my retainers every night this
feelings
tone. week’
Any tweet related to retainer ‘I HATE HATE HATE HATE
Negative
wear expressed in a negative RETAINERS’
feelings
tone.
Any tweet providing ‘Going to the dentist to pick up
information not my retainers and get this screw
Miscellaneous out my jaw then post braces
categorised within the
main themes. life officially starts’

8.3 Results

Of 827 tweets, 660 were included in the content analysis (Figure 14). The
included tweets were posted by 642 users, who had 483,458 followers
overall. The themes most frequently referred to were adherence, impact,
negative feelings and maintenance (Figure 15). Sub-themes were identified
within each of these areas with, for example, impact incorporating issues
such as pain; social effects; issues with fit, eating and sleep; and gingival
symptoms (Figure 16).

Figure 14. Flow diagram of the included tweets.

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Figure 15. Frequency of tweets within each main theme.

Adherence with orthodontic retainers was the most frequently-coded theme


(n= 248). Non-adherence was reported six times more frequently than being
adherent to retainer wear (n= 131 vs. 20). Some of the non-adherent
reported not wearing their retainers for prolonged periods, extending to a few
months and even to years (n= 53), while 18 tweeters reported not wearing
their retainers for short periods of a few days, and three reported never
wearing retainers after debonding. Twenty-four alluded to relapse or the
need for orthodontic retreatment as a consequence of non-adherence.

Barriers and facilitators to retainer wear were mentioned in some tweets (n=
40), with the most commonly-listed issue being forgetting to wear the
retainers (n= 8). Conversely, the most common facilitator mentioned was
fear of relapse and unwillingness to undergo orthodontic retreatment (n= 7).
Other facilitators and barriers are listed in Figure 17. In terms of the impact of
retainer wear on their daily activities or social life, pain or discomfort
associated with retainer wear was referred to commonly (n= 107; Table 21).

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Figure 16. Distribution of tweets within each theme and sub-theme.


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Figure 17. Facilitators and barriers to retainer wear.

Table 21. Impact of orthodontic retainers on daily activities and social


life.

Negative impact Positive impact

Pain attributed to recommencement of wear Less pain with


following a period of no wear, subsequent to increased retainer
Pain
retainer adjustment, during retainer removal, wear (n= 1)
or related to broken fixed retainers (n= 107)
Gingival pain and bleeding (n= 7) -
Gingival health

Difficulty of removing, or wearing both Retainers fitting


Quality of fit maxillary and mandibular retainers at the well (n= 1)
same time (n= 16)
Stuttering and lisp (n= 25) -
Speech
Teased about altered speech (n= 1)
Inability to eat with retainers in place, eating Avoid binge
for long periods interfere with retainer wear eating (n= 1)
Eating
and mistakenly chewing food while retainers
in situ (n= 15)
The necessity to remove retainers prior to -
Embarrassment meals, being displaced due to sneezing or
excessive salivation (n= 3)
Being described as ‘nerdy’ or having ‘false Appearance of
Appearance
teeth’ (n= 6) fuller lips (n= 1)
Retainers displaced during sleep (n= 10) -
Sleeping
Difficulty in sleeping (n= 2)

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Retainer loss was frequently reported (n= 47); of these, seven reported
throwing away their retainers accidentally. In addition, specific reports in
relation to retainer breakage (n= 18), misplacing retainers (n= 10), and
damage by pets or during cleaning (n= 8) were delineated. On the corollary,
finding previously lost retainers was described (n= 15) and modes of storage,
including in pockets, wallets and cases, were alluded to. Issues associated
with maintaining optimal hygiene was also reported with both fixed and
removable orthodontic retainers. While concerns with fixed retainers chiefly
described difficulty in flossing, the issues with removable retainers were
associated with the odor, taste and cleaning methods (n= 14).

Patients frequently tweeted about anticipating disapproval or actually being


rebuked by their dentist or orthodontist for suboptimal retainer wear,
inadequate flossing around fixed retainers, and for having lost or ill-fitting
retainers (n= 16). Interestingly, being repeatedly asked by the clinician about
their retainer wear was a common source of irritation (n= 7), while not being
given the option to select retainer type was also mentioned (n= 1).
Dishonesty regarding retainer wear was also alluded to (n= 9), with some
recounting persuading their orthodontist that they were wearing their
retainers as required and that their retainers still fitted. Four tweeters also
pointed out that their orthodontist was unable to detect non-adherence, while
just a single tweet referred to the orthodontist’s ability to detect suboptimal
retainer wear.

The majority of tweets portrayed retainer wear in a negative light, with most
of these related to the experience of wear (n= 103), with a few also unhappy
with the length of retainer wear or necessity for impressions (n= 8). Some
tweeters explicitly expressed regret for either not wearing their retainers as
required or for losing their retainers. There were considerably fewer positive
(n= 17) than negative (n= 126) tweets. Positive comments were related to
excitement about tapering wear, or to graduating to night-only wear. Few

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tweeted about being proud or feelings of accomplishment related to being


adherent, while admiration for those more adherent was also mentioned.

Advice on the importance of adhering to retainer wear was emphasised by


patients (n= 10) and professionals (n= 12). Professionals also tweeted about
the rationale for retainer wear and storage (n= 4). The wear regimen was for
‘night time for long term’ according to one orthodontic practice. However,
there was a lack of consensus among patients regarding wear regimen, with
‘every other day’, ‘for life’ and ‘night time’ reported in single tweets. In
general, tweeters did not seek advice regarding required wear time, with only
one enquiry concerning the required length of wear. Comparison between
fixed appliances and retainers were discussed (n= 6), with most preferring
the previous. Five tweeters also discussed preferences regarding retainer
type; most preferred fixed over removable.

8.4 Discussion

Based on the number of identified tweets, it appears that Twitter is a platform


in which experiences concerning orthodontic retainers were shared.
However, the number of tweets from patients dwarfed those made by
orthodontic practices and clinicians with the latter primarily using Twitter as
an advertisement platform. The relative preponderance of patient tweets may
go some way to explaining the negative overall impression of orthodontic
retainers highlighted within the present study. The impact that this may have
on adherence levels among social media users can only be speculated upon;
however, further positive engagement in social media by clinicians may help
to counterbalance this narrative. The issue of nonadherence with removable
orthodontic retainers together with the associated effects on both daily and
social activities was identified in the majority of tweets. Moreover, this was
observed to induce feelings of regret, and anxiety among orthodontic
patients. Interestingly, the nature of the patient-clinician relationship during
the retention phase was commonly referred to.

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The majority of tweets concerning orthodontic retainers posted by patients


were in the context of sharing experiences, in keeping with previous studies
concerning Twitter posts related to fixed orthodontic treatment, aligners,
orthognathic surgery, hypodontia and dental pain (Heaivilin et al., 2011;
Rachel Henzell et al., 2014; Chan et al., 2017; Noll et al., 2017; Barber et al.,
2018; Watts et al., 2018). Although a limited number of tweets related to
seeking advice and expressing concerns, the number of patients accessing
Twitter for specific orthodontic information remains unclear. Moreover, the
methods that patients use to seek advice in relation to active orthodontics or
indeed the retention phase remains incompletely understood. Stephens et al.
(2013) highlighted that prospective orthodontic patients seek information
from a range of sources including general dentists, orthodontists as well as
written and electronic advice with 8% alluding to accessing information with
regard to orthodontics on the Internet. It would be intuitive to expect,
however, that those in the retention phase utilise less formal or established
approaches to garnering advice as they may no longer have formal follow-up
appointments (Renkema et al., 2009; Pratt et al., 2011a). Moreover, if
patients are perusing social media and websites to seek information without
professional clinical guidance, the availability of balanced, ideally evidence-
based information would be preferable. This is especially important in the
view of the lack of consistent advice regarding retainer wear regimens
available on other orthodontic websites (Doğramacı and Rossi-Fedele,
2016).

The use of social media has proven effective in educating orthodontic


patients and improving knowledge retention in previous research using
YouTube videos (Al-Silwadi et al., 2015); social media may therefore present
an opportunity for clinicians to provide balanced, easily accessible
information to orthodontic patients. Moreover, Twitter can be harnessed to
promote positive behaviours by allowing patient interaction through contests
or events (Jorgensen, 2012), and by relaying meaningful research findings to
patients in a digestible manner. Nevertheless, there remains minimal

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appreciation of the orthodontists’ usage of Twitter; accessing and setting up


an account can be undertaken done relatively easily.

Quantitative analysis of the identified tweets suggested that those reporting


not wearing retainers exceeded those reporting good retainer wear by a
factor of three. While this figure is not likely representative of the orthodontic
population more widely, the negative connotations associated with reports of
problems associated with retainer wear should not be overlooked. Indeed,
the impact of negative peer influence on adherence with glycemic control in
diabetic patients has previously been reported (Thomas et al., 1997). The net
effect, therefore, is likely to be detrimental and potentially disproportionate in
view of the accessibility of publicly-available tweets in comparison to the
limited access to evidence-based research findings published through
conventional written or electronic means (Grimshaw et al., 2012).

It is important to note that the time period elapsed without wearing the
retainers was likely to have a bearing on the impact of non-adherence; this
aspect was not always clear within this subset. In line with previous research,
the most frequently reported cause of failure to wear retainers was simply
forgetting to wear them (Lin et al., 2015). However, follow-up appointments,
good communication and the use of reminders were associated with
improved adherence. Therefore, novel techniques developed to enhance
retainer wear, such as text messages, e-mail reminders, or use of mobile
applications, which may involve less exposure to formal follow-up
appointments should be developed with an appreciation of these issues.
Furthermore, some form of prolonged and regular follow-up should be
encouraged. Notwithstanding this, the optimal intervals between and duration
of follow-up required remain unclear (Johnston et al., 2008; Renkema et al.,
2009; Pratt et al., 2011a; Lai et al., 2013; Habegger et al., 2016).

The present cross-sectional analysis does suggest that orthodontic retainers


have an impact on daily and social activities, such as pain and
embarrassment related to aesthetics and speech, and difficulty in

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maintaining oral hygiene around fixed retainers (Hichens et al., 2007;


Sawhney, 2014). However, a number of previously unreported issues
including teasing, embarrassment during their removal in public and
displacement due to sneezing and during sleeping were exposed.
Furthermore, symptoms related to the gingival health such as pain and
bleeding, allied to concerns related to the smell and taste of removable
retainers were reported. Furthermore, loss or damage of removable retainers
were frequently referred to, the latter is in line with previous research in
which mean retainer survival did not exceed a year (Sun et al., 2011). The
provision of spare removable retainers following removal of appliances has
been suggested to remedy this (Behrents, 2016).

The role of the treating clinician in improving adherence was apparent. This
reinforces previous research which has confirmed that the dentist-patient
relationship is instrumental in enhancing adherence with orthodontic adjuncts
(Bartsch et al., 1993; Sinha et al., 1996; Bos et al., 2005). The importance of
realistic delineation of the implications of retainer wear with both fixed and
removable retainers was clear. By extension, it may be reasonable to
consider giving patients the option of selecting retainer type in certain
instances, especially in the absence of high-quality evidence to support the
use of one type of retainers over the other (Littlewood et al., 2016).

The present analysis involved an assessment of patient perspectives;


previous research in orthodontics has exposed that a limited number of
studies involve patient-centred analysis, with questionnaires being the
predominant method used (Hichens et al., 2007; Scribante et al., 2011). The
latter approach can risk recall bias in view of the time-lag between the
experience and the timing of the study. A further limitation was the risk of
response bias in which the patient may try to please the clinician. As such,
an analysis of Twitter is powerful as it reflects unvarnished, real-time
experiences of orthodontic patients. Notwithstanding this, the possible
limitation of using Twitter as a source of data is selection bias, in which the
characteristics of patients posting about their experience with retainers are

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not necessarily representative of the population. Furthermore, it was not


feasible to identify the demographic data, as this is dependent on information
shared by the user. Another challenge, was the inability to determine
whether patients were referring to fixed or removable retainers in some
tweets, and indeed the specific type of removable retainer. Although the
sample size in this study was low compared to other studies including data
from Twitter posts (Noll et al., 2017), it was sufficient to allow for thematic
saturation. Furthermore, in this study, coding was performed manually. The
use of sentiment analysis software can aid in categorising tweets into
positive, negative or neutral; however, it does not facilitate in-depth
understanding of the context. Furthermore, the lack of ability to detect irony,
sarcasm or the ability to understand of unusual use of words and phrases is
a major limitation with sentiment analysis software, ensuring it was not a
substitute for detailed individual review of comments (Thelwall et al., 2012).

8.5 Conclusions

Negative experiences in relation to orthodontic retainers are extensively


shared by patients on Twitter. In particular, negative social effects of
retainers and impacts on daily activities in addition to maintenance
requirements were mentioned, while the impact of the clinician-patient
relationship was also commonly referred to. In view of the growing reach of
social media, as well as the negative portrayal of orthodontic retention, the
importance of offering balanced and useful professional orthodontic
information is clear.

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CHAPTER 9. DEVELOPMENT OF ‘MY RETAINERS’


MOBILE APPLICATION: TRIANGULATION OF TWO
QUALITATIVE METHODS

9.1 Background and Aim

The diligent wear of removable orthodontic retainers requires prolonged


adherence and is invariably necessary to preserve optimal results.
Patientinformed behaviour-change interventions represent a promising and
novel means of improving adherence to retainer wear. The aim of this study
was to develop a patient-informed mobile application aimed to enhance
retainer wear (Appendices 1 and 9).

9.2 Methods

Following the initial stages of the Medical Research Council framework


(Craig et al., 2008), interventions tested in published research were identified
(Figure 18). Thereafter, an online search of available websites and mobile
applications both in Apple App Store and Google Play was undertaken. All
available interventions identified were critically reviewed to assess the
opportunity for a mobile application to enhance retainer wear (DA, PSF). An
initial proposed design of a mobile application homescreen, components and
examples of messages to be sent to users was drafted based on
professional opinion (DA, PSF). This formed a basis for the final mobile
application as well as providing a visual probe for interview discussions.

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Figure 18. Stages followed to develop the mobile application features,


content and design.

To assess the feasibility of the initial proposed design, one-to-one


semistructured interviews were conducted with a subset of participants to
account for patient preferences in terms of design and content. Recruitment
continued until saturation of information was achieved. Furthermore,
questions related to factors influencing removable retainer wear were posed
and these findings are presented in Chapter 7. Additional details about
participants’ characteristics and study conduct are described in Chapter 7.

The initial proposed design of a mobile application and daily reminder


messages were presented as visual probes to facilitate discussion. Prompts
were used to allow an in-depth understanding of participants’ responses
(Ritchie et al., 2013) concerning features, content and design. The six key
stages of thematic analysis were followed in a recursive process, namely
familiarisation; generating of initial codes; identifying, reviewing and defining
themes; and reporting the findings (Braun and Clarke, 2006). Data were
analysed by two authors (DA, FCS) using NVivo TM qualitative data analysis
software (QSR international Pty Ltd, Australia, Version 11). Two researchers
(DA, FCS) cross-checked the emergent themes in parallel with data
interpretation to ensure validity of the findings. Any disagreements were
resolved by joint discussion (DA, FCS and PSF).

A total of 7037 publicly-available retainer-related tweets were prospectively


collected over a period of three to four weeks (Chapter 8). Content analysis
of 827 randomly selected tweets was undertaken. Detailed methods are
described in Chapter 8. The findings of the previous study (Chapter 8) were
used to inform the content; for example, the nature and impact of pain,
impaired speech and poor fit of retainers were addressed in the content of
the mobile application.

The final features, content and design of the mobile application were drafted
following liaison with the mobile application developer and was then

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developed using Apple’s XcodeTM application. The application was


subsequently uploaded to the Apple App Store and made compatible with
iPhone and iPad (Apple Inc.).

9.3 Results

 Results of the interviews


Semi-structured interviews were conducted on 15 participants who were at
least four years into the retention phase using thermoplastic retainers.
Participants’ average age was 21.7 ± 2.8 years (range: 19-30 years), and the
majority were females (n= 10). All participants reported the use of a smart
phone.

A variety of platforms were suggested by participants for the delivery of


reminders or retainer-related information including e-mails, social media
platforms and mobile applications. E-mails were perceived as potentially
useful due to their convenience, free availability and universal usage among
adolescents. E-mails can help facilitate direct communication with the
treating clinician, receiving reminders and information about retainers.
Encountering retainer-related posts while ‘scrolling’ through social media
feeds, rather than receiving direct and ‘targeted’ messages was valued.
Specifically, Twitter was appreciated for its functionality of being ‘searchable’
and Instagram for being highly visual. The use of a bespoke mobile
application to enhance retainer wear was considered helpful with a number
of influential factors underpinning its use (Table 22). Participants described
their preferences in relation to the mobile application features, content and
design (Table 23).

Table 22. Facilitators and barriers relating to bespoke mobile


application use.

Facilitators Barriers

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 Contemporary and convenient 


Time-consuming
 Minimise burden of appointment 
Requires commitment Lack
attendance Remote and ease of
of access to a smart phone
 access to relevant information  or Internet connection
Professional recommendation Technical challenges (device
incompatibility and limited
 mobile memory space)

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Table 23. Recommendation and implementation of the mobile


application features, content and design.
Themes Recommendations Implementation
Liaison with the ‘Having a problem? E-mail us’ feature
Features

treating clinician. was added to contact the clinician.

Interactive Contact with other Not implemented.


features users to allow
competitions and
compare scores using
‘leader board’.
Log hours of wear Calendar tool was built in the mobile
with visual application to log in hours of retainer
Tracking representation of wear (Figure 19). The calendar was
progress days in which the colour coded to present the days in
retainers were which the retainers were worn (green),
worn/not worn. not worn (red) as required.
- Friendly and A bank of 29 reminder messages was
short labelled developed to appear as a notification
reminders. - through the mobile application.
Changeable Example:
messages. ‘Hi John. It’s time to put them on!
- Non- Retainers are necessary after braces to
patronising keep your teeth straight.’
Reminder language.
system and
Provision of uplifting An auto-generated responsive feedback
responsive
and friendly feedback system was built with a bank of 30
feedback
on logged hours of responses. Feedback messages
wear. depend on the hours logged in.
Examples:
* ‘Well done, keep going!’
* ‘It doesn’t seem to be a good
retainer day for you, get in touch with us
if you need help.’
- Address users - Address users by their name in
by their name. the first screen and in the reminders.
- Log relevant - Users can upload their photo
dates. - Upload a and log in the following information:
Tailoredmade personal photo. debond date, next appointment date
and clinician’s name.
User-control over:
- reminder alerts. - Users can set notification time.
- background colour. - Not implemented.
Past patients’ To include stories of Not implemented.
Content

accounts past patients.

To include concise A ‘FAQ’ (Figure 20) and ‘quiz’ sections


Written advice and informative were added.
advice. The following were added:
- A Comprehensive list of

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To include practical questions related to retainers. This was


solutions. informed from social media posts
Information about (Chapter 8), as well as from the
reported concerns in the interviews.
general dental health
- Short and concise answers.
and relevant
- Practical tips and solutions were
added.
orthodontic Examples:
information. * ‘Any tips to avoid losing my
retainers?’ * ‘My retainers don’t fit,
what should I do?’ - Oral hygiene
information was added. - Information
about the debond visit was added.
Examples:
* ‘Will it be painful to remove my
braces?’
* ‘What should I expect at the brace
removal (debond) visit?’
Photos of past Photos were added in the ‘FAQ’ and a
patients with optional hyperlink was used to allow optional
viewing of photos of viewing.
Visual aids teeth.
Short videos of past Not implemented.
patients’
experiences.
To add the The following were added in the ‘about’
governing body section:
Credibility
name and logo. - Developers’ affiliation.
- The organisation and funder logos.
To change initial Replacement of initial logos.
Ageappropriat
Design

design to make it
e
age-appropriate.
- Bold font to Main headings in the ‘FAQ’ were
Font emphasise words. changed to bold font and neutral
- Not to use red colours were used.
font.
FAQ: frequently-asked questions.

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Figure 19. Screenshot of the calendar tool in ‘My Retainers’ mobile


application.

Figure 20. Screenshot of the frequently-asked questions section in ‘My


Retainers’ mobile application.

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A. Features
The ability to remotely contact the orthodontist was a valued feature,
especially if concerns were not listed in the mobile application content.
Remotely contacting the clinician, was reported as a way to supplement, but
not substitute the clinical follow-up appointments. Interactivity features with
other users, such as the use of ‘leadership boards’, were described to add a
‘competitive edge’ and may, therefore, act as an ‘incentive’ to retainer wear.
‘The patient will feel they've kind of lost contact with the dentist
because this is how I felt a bit after the braces, because with the
braces, I had regular check-ups. The dentist can assure the patient
that this app would make sure that we have this connection.’
(Participant 14)
‘Just the fact that you have the contact with your dentist, you have the
ability to keep in conversation with him, that alone is, is a selling
point.’ (Participant 4)

Participants highlighted the importance of having a reminder system with


popup notifications and a tracking calendar to log hours of wear. They
preferred changeable and short labelled reminders that were friendly, not
patronising and motivational in nature. However, for some participants,
logging details of retainer wear was perceived as a ‘commitment’ and ‘time-
consuming’. Responsive feedback after logging hours of wear was
appreciated, with an emphasis on the importance of a friendly and uplifting
tone.
‘It's more visual [calendar], you have a plan you know what you are
doing, you are not just going on a whim on yourself. It will make you
feel like “Okay I've done it now, I've got it out of the way”, so you feel
better about it because you know that you’ve completed it and you
don't have to worry about it.’ (Participant 2)
‘I feel like it would be like “Yes, I've done the next five days, I want to
do the next five days”. It's almost like a game. Like, “Let me just see
how far that I can take this”.’ (Participant 15)

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There was a consensus that personalised and tailored features increase both
the attractiveness and acceptability of the mobile application. For example,
addressing users by name, allowing the log of relevant dates and uploading
a personal photo. Additionally, user-control over the frequency and timing of
the reminders as well as to set the background colour was appreciated as a
method for accommodating different users’ preferences.
‘Just to make it “my app”. It would be like a little buddy… It would be
more personal, and it would make me want to go in it more. By having
the app customised, a person will log in more frequently. Rather than
an app being so diverse, it's like a website for anyone to press on.’
(Participant 14)
‘If you can set it to your own personal thing, you're more likely to then
use it. Because then you've invested... You kind of get involved in it
then, it's a weird bond.’ (Participant 15)

B. Content
Participants underlined the advantage of including past patient accounts of
experiences with retainers. The impact of someone else’s story in realising
the benefits of retainer wear and the consequences of poor adherence
provided reassurance.
‘If you hear from past patients, you'd take it more seriously. You relate
to them, because they've been through it.’ (Participant 10)
‘If there was a testimony on someone that felt so uncomfortable that
they didn't want to go out because their teeth are like so bad. Then
obviously someone would relate to that.’ (Participant 13)

Participants noted the importance of concise, informative and comprehensive


written advice. They advocated the use of easy-to-read bullet points and
presenting the information in the form of a ‘frequently-asked questions’ and
‘test your knowledge’. The inclusion of practical solutions and strategies to
overcome challenges related to retainer wear, for example loose or cracked
retainers, was deemed necessary. They also highlighted the importance of
including broad content such as general dental health and other relevant

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orthodontic information. Having the information ‘all in one place’ is likely to


encourage users to access the application.
‘I know how young people are. I would just switch off. Even when
my doctor gave me a booklet about retainers, I didn't read every
single page. I just read the first page and that's it.’ (Participant 12)
‘You could have different solutions. If you're at this stage, book an
appointment now. If you're at this stage, just wear your retainers
more regularly. Which I think would save time.’ (Participant 4)

There was general agreement that visual aids were useful. Participants
suggested using ‘before and after’ images to convey the results of both good
and poor adherence. The former would help set an example to ‘strive for’.
However, a number of participants expressed aversion to viewing photos of
real teeth, considering it to be ‘cringy’. A suggestion to overcome this issue is
by having to click on a hyperlink if users wished to view an image.
‘You want a picture to make it clearer to understand. Especially
because when we're young we don't see a lot of things by that time,
like someone's teeth without or with wearing retainers for six months,
just so they see it.’ (Participant 5)

Videos were regarded as authentic as they are less likely to be edited than
photos. Short videos (20-30 seconds) were particularly perceived to be
engaging and more likely to be watched than longer ones. Furthermore,
videos presented by past patients are likely to relate to, and therefore
perceived to be more attractive than those presented by clinicians.
‘It's so easy to edit a photo. Whereas a video is seen as like, this is
real. It’s that authenticity to them, as opposed to a photo. It could be
photoshopped.' (Participant 13)

Professional endorsement of the mobile application was prerequisite to


ensuring credibility and trustworthiness of the content. Furthermore,
evidencebased information, a university or NHS logo were reported to give
the content greater credence:

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‘To have an app where everything is certified, actually backed with


research information would be really helpful. Because it's NHS-
certified. Or the Dentist Association, I don't know what the governing
body is, but if it was backed up by people who have experience and
knowledge. They've got the qualifications to actually have a valid
opinion on these topics.’ (Participant 4)
‘The fact that my dentist told me to download the app, that means they
trust it as well. So I'm more likely to trust it.’ (Participant 5)

C. Design
Usability of the mobile application was related to aesthetic and
ageappropriate design. A professional, current design with high-quality clear
images was preferred:
‘I think it has to appeal to like a wide frame, like a wide age range.
Because if it is really like childish, like teenagers won't really
download it.’ (Participant 2)
‘If it looks a bit more professional and a little bit less Microsoft Word
1999, you're more likely to keep it on your phone. Whereas if it's
prehistoric looking, not something really current, that wouldn’t be
good.’
(Participant 15)

Participants preferred the use of neutral font colours with delineate important
information by bold font rather than the use of red colour, as the later was
perceived as ‘alarming’.

 Mapping implemented features to underpinning constructs and


expected outcomes
In line with previous research (Peng et al., 2016), implemented features of
the mobile application were mapped to relevant behavioural change
theoretical constructs (Becker et al., 1978; Bandura, 1991; Kreuter et al.,
2000; Noar et al., 2007) to better understand the anticipated underpinning
processes to achieve each expected outcome (Figure 21).

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Figure 21. Mobile application features mapped to theoretical constructs


and the expected outcomes.

 Integration of social media (Twitter) findings


Themes identified from content analysis of the retainer-related Twitter posts
(Chapter 8) were used to inform the ‘frequently-asked questions’ section in
the mobile application (Table 24).

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Table 24. Integration of findings from the Twitter study.


Themes identified from
Examples of questions added in the FAQ section of ‘My
content analysis of Key findings
Retainers’ mobile application
Twitter posts*
Forgetfulness, lack of understanding of the  I keep on forgetting to put on my retainers, what should I do?
rationale of retainer wear and accessibility  Why should I wear my retainers?
issues were identified as barriers to retainer  What is the risk of my teeth moving if I don’t wear my retainers?
Adherence
wear.  Are my retainers doing anything?
 My friend didn’t wear their retainers but their teeth didn’t move.
Why is that?
Negative social effects of retainers in relation  Can I eat or drink with my retainers in?
to speech and embarrassment were reported.  My retainers are causing a change in my speech (lisp, stutter),
what should I do?
Impact  I feel embarrassed about wearing my retainers, what should I do?
Discomfort and gingival pain were commonly  Why are my retainers causing pain?
reported side effects of retainer wear.  My gums hurt when I have my retainers in, what should I do?
Reports of retainer loss, breakage, and issues  How do I keep my retainers clean and get rid of a bad smell or
related to hygiene and storage of the taste from the retainers?
retainers.  I lost my retainers! What should I do?
 Any tips to avoid losing my retainers?
 How do I store my retainers safely?
 Do you have a dog? Read this.
Maintenance  My retainers don’t fit, what should I do?
 My retainers are loose/tight, what should I do?
 My retainers are broken, what should I do?
 How often do I need to replace my retainers?
 I always forget where I placed my retainers, what can I do?
 My retainers fall out while I am sleeping, what should I do?
 Will I need to pay to replace my retainers?
Patient-clinician Tweets pointing out the inability of the  Will my orthodontist figure out if I am not wearing my retainers?
orthodontist to identify lack of retainer wear,  What will my orthodontist say if I am not wearing my retainers?
and fear of the clinician’s reaction to  How do I get in contact with my orthodontist when they are away?
relationship
nonadherence. Furthermore, issues related to
communication and accessing the clinician.
FAQ: frequently-asked questions.
*Further themes were identified but did not inform the content of the mobile application.

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9.4 Discussion

A systematic and iterative process was followed in developing ‘My Retainers’


in line with the Medical Research Council framework for complex
interventions (Craig et al., 2008) making the application patient-informed.
Additionally, existing evidence and behavioural change theories were taken
into consideration. The proposed pathway from the mobile application
features to expected outcomes was described by drawing on existing
behavioural change theories (Becker et al., 1978; Bandura, 1991; Kreuter et
al., 2000; Noar et al., 2007). Participants recommended implementing
features to facilitate contact with the treating clinician, responsive reminder
and tracking systems, the use of visual aids and friendly tone, in addition to
other personalised and interactive features. These findings were generally in
line with a previous study reporting preferences related to another dental
mobile application (Bohn et al., 2018).

In this study, participants described the benefit of a reminder system. This


was underlined in previous research, in which half of the participants
reported forgetfulness as a barrier to retainer wear (Lin et al., 2015).
Furthermore, there was an emphasis on the need to maintain the patient-
clinician relationship during the retention phase; the centrality of this aspect
in influencing adherence has previously been alluded to (Bartsch et al.,
1993). A tracking system was also advocated to monitor progress, and was
therefore implemented by logging daily hours of wear. It was possible to
allow transfer of data gleaned from the embedded micro-electronic sensor
directly to a corresponding mobile application via Bluetooth (Krishnan, 2017;
Castle et al., 2019). Although the latter approach may be costly, it allows
more objective, real-time tracking of wear, and removes the burden of daily
logging of wear.

In previous research, the use of photographs to demonstrate consequences


of poor adherence led to improved retainer wear compared to verbal
instructions alone; however, the difference was not statistically significant

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(Lin et al., 2015). Supplementing verbal advice with the use of photographs
was also recommended to improve the retention of orthodontic information
among prospective patients (Thomson et al., 2001; Patel et al., 2008).
Furthermore, the use of educational videos, both animated and presented by
professionals, was reported to have a positive effect on the intentions to
adhere to long-term retention (Holland, 2019). Moreover, participants in the
current study as well as in previous research (Flett et al., 2014; Kettle et al.,
2017) underlined the value of videos presented by past patients. However,
the effectiveness of videos appears to vary pending on the format and
medium with an educational video posted on YouTube resulting in a
significant improvement in knowledge among orthodontic patients (Al-Silwadi
et al., 2015). Additionally, videos focused on the reinforcement of oral
hygiene, in conjunction with active reminders through a mobile application
prompted improvement of oral hygiene in orthodontic patients (Alkadhi et al.,
2017). However, delivery of videos using more traditional methods such as
video-tape (Lees and Rock, 2000) or DVDs (Watt, 2017) did not result in a
significant improvement in orthodontic knowledge and other outcomes.

Developing rigorous electronic interventions is challenging and requires time


and resources. Therefore, engaging patients in the development process
ensures that their needs and preferences are captured. One-to-one
interviews and focus groups involving patients have been undertaken in 20%
of published qualitative research in dentistry to inform the development of
tools or programmes (Al-Moghrabi et al., 2019). In the orthodontic literature,
qualitative research involving patients has been used to inform the nature of
a novel intervention designed to optimise adherence levels with intra-oral
elastics (Veeroo et al., 2014). Furthermore, patient interviews were
undertaken to inform the design and content of orthognathic information aid
and patient decision aid for people considering fixed orthodontic treatment
(Flett et al., 2014; Marshman et al., 2016).

Implementation of all of the participants’ recommendations was challenging


given the limited resources available. Therefore, a number of suggested

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features were not included in the final design; for example, past patients’
accounts, the videos and the ability to interact with other users. Uptake of the
mobile application itself may be problematic with 93% of patients surveyed
unaware of the available orthodontic mobile applications (Sharif et al., 2019).
Consequently, direct recommendation of the application by the treating
clinician may help in encouraging utilisation, particularly given that 87% of
patients were open to use orthodontic mobile applications (Sharif et al.,
2019).

9.5 Conclusions

Development of a patient-informed mobile application is a multi-step and


iterative process. Desired features, content and design were triangulated
using two qualitative methods. Further refinement of the ‘My Retainers’
application is likely to take place following testing of its effectiveness in a
randomised controlled trial.

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CHAPTER 10. EVALUATION OF THE EFFECTIVENESS OF


‘MY RETAINERS’ MOBILE APPLICATION IN IMPROVING
ADHERENCE WITH THERMOPLASTIC
RETAINERS: A RANDOMISED CONTROLLED TRIAL

10.1 Background and Aims

There is a dearth of studies involving an assessment of the effects of


interventions to enhance wear and ameliorate negative experiences
associated with orthodontic retainers (Chapter 5).

The primary aim of this study was to analyse the effect of receiving the ‘My
Retainers’ mobile application on adherence to thermoplastic retainer (TPR)
wear. The secondary aims were to investigate the effects of receiving the
mobile application on the stability of the outcome and periodontal health
following removal of fixed appliances and patient experiences and knowledge
related to orthodontic retainers. Furthermore, to assess the impact of
objectively-assessed TPR on treatment stability and periodontal health was
assessed (Appendix 1).

The null hypotheses assessed in the current study were that receiving the
mobile application is ineffective in improving:
(1) Adherence to removable orthodontic retainer wear;
(2) Stability;
(3) Periodontal outcomes;
(4) Patient experiences; and
(5) Knowledge related to orthodontic retainers.

10.2 Methods

 Ethical approval and trial registration


Ethical approval was obtained (16/EE/0189, East of England - Cambridge
Central Research Ethics Committee; Appendix 10) and a research grant was
awarded from the European Orthodontic Society to support the project

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(Appendix 11). The trial protocol was registered before the commencement of
the study (ClinicalTrials.gov Identifier: NCT03224481).

 Participants, eligibility criteria and setting


Patients were recruited for inclusion at a routine adjustment appointment prior
to the planned removal of the appliances at the Institute of Dentistry, Barts
and The London School of Medicine and Dentistry. The inclusion criteria
were: 1) aged 12 to 21 years; 2) planned for removable retention with TPRs;
3) on no medication known to have an effect on gingival health; and 4) in the
permanent dentition. The exclusion criteria were: 1) inability to access or
peruse a compatible smart phone (iPhone; Apple Inc.); 2) cleft lip and palate
or other craniofacial anomalies; and 3) a history of periodontal disease. A
patient information sheet (Appendix 12) was provided with both oral and
written consent (Appendix 13) obtained from participants agreeing to take
part.

 Sample size
Based on previous research (Tsomos et al., 2014) alluding to a non-
adherence rate of 31%, characterised by wearing an appliance for less than
two hours daily, a minimum of 68 participants (34 in each group) was
required with a power of 80% to detect a minimum difference of 25% in
adherence rates at the 0.05 level of statistical significance. To compensate
for a drop-out rate of at least 20%, the final number enrolled in the trial was
84.

 Randomisation and allocation concealment


Participants agreeing to take part in the study were randomly allocated to one
of two groups by computer-generated random numbers
(http://www.randomization.com). Randomisation was stratified in a ratio of 1:1
in relation to gender. Allocation was concealed from the treating clinician
using an opaque, sealed envelope system.

 Interventions

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Participants in the intervention group received access to the ‘My Retainers’


mobile application via a unique identification code. The researcher (DA)
demonstrated the use of the mobile application with a brief description of its
features. The features, design and content of the mobile application were
informed by the qualitative findings from the one-to-one interviews and from
posts shared on social media related to orthodontic retainers (Chapters 9).
Participants in the control group did not have access to the mobile
application.

 Outcomes
The primary outcome was objective wear time (hours/day). The following
secondary outcomes were assessed:
1. Maxillary and mandibular Little’s irregularity index (Little, 1975)
2. Periodontal outcomes including: plaque scores, bleeding on probing,
and probing depth
3. Subjective wear time (hours/day)
4. Patient experiences and knowledge related to orthodontic retention

 Standardised procedures and data collection


Standardised oral hygiene instructions were given to all participants at the
debond and recall appointments. Frequency, duration, type of toothbrushing,
the use of other oral hygiene measures, and the time elapsed since the last
general dental visit were recorded at baseline (T0). Maxillary and mandibular
TPRs (Essix ACE® Plastic 1mm in thickness (DENTSPLY)) were fitted 7-10
days post debond. All participants were instructed to wear the TPRs on a
fulltime basis (22 hours) for six months, followed by part-time wear (eight
hours) for a further six months. A TheraMon ® micro-electronic sensor (MC
Technology GmbH, Hargelsberg, Austria) was embedded in the maxillary
TPRs in all participants. Participants in both groups had a follow-up
appointment scheduled at three months (T1) following removal of the
appliances (T0).
The TheraMon® micro-electronic sensor was activated at baseline (T0). A
reading station facilitated data transfer to an encrypted cloud database using

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TheraMon® Azure reader client software (version 1.2.1.1; MC Technology


GmbH, Hargelsberg, Austria). Data were transferred using radio-frequency
identification technology. Appliance wear was recorded within a specific
temperature range (33.5°C and 38.5°C). The TheraMon ® micro-electronic
sensor records temperature at 15-minute intervals; as such, data could be
restored for up to 100 days.

Objective data pertaining to wear were supplemented with subjective data,


involving completion of a retainer wear chart in the control group (Figure 22),
and use of a calendar tool within the mobile application in the intervention
group (Figure 19). Calendars were collected at the follow-up visit, and the
data logged in the mobile application were accessed by the researcher
through a secure webpage.

Figure 22. Retainer wear chart.

Impressions of the maxillary and mandibular arches were taken at T0 and T1


using hydrophilic vinyl polysiloxane (Virtual; Ivoclar Vivadent, Schaan,
Lichtenstein) and study models were made from orthodontic plaster (ISO type
2; Whip Mix Corporation, Louisville, KY, USA). Periodontal outcomes were

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assessed at the retainer fit appointment following removal of the appliances


(T0) and at the three-month recall visit (T1). Periodontal assessment was
undertaken on the labial/buccal and palatal/lingual surfaces of the maxillary
and mandibular first molar to first molar. Each tooth surface was divided into
thirds using vertical lines based on the morphology and position of the dental
papilla to demarcate mesial, mid-buccal/labial/palatal/lingual and distal
surfaces. The plaque scores followed by probing depth and bleeding on
probing (BOP) were scored clinically by one researcher (DA) as follows:
- Plaque scores: a liquid disclosing solution (Plaqsearch TM, TePe®,
Malmö, Sweden) was applied using a swab pressed against each
papilla, followed by 10ml water rinsing. Plaque was scored as present
or absent at six sites per tooth.
- BOP: a binary assessment of BOP was undertaken at six sites per
tooth with a maximum waiting time of 15 seconds.
- Probing depth: measured to the nearest 0.5mm from the gingival
margin to the base of the gingival sulcus at six sites per tooth using a
Williams probe (Hu‐Friedy, Chicago, IL, USA).

Participants in both groups were asked to complete a questionnaire at three


months (T1) concerning their experiences and knowledge in relation to TPRs
(Appendix 14).

 Laboratory procedures
The laboratory technique to embed the TheraMon ® micro-electronic sensor
within the TPRs was adapted and modified from McLaughlin et al. (2014)
(Figure 23).

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Figure 23. Laboratory procedures followed to integrate the TheraMon ®


micro-electronic sensor within the thermoplastic retainer. TPR:
thermoplastic retainer.

 Measurements

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Study model measurements were performed by one researcher (DA) using a


digital caliper (150mm DIN 862, ABSOLUTE Digimatic caliper, model
500191U; Mitutoyo, Andover, Hampshire, UK) with a resolution of ± 0.01mm.
A cumulative score for the contact point displacement in the maxillary and
mandibular inter-canine regions was calculated (Little, 1975).

Mean objectively-assessed hours of retainer wear was obtained from cloud


software (TheraMon Azure®, version 1.2.1.11). Additionally, the proportion of
days in which the appliance was worn for at least eight hours a day and a
minimum of two hours of continuous use was recorded. Graphical display of
the data for each participant was evaluated to detect lack of retainer wear
over a period of three consecutive days or more.

 Blinding
Participants in both groups were aware of being monitored. Blinding of either
the operator or the participants to the allocated arm during treatment was not
possible for the periodontal assessment. However, the use of coded study
models and data ensured that the researcher was kept blind to the treatment
group when undertaking measurements and during data analysis. The
statistician was also kept blind to the group allocation.

 Protocol deviations
All participants failing to attend their routine retainer check visit were given a
further appointment. Participants were free to withdraw from the trial at any
stage, without affecting their follow-up with the data analysis undertaken on
an intention-to-treat basis. In cases in which replacement of the TPR was
required, the reasons were recorded and the same micro-electronic sensor
was used, where possible. If a participant opted to have a TPR without a
microelectronic sensor, a new TPR was fitted and the participant was
retained in the study.

 Statistical analysis

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Data analysis involved both descriptive and analytical statistics. Baseline


characteristics were summarised to ensure that all groups were similar with
respect to potential confounding variables. As the data were not normally
distributed, medians and interquartile range (IQR) are presented. Imputation
of missing data was undertaken to account for losses and to compensate for
uncertainty surrounding missing values. Missing baseline data for periodontal
(plaque levels, bleeding on probing and probing depth) and stability outcomes
were imputed using the corresponding mean for each group (Sullivan et al.,
2018). Objective data pertaining to retainer wear were imputed by creating
new datasets (n= 40 iterations) with ten values imputed by the software. For
each of these datasets, estimates were calculated by fitting a corresponding
separate model (Sterne et al., 2009). Consequently, the estimates were
combined to produce the average final estimate (Verbeke and Molenberghs
2000). The linear regression model accounted for treatment group, available
subjective data as well as complete observation variables including age and
gender. This permitted imputation of missing values using values drawn from
a distribution based on observed participant values with similar baseline
characteristics. A series of mixed-models were then fitted in the imputed
dataset accounting for correlation. The level of statistical significance was set
at 0.05 with all analyses undertaken using the Stata statistical software
package (version 15.1; StataCorp, College Station, Tex). Additionally, median
regression was used to evaluate the impact of the objectively-assessed TPR
wear on stability and periodontal outcomes. The exact Mann-Whitney U test
was used to compare knowledge and experience outcomes between the
treatment groups. The analysis was performed in R software (R Core Team,
2013).

 Calibration
An online course was completed (DA) to facilitate familiarisation with the
measurement of periodontal outcomes. For stability measurements,
intraexaminer reliability was performed on ten randomly selected study
models, four weeks after the initial measurement. Intra-examiner reliability in
relation to plaque scoring was assessed by repeating measurements on ten

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intra-oral photographs at a four-week interval. Probing depth measurements


were repeated on ten healthy volunteers 30 minutes apart. Differences
between the repeated measurements relating to stability, mean probing depth
and mean plaque scores per tooth were assessed using intraclass
correlation. Excellent agreement was observed for stability (intraclass
correlation coefficient (ICC): 0.97) and periodontal outcomes including plaque
score (ICC: 0.96) and probing depth (ICC: 0.93).

10.3 Results

The full trial dataset is available online (https://doi.org/10.17636/01059856).


Eighty-four participants were enrolled and randomised with 42 participants
per group and equal gender distribution (Table 25). Overall, the groups were
wellmatched in terms of age, duration of orthodontic treatment and self-
reported oral hygiene practices (Table 25). Slightly more participants were
treated without extractions in the control group.

Stability and periodontal data were recorded for 80 participants at baseline


and 64 at three-month follow-up (Figure 24). Reported failures of retainers
with reasons throughout the course of the study are presented in Table 26.
The mean duration from T0 to T1 was 100.78 (standard deviation (SD):
23.49) days.

Table 25. Baseline characteristics of the sample (n= 84).


Overall Control Intervention
sample group group n=
n= 84 n= 42 42
Mean age in years ± SD 17.23 ± 1.9 17.20 ± 1.89 17.24 ± 2.0
Males n= 42 n= 21 n= 21
Gender
Females n= 42 n= 21 n= 21
Mean duration (years) of 2.63 ± 0.86 2.72 ± 1.04 2.55 ± 0.64
orthodontic treatment ± SD
Treatment n= 51 n= 29 (Mx n= 22 (Mx
Extraction
protocol only n= 7; Mn only n= 2; Mn

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only n= 4; only n= 3;
both arches both arches
n= 18) n= 17)
Non-extraction n= 33 n= 13 n= 20
Manual n= 60 n= 30 n= 30
Type of
Electric n= 20 n= 10 n= 10
toothbrush
NI n= 4 n= 2 n= 2
Once n= 11 n= 6 n= 5
Daily Twice n= 67 n= 32 n= 35
toothbrushing
frequency Three times n= 2 n= 2 n= 0
NI n= 4 n= 2 n= 2
< 1 minute n= 3 n= 2 n= 1
Time spent in 1-2 minutes n= 56 n= 29 n= 27
toothbrushing > 2 minutes n= 21 n= 9 n= 12
NI n= 4 n= 2 n= 2
None n= 45 n= 20 n= 25
Use of other Dental floss n= 12 n= 8 n= 4
oral hygiene Interdental brush n= 10 n= 6 n= 4
measures Toothpick n= 13 n= 6 n= 7
NI n= 4 n= 2 n= 2
≤ 6 months n= 18 n= 9 n= 9
> 6 months - 1 n= 15 n= 8 n= 7
Last visit to year
the dentist
> 1 year n= 47 n= 23 n= 24
NI n= 4 n= 2 n= 2
Smokers n= 4 n= 2 n= 2
Pregnancy n= 0 n= 0 n= 0
Mn: mandibular; Mx: maxillary; NI: no information; SD: standard deviation.

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Figure 24. CONSORT diagram showing the flow of participants.


Mn: mandibular; Mx: maxillary.

Table 26. Thermoplastic retainer failures during the study.


Reasons Maxillary TPR Mandibular TPR
Poor fit n= 4 n= 5
Retainer loss n= 2 n= 2
Breakage of the retainer n= 7 n= 0
Detachment of the micro-electronic sensor n= 2 n/a
Total n= 15 n= 7
n/a: not applicable; TPR: thermoplastic retainer.

The median duration of the objectively-assessed retainer wear was slightly


higher in the intervention group (7.25 hours/day) in comparison to the control

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group (6.21 hours/day). After adjusting for confounders, the median


betweengroups difference was 0.91 hours/day higher in intervention group
(95% CI: 2.19, 4.01 hours/day), however, the difference was not statistically
significant (P= 0.56) (Table 27). A period of no wear for three consecutive
days or more was observed in more than half of the sample in both groups
(Table 27). The median percentage of days in which the retainers were worn
for less than eight hours a day and a minimum of two hours of continuous
use was 44.3% in the intervention group, and 53.3% in the control group
(Table 27). Objectively-assessed retainer wear data were available for a
mean of 87.41 (SD: 20.1) days. A median discrepancy of 4.96 hours was
observed between the subjective and objective wear time, based on 30
participants with both measures available. However, subjective data were
available for only 25 subjects in the intervention group and 15 in the control
group. Furthermore, the median number of days with available subjective
retainer wear data was just 11 (IQR: 51) in the intervention group, and 78
(IQR: 29.5) in the control group, and reflecting the different methods of
subjective data collection.

No significant difference between the treatment groups was observed in


terms of incisor irregularity (P= 0.92) and periodontal outcomes including
plaque scores (P= 0.44), bleeding on probing (P= 0.61) and probing depth
(P= 0.79) (Table 27). Additionally, based on median regression analysis
increased retainer wear did not significantly influence changes in stability and
periodontal outcomes during the first three months of retention (Table 28).

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Table 27. Data pertaining to retainer wear, stability and periodontal outcomes in both treatment groups. Data presented as median
(interquartile range).
Intervention
Outcomes Control group* Coefficient† 95% CI P-value
group
Objective data (h/d) 6.21 (7.86) 7.25 (6.71) -0.91 -4.01, 2.19 0.56
Adherence
levels

Percentage of participants with ≥3 consecutive days of no 57.6% 53.6% -


retainer wear
Median percentage of days with wear as instructed (8 h/d 46.67 (70.26) 55.70 (59.86) -
and a minimum of 2 hours of continuous use)
T0: 0.12 (0.1) T0: 0.16 (0.18) 0.002 -0.03, 0.04 0.92
Maxilla
outcomes

T1: 0.14 (0.17) T1: 0.19 (0.22)


Stability

T0: 0.16 (0.14) T0: 0.11 (0.12)


Mandible
T1: 0.16 (0.21) T1: 0.16 (0.13)
T0: 0.84 (0.27) T0: 0.84 (0.18) -0.02 -0.07, 0.03 0.44
Maxilla
T1: 0.74 (0.22) T1: 0.75 (0.17)
Periodontal outcomes

Plaque scores
T0: 0.79 (0.25) T0: 0.84 (0.17)
Mandible
T1: 0.76 (0.18) T1: 0.77 (0.17)
T0: 0.17 (0.18) T0: 0.16 (0.17) -0.01 -0.05, 0.03 0.61
Maxilla
Bleeding on T1: 0.09 (0.1) T1: 0.08 (0.14)
probing T0: 0.17 (0.18) T0: 0.20 (0.14)
Mandible
T1: 0.1 (0.14) T1: 0.11 (0.1)
T0: 2.0 (0.18) T0: 2.0 (0.25) -0.01 -0.09, 0.07 0.79
Maxilla
Probing depth T1: 1.93 (0.24) T1: 1.92 (0.31)
(mm) T0: 1.7 (0.27) T0: 1.8 (0.18)
Mandible
T1: 1.62 (0.22) T1: 1.6 (0.27)
CI: confidence interval; h/d: hours/day; mm: millimetres.
*Reference group.
Effect of treatment group on the outcome variables at T1.

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Table 28. Median regression on the impact of objective wear on stability


and periodontal outcomes accounting for baseline data.
Dental arch
Outcome Coefficient P-value 95% CI

Maxilla 0 0.89 -0.003, 0.002


Stability outcomes
Mandible -0.003 0.16 -0.01, 0.001

Maxilla 0.002 0.68 -0.01, 0.01


Plaque
scores
Mandible 0 0.97 -0.01, 0.01

Bleeding Maxilla -0.002 0.43 -0.01, 0


Periodontal
on
outcomes
probing Mandible 0 0.21 0, 0.01

Probing Maxilla -0.01 0.33 -0.02, 0.01


depth
(mm) Mandible 0.01 0.27 -0.004, 0.01
CI: confidence interval; mm: millimetres.

In terms of patient experiences, the highest scores (4 and 5) were most


frequently selected in both groups, indicating similar levels of satisfaction in
both treatment groups (Table 29). Levels of knowledge were marginally
better in the intervention group (Table 30). However, no significant difference
was observed between intervention and control groups for both outcomes
(Table 31).

Table 29. Responses concerning experiences during retention.


3.
1. Neither 5.
Treatment 2. 4.
Questions* Very satisfied Very
group Dissatisfied Satisfied
dissatisfied nor satisfied
dissatisfied
Do you feel Control (n= 0 (0%) 0 (0%) 3 (8.57%) 9 23
involved in the 35) (25.71%) (65.71%)
process of
wearing and Intervention 0 (0%) 0 (0%) 4 (13.79%) 6 19
taking care of (n= 29) (20.69%) (65.52%)
your
retainers?
How well do Control (n= 0 (0%) 0 (0%) 2 (5.71%) 14 (40%) 19
you feel you 35) (54.29%)
are being

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looked after Intervention 1 (3.45%) 0 (0%) 2 (6.9%) 5 21


since your (n= 29) (17.24%) (72.41%)
braces were
removed?
How would Control (n= 0 (0%) 0 (0%) 5 (14.29%) 9 21 (60%)
you rate your 35) (25.71%)
overall
experience
within the last
3 months in Intervention 0 (0%) 2 (6.9%) 2 (6.9%) 11 14
terms of your (n= 29) (37.93%) (48.28%)
use of
retainers and
contact with
the clinic?
*Additional descriptive data are presented in Appendix 15.

Table 30. Percentage of correct responses concerning levels of


knowledge related to orthodontic retainers.
Control group Intervention group
Knowledge questions
(n= 35) (n= 28)
If I wear the retainers really well for the first 29/35 (82.86%) 25/28 (89.29%)
year, I can stop wearing them after that
(true or false).
How many hours a day do you need to 21/35 (60%) 19/28 (67.86%)
wear the retainers?
If you stopped wearing the retainers, what 35/35 (100%) 28/28 (100%)
is likely to happen after a few weeks?
How long do you need to wear your 29/35 (82.86%) 24/28 (85.71%)
retainers for?
What would you do if your retainers no 31/35 (88.57%) 26/28 (92.86%)
longer fit or if you had problems with
wearing them?

Table 31. Experience and knowledge outcomes in treatment groups


(exact Mann-Whitney U test).
Scores (median
Outcomes Treatment group (IQR)) P-value

Control group (n= 35) 14 (3)


Patient experiences
0.94
(score out of 15)
Intervention group (n= 29) 14 (2)

Control group (n= 35) 4 (1)


Knowledge
0.26
(score out of 5)
Intervention group (n= 28) 5 (1)

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IQR: interquartile range.

10.4 Discussion

Receipt of the mobile application did not appear to significantly improve


objectively-assessed adherence levels, stability, periodontal outcomes,
patient experiences and knowledge related to orthodontic retainers at
threemonth follow-up. The limited benefit of interventions directed at
enhancing adherence levels with orthodontic retainers has been exposed in
previous research (Gross et al., 1991; Ackerman and Thornton, 2011; Hyun
et al., 2015; Lin et al., 2015; Goldenberg, 2016). This may relate to the
complex and multifaceted nature of adherence with extraneous factors
including associated negative impact on quality of life and pragmatic issues
related to retainer wear also being important (Chapter 7).

The development of the mobile application was rigorous and was informed
by patients (Chapter 9). The multitude of functions built in the ‘My Retainers’
mobile application were designed to address reported barriers to retainer
wear (Chapter 7). For example, a reminder system was included to
overcome forgetfulness. An exhaustive list of frequently-asked questions and
the ability to contact the researcher were included to address any potential
concerns related to retainer wear. Furthermore, this intervention was
underpinned by key behavioural change theories (Becker et al., 1978;
Bandura, 1991; Kreuter et al., 2000; Noar et al., 2007). The potential benefit
of utilising a combination of approaches to behaviour change in developing
Internet-based healthrelated interventions was highlighted in a previous
systematic review (Webb et al., 2010).

The use of supplementary methods for information provision such as written,


audio and visual information has been shown to result in improvement in
recall of orthodontic information (Thomson et al., 2001; Kang et al., 2009; Al-
Silwadi et al., 2015). On the corollary, participants in the mobile application
group exhibited slightly higher levels of knowledge; however, retainer wear

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remained suboptimal. Similar findings have been reported within the medical
literature with no clear association observed between the patients’
knowledge concerning diabetes and adherence behaviours (Chan and
Molassiotis, 1999). The limited effect of the mobile application on adherence
may be explained by the inadequate usage of the different features. This was
evident in the median number of days in which the retainer wear was logged
(n= 11; IQR: 51) and the limited interaction in terms of the number of e-mails
sent by participants (n= 6) throughout the study. However, user engagement
with the intervention, the number of times participants accessed the mobile
application, consistency of use and time spent viewing its content are
unclear. Unknown barriers to the limited effectiveness of the mobile
application will be addressed using an explanatory qualitative study in
keeping with previous approaches (O’Cathain et al., 2013). Additionally,
qualitative findings may assist in refining the mobile application based on
participants’ feedback.

In line with previous research, subjective reports overestimated removable


retainer wear of the order of five hours was identified, which may relate to
recall and/or response bias. Therefore, objective measurement using the
TheraMon® micro-electronic sensor was particularly helpful in providing a
more realistic estimate of retainer wear. The median wear time was slightly
higher in the intervention compared to the control group; however, the
difference was not statistically significant. Nevertheless, the median
objectively-assessed retainer wear was just 28.2% and 33% of 22 hours
stipulated in the control and intervention groups, respectively. Moreover,
participants were aware of being monitored in the current study with the latter
considered to lead to artificially high wear levels. Micro-electronic sensors
have been shown to underreport wear duration by the order of 4% (Brierley
et al., 2017); this discrepancy was dwarfed by the low objective readings
identified among the present group of participants. In a previous study with
similar stipulated wear time, better levels of adherence (45.5-60%) were
reported with Hawley retainers at three-month follow-up (Goldenberg, 2016).
However, details of both randomisation and allocation concealment were not

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reported in the latter study. Mean wear rates varied significantly (019.9
hours/day) and the participants overestimated wear by an average of 5.6
hours daily (Goldenberg, 2016). It was also possible that the visibility of the
Hawley retainer with associated labial bow may serve as a reminder to wear
this type of retainer among both patient and peers.

A number of participants in the current study relayed concerns in relation to


the appearance and bulk of the retainer associated with the indwelling
microelectronic sensor. Related data were collected at the six-month follow-
up; the latter will be analysed in future. It was conceivable that this may have
contributed to suboptimal adherence levels. Furthermore, patient motivation
and attitudes towards treatment have been shown to influence adherence
levels in orthodontics, pointing to overlapping patterns of behaviour
(Clemmer and Hayes, 1979; Bartsch et al., 1993). In the current study,
significant plaque accumulation and bleeding on probing were observed in
both groups at baseline; however, the association between oral hygiene
behaviours and retainer wear was unclear.

No significant difference was observed between the groups in relation to the


stability outcomes measured in both dental arches. This may relate to the
comparable objectively-assessed adherence levels in both groups but
particularly to the relatively short period of follow-up. The duration of retainer
wear did not significantly influence stability of the orthodontic outcomes. The
lack of a clear impact of the duration of wear on the treatment outcomes was
also reported in a previous study concerning headgear (Tulloch et al.,
1997b). In a recent randomised controlled trial (RCT), access to a moderated
WhatsApp group involving photo sharing and monthly ranking was
postulated to improve Hawley retainer wear, based on the superior stability
outcomes in terms of inter-canine width at one-year follow-up (Zotti et al.,
2019). However, neither objective nor subjective wear time was assessed.
As such, differences in terms of stability may relate to confounders including
pre-existing malocclusion and treatment-induced changes.

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Although objectively-assessed retainer wear may provide an overall


assessment of the adherence levels over a particular observation period, it
does not reflect patterns, consistency and distribution of wear. Fluctuations in
the adherence levels were previously observed with both removable and
functional appliances (Schott and Ludwig, 2014a; El-Huni et al., 2019).
Similar findings were observed in the current study, with no retainer wear
over at least three consecutive days observed in more than half of the
sample. Similarly, headgear (Huanca Ghislanzoni et al., 2019) and
removable functional appliances (Charavet et al., 2019) were not worn for an
average of 30% and 12% of the duration within individual studies. This period
of no wear, negatively influenced the transverse changes obtained with
functional appliances (Charavet et al., 2019). However, the implications of
extended periods of an absence of wear may be particularly problematic with
retainers, with sustained periods of non-adherence risking irreversible
impairment of retainer fit and post-treatment dental changes over time.

The primary focus of the mobile application tested in the current study was to
enhance retainer wear, experience and knowledge related to retainers.
However, the content also included general dental and oral health
information. No significant difference was observed between both groups in
terms of the periodontal measures. Both plaque scores and bleeding on
probing were recorded as a binary outcome to provide an overall
assessment, although consideration of the extension of plaque or severity of
bleeding on probing would have provided more detailed information.

In previous research, superior periodontal outcomes were reported at


onemonth follow-up in patients receiving a mobile application including
notification messages and access to an educational video focusing on oral
hygiene (Alkadhi et al., 2017); however, detailed description of the
intervention was not reported. Similarly, an interactive intervention involving
a WhatsApp group messaging resulted in better periodontal outcomes at
one-year follow-up, although the difference was not significant at the three-
month follow-up (Zotti et al., 2016). Similarly, the use of a mobile application

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to allow tracking of toothbrushing frequency and duration did not result in a


significant difference in plaque accumulation and gingival inflammation at
three-month follow-up (Samuelson 2017). Therefore, it appears that
differences in periodontal outcomes may be observed at longer follow-up
periods.

Fixed retention offers superior preservation of the alignment of the


mandibular anterior teeth in the long term (Chapter 6). However, TPRs
continue to be used due to their acceptability, simplicity and cost-
effectiveness (Hichens et al., 2007). Removable retainers may be prescribed
for those exhibiting suboptimal oral hygiene, especially given that fixed
retainers are known to hinder oral hygiene maintenance. This might explain
the significant plaque accumulation and bleeding on probing noted at
baseline in both groups. Notwithstanding this, TPRs may impede the flushing
of saliva from dental surfaces resulting in a significant increase in
Streptococcus mutans and Lactobacillus counts (Türköz et al., 2012). An
initial phase of full-time wear (Valiathan and Hughes, 2010; Meade and
Millett, 2013) is often prescribed with removable retention; however, there
are limited data on the effect of prolonged removable retainer wear on
periodontal health. Interestingly, a reduction in plaque and calculus
accumulation, gingival inflammation and bleeding on probing was noted
following shifting to part-time vacuum-formed retainer (VFR) wear in a
previous clinical trial (Manzon et al., 2018). However, in the current study no
clear impact of the objectively-assessed retainer wear on periodontal
outcomes was identified.

The type of material used to fabricate the TPR in the current study (Essix
ACE® Plastic) was observed to have superior wear resistance in comparison
to the other types of commercially available materials in an in vitro study
(Raja et al., 2014). However, a substantial proportion of the retainers
required replacement (n= 22) mainly due to poor fit and breakage, despite
the short period of followup of the present study. Lower breakage rates were
observed in a previous RCT, in which only 6.6% of the participants reported

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breakage with VFRs in the first six months of retention (Hichens et al., 2007).
This could be explained by the difference in the type and thickness of the
material used in the previous study (1.5mm) (Hichens et al., 2007). It is also
possible that the incorporation of the micro-electronic sensor in the present
study may have predisposed to fracture of the retainers. Notwithstanding
this, higher failure rates were observed in similar studies with the fracture of
44 TPRs of 0.75mm thickness among 59 participants reported over the first
year of retention in one prospective study (Sun et al., 2011). Similarly, a
substantial number of 0.8mm thickness VFRs (45.7%) worn full-time showed
some degree of breakage at the three-month follow up (Manzon et al., 2018).

Drop-out rates in orthodontic RCTs is typically of the order of 13% of those


recruited (Koletsi et al., 2014). This was accounted for in the present study
statistically by the imputation of missing data as well as by inflation of the
sample size by 20% in order to retain adequate power. However, the drop-
out rate was 24%. A greater proportion of drop-outs are typical of trials
concerning retention particularly as no active treatment is being provided
(Chapter 6), highlighting the importance of making an adequate allowance
for drop-outs in future research on orthodontic retention. The loss of
objective adherence data was inevitable due to the capacity of the
TheraMon® micro-electronic sensor to restore data for no more than 100
days with a measurement interval set to 15 minutes.

The stipulated wear time in the current study was in line with previous
research (Atack et al., 2007). However, there is some evidence to suggest
similar outcomes with part-time wear (Littlewood et al., 2016). Part-time wear
was also regarded as more realistic and achievable with minimal impact on
daily activities (Chapter 7; El-Huni et al., 2019). This may explain the part-
time wear of Twin Blocks despite full-time prescription, with mean wear rates
of 12 hours daily observed in a group advised to wear the appliance full-time
and eight hours daily in the prescribed part-time group (Parekh et al., 2019).
It is conceivable that the relatively disappointing wear times reported with
retainers in the present study may reflect both complacency as well as a lack

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of understanding of the implications of poor wear in this cohort (Kearney et


al., 2016). In the present study participants were randomised; therefore,
similar baseline characteristics were observed. Stratified randomisation was
undertaken to ensure balanced gender distribution in the treatment groups.
This was considered important as the adherence levels to intra-oral
removable appliance wear have been shown to vary significantly based on
gender (Schäfer et al., 2015). The present study was undertaken in one
university hospital in which orthodontic treatment was funded through a
national healthcare system. A significant difference between university
hospital and private practice has been identified in previous research
(Schäfer et al., 2015). Therefore, the applicability to other settings hinges on
the comparability of patient characteristics. The relatively short follow-up
period might limit the holistic evaluation of the intervention. Notwithstanding
this, adherence to removable appliance wear also tends to reduce over time
(Chapter 7); it is therefore conceivable that the benefit of the mobile
application may become more apparent over a more prolonged follow-up
period. It is therefore planned to undertake further follow-up of participants in
the present study up to one year post-treatment.

10.5 Conclusions

The receipt of a bespoke mobile application did not result in any significant
improvement in the adherence to TPR wear, stability and periodontal
outcomes and experiences with retainers in the short term. Knowledge
concerning orthodontic retainers was slightly higher in the intervention group;
however, the difference was not statistically significant. Evaluation of the
effectiveness of the mobile application over a longer follow-up period as well
as further refinement are required.

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CHAPTER 11. OVERALL CONCLUSIONS

A holistic assessment of clinical effectiveness, periodontal implications and


patient-reported outcomes associated with orthodontic retention was
undertaken. Complementary research methods were used including
systematic reviews, randomised controlled trials and qualitative methods.

Overall conclusions based on this research include:

 Based on the initial systematic review, there was a lack of evidence to


endorse the use of one type of orthodontic retainer in terms of their
effect on periodontal health, survival and failure rates, patient-reported
outcomes, and cost-effectiveness at least in the short term. There was
a lack of well-designed prospective studies elucidating the benefits
and potential harms associated with orthodontic retainers, particularly
in the medium- and long- term.
 Based on the systematic review of the literature, adherence to wear of
removable orthodontic appliances and adjuncts was suboptimal, and
patients routinely overestimate the duration of wear. Actual wear time
was approximately five hours/day less than that stipulated. Factors
influencing adherence levels were not fully understood and
techniques to improve wear have promise but require further
evaluation in highlevel research.
 Based on a randomised controlled trial, fixed retention offers the
potential benefit of an improved preservation of alignment of the
mandibular labial segment when compared with thermoplastic
retainers in the long term. However, periodontal outcomes were
similar in both treatment groups four years post-treatment.
 Prolonged adherence to removable retainer wear was regarded as
highly onerous. Six key influencers of prolonged adherence with
thermoplastic retainer wear were identified.
CHAPTER 11

202
 Subjective experiences in relation to orthodontic retainers were
commonly shared on Twitter. Most of the publicly-available tweets
portrayed retainer wear in a negative light.
 A holistic process involving input from patients informed the
development of the ‘My Retainers’ mobile application. Short-term use
of the mobile application did not significantly improve retainer wear,
periodontal outcomes, patients’ experiences and knowledge related to
retainers. Further research is required in order to evaluate the impact
of bespoke reminder systems in improving adherence to retainer wear
in the longer term.

203
RECOMMENDATIONS FOR FUTURE RESEARCH DIRECTIONS

RECOMMENDATIONS FOR FUTURE RESEARCH


DIRECTIONS

Life-long orthodontic retention is almost uniformly prescribed following


orthodontic treatment. There is therefore, a pressing need for primary
research to provide a more holistic evaluation of benefits and harms
associated with life-long wear of orthodontic retainers.

Future research could be directed at evaluating the effectiveness of different


methods to enhance the overall experience during retention, and to improve
adherence to removable retainer wear by enhancing communication with the
treating clinician during the retention phase. Additionally, further focus on
comparison of different retainer materials to ultimately identify the ideal type
of retainer is required.

The randomised controlled trials reported in Chapters 6 and 10, as well as


the preponderance of orthodontic retention studies identified in the
systematic review (Chapter 4), were conducted in university hospitals, thus
limiting the applicability of the findings to other settings. Therefore, the
involvement of specialist orthodontists and general dentists to partake in
practice-based research would be beneficial in order to provide a more
holistic and generalisable assessment of comparative effectiveness of
approaches to retention regimen.

Researchers should be mindful of the need to inflate the sample size in order
to counteract the likelihood of high drop-outs in orthodontic retention trials.
Researchers are encouraged to share trial datasets as this may help in
transparent reporting of findings and the facilitation of data synthesis in future
systematic reviews. Therefore, the full trial dataset reported in Chapter 10
has been made available online.

204
Future research undertaken concerning the effectiveness of orthodontic
retention should account for the centrality of patient-reported outcomes, to
ultimately improve patient care and treatment outcomes. This could be in the

205
RECOMMENDATIONS FOR FUTURE RESEARCH DIRECTIONS

form of obtaining questionnaire-based data or complimentary qualitative


research. An explanatory qualitative study has been undertaken on a subset
of participants to gather their feedback on the intervention received (Chapter
10). Research focusing on the evaluation of experiences and care provision
during retention, such as the frequency of follow-ups and transfer of patients
from tertiary hospital care to management with general dentists might
provide useful information relating to overall patient satisfaction.

The issue of poor adherence with removable retention should be addressed


more extensively in the future. The ability to predict adherence levels from
the outset is an area worth exploring. Moreover, the identification of a
minimum cut-off point for the duration of the removable retainer wear
required to prevent dental changes would be worthwhile. Additionally,
obtaining further objective data in relation to retainer wear would be valuable.
Furthermore, the advent of more subtle micro-electronic sensors that do not
affect the appearance of the removable retainers would be useful in this
respect.

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236
Appendix 1

APPENDICES

Appendix 1. List of published articles

237
1. Al-Moghrabi, D., Pandis, N., Fleming, P.S. (2016). The effects of fixed
and removable orthodontic retainers: a systematic review. Progress in
Orthodontics. 17, 24.

2. Al-Moghrabi, D., Salazar, F.C., Pandis, N., Fleming, P.S. (2017).


Compliance with removable orthodontic appliances and adjuncts: A
systematic review and meta-analysis. American Journal of
Orthodontics and Dentofacial Orthopedics. 152, 17-32.

3. Al-Moghrabi, D., Johal, A., Fleming, P.S. (2017). What are people
tweeting about orthodontic retention? A cross-sectional content
analysis. American Journal of Orthodontics and Dentofacial
Orthopedics. 152, 516-522.

4. Al-Moghrabi, D., Johal, A., O'Rourke, N., Donos, N., Pandis, N.,
Gonzales-Marin, C., Fleming, P.S. (2018). Effects of fixed vs
removable orthodontic retainers on stability and periodontal health: 4-
year follow-up of a randomized controlled trial. American Journal of
Orthodontics and Dentofacial Orthopedics. 154, 167-174.

5. Al-Moghrabi, D., Colonio Salazar, F.B., Johal, A., Fleming, P.S. (2019).
Factors influencing adherence to vacuum-formed retainer wear: A
qualitative study. Journal of Orthodontics. 46, 212-219.

6. Al-Moghrabi, D., Pandis, N., McLaughlin, K., Johal, A., Donos, N.,
Fleming, P.S. (2019). Evaluation of the effectiveness of a tailored
mobile application in increasing the duration of wear of thermoplastic
retainers: a randomized controlled trial. European Journal of
Orthodontics. Epub ahead of print: 10.1093/ejo/cjz088.

7. Al-Moghrabi, D., Colonio-Salazar, F.B., Johal, A., Fleming, P.S. (2020).


Development of ‘My Retainers’ mobile application: Triangulation of two
qualitative methods. Journal of Dentistry. Epub ahead of print:
10.1016/j.jdent.2020.103281.

Appendix 2

Appendix 2. MEDLINE search via OVID (1946 to 31st of October, 2015)

238
Search Strategy:
1 RANDOMIZED CONTROLLED TRIAL.pt. (413632)
2 CONTROLLED CLINICAL TRIAL.pt. (91880)
3 RANDOM ALLOCATION.sh. (86446)
4 DOUBLE BLIND METHOD.sh. (135365)
5 SINGLE BLIND METHOD.sh. (21423)
6 or/1-5 (586980)
7 (ANIMALS not HUMANS).sh. (4033465)
8 CLINICAL TRIAL.pt. (506935)
9 exp Clinical Trial/ (849000)
10 (clin$ adj25 trial$).ti,ab. (308227)
11 ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ti,ab.
(146187)
12 PLACEBOS.sh. (34034)
13 placebo$.ti,ab. (174121)
14 random$.ti,ab. (804059)
15 RESEARCH DESIGN.sh. (84544) 16 or/9-15 (1594056)
17 16 not 7 (1478011)
18 17 not 8 (977433)
19 8 or 18 (1484368)
20 exp ORTHODONTICS/ (46224)
21 orthod$.mp. (53863)
22 20 or 21 (61325)
23 (retain$ or retent$).mp. (294935)
24 (fixed$ or removable$ or bonded$ or Essix$ or Hawley$).mp. (221824)
25 22 and 23 and 24 (1152)
26 25 and 19 (174)

239
Appendix 3

Appendix 3. MEDLINE search via OVID (1946 to 1st week of May, 2016)

Search Strategy (4 different searches):


1. orthodontic* and (complian* or adhere* or wear* or use) (1861
results)
2. (orthodontic and (cooperation or reward or diary or calendar)).af. (326
results)
3. orthodontic* and reminder* (35 results)
4. (orthodontic* and timer).af. (11 results)

240
Appendix 4
Appendix 4. Risk of bias assessment in non-randomised studies using
(ROBINS-I) tool

241
Appendix 4

242
Appendix 4

243
Appendix 4

244
Appendix 4

245
Appendix 4

246
Appendix 4

247
Appendix 4

248
Appendix 4

249
Appendix 4

250
Appendix 4

251
Appendix 4

252
Appendix 4

253
Appendix 4

254
Appendix 4

255
Appendix 4

256
Appendix 4

257
Appendix 5

Appendix 5. Ethical approval for the follow-up RCT and the one-to-one
interviews

Appendix 5

258
259
Appendix 6

Appendix 6. Information sheet for the follow-up RCT and the one-to-one
interviews

260
Appendix 6

261
262
Appendix 7

Appendix 7. Consent form for the follow-up RCT and the one-to-one
interviews

263
Appendix 8

Appendix 8. Topic guide

Introduction
- Presenting myself and my role in the study.
- We are carrying out a study to explore the factors that make people
wear their retainers more or less than others. We would like you to
share your thoughts about your experience with the retainers you
were asked to wear after your braces were removed.
- Please make sure you have read the information sheet and consent
form and have signed it.
- The conversation we are about to start will be recorded using a digital
recorder and you will be notified about the start and finish of the
recording. However, your name, address or any identifiable
information will be kept confidential and will not be published. Your
participation is voluntary and you are free to stop me at any time
during the conversation.
- It is important to note that there are no right or wrong answers. - Do
you have any questions before we start?

[Turn on the recorder]

Warm-up questions
- How old are you?
- What year are you in at school?

Background information about getting braces


- What made you see the orthodontist? Why did you get braces?
- What was it like having braces?

Day of debond
- Tell me about the day when you had the braces off? How did it feel?
- What did you think of your teeth at the end?
- What did your family and friends think of the results? How did it make
you feel?
- What advice was given to you at that day? Any examples?
- Did you look for any advice from other sources? If yes, why, and what
were these sources.

Retention phase
- What do you think of your retainers?
- How did it feel when you had your retainers at the start?
- Tell me more about your experience with the retainers when you had
to wear them for full-time/part-time.

264
 [Prompt] If the participant reports wearing their retainers: What
makes you wear them? Can you give me some examples?
 [Prompt] If the participant reports not wearing the retainers:
What makes you not wear them?
Appendix 8

 [Prompt] If the participant mentions forgetting to wear the


retainers: When do you usually forget? Why do you think that
is? Can you tell me some examples?
- What do you understand about having to wear the retainers ‘long
term’? What are your thoughts about it?

Electronic reminders
- Do you generally use mobile applications or access any social media
platform? If yes, what are the reasons of use and how often?
- What do you think of receiving retainer wear reminders through your
mobile phone?
- Which platform do you think these reminders should be sent through
and why? In what frequency and timing?
- What do you think about the idea of designing a mobile application
specific for retainers? What would make patients use/not use the
mobile application and why?
- What type of information would you want to be included? In which
format and why?
- What other methods would you suggest to remind patients to wear
their retainers?

* Present visual prompts and ask the following questions:


- What do you think of the initial proposed design and features of the
mobile application?
- What did you like/dislike?
- What features should be added/eliminated and why?

Conclusion
- Thank you for your time.
- As we mentioned before, this interview is confidential and will be
anonymous.
- The information taken from this interview will help us understand
facilitators and barriers to retainer wear.
- That was everything I wanted to ask you. Is there anything else you
would like to add/ask me?

[Turn off the recorder]

265
Appendix 9

Appendix 9. Content of ‘My Retainers’ mobile application

a) About ‘My Retainers’ mobile application

b) Content of the reminder messages

266
Appendix 9

c) Content of the feedback responses

267
Appendix 9

Logged hours of wear more than 75% Logged hours of wear less than 75%
of stipulated wear time of stipulated wear time
 Great, you’ve done it for today!  Come on, you always wanted straight
 You are doing a great job! teeth
 Make sure you are rewarding yourself  You went through a lot during braces,
for doing it! make it count
 Well done, you are taking good care of  I believe you can do even more
yourself  I am sure you can do better
 You made it today!  Never give up
 Great job!  Sometimes you might not feel the
 You are doing really well benefit of retainer wear, until it’s too
 Take time to enjoy your late. Let’s not make that happen
accomplishment today!  It doesn’t seem to be a good retainer
 You made it today! Well done! day for you, get in touch with us if you
 You must feel proud! need help
 Well done, keep going!  Tomorrow will definitely be a better
day!
 Well done, it’s worth it!
 You can and will be better tomorrow
 Excellent. Keep going!
 Repeat after me 'I can do better with
 Well done, that’s impressive!
my retainers!'
 Super!
 If you are going through difficult time,
please get in touch
 Set a goal for tomorrow, I am sure you
can make it!
 Tomorrow is a good day to catch up
 Get in touch with us and we might find
a way to make it work
 You will not give up, tomorrow is a
new chance
 Losing track? Please get in touch or
go through our tips in the FAQ

d) Content of the frequently-asked questions section

Why do retainers
matter?

268
Appendix 9

 To keep
Why your Iteeth
should wearstraight
my after braces. When your braces come off, teeth
aren’t stable in their new position, retainers will help them to stay where
retainers?

What is thetorisk
want them be. of my teeth moving if I don’t wear my retainers?
 Nearly all people who don’t wear their retainers as required will have some
movement of their teeth. The amount of movement differs from person to

person.
 Yes,
Are myretainers are doing
retainers holding your teeth in their position and preventing them
anything?
My friend didn’t wear their retainers but their teeth didn’t move. Why
from getting
It is more than likely that their teeth are moving gradually over time. At the
crooked.
 moment,
is that? inchanges
time. might be hard to see, but these will definitely be obvious
Maintaining my
retainers
How do I keep my retainers clean and get rid of a bad smell or taste

Usingthe
from a toothbrush, brush your retainers under cold running water without
retainers?
I lost my retainers! What should I do?
Contact your orthodontist as soon as possible by phone or by sending us
using toothpaste.

Any tips to avoid losing my retainers?
If they are not
an e-mail in your
through themouth, always keep them in the box given to you.
You can write
app. your name on the box as well. If you are wearing the
 retainers at night-time only, always keep the box beside your bed.
How do I store my retainers safely?
Always keep them in the box given to you. Never wrap them with tissues or


A number of patients told us that their dog damaged or ate their retainers.
Make sure in
put them you keep it away from them and safe in your
your
pocket. box.
 My retainers
Do you have a don’t fit, what should I do?
If yourRead
dog? retainers
this. don’t fit, that might be due to some movements of the
teeth or damaged retainers. Make sure you contact your orthodontist as
soon as possible by phone or by sending us an e-mail through the app.
 My retainers are loose/tight, what should I do?
If your retainers are tight, it is likely that your teeth have moved slightly. If
you can tolerate the tightness, wear your retainers full-time for two weeks.
If not, contact your orthodontist as soon as possible by phone or by
 sending us an e-mail through the app to provide you with new retainers if
needed. If your retainers are loose, it may be that your gums have settled
and shrunk back a little after brace treatment or the retainers may be
damaged. Contact your orthodontist as soon as possible to provide you
with new retainers if

My retainers are broken, what should I do?


Contact your orthodontist as soon as possible by phone or by sending us
needed.
mail through the app to repair/replace your retainers.
 an e-

269
Appendix 9

 How often do I need to replace my retainers?


As long as your retainers are fitting well there is no need to replace them. It
is likely that the retainers will last for a few years.
 Retainers are painful, what should I do?
Is it because they are tight? It is likely that your teeth have moved slightly.
If you can tolerate the tightness, wear your retainers full-time for two
weeks. If not, contact your orthodontist as soon as possible by phone or
by sending us an e-mail through the app to provide you with new retainers
if needed. Is it because the retainers have a sharp end? Contact your
orthodontist by phone or by sending us an e-mail through the app and
they should be able to smoothen it for you.
 Why does wearing retainers cause pain?
This may be because you stopped wearing your retainers for a while and
the teeth have moved slightly making it difficult to fit the retainers.
 How do I brush my teeth if I am wearing retainers?
Take off the retainers and brush your teeth for 2 minutes. Then, using the
same toothbrush, brush your retainers without using a toothpaste under
cold running water.
 I always forget where I placed my retainers, what can I do?
Always keep them in the box given to you. Never wrap them in tissues or
put them in your pocket.
 My retainers fall out while I am sleeping, what should I do?
Contact your orthodontist as soon as possible by phone or by sending us
an e-mail through the app to provide you with new retainers if needed.
 Will I need to pay to replace my retainers?
A new set of retainers will be replaced for free; however, if you lose them
again, you might need to pay. The cost varies but is usually around £100
each.
 Can I drink juice or hot tea with my retainers in?
Always take off your retainers when drinking juice or hot drinks.
Wearing my
retainers
How long do I need to wear my retainers for?
 As long as you want your teeth to be straight, you will need to wear the
retainers. There is always a tendency for the teeth to move back to their
position following taking braces off. You will need to wear the retainers on
a full-time basis (at least 22 hours a day) for the first 6 months, part-time
only (8 hours a day) for the second 6 months, and alternate nights from 12
to 18 months following removal of the braces. Thereafter, intermittent
nights-only wear (1 to 2 nights weekly).
What will happen if I don’t wear my retainers?
 Teeth always want to move back to their starting position once braces are
removed. Also, if your teeth move slightly and you try fitting your retainer,
the retainers will feel tight and might be painful. If your teeth move
significantly, the retainers may not fit your teeth anymore. What will my
teeth look like if I stop wearing my retainers?
 Your teeth will start moving. They will get crooked and may begin to look
as they did before braces. Click here to view photos of teeth that became
crooked. This is an example of how the teeth might move if the retainers
are not worn as advised for a period of time (red arrows pointing to teeth
that have moved significantly). Remember that these changes happen
gradually over

270
Appendix 9

time.


How will my teeth look if I wear the retainers as advised?
Your teeth will stay in their position. Click here to view photos of teeth that
stayed in position following having the braces off.

Photo taken when the Photo taken after 6 months


braces were just taken off of good retainer wear

 What do the retainers look like?


The retainers are clear and cover your teeth as shown in the photos. Click
here to view the photos.

Do I need to wear top and bottom retainers at the same time?


Not necessarily, as long as you meet the required hours of wear for each.
 If you wear them less than is required in one jaw, then the teeth are likely
to move.
 Do I really need to wear them that long?
Yes, you need to wear them for the required time to make sure your teeth
stay in their position.
 What does 'long-term wear of retainer' mean?
It means for as long as you want your teeth to be straight.
 I keep on forgetting to put on my retainers, what should I do?
Try the following tips:
* Keep the retainer box in a place where you can see it.
* Ask one of your family members to remind you.
* Set a reminder in the app.
* Remind yourself how important it is for you to have straight teeth.
* Remind yourself that you spent years wearing braces, you don’t want to

271
Appendix 9

go through that again.


 My teeth have started to move, what should I do?
If your teeth move slightly, when you try to fit your retainer they will feel
tight and might be painful. If the discomfort is not too severe, try wearing
the retainers full-time for 2 weeks until it fits properly again.
If your teeth have moved significantly then the retainers will not fit your
teeth anymore. You need to contact your orthodontist as soon as possible
by phone or by sending us an e-mail through the app, they can make you
a new set of retainers to prevent any further movement.

 When should I not wear my retainers?


During toothbrushing, eating, swimming and contact sports.
My orthodontist
 How do I get in contact with my orthodontist when they are away?
You are likely to be seen as a casualty appointment by other staff
members who will be able to help you and answer your questions.
They can make a note for your orthodontist and pass on any relevant
information for when they return to work. Alternatively, you can send an
e-mail through the app and we will get back to you as soon as possible.
 Will my orthodontist figure out if I am not wearing my retainers?
After a period of not wearing the retainers, teeth start to move
gradually. At the early stages, these changes might be too small to be
noticed, but over time they will become more noticeable, and your
these changes.
orthodontist will detect

What will my orthodontist say if I am not wearing my retainers? If
you find it hard to wear your retainers due to sharp edges, for example,
your orthodontist will adjust them for you to make them more
comfortable. If you are finding it difficult to remember to wear your
retainers, the orthodontist might give you some useful tips.
Your orthodontist
wearing retainers. will motivate you and remind you of the importance of

Orthodontic visits

272
Appendix 9


What will my orthodontist do at the follow-up appointment?
Your orthodontist will check your retainers, how well they fit your teeth,
position of your teeth.
and whether you have any problems wearing them. They will also check

Do I need to attend follow-up appointments?


wearing
Yes, them.
at the follow-up appointment the orthodontist will check your
 retainers and how well they fit your teeth, and whether you have any
problems in

What should I do if I don’t have a follow-up appointment?


 Please get in contact with the department and ask them to arrange an
appointment for you. Alternatively, you can get in contact with us by
sending us an e-mail through the app.
upWhy
appointments.
will I be discharged after 12 months? What should I do after

This is the policy within the orthodontic department. Your general
replaced?
dentist is asked to monitor your retainers after this time at your routine
dental checkWill I have a mould of my teeth taken before getting

Yes, in order to make new or replacement retainers, we need to have a


mould of your teeth so that the retainers will fit your teeth perfectly.
Impact of retainers
 Can I eat or drink with my retainers in?
No, you should take your retainers out during eating and drinking.
However, if you are drinking water, then you can keep them in.
 Why are my retainers causing pain?
- Is it because they are tight? It is likely that your teeth have moved
slightly. If you can tolerate the tightness, wear your retainers full-time
for two weeks. If not, contact your orthodontist as soon as possible by
phone or by sending us an e-mail through the app to provide you with
ifnew
needed.
retainers

- Is it because the retainers have a sharp end? Contact your orthodontist


by phone or by sending an e-mail through the app and they should be
able to smoothen your retainer for you.
 My retainers are causing a change in my speech (lisp, stutter), what
should I do?
At the start you might have a lisp because you are not used to wearing the
retainers yet. Give it more time and it should improve.
 I feel embarrassed about wearing my retainers, what should I do?
Remind yourself how important it is for you to have straight teeth, and to
maintain your results. Also, full-time retainer wear is only suggested for
the first 6 months. After that, you will be told to wear them part-time only.
 My gums hurt when I have my retainers in, what should I do?
Contact your orthodontist by phone or by sending an e-mail through the
app. They can trim or smoothen the edges of the retainers and make it
more comfortable for you.

273
Appendix 9

Othe
r What are the different types of retainer?
 There are two types of retainers- those which you can remove and place
yourself, and another type which is fixed to your front teeth.
What will happen after having my braces off?
 After having your braces off, you will have a mould taken for your retainers,
which will be given to you at a later appointment.
Do I need to attend the appointment to get my retainers?
 Yes. Your orthodontist will ensure that the retainer fits well and is
comfortable. You will also be given advice about wearing and looking after
your retainers.
How much does a new set of retainers cost?
 A new set of retainers will be replaced for free, however, if you lose them
again, you might need to pay for it. The cost varies but is usually around
£100 each.
How much does having braces for the second time cost?
 If you need braces again because of not wearing your retainers as advised,
this usually costs around £3,000 to £4,000.

General dental
health How often should I brush my teeth?
 At least twice a day- first thing in the morning and last thing at night.
Which one is better: electric or manual
toothbrush?
Both are good if you brush all teeth surfaces for 2-3 minutes a day.
 What is the best toothpaste to use?
The best toothpaste is the one that contains the correct amount of fluoride
for your age. For adults, that is 1,350 to 1,500 ppm of fluoride.
 What is the best toothbrush to use?
If you are using a manual toothbrush make sure it has soft bristles and the
size of the head is correct. If you are using an electric toothbrush, make
sure it has a rotating
head.How do I brush my teeth? (content includes
 photos)
Using a soft-bristled brush and fluoridated toothpaste. Make sure to clean
all tooth surfaces (outer, inner and chewing surfaces) gently and
thoroughly in strokes. Also, position the bristles at a 45-degree angle to
your the
view gums. Spit out any remaining toothpaste. Click here to view photos.
photos.

274
Appendix 9

 Why is it important to use dental floss?


Using dental floss helps to clean in between the teeth. These areas
are difficult to reach using a toothbrush only. Flossing can help to
prevent gum disease.
 How often should I use dental floss?
At least once every day.
 How do you clean in between the teeth?
By using dental floss.
 How often should I change my toothbrush?
Around every 3 months as the bristles tend to become worn.
 Do I need to avoid any type of food?
Try to limit sugary food and avoid fizzy drinks.
 How often should I visit my dentist?
At least once every 6 months for routine dental check-ups, unless advised
otherwise by your dentist.

275
Appendix 9

Removal of my
braces
 What should I do before my appointment?
- Go through the ‘frequently-asked questions’ section in the app. In
particular, please review the information related to getting braces off and
the importance of retainers. Make a note of any questions you might
have to ask your orthodontist.
- Don’t be disappointed if your orthodontist postpones removal of the
braces for minor adjustments, as this will help you to achieve the very
best result.
- Check your schedule to make sure that you are able to attend an
appointment around 7-10 working days after that visit to have your
retainers fitted.
 How long will it take to remove my braces?
Clipping the brackets off the teeth takes just a few minutes. However,
cleaning the glue off, taking moulds and photos will take another 30-40
minutes.
 Will it be painful to remove my braces?
You will feel some pressure while we remove the braces. However, this
should not be painful.
 How are braces removed?
1. Using a pair of plier to clip the attachments off each tooth.
2. If you had metal rings placed on one of your back teeth, we will remove
that using another pair of pliers.
3. After removing the brackets, there will be some glue left on your teeth.
4. We will remove this layer of glue using a rotating handpiece.
5. We will then take a mould of your top and bottom teeth.
6. Finally, we will take photos of your teeth and smile.
 What should I expect at the brace removal (debond) visit?
1. First, the braces will be removed.
2. We will then take a mould of your top and bottom teeth.
3. Finally, we will take photos of your teeth and smile. You can refer to the
question: ‘How are braces removed?’ for further details.
4. You can eat and drink normally afterwards.
5. Your gums might be swollen but should heal with good brushing and
flossing for a few days afterwards.
 How do patients usually feel after having their braces off?
They are usually happy and excited to see a big change in their smile and
to be able to see their straight teeth without braces. Some patients say
that it feels 'weird' to be able to run their tongue over their teeth as they
may feel very smooth. Toothbrushing and flossing also become much
easier.

276
Appendix 9

e) Content of the quiz section

Questions Explanation
1. I just need to wear my retainers for the first As long as you want your teeth to
year after having my braces off. be straight, you will need to wear
☐ True the retainers. Teeth always want
☐ False to move back to their starting
position once braces are
removed.
2. How many hours a day do you need to You will need to wear the
wear the retainers during the first 6 retainers on a full-time basis (at
months? least 22 hours a day) for the first 6
☐ 8 hours months, part-time only (8 hours a
☐ 10 hours day) for the second 6 months.
☐ 22 hours
☐ 24 hours
3. If I wear the retainers really well at the Teeth always want to move back
start, I can then stop wearing them as my to their starting position once
teeth are more stable. braces are removed.
☐ True
☐ False
4. How long do you need to wear your Retainers are for life.
retainers for?
☐ 3 months
☐ 12 months
☐ Long term
5. If I have problems with my retainers, I You need to attend a casualty
should wait for my next appointment to let appointment so that we can help
my dentist know. you. Otherwise, there is a chance
☐ True that the teeth might move.
☐ False
6. How often should you brush your teeth per At least twice a day for 2 minutes,
day? first thing in the morning and last
☐ 1 time per day for at least 2 minutes thing at night.
☐ 2 times per day for at least 1 minute
☐ 2 times per day for at least 2
minutes

7. How often should you visit your dentist? Once every 6 months for
☐ At least once every 6 months routine check-ups, unless
☐ At least once every year advised otherwise by your
dentist.
☐ At least once every 2 years
8. How often should I floss my teeth? ☐ At least once a day to help clean
At least once a day in between the teeth. These areas
☐ At least once every 3 days are difficult to reach using a

277
Appendix 9

☐ At least once a week toothbrush only. Flossing can help


to prevent gum disease.

278
Appendix 10

Appendix 10. Ethical approval for the mobile application RCT

279
Appendix 10

280
Appendix 10

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Appendix 10

282
Appendix 10

283
Appendix 11

Appendix 11. European Orthodontic Society grant application letter

Appendix 12. Information sheets for the mobile application RCT

284
Appendix 12

285
Appendix 12

286
Appendix 12

287
Appendix 12

288
Appendix 12

289
Appendix 12

290
Appendix 12

291
Appendix 12

292
Appendix 12

293
Appendix 12

294
Appendix 12

295
Appendix 12

296
Appendix 13

Appendix 13. Consent forms for the mobile application RCT

297
Appendix 13

298
Appendix 13

299
Appendix 14

Appendix 14. Questionnaire to assess knowledge and experiences


related to retainer wear

300
Appendix 14

301
Appendix 15

302
Appendix 15. Additional data from the experience and knowledge
questionnaire not included in the inferential analysis

3.
1. Neither 5.
Treatment 2. 4.
Questions Very Very
group Dissatisfied satisfied nor Satisfied
dissatisfied dissatisfied satisfied

How well do you Control (n= 0 (0%) 0 (0%) 3 (8.57%) 6 26


understand the 35) (17.14%) (74.29%)
reasons for wearing
Intervention 0 (0%) 1 (3.45%) 3 (10.34%) 6 19
the retainers?
(n= 29) (20.69%) (65.52%)
What do you think of Control (n= 0 (0%) 0 (0%) 4 (11.43%) 12 19
the frequency of your 35) (34.29%) (54.29%)
follow-up
Intervention 0 (0%) 0 (0%) 4 (13.79%) 13 12
appointments?
(n= 29) (44.83%) (41.38%)
Do you know where to Control (n= 1 (2.86%) 0 (0%) 2 (5.71%) 9 23
seek advice regarding 35) (25.71%) (65.71%)
your retainers?
Intervention 0 (0%) 1 (3.45%) 6 (20.69%) 7 15
(n= 29) (24.14%) (51.72%)
Do you feel informed Control (n= 0 (0%) 0 (0%) 2 (5.71%) 8 25
about the importance 35) (22.86%) (71.43%)
of retainers?
Intervention 0 (0%) 0 (0%) 3 (10.34%) 3 23
(n= 29) (10.34%) (79.31%)
How confident are you Control (n= 2 (5.71%) 2 (5.71%) 2 (5.71%) 12 17
that your teeth won’t 35) (34.29%) (48.57%)
move if you wear the
Intervention 0 (0%) 0 (0%) 5 (17.24%) 5 19
retainers as advised?
(n= 29) (17.24%) (65.52%)
How satisfied are you Control (n= 0 (0%) 0 (0%) 1 (2.86%) 11 23
that your questions 35) (31.43%) (65.71%)
about retainers are
Intervention 0 (0%) 0 (0%) 4 (13.79%) 10 15
answered?
(n= 29) (34.48%) (51.72%)
How well do you Control (n= 0 (0%) 1 (2.86%) 12 (34.29%) 14 (40%) 8
remember to wear 35) (22.86%)
your retainers?
Intervention 1 (3.45%) 2 (6.9%) 5 (17.24%) 12 9
(n= 29) (41.38%) (31.03%)
How well do you Control (n= 0 (0%) 0 (0%) 0 (0%) 12 22
remember where to 34) (35.29%) (64.71%)
store your retainers?
Intervention 0 (0%) 2 (6.9%) 3 (10.34%) 6 18
(n= 29) (20.69%) (62.07%)

303

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