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October 2019 . Volume 12 .

Number 4

Tooth Autotransplantation Part 3:


Surgical Planning and Technique
Multiple Unerupted Teeth
– an Interesting Challenge
Primary Failure of Eruption
– a Review and Case Report
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October 2019 Orthodontic Update 123

INSIDE THIS ISSUE

125 COMMENT A Atwal and PE Benson


Objective: To understand the importance of research questions(s) and
have some knowledge about what should be included in a protocol for
126 ORTHODONTICS a clinical trial.
Tooth Autotransplantation Part 3: Surgical Planning and Technique Enhanced CPD DO C
H Nazzal, S Barber, Z Jawad, N Houghton and M Duggal
Objective: To describe the assessment of the donor tooth and recipient 150 BOOK REVIEW
site during planning and to highlight pre-surgical considerations, surgical
procedure and post-surgical management of transplanted teeth. 151 ORTHODONTICS
Enhanced CPD DO C Lingual Orthodontics with Customized Functional Appliance
S Premkumar and V Peter
134 ORTHODONTICS Objective: To utilize the advantage of combining lingual orthodontics
Multiple Unerupted Teeth – an Interesting Challenge with custom-made functional appliances and communicate this to the
N Adam, A Flett and C Sandler patients using proper diagnosis and treatment planning.
Objective: To describe the different situations in which a tooth or teeth Enhanced CPD DO C
might fail to erupt and discuss appropriate management plans.
Enhanced CPD DO C
157 ORTHODONTICS
Five Years and Counting…..Reflections on the First Years of Owning a
140 ORTHODONTICS Specialist Practice
Primary Failure of Eruption – a Review and Case Report A Patel
B Harlow, K Parker and S Hodges Objective: To advise on setting up a specialist orthodontic practice.
Objective: To outline the diagnosis and management options of primary Enhanced CPD DO C
failure of eruption.
Enhanced CPD DO C
161 Tricks of the Trade
144 BOOK REVIEW A New Method of Active Tie-Back for Space Closure
R Bangera, RD Naik, AK Patil, ShashiKumar B and PraveenKumar
145 ORTHODONTICS
How to Design and Set Up a Clinical Trial Part 2: Protocols and Approvals 162 CPD QUESTIONS

EDITORIAL DIRECTOR
Professor Jonathan Sandler Nerina Hendrickse Alison Murray
Consultant Orthodontist GDP Consultant Orthodontist
Chesterfield and Winchester Royal Derby Hospital
North Derbyshire Royal Hospital Hants Derby DE22 3NE
Calow, Chesterfield
Derbyshire S44 5BL Professor Anthony J Ireland Andrew Shelton
Consultant Orthodontist Consultant Orthodontist
EXECUTIVE EDITOR Division of Child Dental Health Orthodontic Department
Angela Stroud Bristol Dental Hospital and School Montagu Hospital
Lower Maudlin Street Mexborough S64 OAZ
EDITORIAL BOARD Bristol BS1 2LY
Professor F J Trevor Burke
Birmingham Dental Hospital and Lynda Kirk
School of Dentistry Orthodontic Therapist
5 Mill Pool Way Royal Derby Hospital
Edgbaston Uttoxeter New Road
Birmingham B5 7EG Derby DE22 3NE

CPD in Orthodontic Update in partnership with Cover Picture: ‘Brace your Brackets’: Orthodontic
brackets for a fixed appliance. (Courtesy of Dr Avita
Rath, Lecturer, and Dr Arun Paul, Senior Lecturer,
Faculty of Dentistry, SEGi University, Malaysia).

OU ISSN 1756-6401
October 2019 Orthodontic Update 125

Comment

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126 Orthodontics October 2019

Enhanced CPD DO C

Hani Nazzal Sophy Barber, Zynab Jawad, Nadine Houghton and Monty Duggal

Tooth Autotransplantation
Part 3: Surgical Planning
and Technique
Abstract: The practical aspects of pre-operative assessment and surgical procedure for autotransplantation are discussed in this part of
the series. The success of tooth transplantation is dependent on case selection, careful planning and a surgical procedure that maintains
viable periodontal ligament cells and intact cementum of the transplanted teeth. A thorough assessment of the donor tooth and recipient
site is vital for successful planning and execution of tooth autotransplantation. The surgical procedure involves atraumatic extraction of
the donor tooth, socket preparation and splinting of the transplanted tooth. Post-surgical procedures include monitoring of pulp and
periodontal healing and restorative camouflage of the donor tooth.
CPD/Clinical Relevance: Surgical planning and procedures are vital to the success of autotransplantation. Orthodontists should be aware of
these factors and bear them in mind when preparing patients for autotransplantation to optimize surgical success.
Ortho Update 2019; 12: 126–133

Surgical planning and technique and cervical dimension of the crown. commonly the preferred choice due to
are vital aspects to the success of The mesio-distal widths of upper and their single root morphology and high
autotransplantation. A number of key lower premolars are usually only 1.5 mm frequency of single canal (85%) and
factors relating to the donor tooth smaller than that of upper central incisors single foramen (97.5%). The mandibular
and recipient site are considered (7 mm compared to 8.5 mm at maximum first premolars similarly have a single root
during assessment and planning for bulbosity), although the cervical areas are morphology but the frequency of a single
autotransplantation. usually considerably smaller. To manage canal is lower (73%) and the likelihood
this discrepancy it has been suggested of a single canal dividing into two apical
Donor tooth assessment that rotating the donor premolar tooth foramens is higher (25%) than the
Crown assessment approximately 90 degrees improves the mandibular second premolar. Maxillary
Donor tooth assessment is usually emergence profile when transplanted into second premolars are less commonly
considered in terms of assessment of the the upper central incisor region (Figure 1). used as only 40% of cases demonstrate a
crown and roots. A donor tooth crown single root with single root morphology
should be assessed for dental caries, crown Root assessment canal system.1
anomalies and crown dimension. One of Donor tooth roots are assessed with Immature teeth are associated
the main considerations, when assessing regards to number of roots, stage of with better long-term success than
the recipient site, is whether adequate formation, morphology and dimensions in mature teeth and present fewer
space exists for the donor tooth. It is order to inform recipient site preparation. restrictions in terms of bone height and
therefore essential that the donor tooth Single-rooted donor teeth with a single tooth positioning. The ideal time for
size is measured accurately at maximum root canal system, such as mandibular transplantation is when root formation
bulbosity including the maximum bulbosity second premolars, canines and incisors, are is approximately 75% with an apical

Hani Nazzal, BDS, MFDS RCS Ire, PhD, FDS RCS Canada, Lecturer and Locum Consultant in Paediatric Dentistry, University of Leeds (email:
denha@leeds.ac.uk), Sophy Barber, BDS, MJDF(RCS Eng), MSc, MOrth(RCS Ed), Post-CCST Registrar in Orthodontics, Leeds Dental Institute,
Zynab Jawad, BChD, MFDS RCSEng, MSc Orthodontics, MOrth RCSEd, Post-CCST Orthodontics, Leeds Dental Institute, Nadine Houghton,
BDS, MFDS, MDSci, MOrth(RCS Eng), FDS Orth(RCS Eng), Consultant Orthodontist, Bradford Teaching Hospitals Foundation Trust and Monty
Duggal, BDS, MDSc, FDS Paed Dent(RCS Eng), PhD, Professor in Paediatric Dentistry, National University Health System, Singapore.
October 2019 Orthodontics 127

opening of at least 1 mm to encourage and subsequent extraction was reported alveolar ridge in order to identify bony
revascularization of the root canal bundle.2 to be 70% less than those teeth with deficits and soft tissue morphology,
In these teeth, the risk of transplant failure closed apices.3 supplemented with appropriate
For teeth with complete root radiographs (Figure 3). In a growing child,
formation, careful selection is required the alveolar bone is vulnerable to atrophy
a as the root length can introduce height following tooth loss. To avoid alveolar
restrictions for positioning the donor bone loss in the recipient site, attempts
tooth within the recipient bone. The should be made to maintain teeth in
average root length of premolars and the recipient site, even if the prognosis
canines is 13–16 mm. Such average root of the tooth is poor. Teeth remaining in
lengths provide an indication of the bone the recipient site should be monitored
height required at the recipient site. regularly for infraocclusion, which may
cause a localized obstruction to vertical
Radiographic assessment bone growth in the region leading to
Two-dimensional radiographs, severe bony defects.
b such as long-cone periapicals and Coronal space is required
orthopantograms (OPTs), are usually between the teeth adjacent to the
sufficient for assessing donor tooth recipient site to enable placement of the
morphology and stage of root donor tooth. Space requirements can be
development (Figure 2). The use of cone- estimated by measuring the crown of
beam computed tomography (CBCT) the donor tooth. The space available in
is gaining popularity for pre-surgical the recipient site should be measured at
assessment and can aid planning for the gingival and incisal level. If the donor
potential donor teeth with unclear root tooth is to be restored prior to definitive
morphology. orthodontic treatment, sufficient space
Figure 1. Placement of a premolar transplant is also required for the restorative
into the socket of a maxillary central incisor Recipient site assessment camouflage. In cases with single tooth
postion demonstrating: (a) the difference in the Clinical assessment transplantation, this can be estimated
mesio-distal crown widths at maximum bulbosity The recipient site should be carefully by measuring the contralateral tooth. In
and the emergence profile at the cervical level examined to assess bone volume, soft cases where a contralateral tooth is not
between the premolar donor tooth and the
tissue morphology and the proximity available, the ideal coronal dimensions
contralateral central incisor; (b) the effect of
of adjacent structures. Bone volume is can be estimated from adjacent teeth
rotating the donor premolar tooth to improve
assessed clinically by palpation of the using average relative proportions.4
the mesio-distal crown width and emergence
profile.

a b c

Figure 2. Radiographic examination showing: (a) potential donor tooth for transplantation to replace a maxillary central incisor. The second premolar was
partially erupted with a single root and canal with incomplete root formation; (b) the transplanted premolar in the maxillary right central incisor position
immediately post-operatively; (c) continued root development 6 months post-operatively.
128 Orthodontics October 2019

The occlusion should be transplant can be protected by the use of a in terms of management of bone in
checked in static and dynamic function removable appliance with posterior buccal the recipient site, space maintenance
prior to or during surgery. This ensures capping if it is not possible to remove or creation and management of any
that there is sufficient occlusal clearance occlusal interferences prior to or during pathology associated with failing teeth
to allow the transplant to be placed surgery. in the recipient site. Management of
with minimal occlusal interferences. The young patients prior to their entry into
Radiographic assessment the autotransplantation care pathway
Radiographic assessment is crucial for should aim to maintain bone height
assessing bone volume, the health of the and width. This may be difficult in cases
teeth at the recipient site and proximity of where tooth loss was unavoidable, such
adjacent structures. This assessment usually as avulsed teeth that were not suitable
involves conventional radiographs (Figures for replantation, forced tooth extraction
2 and 3) supplemented with 3-dimensional following complex injuries or persistent
imaging, where further details are required. periapical pathology. Methods for
Radicular infection, infection-related managing the bone are described further
in the fourth article in this series.
resorption and any other pathology at
Teeth provide an ideal
the recipient site must be diagnosed
natural space maintainer and even teeth
and appropriately managed in order to
with poor long-term prognosis may be
optimize bone quality. The proximity of
retained prior to autotransplantation
adjacent structures, such as adjacent tooth
to maintain space. In sites where the
roots, the maxillary sinus and mental nerve,
tooth has been lost, space should
will impact on treatment planning. be maintained using a fixed or
removable space maintainer, such as a
Figure 3. Upper standard occlusal radiograph Preparation for surgery temporary resin-bonded bridge or an
used to assess bone levels in the maxillary left Preparation for surgery may be considered upper removable appliance. In cases
central incisor recipient site.

a d g

b e h

c f i

Figure 4. Surgical steps involved in transplantation of the mandibular second premolar (LL5) into the maxillary right central incisor (UR1) position: (a) infra-
occluded UR1 judged to have poor prognosis due to replacement resorption following avulsion and replantation; (b) extraction of the UR1 at the time of
the transplantation; (c) atraumatic extraction of the LL5; (d) the use of a surgical template to assess the depth and width of the donor site socket; (e, f)
the use of a surgical bur (e) and osteotomes (f) to modify socket depth and width; (g, h) transplantation of the donor tooth into the prepared socket and
confirmation that there are no occlusal interferences on the transplanted tooth; (i) the transplant is splinted using a titanium trauma splint.
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October 2019 Orthodontics 131

where space has been lost, pre-surgical Socket preparation for a recipient site with a
orthodontics will be required to recreate a poor prognosis tooth is shown in Figure 4.
the space, as described in the previous
article. 3. Socket assessment
Pathology in the recipient The socket is assessed during preparation
site should be managed in order to to ensure that it is able to accommodate
ensure optimal bone health at the time the donor tooth. Traditionally, this was
of transplantation. Pre-existing infection achieved by transplantation of the donor
can be managed through disinfection of tooth into the prepared socket. Several
the root canal system, use of antibiotics, attempts are usually made before a suitable
extraction of the tooth or surgical removal socket is created, which risks further
of the existing pathology. damage to the periodontal ligament cells
and increases the risk of future ankyloses.5
Surgical technique Consequently, different techniques
The choice for undertaking the surgical have been proposed to aid assessment
procedures using local analgesia, sedation of socket height and width (Figure 5).
or general anaesthesia will depend on the These include pre-surgical radiographic
patient’s age, co-operation, preference, measurements,2 acrylic stents constructed
medical history and the expected using radiographic measurements,6 surgical
b
complexity of the surgery. Careful metal stents constructed using average
7
discussion with patients and those with measurements of premolar teeth and
parental responsibilities outlining the construction of 3D tooth replicas using
components of the surgical procedure and Cone-Beam Computerized Tomography
the advantages and disadvantages of each (CBCT).8 Pre-fabricated surgical templates
treatment modality is required for informed assist the surgical component of premolar
consent. transplantation by establishing and
The surgical technique can be replicating the root dimensions of the
divided into five stages: donor premolar tooth. The correct template
1. Extraction and assessment of the donor is used to assess the width and depth of the
tooth; socket preparation prior to placement of c
2. Socket preparation; the transplant in the recipient site.
3. Socket assessment;
4. Placement of the transplant; 4. Placement of the transplant
5. Transplant splinting. The transplanted tooth should ideally be
seated a few millimetres from the occlusal
1. Extraction of the donor tooth plane to prevent occlusal trauma and
Extraction of the donor teeth using only damage to the periodontal ligaments. This
coronal force application is performed has the additional advantage of allowing
to ensure minimal trauma to the root, the tooth to erupt into a functional position
Figure 5. Different methods of replicating the
and prevent damage to the periodontal with corresponding bone deposition. transplant tooth to aid surgical preparation of
ligament and cementum. Traumatic Transplants with complete root formation the socket for the transplant: (a) 3D printed
extraction with significant damage to require root canal treatment, therefore stents developed from a cone beam scan of the
the periodontal ligament is less likely to coronal reduction could be performed at donor tooth; (b, c) two different designs of pre-
recover and will result in the transplanted time of transplantation, if required. On the fabricated surgical templates. The correct size
tooth becoming ankylosed. In cases where contrary, particular care should be taken can be selected based on the proportions of the
there is more than one tooth available for with immature teeth, as revascularization donor tooth.
transplantation, donor tooth selection is is desirable and may be compromised by
made based on root morphology, stage enamel reduction. If ideal positioning is not
of development and anticipated ease of possible, occlusal reduction of immature
extraction. Direct visual assessment can be teeth could be undertaken gradually adjacent teeth are available for bonding
used to determine the root shape following to optimize pulp recovery. Positioning a splint, but care must be taken to ensure
extraction. The preferred donor tooth is immature teeth in relation to the occlusal that the sutures provide adequate
then repositioned back into its original plane is less critical as these teeth have stabilization of the transplanted tooth.
socket to prevent damage to periodontal the potential to erupt, encouraging bone The splint should be passive to prevent
ligament cells while the socket is prepared growth and improved gingival contour. damage to periodontal cells and attached
in the recipient site. to the teeth with composite.
5. Transplant splinting
2. Socket preparation The transplanted tooth is splinted using Antibiotic prophylaxis
The steps required for socket preparation a physiologic splint such as a titanium There is little evidence for use of
depend on the presence or absence of a trauma splint (TTS) with the transplanted systemic antibiotic administration
tooth in the recipient site. Preparation of tooth splinted to at least one tooth on after transplantation. Although a
existing sockets is easier than creation of either side (Figure 4g). Sutures are reported positive effect has been demonstrated
new ones in an edentulous alveolar ridge. for splinting teeth, particularly where no in several studies for prophylactic
132 Orthodontics October 2019

a resorption of tooth autotransplantation healthy gingiva can be camouflaged using


were 2.5 times and 1.4 times higher in direct composite veneers.
studies where no systemic antibiotics
have been used, respectively. Therefore, Medium term care
the use of systemic antibiotics, albeit Monitoring healing
controversial, seems to be beneficial in Transplanted teeth are then followed up
tooth autotransplantation. clinically and radiographically following the
same guidelines for avulsed and replanted
b Short-term post-surgical teeth. The initial follow-up appointment
care is after 7–10 days where splint removal
Post-operative instructions and the interim composite camouflage
Post-surgical instructions for restoration is placed. For transplants with
autotransplant patients are given as closed apices, where revascularization is
follows: not expected, pulp extirpation is performed
„ Appropriate analgesia to manage any at this appointment. This is followed by an
post-operative pain; appointment 4 weeks post-transplantation
„ Meticulous oral hygiene to encourage for completion of endodontic treatment
healing and prevent infections; with definitive obturation. The
„ Use of a Chlorhexidine Digluconate transplant is then reviewed clinically and
mouthwash (0.2%) or gel (1%) to radiographically at 3 months, 6 months and
Figure 6. (a, b) Interim restoration placed on
support oral hygiene, particularly during 12 months.
the transplanted premolar in the maxillary the first few days post-operatively while Transplants are assessed in
right central incisor position for the duration of brushing may be difficult; relation to:
orthodontic treatment. „ A soft diet is recommended for two „ Oral hygiene and gingival health;
weeks following the procedure to „ Clinical signs and symptoms of periapical
prevent detachment of the splint and pathology (pain, tenderness to percussion,
movement of the transplant; mobility and sensibility testing in immature
a
„ Contact sports are prohibited during teeth);
the recovery period. „ Clinical signs of ankylosis (infraocclusion,
altered percussion sound);
Pulp and PDL management
„ Radiographic signs of replacement
Patients are reviewed, following the
resorption, pathology and root resorption.
autotransplantation, after 7–10 days
to assess recovery and healing. Clinical
Definitive restoration
examination focuses on:
Following completion of orthodontic
„ Oral hygiene assessment and
b treatment, a definitive restoration can be
reinforcement;
provided if required. Composite veneers
„ Periodontal healing of transplanted
are preferable to porcelain veneers
tooth;
as modification to address continued
„ Pulp extirpation for teeth
growth and gingival maturation is easier.
transplanted with complete root
Adjunctive treatments, such as gingival
formation;
re-contouring and tooth bleaching, can
„ Splint removal with assessment
be used to improve the aesthetic outcome
of transplant mobility and gingival
(Figure 7).
healing;
„ Mobile transplants or those with
inflamed gingival tissues should be Conclusions
Figure 7. (a, b) A transplanted premolar splinted for a further week; Successful autotransplantation relies on
replacing the maxillary right central incisor „ Interim restorative camouflage of the careful pre-surgical assessment of the
(shown in Figure 6) following definitive transplant (Figure 6). donor tooth and recipient site. The recipient
restoration. This involved single tooth bleaching site is prepared to optimize the bone
of the premolar transplant followed by Interim restorative camouflage quality and health. Surgery aims to remove
placement of a porcelain veneer.
At the review appointment, an interim the donor tooth atraumatically, preserving
temporary restoration can be provided the periodontal ligament. The transplant
to improve the appearance of the is placed into the prepared recipient site
systemic antibiotics with avulsed transplant if required. This has the and splinted during the healing period. A
and re-implanted teeth, there is advantage of improving aesthetics and standardized review protocol is followed to
limited evidence to support their normalizing the coronal morphology ensure that transplant healing is monitored
use in autotransplantation where for positioning adjacent teeth; however, and timely follow-up orthodontic and
the conditions are controlled.9,10 A it may also obscure the transplant restorative care is provided.
recent systematic review and meta- morphology during orthodontic
analysis has shown that the failure rate tooth positioning and increase plaque Compliance with Ethical Standards
and occurrence of infection-related stagnation. Firm transplants with Conflict of Interest: The authors declare that
October 2019 Orthodontics 133

they have no conflict of interest. of teeth: requirements for Diangellis AJ et al. International
Informed Consent: Informed consent predictable success. Dent Association of Dental Traumatology
was obtained from all individual Traumatol 2002; 18: 157–180. guidelines for the management of
participants included in the article. 6. Clokie CM, Yau DM, Chano traumatic dental injuries: 2. Avulsion
LM. Autogenous tooth of permanent teeth. Dent Traumatol
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1. Carrotte P. Endodontics: Part 4
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7. Day PF, Lewis BR, Spencer RJ,
system. Br Dent J 2004; 197;
Barber SK, Duggal MS. The
CPD Answers for
379–383.
2. Andreasen JO, Paulsen HU, Yu Z,
design and development of
surgical templates for premolar
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Bayer T, Schwartz O. A long-term
transplants in adolescents. Int
study of 370 autotransplanted Endod J 2012; 45: 1042–1052.
premolars. Part II. Tooth survival 8. Shahbazian M, Jacobs R, Wyatt 1. C
and pulp healing subsequent to J, Willems G, Pattijn V, Dhoore E,
transplantation. Eur J Orthod 1990; Vinckier F. Accuracy and surgical 2. B
12; 14–24. feasibility of a CBCT-based
3. Almpani K, Papageorgiou stereolithographic surgical guide 3. B
SN, Papadopoulos MA.
Autotransplantation of teeth in
aiding autotransplantation of
teeth: in vitro validation. J Oral
4. C
humans: a systematic review and
meta-analysis. Clin Oral Investig
Rehabil 2010; 37: 854–859. 5. B
9. Day PF, Gregg TA. Treatment
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4. Snow SR. Esthetic smile analysis of Children. UK BSPD National
maxillary anterior tooth width: the Clinical Guidelines in Paediatric 7. B
golden percentage. J Esthet Dent Dentistry, 2012.
1999; 11: 177–184. 10. Andersson L, Andreasen JO,
5. Tsukiboshi M. Autotransplantation Day P, Heithersay G, Trope M,

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134 Orthodontics October 2019

Enhanced CPD DO C

Naeem Adam Andrew Flett and Cara Sandler

Multiple Unerupted Teeth


– an Interesting Challenge
Abstract: This paper describes primary failure of eruption and presents some of the theories about the aetiology of this clinical condition.
It also covers single ankylosed teeth as well as cases that present with multiple unerupted teeth. The various approaches to the clinical
management of this not uncommon problem are discussed, along with the pros and cons of some of these techniques.
One difficult clinical challenge is documented, where a 14-year-old patient presented with 19 unerupted permanent teeth and, with the
help of rare-earth magnets and upper and lower fixed appliances, within a two-year period a good result was achieved.
CPD/Clinical Relevance: Clinicians encounter teeth that have failed to erupt on a regular basis. Appropriate diagnosis and treatment
planning of these cases, and subsequent effective clinical management, is imperative to ensure the most favourable outcome for our
patients.
Ortho Update 2019; 12: 134–139

Permanent teeth may fail to erupt because vital to distinguish obstructive failure further;
of obstruction, or disruption, of the of eruption, PFE and isolated ankylosis. „ The occlusion manifests as a lateral open
eruptive mechanism. Eruption may be Not doing so may jeopardize successful bite;
obstructed by the presence of pathology, orthodontic management and potentially „ Involvement can be unilateral or bilateral;
ectopic tooth position, interferences from cause harm to the patient. This is „ Application of orthodontic forces to
adjacent teeth or lateral forces from the particularly pertinent in cases of PFE, where the affected teeth sometimes precipitates
tongue.1 Teeth may also fail to erupt due the injudicious application of traction ankylosis rather than normal tooth
to primary failure of eruption (PFE) or may precipitate ankylosis of the offending movement;
ankylosis. The latter is defined as the fusion tooth and consequent intrusion of adjacent „ PFE is associated with a mutation in the
of cementum to bone in at least one area normal teeth.3 parathyroid hormone 1 receptor (PTH1R)
lacking a periodontal ligament space.2 gene.
Primary failure of eruption (PFE) Primary failure of eruption Raghoebar et al subdivided
is defined as incomplete tooth eruption The term PFE was coined by Proffit and PFE into primary and secondary retention;
despite the presence of a clear eruptive Vig in their seminal research on the topic.4 primary if the tooth failed to erupt, and
pathway.1 There is no ankylosis and it is the It is a rare condition with a prevalence of secondary if there was cessation after initial
eruptive mechanism itself that is disturbed.2 0.06%.5 Subsequent research has refuted penetration through the oral mucosa.7
This article will review the literature on PFE some of their initial observations, but the Frazier-Bowers et al described three
and failure of eruption from ankylosis. We literature demonstrates consensus on the different forms of PFE:8
also present a case of multiple unerupted following features:1,2,6 „ Type I, where all affected teeth have
teeth, treated with the use of neodymium „ Posterior teeth are more frequently a similar lack of eruptive potential and
iron boron magnets, as well as the more affected than anteriors; a posterior open bite establishes with
conventional deployment of gold chains to „ Teeth posterior to the most anteriorly worsening severity from anterior to
facilitate orthodontic traction. affected tooth may be involved; posterior;
Establishing the correct „ Affected teeth may completely fail to „ Type II, where a more varied eruption
diagnosis forms the basis of satisfactory erupt, or may initially erupt through the potential is seen between the affected
management of unerupted teeth. It is oral mucosa, before ceasing to erupt teeth. In such cases, a tooth distal to the

Naeem Adam, BDS(Hons) MaxFac DCT2, Leeds Dental Hospital (email: naeem.i.adam@gmail.com), Andrew Flett, BDS, MJDF RCS,
MClinDent, MOrth RCS, Consultant Orthodontist, Nottingham University Hospital and Cara Sandler, BDS MaxFac DCT1, Royal Sussex
County Hospital, Brighton, UK.
October 2019 Orthodontics 135

most mesial affected tooth may show Ankylosis and failure of biological underpinnings of tooth
greater, but still inadequate, eruptive eruption eruption are presently poorly
potential; Isolated ankylosis is a rare condition understood, however, several
„ In Type III, subjects have both Type I and with a similar presentation to PFE. rare diseases and syndromes are
Type II tendencies co-existing in different A diagnostic feature distinguishing associated with delayed tooth
quadrants. between the two is that ankylosis eruption.13
Several systemic or syndromic typically affects a single tooth, with Occasionally, failure of
conditions, such as cherubism and distal teeth being unaffected.1 This eruption of multiple teeth cannot
cleidocranial dysplasia, have failure of tooth naturally makes diagnosis difficult in be attributed to a local or systemic
eruption as an identifying feature, and must a child in the mixed dentition, as one condition. This is a rare occurrence
be excluded when establishing a diagnosis cannot be certain of the status of the and the literature contains relatively
of PFE.1 A family history of PFE appears unerupted teeth. Partially erupted teeth few examples of such cases. Their
to be a risk factor for its development, that are ankylosed will exhibit a dull orthodontic management is varied,
and inheritance appears to be autosomal metallic sound when percussed. These and differing approaches, applied
dominant with variable expressivity.9 teeth cease to erupt, drift or move, with varying levels of success, have
Earlier research found the level of dental despite normal adolescent growth or been reported.14,15,16
anomalies, such as hypodontia, to be orthodontic traction. They may further
considerably higher than average in disturb the occlusion by allowing Orthodontic application of
individuals with PFE, but more recent adjacent teeth to tilt and opposing magnets
research refutes this.1,6 teeth to overerupt. Radiographically, Many options are available for the
PFE appears to be associated ankylosis gives the appearance management of unerupted teeth
with a mutation in the PTH1R gene and, of relative submergence, and the and these vary in their invasiveness
consequently, genetic testing may assist in periodontal ligament space may be and ease of application. The least
early and accurate diagnosis.10 focally absent.3,11,12 invasive is the creation of space to
Even in the absence of a known The orthodontic facilitate spontaneous eruption, and
genetic, pathological or environmental management of ankylosis differs the next line is surgical exposure of
factor responsible for failure of tooth significantly from that of primary failure the unerupted tooth with attachment
eruption, a true definitive diagnosis of PFE of eruption. Isolated ankylosis responds of a gold chain to allow application
may only ever be given retrospectively, well to treatment and may be managed of orthodontic traction. This latter
after attempts at orthodontic extrusion of by extracting the affected tooth approach is probably the most
the affected teeth have failed. Management at the appropriate age, or through common approach to impacted
of PFE is made difficult by the tendency luxation and subsequent orthodontic teeth, but it does require a surgical
for affected teeth to ankylose when alignment.3,12 procedure, usually under general
orthodontic forces are applied.1 The anaesthetic, and the operator must
literature describes various techniques from Multiple unerupted teeth provide treatment that is relatively
coronal build-ups of the affected teeth Delayed tooth eruption (DTE) is defined technique sensitive.
to segmental osteotomy, but treatment as the emergence of a tooth into the Blechman and Smiley
in severe cases is invariably complex and oral cavity at a time that deviates first described the use of magnets to
often multidisciplinary.3 The case presented significantly from the norms established achieve orthodontic tooth movement,
here responded well to orthodontic for different races, ethnicities and and since then magnets have been
traction, excluding a diagnosis of PFE. gender.11 The mechanisms and used successfully in a wide variety
of orthodontic applications.17,18 An
application for impacted teeth was
first described by Sandler et al and
involved the attachment of paralene
coated, rare earth magnets to the
unerupted tooth using composite
resin, followed by provision of a
removable appliance containing a
larger magnet.19 The magnets must
be correctly placed with opposing
poles approximated, and properly
aligned to ensure optimal direction of
pull. Once they are in place, the only
adjustment required is the occasional
repositioning of the magnet
contained within the removable
appliance, until the two magnets are
almost in apposition.
This method requires
little manual dexterity of either the
Figure 1. OPT showing multiple unerupted teeth.
operator or the patient. The speed
136 Orthodontics October 2019

a a

Figure 4. Rare earth magnets embedded in an


upper removable appliance.

Dysmorphic features (Figure


b c 2a, b), such as low set ears, had raised
concerns in the past and she was under
review by a geneticist. However, no
specific diagnosis was made. It had
been noted that she had hypertelorism,
a small mandible, slightly high palate
and hypermobile wrists. There was no
evidence of cranial nerve compression
and fundoscopy was unremarkable.
d After seeing a Consultant in
Clinical Genetics, the patient enrolled
into a research study called Deciphering
Developmental Disorders (DDD). The
initial report from that study said ‘No
plausible pathogenic variants currently
identified’.
Figure 2. (a, b) Dysmorphic features of
The orthodontic diagnosis
hypertelorism and a small, retropositioned
mandible.
was made of Class II incisor relationship
on a mild Class II skeletal base with
slight maxillary hypoplasia, and
e
mandibular retrognathia, increased
MMPA and lower facial height. She
was still in the mixed dentition, with
of tooth movement appears to be as retained upper Cs and Ds and multiple
quick as other methods, and the slowly unerupted teeth suffering from primary
increasing, continuous force may be failure in eruption (Figures 3a–e).
more physiological. Palatally directed
forces are more readily applied, helping Figure 3. (a–e) Intra-oral views from initial Treatment plan
to ensure that teeth do not erupt presentation. The patient was referred to Chesterfield
through the labial plate, and that Royal Hospital for orthodontic
they end up with an adequate cuff of treatment and a plan was devised to
attached gingiva on eruption. encourage her unerupted teeth into
Diagnosis occlusion. This included extraction of
Case report A panoramic radiograph (Figure 1) remaining deciduous teeth, placement
A 14-year-old female patient presented revealed the presence of 19 unerupted of an upper removable appliance
with delayed eruption of multiple permanent teeth. The consultant in containing rare earth magnets, and
teeth. Medically she was fit and well dental radiology reporting the OPT bonding of opposite pole magnets
and presented with a caries-free mixed said that he could understand why to the upper unerupted teeth to
dentition and excellent oral hygiene. some teeth had not erupted. He encourage eruption.
Her initial complaint was that she was noted that the ‘bone on the left side
extremely anxious about the delayed of the mandible looked a bit dense’, Treatment
eruption of her teeth, and had difficulty however, did not suspect osteopetrosis. Orthodontic treatment was carried out
chewing on the left-hand side. There The patient also saw a consultant of over a 20-month period. Under general
was no relevant family history and paediatric bone care who noted that anaesthetic the remaining deciduous
a genetic aetiology had not been there were no concerns regarding her teeth, upper Ds and Cs, were removed
identified. skeleton. and Neodymium Iron Boron magnets (3
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138 Orthodontics October 2019

a b upper and lower fixed appliances and


attempted correction of the lateral
open bite on the left with red elastics
to Kobyashi hooks. Sadly, these teeth
proved to be resistant to eruption
(Figures 6a–c). An orthognathic
opinion had been sought during
treatment. It was decided that,
although BSSO advancement would
theoretically be possible, the risks
c
of surgery were high due to thin
mandible and uncertain quality of
the bone. Lower second and third
molars were also present, removal of
which would be required prior to any
osteotomy.
It was decided that
the treatment had been largely
successful, although it was impossible
to achieve full closure of the lateral
open bite. Despite this, the patient
was completely happy with the
results and declined any further
intervention. She was, however, given
the option of reconsidering further
treatment in the future.
Three years after the end
of treatment, the patient was still
delighted with the result achieved,
was really pleased with her smile and
had no wish for further intervention
(Figures 7a–g).
Figure 5. (a, b) Unerupted teeth in a more favourable position for bonding. (c) OPT showing progress
9/12 into treatment. Conclusions
There is a variety of causes for
unerupted teeth and it is helpful
a for all practitioners to be familiar
x 3 x 1 mm) were bonded to UL542 and with the various aetiological factors.
UR2456. Gold chains were bonded to It is certainly helpful if they can
the upper left canine, to the lower first distinguish between primary failure of
premolars and to the lower left molar, eruption and ankylosis.
to aid their eruption by eventually Many different treatment
applying direct traction to the fixed approaches have been advocated
appliances. An upper removable for the management of unerupted
b appliance was fabricated containing the teeth. In cases of multiple unerupted
larger magnets (5 x 5 x 2 mm) (Figure teeth, it is worthwhile considering
4). Magnetic forces were applied for using rare earth magnets, as multiple
7 months until the unerupted teeth tooth movements can be carried out
were in a position where attachments simultaneously to bring the teeth to a
could be placed to allow the direct point where they can be bonded with
orthodontic traction (Figure 5a–c). conventional appliances and aligned.
The case was re-assessed
c Compliance with Ethical Standards
at this stage with the aid of a CT scan
which showed clear root damage to the Conflict of Interest: The authors
UR2 from the unerupted UR3. It was declare that they have no conflict of
therefore decided that the UR2 should interest.
be sacrificed along with the UL3. During Informed Consent: Informed consent
the surgery, the surgeons also removed was obtained from all individual
a triangle of bone mesial to the LL7 to participants included in the article.

Figure 6. (a–c) Upper and lower SWA elastics to


aid eruption and exposed the UR7.
attempt open bite closure. A routine course of References
orthodontics now followed involving 1. Hanisch M, Hanisch L, Kleinheinz
October 2019 Orthodontics 139

a c permanent molars: a review. J Oral


Pathol Med 1991; 20: 159–166.
8. Frazier-Bowers SA, Koehler KE,
Ackerman JL, Proffit WR. Primary
failure of eruption: further
characterization of a rare eruption
disorder. Am J Orthod Dentofacial
Orthop 2007; 131: 578.e1–11.
9. Frazier-Bowers SA, Simmons D,
Wright JT, Proffit WR, Ackerman
JL. Primary failure of eruption and
PTH1R: the importance of a genetic
d diagnosis for orthodontic treatment
planning. Am J Orthod Dentofacial
Orthop 2010; 137: 160.e1–7.
10. Decker E, Stellzig-Eisenhauer A,
Fiebig BS, Rau C, Kress W, Saar K,
Ruschendorf F, Hubner N, Grimm T,
Weber BH. PTHR1 loss-of-function
mutations in familial, nonsyndromic
primary failure of tooth eruption. Am
b e J Hum Genet 2008; 83: 781–786.
11. Mubeen S, Seehra J. Failure of
eruption of first permanent molar
teeth: a diagnostic challenge. J
Orthod 2018; 45:129–134.
12. Suri L, Gagari E, Vastardis H. Delayed
tooth eruption: pathogenesis,
f diagnosis, and treatment. A literature
review. Am J Orthod Dentofacial
Orthop 2004; 126: 432–445.
13. Kjær I. Mechanism of human tooth
eruption: review article including a
new theory for future studies on the
eruption process. Scientifica 2014:
341905.
g 14. Yildirim D, Yilmaz HH, Aydin U.
Multiple impacted permanent and
deciduous teeth. Dentomaxillofac
Radiol 2004; 33: 133–135.
15. Nagpal A, Sharma G, Sarkar A, Pai
KM. Eruption disturbances: an
aetiological-cum-management
perspective. Dentomaxillofac Radiol
Figure 7. (a–g) Long term result – 3 years after debond. 2005; 34: 59–63.
16. Sivakumar A, Valiathan A, Gandhi
S, Mohandas AA. Idiopathic failure
of eruption of multiple permanent
teeth: report of 2 adults with a
J, Jung S. Primary failure of eruption eruption: a possible cause of posterior highlight on molecular biology. Am
(PFE): a systematic review. Head Face open-bite. Am J Orthod 1981; 80: J Orthod Dentofacial Orthop 2007;
Med 2018; 14: 5. 173–190. 132: 687–692.
2. Rhoads SG, Hendricks HM, Frazier- 5. Baccetti T. Tooth anomalies associated 17. Blechman AM, Smiley H. Magnetic
Bowers SA. Establishing the diagnostic with failure of eruption of first and force in orthodontics. Am J Orthod
criteria for eruption disorders based second permanent molars. Am J 1978; 74: 435–443.
on genetic and clinical data. Am J Orthod Dentofacial Orthop 2000; 118: 18. Sandler JP. An attractive solution
Orthod Dentofacial Orthop 2013; 144: 608–610. to unerupted teeth. Am J Orthod
194–202. 6. Ahmad S, Bister D, Cobourne MT. Dentofacial Orthop 1991; 100:
3. Sharma G, Kneafsey L, Ashley P, Noar The clinical features and aetiological 489–493.
J. Failure of eruption of permanent basis of primary eruption failure. Eur J 19. Sandler PJ, Meghji S, Murray AM,
molars: a diagnostic dilemma. Int J Orthod 2006; 28: 535–540. Springate SD, Sandy JR, Crow V, Reed
Paediatr Dent 2016; 26: 91–99. 7. Raghoebar GM, Boering G, Vissink A, RT. Magnets and orthodontics. Br J
4. Proffit WR, Vig KWL. Primary failure of Stegenga B. Eruption disturbances of Orthod 1989; 16: 243–249.
140 Orthodontics October 2019

Enhanced CPD DO C

Benjamin Marlow Kate Parker and Samantha Hodges

Primary Failure of Eruption


– a Review and Case Report
Abstract: Partial or complete failure of tooth eruption may be due to several causes, including primary failure of eruption (PFE), and an
accurate diagnosis is essential for appropriate management. This article reviews PFE and the possible treatment options. Case reports of
two patients diagnosed with PFE are presented and their management discussed.
CPD/Clinical Relevance: Primary failure of eruption can be difficult to diagnose and differentiate from other causes of failure of eruption.
This paper highlights the clinical presentation of PFE through a review of the literature and by illustration with two clinical cases.
Ortho Update 2019; 12: 140–142

Failure of eruption of first and second molars is 1. Posterior teeth are involved more than anterior teeth
rare, with the prevalence estimated at 0.01% for
first permanent molars and 0.06% for second 2. Involved teeth may erupt partially and cease in eruption
permanent molars.1,2 Eruption failure may 3. Deciduous as well as permanent molars are likely to be involved
result from a number of causes. These include
mechanical interference with eruption or failure 4. Involvement may be unilateral or bilateral
of the eruptive mechanism of the tooth so that 5. Ankylosis may be a secondary feature of involved teeth
the expected amount of eruption does not
6. Application of orthodontic forces is likely to cause ankylosis
occur.3 Mechanical failure of eruption (MFE) is
characterized by single tooth anklyosis, whereas 7. There is no close familial or systemic association
primary failure of eruption (PFE) is a condition Table 1. The seven features of primary failure of eruption.
in which unimpeded, non-ankylosed teeth fail
to erupt with an absence of systemic factors.3
Primary failure of eruption is diagnosed based
on its clinical appearance, which is reported to Previously, diagnosis between MFE 3. Restorative correction of the occlusion once
include the seven features shown in Table 1.3The and PFE has been difficult due to a lack of clear growth has ceased:
last of these clinical features has been disputed. diagnostic criteria in the literature. A flow diagram a. Coronal build-up or onlay of the
Advances in gene discovery and identification was published by Sharma and colleagues to help affected teeth;
have been able to show a heritable basis of this clinicians with their decision-making regarding b. A removable prosthesis over
dental phenotype,4-8 and recently mutations in diagnosing PFE and MFE (Figure 1).10 the affected teeth.
parathyroid hormone 1 receptor (PTH1R) have 4. Extraction of affected teeth and prosthetic
been identified in several familial cases of PFE.9 Treatment options replacement.
Primary failure of eruption has been Treatment of patients with PFE can often be Exposing and bonding teeth
characterized further by Frazier-Bowers and challenging. An interdisciplinary approach is affected by PFE is not advised as treatment via
colleagues,7 who described three different types: required when considering the management of orthodontic forces has been suggested to lead
„ Type I: showed all affected teeth to have a this rare condition. The various treatment options to localized ankylosis.3
similar level of reduced eruptive potential; include:
„ Type II: included subjects for whom teeth distal 1. Accept the infraocclusion; Case report
to their most mesially affected tooth had a greater 2. Surgical repositioning of the affected area with Patient 1
level, but still inadequate levels, of eruption; a segmental osteotomy once growth has ceased, A 14-year-old boy was referred to the
„ Type III: included subjects who had a mixture of although limited success has been reported using orthodontic department concerning his
both types of PFE occurring in different quadrants. this approach;11 infraoccluded UR6 and LR6 with a resultant

Benjamin Marlow, MOrth RCS(Eng), BchD, MFDS(Ed), Kate Parker, MOrth RCS(Eng) BDS(Hons), BA(Hons), MJDF RCS(Eng), Post-CCST in
Orthodontics (email: mailto:kate.parker3@nhs.net) and Samantha Hodges, BDS(Hons), MSc, FDS, MOrth, FDS(Orth), FHEA, Consultant
Orthodontist, Department of Orthodontics, Eastman Dental Hospital, 256 Gray’s Inn Road, London, WC1X 8LD, UK.
October 2019 Orthodontics 141

study models, repeated intra-oral photographs


and measuring the level of the infraoccluded
teeth relative to the adjacent teeth. Had
the patient wanted restorative treatment to
improve his aesthetics and function, composite
build-ups or onlay restorations could have
been considered as long as growth had been
completed and following determination that the
infraocclusion had stabilized. Due to the severity
of the infraocclusion, it is unlikely that full
correction of the lateral open bite could have
been achieved.

Patient 2
A 17-year-old boy was referred to the
orthodontic department concerning a partially
erupted LR6. The patient’s main concern was
that he had a bad taste coming from this area,
however, he had no aesthetic or functional
concerns. The patient was medically fit and
healthy and there was no family history of
delayed eruption or failure of eruption.
On examination, the patient
presented with a Class II division 2 incisor
relationship on a mild Class II skeletal base with
reduced vertical facial proportions. Intra-orally
Figure 1. A flow diagram to aid diagnosis of failure of eruption of the first permanent molar tooth/ the patient was in the permanent dentition. The
teeth.10 LR6 was severely infraoccluded and carious. The
LR7 was partially erupted, mesially angulated
and impacted on the distal aspect of the LR6
a and UR7 were all infraoccluded with the uppers and severely carious. The LL7 and the UL6 were
more severely affected than the lowers. There also infraoccluded. There was no contact distal
was a buccal crossbite present affecting the UL5 to the second premolars on the right side and
and LL6, with mesial occlusal contact present distal to the first premolars on the left side with
between the two. Whilst there was also a degree resulting lateral open bites (Figure 4).
of infraocclusion affecting the UL6 and LL6, both A Cone Beam CT (CBCT) of the right
teeth were in contact with the opposing dentition. and left posterior regions was taken to confirm
b
Intra-oral photographs can be seen in Figure 2. the extent of the infraocclusion and to identify
A radiographic assessment was the proximity of the lower molars to the inferior
conducted which included a dental panoramic alveolar dental nerve (Figure 5). The CBCT
tomograph (DPT) and lateral cephalogram. The confirmed the failure of eruption of the LR6 and
radiographs confirmed the clinical findings and shows it to be in close proximity to the lower
show the severity of the infraoccluded teeth border of the mandible.
c (Figure 3). Following the CBCT, the patient was
The diagnosis of primary failure of assessed on the joint orthodontic-paediatric
eruption was made based on the non-eruption clinic and diagnosed with PFE affecting the LR6,
of both the UR56 and LR6 and all teeth distal to LR7, LL7, LL8, UL5, UL6, UL7 and UR7. Although
these. With mild infraocclusion affecting the UL6 the LL8 would not have been expected to be
and the non-eruption of the UL7, it was suspected erupted at this point, it was felt that it would
that these teeth were also affected by PFE and, as also be affected by PFE because all teeth distal
Figure 2. (a–c) Intra-oral views of Patient 1 such, both will be monitored to assess any further to the most mesially affected tooth are affected.
showing a mild lateral open bite on the left and a progression in their eruption. The position of the Different treatment options were considered,
marked lateral open bite on the right. infraoccluded teeth was accepted and no active including accepting the infraocclusion,
treatment was undertaken due to the limited restorative management with either onlays
chance of successful eruption under orthodontic or removable prosthesis or extraction of the
lateral open bite. The patient was concerned traction. In addition, restorative treatment was not affected teeth.
with the lack of eruption of the posterior teeth, considered because the patient had no functional Whilst the vertical growth of both
although he did not have any aesthetic or or aesthetic concerns. the maxilla and mandible for this patient is
functional concerns. The patient was medically The patient was made aware that, not yet complete, any further changes past
fit and healthy and there was no family history of depending on his further vertical alveolar growth the age of 17 are likely to be insignificant and
delayed eruption or failure of eruption. and the amount of infraocclusion, extraction certainly would not alter the posterior occlusion
On examination, the patient of the most severely infraoccluded teeth might in a substantive way. One of the advantages
presented with a Class I incisor relationship on a be required in the future due to difficulties of treating the lateral open bites with either
Class I skeletal base with average vertical facial in maintaining adequate oral hygiene. The composite onlays or partial dentures is that,
proportions. Intra-orally, the patient was in the infraocclusion is being monitored regularly by the should any further vertical growth occur,
permanent dentition. The LR6, LR7, UR5, UR6 patient’s general dental practitioner using serial simple occlusal adjustments can be made to
142 Orthodontics October 2019

a b

Figure 3. (a) DPT and (b) lateral cephalogram radiographs of Patient 1.

a d a

Figure 4. (a–e) Intra-oral views of Patient 2 showing bilateral open bites.

the composite or acrylic to restore a balanced MFE and impaction. Impacted teeth should
occlusion. erupt once the physical obstruction is removed,
The definitive treatment plan was however, teeth affected by PFE and MFE will
based on the severity of the infraocclusion and not. It is important to remember that applying Figure 5. (a, b) A CBCT of Patient 2 showing
patient preference and comprised the surgical orthodontic traction to teeth affected by PFE the severely infraoccluded LR6 and mesially
extraction of the LR6, LR7, LL7, LL8 and occlusal and MFE will not be successful and, indeed, impacted LR7.
onlays for the UL5 and LL6 to establish occlusal may cause ankylosis.3 These two cases highlight
contact. In order to monitor the patient’s the importance of accurate diagnosis and the
vertical growth, which may give rise to further implications for treatment planning. Proffit WR. Primary failure of eruption: further
infraocclusion of the restored teeth, the patient characterization of a rare eruption disorder. Am J
will be reviewed by the restorative department. References Orthod Dentofacial Orthop 2007; 131: 578.e1–11.
Should the patient present with an altered 1. Grover PS, Lorton L. The incidence of unerupted 8. Frazier-Bowers SA, Simmons D, Koehler K, Zhou
permanent teeth and related clinical cases. Oral J. Genetic analysis of familial non-syndromic
posterior occlusion, the composite restorations
Surg Oral Med Oral Pathol 1985; 59: 420–425. primary failure of eruption. Orthod Craniofac Res
can be contoured or added to in order to 2009; 12: 74–81.
2. Ireland AJ. Familial posterior open bite: a primary
maintain a well-balanced occlusion. Once the failure of eruption. Br J Orthod 1991; 18: 233–237. 9. Decker E, Stellzig-Eisenhauer A, Fiebig BS, Rau
patient has reached the age of 18 and at the 3. Proffit WR, Vig KW. Primary failure of eruption: C, Kress W, Saar K et al. PTHR1 loss-of-function
point of growth maturation, he may consider a possible cause of posterior open-bite. Am J mutations in familial, non-syndromic primary
implants for restoration of the previously Orthod 1981; 80: 173–190. failure of tooth eruption. Am J Hum Genet 2008;
extracted teeth, with or without the extraction 4. Bosker H, ten Kate LP, Nijenhuis LE. Familial 83: 781–786.
reinclusion of permanent molars. Clin Genet 1978; 10. Sharma G, Kneafsey L, Ashley P, Noar J. Failure
of the infraoccluded and restored teeth. 13: 314–320. of eruption of permanent molars: a diagnostic
5. Brady J. Familial primary failure of eruption of dilemma. Int J Paediatr Dent 2016; 26: 91–99.
Conclusion permanent teeth. Br J Orthod 1990; 17: 109–113. 11. Susami T, Matsuzaki M, Ogihara Y, Sakiyama M,
6. DiBiase AT, Leggat TG. Primary failure of eruption Takato T, Sugawara Y, Matsumoto S. Segmental
When faced with failure of eruption, it is in the permanent dentition of siblings. Int J alveolar distraction for the correction of unilateral
important to be mindful of the true aetiology Paediatr Dent 2000; 10: 153–157. open-bite caused by multiple ankylosed teeth: a
given the similar clinical presentations of PFE, 7. Frazier-Bowers SA, Koehler KE, Ackerman JL, case report. J Orthod 2006; 33: 153–159.
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October 2019 Orthodontics 145

Enhanced CPD DO C

Amarpreet Atwal Philip E Benson

How to Design and Set


Up a Clinical Trial Part 2:
Protocols and Approvals
Abstract: Data from clinical trials involving human participants are essential in establishing an evidence base about the safety and
effectiveness of our treatments. This second article describes the steps involved in designing and setting up a clinical trial, from writing a
protocol to gaining the necessary approvals. Acquiring some knowledge about how to set up a clinical trial will allow the conscientious
clinician to use the most relevant information to provide the highest possible standards of clinical care for his/her patients.
CPD/Clinical Relevance: Even if a clinician is not, has never been, nor is ever planning to be involved in research, he/she should understand
and be able to interpret the data from clinical trials.
Ortho Update 2019; 12: 145–150

This article will describe the steps involved criteria will allow others to interpret in of answering the research question posed.
in designing and setting up a clinical trial, which patients the results of the trial will Also, individuals are putting themselves
from writing a protocol to gaining the apply. Baseline participant characteristics at risk (however small) when volunteering
necessary approvals. should be collected during the clinical trial to participate in a study with an unknown
for the same purpose.1 outcome, and ethically you would not
How to write a protocol want to put more individuals at risk than
Study setting and location Sample size calculation is absolutely necessary. Practically, only a
The number (single or multi-centre), All clinical trials involve selecting a group certain amount of funding and time will
location (country), types of settings and of individuals (ie the sample), from a be available to run the trial and therefore
care providers involved (eg primary, population, usually with a particular it would not be possible to include an
secondary, tertiary or community) must condition (target population). The sample endless number of participants.
be determined. These will influence the group is investigated and the results are There are a number of excellent
generalizability and relevance of the trial to used to infer that a similar outcome would articles about how to undertake a sample
other settings and therefore the ability to occur in all individuals with that condition, size calculation.2 It is common to recruit a
guide clinical practice and policy.1 because it is not practical to include all few participants more than the sample size
individuals with that condition in a study. calculation initially suggests, to account for
Eligibility criteria Before starting the trial, it is an inevitable number being lost to follow-
The main research question will aid necessary to try to estimate how many up, either through withdrawal or dropout.
researchers to determine the type of participants should be included in the
participants required (Figure 1). Clear study. The reasons for this are both ethical Recruitment
inclusion and exclusion criteria are required and practical. It would be unethical to It is important to describe how participants
to recruit suitable participants and simplify start a study unless there were sufficient will be identified and recruited. The
implementation of the trial. The eligibility participants to have a reasonable chance recruitment process (eg referral, self-

Amarpreet Atwal, BDS Hons, MOrth RCSEd, ISFE Orthodontics, Consultant in Orthodontics, Royal Derby Hospital (email: amarpreet83@
hotmail.co.uk) and Philip E Benson, BDS, FDS(Orth), PhD, Professor and Honorary Consultant in Orthodontics, University of Sheffield,
Claremont Crescent, Sheffield S10 2TA, UK.
146 Orthodontics October 2019

data are to be assessed should also be


decided. This is used to estimate how
many participants should be recruited to
the trial.
Multiplicity of primary
outcomes, as well as statistical testing,
should be avoided, as this reduces clarity
Figure 1. Deciding on the study sample for the trial. and increases the risk of spurious findings
(eg finding a statistically significant
difference by chance).1 There can be
Enrolment several secondary outcomes (eg including
Assessed for eligibility (n= ) harms), but the same needs to be borne
in mind.
Exclude (n= ) The Core Outcome Measures
• Not meeting inclusion criteria (n= ) in Effectiveness Trials Initiative (COMET)
• Declined to participate (n= ) is an organization which supports the
• Other reasons (n= ) development of Core Outcome Sets
(COS).3 These are agreed, standardized
Randomized (n= )
sets of outcomes, which represent the
minimum that should always be measured
and reported in clinical trials of a specific
Allocation condition. COS allow the results of
Allocated to intervention (n= ) Allocated to intervention (n= ) different studies to be compared and
• Received allocated intervention (n= ) • Received allocated intervention (n= ) combined, as appropriate.
• Did not receive allocated intervention • Did not receive allocated intervention Once the primary and
(give reasons) (n= ) (give reasons) (n= ) secondary outcomes have been defined,
it is necessary to determine valid outcome
Follow-Up measurement tools. It is usually best to
use an existing tool that has a proven track
Lost to follow-up (give reasons) (n= ) Lost to follow-up (give reasons) (n= )
Discontinued intervention (give reasons) Discontinued intervention (give reasons)
record and has been tested for validity
(n= ) (n= ) and reproducibility. This will enhance
quality and allow comparisons with other
studies.1 Other important considerations
Analysis include: who will make the assessments;
Analysed (n= ) Analysed (n= ) if there will be any masking of allocation
• Excluded from analysis (give reasons) • Excluded from analysis (give reasons) during measurement (blinding); and if
(n= ) (n= ) there will be any means of determining
Figure 2. CONSORT flow diagram. (Available from http://www.consort-statement.org). the consistency of measurements by the
same rater (intra-rater repeatability) and/or
between raters (inter-rater reproducibility).

Follow-up and end-points


selection through advertisement, to the chosen method of assignment (ie
The time-points of assessment (frequency)
financial incentives) must be described matching, non-randomized, randomized
and the end-point of assessment (duration
in the protocol. Recruitment can etc).
of follow-up) should be explicit and
be time consuming and a realistic
clinically appropriate to answering the
amount of time should be allowed Blinding
primary research question.
for this. The dates of recruitment The protocol should describe who will
should be defined, as this will affect be blinded (ie unaware of participant Informed consent
the generalizability of the trial (eg assignment) to the intervention group(s), An assessment of capacity must be
accepted medical and surgical including the trial participants, treating performed on all potential participants
practices continually change and clinicians, and outcome assessors. within a trial and written informed consent
this could affect the routine/control obtained.1,4,5 Information should usually
treatment given to patients).1 Outcomes be given verbally, through discussion
Prior to undertaking the trial, the primary and in another form (eg written, audio-
Interventions and secondary outcomes must be visual, etc) which should be outlined in
All interventions should be thoroughly predefined.1 It is important to have one the protocol. This should include the trial
described, including any control primary outcome (or at most two). This aims, methods, potential benefits/risks,
interventions, to allow other is the outcome that is judged to be of post-study arrangements and any other
clinicians to reproduce the methods.1 single most importance to all stakeholders relevant aspects (eg sources of funding,
Interventions should only be and which could be used to answer the possible conflicts of interest, researcher
administered once the participant has main question/focus of the study.1 The affiliations, etc.).6 Participants must have
been enrolled in the trial, according time point(s) when the primary outcome the opportunity to ask questions, told
October 2019 Orthodontics 147

that they do not have to take part, and can body (eg NIHR or Medical Research necessary legal permissions and approvals
withdraw consent at any time without it Council) or from a charity (eg the British must be sought.10
affecting their treatment. Orthodontic Society Foundation).
Three types of research costs Ethical and regulatory considerations
Flow of patients through the trial are defined by the Department of Health Clinical trials require ethical11 and research
The Consolidated Standards of Reporting (DH):8 governance6 approval. Other approvals that
Trials (CONSORT) group recommend 1. Research costs − these are related may be required include the Medicine and
explicitly describing the flow of participants to activities carried out to answer the Healthcare Products Regulatory Agency
through the study when reporting research question (eg data collection (MHRA).12 The process for approval has
randomized trials, including the reasons for and analysis, and are usually met by the been simplified, with an online system
exclusions and loss to follow-up. A CONSORT funders of the trial); called the Integrated Research Application
flow diagram (Figure 2) must be planned in 2. Treatment costs − these are related to System (IRAS).13 This is a single, streamlined
the protocol and completed within the trial.7 patient care, and are usually met through system to apply for permissions for health
This will allow others to judge how much the the normal NHS commissioning process; and social care research in the UK. With this
estimated effect of the intervention might 3. NHS service support costs − these are system, the information for the trial can
be over- or under-estimated in comparison related to additional activities, which are be entered onto one form and IRAS will
with ideal circumstances.1 part of the research process, rather than automatically update the information onto
the treatment (eg consenting patients for all of the relevant approval forms.
Interim analysis and stopping guidelines the study) and are usually administered IRAS captures the relevant
This is usually at pre-determined time-points through the local Clinical Research approvals from the following review bodies:
and involves analysing the interim results, Networks (CRNs)). „ Administration of Radioactive Substances
with or without maintaining the blinding For a commercial research trial Advisory Committee (ARSAC);
present.1 If an intervention is showing larger (eg pharmaceutical company) the NHS „ Confidentiality Advisory Group (CAG);
than expected benefits or harms, or no is required to recover all costs, over and „ Gene Therapy Advisory Committee
important difference, the data monitoring above the standard NHS treatment, from (GTAC);
(and ethics) committee can recommend that industry. „ Health Research Authority (HRA) for
the trial continues, is modified or stopped projects seeking HRA approval;
earlier than planned.5 Sponsorship „ Medicines and Healthcare Products
A sponsor is required for any research Regulatory Agency (MHRA);
Statistical methods involving patients, their tissues or „ NHS/HSC Research and Development
Statistical methods can be used to compare NHS resources.6,9 The sponsor can be offices (R&D);
the groups in the trial for both the primary defined as an individual, company (eg „ NHS/HSC Research Ethics Committee
and secondary outcomes.1 Additional pharmaceutical company), institution (REC);
analyses, such as subgroup analyses and (eg university hosting the research), „ Social Care Research Ethics Committee
adjusted analyses can be undertaken, but or organization (eg NHS organization), (REC).
care should be exercised to avoid increasing which assumes overall responsibility for Once completed, the forms are
the risk of finding spurious results. starting and managing the trial, and is transferred electronically to the appropriate
An intention-to-treat analysis not necessarily the main funder. These organizations, along with any supporting
is often recommended for RCTs, as any responsibilities may be shared by joint- or documentation (eg participant information
missing participant data in the analyses co-sponsors. A risk assessment is usually sheets and consent forms). Depending on
(ie due to exclusion, loss to follow-up undertaken using the study protocol and what is involved in the study, compliance
and/or deviations from the protocol) will a decision made about whether to grant with other regulatory bodies may be
compromise the randomization and may sponsorship or not. If successful, a letter required including ionizing radiation
lead to bias.1 An intention-to-treat analysis of sponsorship is issued. Sponsorship is (IRMER), Medicines for Human Use (Clinical
involves analysing all participants that required prior to any other approvals.10 Trials) Regulations (2004), etc.
were enrolled and randomized, in the exact
groups to which they were randomized. This Peer review Data protection, patient confidentiality and
can be quite difficult if there is missing data.1 Finally, the protocol should be Caldicott guardians
Solutions might include inputing the final scientifically peer reviewed by a number Privacy and confidentiality for research
outcomes or, less favourably, carrying the of independent clinicians and preferably participants and their personal information
last known observation forward.1 patients as well. It may be necessary to are essential.5 Caldicott guardians are
make changes to the protocol during individuals within an organization who
Post-trial provisions the trial, in response to changing should be notified of all research and
Before the trial starts, access to treatments circumstances, but such changes should related activities, to ensure that any patient
found beneficial, after the trial has finished, be transparent and acknowledged identifiable information (PII) used complies
should be considered and this information during reporting, to allow a reasonable with the Caldicott principles,14 Data
disclosed during the consenting process.5 interpretation of the results.1 Protection Act and General Data Protection
Regulations (GDPR).15
Obtaining funding and support grants Approvals required to
The cost of the trial should be considered at commence a trial within the Indemnity insurance
the protocol stage. Money can be obtained UK All trials should be covered by some form
from industry (eg new medicinal product, After the protocol, funding and of indemnity insurance, either through the
device or technology), a research funding sponsorship have been agreed, the hospital trust or university.
148 Orthodontics October 2019

Trial Design Reporting Statement data collected and analysed, a report


must be prepared and disseminated,
RCT CONSORT so the results can be used in clinical
Diagnostic accuracy studies STARD practice. If this is not done, then the
Observational studies STROBE contributions of the researchers and
participants will have been wasted.
Systematic review of trials PRISMA There are many ways of publicizing the
Meta-analyses of observational studies MOOSE results, usually through a conference
presentation and publication in a
Table 1. Reporting statements for different trial designs. (Available from: http://www.equator- suitable academic journal (preferably
network.org).
open access). There are a number of
statements that outline what should be
included in the report of a clinical trial
Trial registration team might include a trial co-ordinator/ to ensure quality and transparency of
All clinical trials must be registered manager, research nurse, data manager, reporting. The appropriate statement
on a publically accessible database.1,5 programmer, site monitor, statistician, to use depends upon the design of the
Trial registration and publication helps health economist, data entry/clerical study (Table 1) and most can be found
prevent duplication, non-publication and support, etc. on the Equator Network.24
selective reporting of outcomes. There are
several trial registration sites to choose Trial committees Summary
from and, once registered, a unique trial Trial Management Committee: Meets This second article has described
registration number is given. regularly to ensure that all practical the steps involved in designing and
details of the trial are progressing and setting up a clinical trial from writing
Common trial reference numbers everyone understands the processes. a protocol to gaining the necessary
IRAS number Trial Steering Committee: approvals. Clinicians should be aware of
The IRAS number is generated by IRAS Meets regularly to ensure that the trial how research is undertaken. Without a
and will be the primary reference number is running well and sends reports to the reasonable knowledge about how data
for the trial used by REC, HRA and, if sponsor. The majority of its members related to the safety and effectiveness
applicable, MHRA. must be independent of the trial of treatments is obtained, it would be
(including the chair), and it is desirable to challenging to undertake appropriate
EudraCT number include experienced trial researchers and evidence-based clinical practice.
It is now compulsory that all Clinical Trials patient representatives.20
of Investigational Medicinal Products
(CTIMPs) are registered on the EudraCT
Data monitoring (and References
ethics) committee: Scrutinizes the study 1. Moher D, Hopewell S, Schulz KF,
database.16 progression and its members must be Montori V, Gøtzsche PC, Devereaux
independent of the trial.20 P. CONSORT 2010 explanation and
Clinical trials register number
Acceptable registers include EU Clinical elaboration: updated guidelines
Training requirements for researchers and for reporting parallel group
Trials Register,17 International Standard Good Clinical Practice (GCP)
Randomized Controlled Trials Number randomised trials. J Clin Epidemiol
The international ethical, scientific and 2010; 63: 1−37.
(ISRCTN) Register18 and ClinicalTrials.gov19 practical standard for conducting clinical 2. Petrie A, Bulman JS, Osborn JF.
research is called Good Clinical Practice Further statistics in dentistry. Part 4:
Sponsors number
(GCP).21,22 All individuals conducting a Clinical trials 2. Br Dent J 2002; 193:
Generated by the sponsor. trial should be suitably educated, trained 557−561.
and experienced to perform their tasks.21 3. Core Outcome Measures in
Funders number
GCP compliance reassures the public Effectiveness Trials Initiative. COMET
Generated by the funder.
that the rights, safety and wellbeing of initiative 2011−2016. Available
research participants are protected and from: http://www.comet-
Roles and responsibilities of trial team and
committees the research data is reliable.23 Depending initiative.org
Trial team upon each individual’s role within the 4. United Kingdom Legislation. Mental
Chief Investigator: The named Chief trial, there may be a requirement to Capacity Act 2005. Available from
Investigator (CI) is responsible for the undertake GCP training.23 https://www.legislation.gov.uk
conduct of the research (eg design, 5. World Medical Association.
management, reporting) in the UK and, if Typical trial time line Declaration of Helsinki: ethical
at more than one site, the co-ordination A typical clinical trial time line is: principle for medical research
of the Principal Investigators. „ Set-up (9 months); involving human subjects 2013.
Principal Investigator: The „ Recruitment (2 years); Available from https://www.wma.
Principal Investigator (PI) is responsible „ Follow-up (1−3 years); net/policies
for his/her own research site. „ Analysis (6 months). 6. Department of Health. Research
In a single-site study, the Governance Framework for Health
CI and PI will usually be the same Dissemination and Social Care 2005. Available
person. Other members of the trial Once participants have been recruited, from https://www.hra.nhs.uk
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150 Orthodontics October 2019

7. Moher D, Schulz KF, Altman DG. https://www.myresearchproject. 18. International Standard Randomised
The CONSORT statement: revised org.uk/Signin.aspx Controlled Trials Number (ISRCTN)
recommendations for improving the 14. National Data Guardian. Caldicott Register 2000−2016. Available from:
quality of reports of parallel-group Review: Information Governance in http://www.isrctn.com/login
randomised trials. Lancet 2001; The Health and Care System 2013. 19. US National Library of Medicine.
357(9263): 1191−1194. Available from https://www.gov. ClinicalTrials.gov 1993−2016.
8. Department of Health. Attributing uk/government/publications/ Available from: https://clinicaltrials.
the costs of health and social care the-information-governance- gov
Research & Development (AcoRD) review 20. NHS National Patient Safety Agency.
2015. Available from https://www. 15. European Parliament and Data Monitoring Committees in
gov.uk Council. General Data Protection Clinical Trials Guidance for Research
9. United Kingdom Legislation. The Regulation 2018. Available Ethics Committee 2010. Available
Medicines for Human Use (Clinical from https://ec.europa.eu/ from https://www.hra.nhs.uk
Trials) Regulations 2004. Available commission/priorities/justice- 21. National Health Research Authority.
from https://www.legislation.gov. and-fundamental-rights/data- Training Requirements for Researchers
uk protection/2018-reform-eu- – Progress Update 2013. Available
10. Greene LE, Bearn DR. Setting up a data-protection-rules_en#abo from: https://www.hra.nhs.uk
randomized clinical trial in the UK: uttheregulationanddataprote 22. ICH Expert Working Group. Guideline
approvals and process. J Orthod ction for Good Clinical Practice E6(R1) 1996.
2013; 40: 104−111. 16. European Medicines Agency. Available from: https://www.ich.
11. NHS Health Research Authority. HRA European Clinical Trials Database org/home.html
Approval. Available from https:// (EudraCT) 1995−2016. Available 23. National Institute for Health
www.hra.nhs.uk from: https://eudract.ema. Research. Good Clinical Practice
12. Medicines & Healthcare Products europa.eu (GCP). Available from: https://www.
Regulatory Agency. Available from: 17. European Union Clinical nihr.ac.uk
https://www.gov.uk Trials Register 1995−2016. 24. Equator Network. Enhancing the
13. Health Research Authority. Available from: https://www. Quality and Transparency of Health
Integrated Research Application clinicaltrialsregister.eu/ctr- Research. Available from: http://
System (IRAS). Available from search/search www.equator-network.org

Book Review Down the left side of each education over just buying the correct
page is a section suggesting background camera and having the right settings.
Dental Photography – Portfolio Guidelines.
Krzysztof Chmielewski, ed. Quintessence set-up, camera type and settings. Along Purchase of this book should be seen
Publishing, 2016 (59 pp (spiral bound with the bottom of each page is a tips section as an adjunct to having someone in the
slipcase); 64 illus). ISBN 978-1-85097-297-6. consisting of suggestions on how to team already adept at photography, or in
position the subject, instructions to give preparation for undertaking a hands-on/
On first receiving this book, I was to the patient and how each shot may educational course. Diligent readers will
delighted to hold and review the book be useful in diagnosis or treatment. The find a link to the author’s dedicated ‘dental
due to its outstanding binding and teeth image section provides additional photo master’ website where, for an annual
presentation. The book itself comes in information on retractors and contrasters fee of $749/year, you can access videos and
in order for the reader to achieve tutorials to compliment this well presented
A4 landscape format, with a solid metal
publication.
ring binder and pop-out flip stand for excellence. The quality of the images is
presentation of selected pages. The first very good, and this book could be used
Andrew Flett, Consultant Orthodontist
two pages of the book encompass the as an aide-memoire to enable assistants Queen’s Medical Centre, Nottingham
author’s preferred equipment ‘load out’ to capture the perfect shot. King’s Mill Hospital
using a Nikon camera. At the bottom of As a keen dental Sutton-inAshfield
these pages are some recommended photographer myself, I understand the
alternative cameras, lens, flashes and value of taking regular pictures of my
accessories options. patients’ dentition, to ensure outstanding
The book is split into three results and, in rare cases, identify
main sections, displaying all necessary problems early on in treatment. This book
portrait, lips and teeth shots. At the start added to my knowledge of photography
of each section the full range of shots are and provided me with information about
summarized, which would be useful for shots I could take, in addition to my
teaching a team in-house. Each selected standard set.
photographic image is then displayed However, this book is not for
with a high-quality gloss finish, on the the novice as there is far more to dental
right-hand side, with the remainder of photography than what is written on
the page having a tactile matt plastic these pages. Producing consistently
finish. superb photos takes practise and some
October 2019 Orthodontics 151

Enhanced CPD DO C

Sridhar Premkumar Varun Peter

Lingual Orthodontics with


Customized Functional
Appliance
Abstract: Every treatment technique in the orthodontic specialty has its own set of advantages. Combining the techniques in an effective
manner could result in a synergistic effect. Two such techniques are lingual orthodontics and functional orthopaedic appliances. This case
report shows the effective and efficient use of a customized functional appliance, along with lingual orthodontics, in the management of
Class II division 1 malocclusion. It emphasizes the importance of combining the benefits of different strategies of orthodontic treatment.
CPD/Clinical Relevance: The use of a customized functional appliance along with lingual orthodontics can produce desirable changes in
Class II division 1 cases and clinicians should be aware of these advantages.
Ortho Update 2019; 12: 151–156

Orthodontic treatment offers our patients nasolabial angle, deep mentolabial sulcus findings with the mandibular midline shifted
improvement of mastication, speech, and incompetent lips. Intra-oral clinical 2 mm towards the patient’s right side.
appearance, as well as overall health, comfort examination revealed a deep overbite Cephalometric analyses revealed a Class II
and self-esteem. Many adult patients require with a Class II molar relation, asymmetric skeletal relationship (ANB = 7˚), maxillary
well aligned teeth to improve their aesthetics, maxillary and mandibular arches, spaced prognathism (SNA = 86˚) and an orthognathic
as dental exposure and smile are fundamental anterior dentition, with the lower midline mandibule (SNB = 79˚) in relation to the
for the aesthetics of the face. The clinical shifted towards the patient’s right side and anterior cranial base. Both maxillary and
case presented is an example of treatment a moderate amount of crowding in the mandibular incisors were protruded in
in a case of Class II division 1 malocclusion. mandibular premolar region. The upper relation to their alveolar base (Table 1). The
This article describes the use of a customized incisors were proclined with an overjet of 14 case was diagnosed as an Angle’s Class II
functional appliance, along with lingual mm (Figure 1). division l malocclusion on a Class II skeletal
orthodontics, in an adult patient with a Class base attributed to a prognathic maxilla and
II, division 1 malocclusion treated without Investigations
Extra-oral and intra-oral photographs, an orthognathic mandible with a horizontal
extraction.
study models, lateral cephalometric growth pattern associated with proclined
radiograph, panoramic radiograph, functional upper and lower incisors and protrusive
Case report examination and video recording of the upper lips.
An 18-year-old female patient reported patient were conducted. She had an atypical
to the department of orthodontics with a Therapeutic focus and treatment
swallowing pattern, the mandible moved
chief complaint of protrusive upper front upwards and backwards on closure, and there The main goals of the treatment were
teeth. No relevant medical and dental was 4 mm of incisal exposure at rest and to correct the deep bite, to rotate the
history was elicited. She was a mesomorphic 100% incisor exposure during smiling. mandible clockwise to open the bite, retract
individual and her facial analysis revealed the maxillary anterior teeth to correct the
an average clinical facial height. The patient Diagnostic focus and assessment protrusion, retract the proclined mandibular
also had a convex facial profile with acute Study model analyses confirmed the clinical incisors and eliminate the functional retrusion

Sridhar Premkumar, MDS, Professor and Head of Orthodontics (email: mailto:dr_premsridhar@yahoo.co.in) and Varun Peter,
Postgraduate Student, Department of Orthodontics, Tamilnadu Government Dental College and Hospital, Chennai, India.
152 Orthodontics October 2019

a b d

c e

Figure 1. (a–e) Pre-treatment intra-oral and extra-oral views.

Measurements Normal Pre-treatment Post-treatment


Angular
Sella-Nasion-Point A Angle SNA 82° ± 2° 86° 83°
Sella-Nasion-Point B Angle SNB 80° ± 2° 79° 80°
Point A-Nasion-Point B Angle ANB 2° 7° 3°
Mandibular Plane-Frankfort Horizontal Plane Angle 25° 18° 20°
Facial Angle (FH-NPg) 87° ± 3° 87° 90°
Palatal Plane–Occlusal Plane Angle PP–OP 8° ± 2° 9° 9°
Occlusal Plane–Mandibular Plane Angle OP–MP 14° 15° 18°
Upper Gonial Angle (Ar-Go-N) 50°–55° 54° 55°
Lower Gonial Angle (N-Go-Gn) 70°–75° 63° 67°
Incisor Mandibular Plane Angle (IMPA) 90° 112° 109°
Upper Incisor to Nasion-Point A Angle 1 to NA 22° 43° 28°
Lower Incisor to Nasion-Point B Angle T 1 to NB 25° 36° 34°
Interincisal Angle 132° 93° 120°

Linear
AO-BO Difference AO = BO AO>BO by +4 mm AO>BO by +1 mm
Upper Incisor to Nasion–Point A Angle 1 to NA 4 mm 9 mm 5 mm
Lower Incisor to Nasion–Point B Angle T 1 to NB 4 mm 7 mm 7 mm
Convexity of Pt–A 2 ± 2 mm +5 mm +2 mm
Table 1. Cephalometric analysis values.

of the mandible. The patient was concerned adults to commit themselves to orthodontic plane effect also allows efficient bite opening
about aesthetics and was apprehensive about treatment is a more complex issue than for in deep bite cases. It is difficult to visualize
the visibility of brackets. The patient and her the younger age groups, as they have the and accurately position the lingual brackets if
parents were also cautious regarding invasive demands of their work and broader social they are directly bonded. Indirect bonding is
procedures like implant-assisted orthodontics needs to consider. With increasing number therefore the standard in lingual orthodontics
and orthognathic surgery. The patient insisted of adult patients seeking orthodontic and the CLASS (Custom Lingual Appliance
on ‘invisible’ fixed orthodontic therapy, to treatment,1 lingual orthodontics has become Set-up Service) system was employed for
hide the presence of the device completely. the ‘aesthetic’ solution for meeting the needs this patient. A full archwire of 0.016” Copper
It was decided to avoid extractions and of these patients.2 The 7th generation lingual Nickel Titanium (Cu-NiTi) followed by 0.017” x
mini implants for the patient and to treat brackets are edgewise brackets specifically 0.017” Cu-NiTi was used for alignment of the
with lingual orthodontics and a customized designed for the lingual surface of the teeth.3 teeth. Torque establishment of the anterior
functional appliance to eliminate lip trap and The maxillary anterior brackets have a built-in teeth is necessary prior to en mass retraction,
functional retrusion. bite plane which helps minimize accidental 0.017" x 0. 025" TMA archwires were used
The decision taken by young debonding from the lower incisors. The bite for torque levelling. Sliding mechanics was
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October 2019 Orthodontics 155

a c mandible, bilateral buccal shields and occlusal


blocks holding the mandible in advanced
position, along with the wire components,
made up the customized functional
appliance. The patient was instructed to
wear the functional appliance for 2–4 hours
for the first two weeks, followed by night-
time wear for the next two weeks. Full-time
wear was recommended after one month of
acclimatization to the functional appliance.

b d Follow-up and outcome


Favourable clinical results were observed
within 9 months (Figure 3). Bite opening
was evident with reduction in overjet and
improvement of the profile. The bite planes
on the maxillary incisor brackets cause rapid
bite opening, making the lingual appliance
most effective in deep bite cases,7,8 and this
patient has certainly benefited from this. At
the end of the treatment, functional occlusion
was observed with normal overjet, overbite
Figure 2. (a–d) Initial stages of treatment and the customized functional appliance. and adequate intercuspation, with Class I
molar relation and Class I canine relation
a c bilaterally, nearly coincident midlines, normal
maxillary and mandibular incisor inclination
(Figure 4). Vertical skeletal dysplasia with
deep bite was eliminated and cephalometric
measurements showed maxillary clockwise
rotation and mandibular clockwise rotation,
contributing to improved facial profile.
Maxillary and mandibular incisor axial
inclinations were corrected (Figures 5 and 6;
Table 1). The patient was extremely satisfied
b d with the treatment results.

Discussion
Adult patients are composing an ever
increasing demographic in orthodontic
practice. According to Proffit there are two
main groups of adults seeking orthodontic
treatment.1 The first group is after some sort
of adjunct orthodontic treatment to facilitate
other dental work, such as pre-prosthetic
Figure 3. (a–d) Mid-treatment views taken nine months after commencement of treatment. Reduction orthodontics or implant space preparations.
in overjet, opening of bite and Class I molar relation is evident. Posterior teeth require settling. These patients are usually middle-aged
adults in their 40s and 50s. The second group
is adults after comprehensive orthodontic
treatment. They are usually younger adults
used for closure of the space (Figure 2). functional appliance to use can be difficult
who have always wanted orthodontic
Compensating curves and gable bends were with lingual orthodontics. It was therefore
treatment but did not undergo this during
placed in the archwires to counteract the decided to follow the component approach
their adolescence as they could not afford
bowing effects. In the detailing stage, 0.016” advocated by Vig and Vig.5 The occlusal it then. Very few studies had examined
TMA archwire was used. bite block of Clark’s twin block was also the effect of the removable functional
A functional appliance can be incorporated6 (Figure 2). A construction bite orthopaedic treatment on young adults and
defined as a removable or fixed appliance with a sagittal advancement of 3 mm and all those studies searched the effect of the
which changes the position of the mandible vertical opening of 3 mm was recorded. The fixed functional appliances 9,10 McNamara
so as to transmit forces generated by the wire components included were a labial bow described the skeletal and dental adaptations
stretching of the muscles, fascia and/ for the maxillary arch, which will provide a occurring in three adult patients treated with
or periosteum, through the acrylic and retrusive effect to the maxilla. Connecting the functional regulator (FR-2) of Frankel.11
wirework, to the dentition and underlying wires between buccal shields and lip pads, as During the treatment, the
skeletal structures, and favourably changes well as interconnecting wire between the lip co-operation of the patient was good. A full
the soft tissue environment.4 Deciding which pads, were also incorporated. Lip pads in the Angle Class I relationship was achieved and
156 Orthodontics October 2019

a c an effective procedure when carried out


with good planning, proper execution and
attention to detail.

Conclusion
Emphasis should be placed on a
thorough understanding of facial
b d and dento-alveolar discrepancy in
orthodontic treatment planning. A
combination of lingual orthodontics
and customized functional appliance
can expand the scope of treatment
delivery.
Figure 4. (a–d) Comparison of pre-treatment and post-treatment intra-oral views. Informed consent
The patient has provided written informed
a b c d
consent.

References
1. Proffit WR. Treatment for adults. In:
Contemporary Orthodontics 3rd edn
Proffit WR, ed. St Louis: Mosby, 2000:
p644.
2. Fritz U, Diedrich P, Wiechmann D. Lingual
technique – patients’ characteristics,
motivation and acceptance. J Orofac
Orthop 2002; 63: 227–233.
3. Garland-Parker L. The Complete Lingual
Figure 5. (a–d) Comparison of pre-treatment and post-treatment extra-oral views.
Orthodontic Training Manual 3rd edn.
Professional Orthodontic Consulting,
1994.
a b 4. Frankel R. Decrowding during eruption
under the screening influence of
vestibular shields. Am J Orthod 1974; 65:
372–406.
5. Vig PS, Vig KWL. Hybrid appliances: a
component approach to dentofacial
orthopaedics. Am J Orthod Dentofacial
Orthop 1988; 90: 273–285.
6. Clark WJ. The twin block technique:
a functional appliance system. Am J
Orthod Dentofacial Orthop 1988; 93:
1–18.
7. Alexander CM, Alexander RG, Gorman
JC, Hilgers JJ, Kurz C, Scholz RP et al.
Lingual orthodontics: a status report.
Part 5. Lingual mechanotherapy. J Clin
Orthod 1983; 17: 99–115.
8. Creekmore T. Lingual orthodontics: its
renaissance. Am J Orthod Dentofacial
Orthop 1989; 96:120–137.
9. Ruf S, Pancherz H. Dentoskeletal effects
and facial profile changes in young
adults treated with the Herbst appliance.
Angle Orthod 1999; 69: 239–246.
Figure 6. (a, b) Pre-treatment and post-treatment lateral cephalometric radiographs. 10. Chaiyongsirisern A, Bakr RA, Ricky
W, Wong K. Stepwise advancement
herbst appliance versus mandibular
sagittal split osteotomy treatment
normal overjet and overbite established months of combined lingual orthodontic and
effects and long-term stability of adult
with coincident midlines: SNA decreased by functional appliance treatment. The patient class II patients. Angle Orthod 2009; 79:
3°; SNB increased by 1°; the upper incisor was followed for one year during retention 1084–1094.
teeth were retroclined; the lower incisor and the results were stable. Clinically, the 11. McNamara JA. Dentofacial adaptations
teeth were proclined, with a resultant overall improvement in facial appearance, in adult patients following functional
increase in inter-incisal angle and an and the attainment of a Class I dento-alveolar regulator therapy. Am J Orthod 1984; 85:
increase in the total face height in the 18 relation with stable results, has made this 57–71.
October 2019 Practice Tips 157

Anjli Patel

Five Years and


Counting…….Reflections
on the First Years of Owning
a Specialist Practice
Abstract: This essay highlights what has helped make our practice successful. I share some advice on how to empower your team and how
to achieve your goals.
Ortho Update 2019; 12: 157–160

In June 2012, I was invited to join a successful and profitable orthodontic Have a clear vision for your
consultant colleague to purchase a NHS practice. practice
specialist orthodontic practice. At that In the very beginning my business
time, I was working as a Consultant Be a good leader partner and I drew up lists of where
Orthodontist for three days a week and we wanted to take the business and
Leadership skills are learned throughout
as an associate in a specialist practice for
life. As an associate it was easy to where we saw ourselves in five years’
one day a week. I had just had my first
be part of the team and never rock time. We were united in our vision for
child and I liked my work-life balance.
the boat. Prior to taking over as a the business. We wanted a practice
However, NHS contracts are hard to
co-principal of the practice, I read that would be a pleasure to work in,
obtain and this was an opportunity
several texts on how to be an effective that felt like a sanctuary and to create a
not to be missed. I was glad to have a
partner to share the load and we worked leader and run a successful dental modern, yet comfortable environment
well together in the hospital, so I went practice. They all said similar things: where people want to be. Most of all,
for it! We bought a leasehold practice have a vision, form a strategy to achieve we wanted our practice to be about our
and four years later bought a house, your goals and align your team to patients, making the patient experience
converted it into a state it. It took us a few weeks to assert even better.
of the art orthodontic practice and ourselves in the practice, as we were We bought an existing
relocated (Figure 1). It was a huge new to business and to primary care. specialist practice housed in the ground
undertaking but we have not looked The practice had been run previously floor of an end-of-terrace house. People
back once. by a single-handed orthodontist who politely described it as being ‘bijoux’ and
I wrote this to share what the staff adored but did not necessarily we knew our business would outgrow
I have learned along the way to run a work in the same way that we did. the property. Our plan was to use the

Anjli Patel, BDS, MFDS, MSc, MOrth, FDS Orth, No 1 The Orthodontic Specialists, 1 Station Road, Mickleover, Derby, DE3 9GH, UK (email:
anjlipatel77@gmail.com). www.no1braces.co.uk
158 Practice Tips October 2019

business and our psyche. Our policy is to


recruit the right people and to share our
vision for the practice. This empowers
the team to thrive and be ambassadors
for the business. We believe you should
never give anyone a job you would not
do yourself. Make sure you do everything
to achieve your vision and lead by
example (Figure 2).
We started off with a
small team of three part-time staff
and two principal orthodontists. We
have now grown to seven staff, one
orthodontic therapist and two principal
orthodontists. It has not been easy
and two nurse team members left
within their first year. They were leaving
dentistry, which was less of a blow to my
ego.
Two-way communication
is essential in running a business. We
Figure 1. The Practice. regularly have practice training days and
practice meetings. These days are a great
platform to hear what the team has to
say about what they feel the business
can improve upon and it is vital that all
the team is aware of the core values for
the business and buy into the vision and
mission of the business. We work hard
to create a culture of respect, trust and
support; each member has an opinion
and is listened to. Everybody works
hard but one of the best compliments
we receive from patients is that they
love the feeling of the practice and
camaraderie amidst the team.
Recognition and appreciation
of excellent work makes us all feel good,
and your staff are no different – it will
boost their esteem. We take the team
to conferences, awards ceremonies and
on team-building events. Each team
member has regular appraisals. We
promote training and try to develop
Figure 2. Our team that is growing. their hospitality skills. They have
incentives to achieve the goals we
have set them, such as getting their
radiography qualification. Their Personal
Development Plans help identify how
four years left on the lease to grow the and to convey this to our team. Within they want to develop their careers and
business and find a suitable building for days of defining our new plans, we we work with them to accomplish their
our own future premises. Once we had noticed a big change in our team – they goals.
found the building, and working with the were excited and more motivated to Initially, we wanted
nurses and the architect, we could spend help achieve our new goals of growing everybody to be able to do every job.
time deciding exactly how to design the the business. The NHS contracts are However, as the team grew it was
practice so that we were able to achieve changing and our business needs to be evident that we needed to give people
our vision. defined roles and to work to their
prepared for this.
Once we moved, our goals individual strengths. Everyone knows
became slightly blurred as we grappled where they fit within our business and
with the pressures of running a larger Look after your staff and who to go to for various issues.
practice with a larger team, many of build an unstoppable team Staff management is
whom were new to orthodontics. It was We learnt very quickly that having an notoriously difficult and we are lucky to
important though to redefine our vision enthusiastic team did more for our have an excellent team. Most of them
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160 Practice Tips October 2019

that we need to have an annual budget


so we can focus on our vision, strategy
and goals. We tend to look at last year’s
expenses and add a percentage and also
add any new expenses we may need.
Finances are easier to manage
with accounting software. You can get
management accounts with the press
of a button to give you a snap shot of
where you are compared with the year
before. Like everything, the programme
we use took time to learn, but we could
not do without it now. It is easy to work
out how much it costs to run the practice
each hour. That helps us adjust our fees
accordingly.

Get to know your


commissioners and referrers
Figure 3. The website.
Try to become involved with your
Local Professional Network (LPN) and
Managed Clinical Network (MCN). It is a
genuinely love their jobs and it shows! your goals if you are not testing, great forum to keep abreast of changes
measuring and tracking your results. Key in commissioning and the needs of the
Provide an excellent Performance Indicators (KPIs) make it area. Local dentists are more likely to
customer experience easy to keep track of what is happening. refer patients to you if they know your
A dental practice is only successful if The NHSBSA have set out the KPIs for face. You could offer ‘Lunch and Learn’
its clients value the service. Our goal PDS contracts. In addition, we had our sessions, join the Local Dental Committee
is to create the best impression to our own business KPIs, which are reviewed (LDC) and attend the local British Dental
clients so that they want to return each business meeting: Association (BDA) meetings.
and will tell others about us. We want „ How many Units of Orthodontic
them to become part of our family. We Activity (UOAs) have we fulfilled?;
Personal goals
have a suggestion book and regularly „ What is our new to follow-up ratio?;
At present out business goals take
ask for feedback. Patients rave about „ How many active patients do we have
(broken down into when they started precedence over our personal goals as
the ambience in the practice and how we are still establishing ourselves. We
friendly our team is. Our ‘word-of-mouth’ treatment);
„ What is our treatment conversion rate definitely need to improve our work-life
referrals are increasing daily – and we
for private patients?; balance and would like to work less. I
encourage this, it’s free marketing!
„ How many of our free consultations would like to have more time with my
convert to patients?; family. We are fortunate in that we’re in
Advertise your business „ How many complaints have we had?; a job that we love but we still need to
Get your branding and identity correct. „ Patient feedback. get the balance right. I don’t think about
It is worth spending time to ensure your For the first three months, retirement all the time but it still needs
website works well and is optimized for we were appalling at measuring our planning – 20 years is what my financial
all media (Figure 3). performance apart from knowing how advisor is suggesting! I have tried to
Patients are the best many UOAs we had fulfilled. We carried be realistic about my personal goals as
advertisers so ask them to spread the out a SWOT (Strengths, Weaknesses, I would be disappointed if I had set a
word if they were happy with their Opportunities and Threats) analysis and target to work two days a week after five
experience. Social media is a very cost organized to have monthly business years of buying the practice!
efficient way to tell everyone you are meetings with the senior members Owning a practice is hard
here. Revise your strategy according of the team. We discuss our KPIs. A work and not for everyone but, if carried
to your capacity – it is not appreciated top tip is to invest in a good practice out correctly, and with the right team
when you have a heavy advertising management system that can help around you, it can prove to be very
campaign only to find you cannot cope measure performance about patient rewarding personally and hopefully
with the avalanche of enquiries or numbers, UOA claims, and number of financially in the future!
referrals. appointments available, etc at the click
of a button Acknowledgements
Performance management I would like to thank Anne-Marie Smith
Test and measure everything. You cannot Stay on top of your and Alison Murray for editing this essay. I
change what you don’t measure and accounting would also like to thank our team and our
you cannot tell if you are achieving We are only just beginning to realize families for making our dreams possible.
October 2019 Orthodontics 161

Tricks of the Trade: a New


Method of Active Tie-Back
for Space Closure
The usual method of space closure
by sliding mechanics is by active tie-
backs or elastomeric chain.1 The various
drawbacks encountered with the use
of active tie-backs is laceration on the
buccal mucosa/inner surface of the
cheek, impingement on soft tissue
and gingival overgrowth, thereby
often creating discomfort to patients.
The following is a simple and unique
method of space closure with the help Figure 4. Placement of active tie-back
of sectional 0.019” x 0.025” SS wire Figure 1. Fabrication of hook on either end of (elastomeric module on both the ends).
(Ortho organizers) and elastomeric the wire 0.019’’ x 0.025” SS.
module (Ormco).
both ends of the rigid sectional wire.
Procedure 2. Problems encountered with active
1. Cut a piece of 0.019” x 0.025” SS wire tie-back, such as frequent breakage of
and fabricate hooks on either end with ligature wire or disengagement of the
the help of a bird beak plier (Figure 1). active tie-back, can be overcome by
2. Depending on the requirement using stiffer wire which snugly holds the
of force levels, there are two ways of crimpable hook and does not compromise
utilizing this sectional wire (Figure 2). on the forces applied for space closure.
3. Engage an elastomeric module on 3. Level of patient comfort can be
one end of the wire, which is engaged increased by contouring the sectional wire
on the molar hook, and the other end Figure 2. Variation in design for patient comfort. according to the arch, thus preventing
of the wire is free to hook onto the impingement.
crimpable hook used for retraction 4. It is easy to fabricate and does not need
(Figure 3). special equipment. No extra material
4. When there is a greater distance is required as the cut ends of the pre-
between anterior and posterior formed rigid 0.019” x 0.025” SS wire used
segments, engage elastomeric modules for space closure during sliding mechanics
on both ends of the wire, one end can be utilized to fabricate this sectional
secured to the molar tube and the other wire.
end to the crimpable hook delivering 5. It can be pre-fabricated in the absence
Figure 3. Placement of active tie-back
light continuous forces efficiently (elastomeric module only on one end). of patients on their casts. Re-activation
(Figure 4). is easy, thereby reducing the overall
5. The length of the sectional wire can chairside time.
be adjusted during the course of space
closure by shortening one end of the Reference
wire and fabricating a similar hook. Advantages
1. McLaughlin RP, Bennett JC, Trevisi
6. The elastomeric module can also be 1. This technique has simplicity and
HJ. Systemized Orthodontic Treatment
substituted with separator modules efficiency, where force levels can be
Mechanics 1st edn. St Louis Missouri:
during higher force requirements. adjusted by placing modules on one end or
Mosby Company, 2001: pp254–258.

Rithesh Bangera, Postgraduate student (email: rrbangera14@gmail.com), Roopak D Naik, Associate Professor, Anand K Patil,, Professor
and Head, ShashiKumar B, Associate Professor PraveenKumar, Assistant Professor, Department of Orthodontics and Dentofacial
Orthopedics, SDM Dental College And Hospitals, Sattur, Dharwad, Karnataka, India.
162 Orthodontic Update October 2019

CPD
A.continuing education

Test your knowledge on the content of the articles published.


The following 7 questions relate to some of the articles carried this month. Only one answer is correct.

To receive CPD credit, answer the questions online at www.orthodontic-update.co.uk

Q1 NAZZAL ET AL 12: 126–133 Q5 HARLOW, PARKER AND HODGES 12: 140–142

The least preferred socket assessment technique is: When considering the treatment options for PFE the following
A. The use of acrylic stents. should be considered:
B. The use of metal stents. A. Teeth affected by PFE will not respond to orthodontic traction.
C. The use of 3 dimensional transplant replicas using 3-dimensional B. Exposure and bonding of teeth affected by PFE has been shown to be
prints. successful.
D. Use of the donor tooth. C. The eruption pathway of teeth affected by PFE is usually blocked,
therefore these teeth usually erupt spontaneously once sufficient space
is created.
Q2 ADAM, FLETT AND SANDLER 12: 134–139 D. Eruption is purely delayed and given time these teeth will erupt
unaided with no intervention.
Primary failure of eruption has a prevalence of:
A. 0.06%.
B. 0.6%.
C. 1%.
D. 0.1%. Q6 ATWAL AND BENSON 12: 145–150

The single streamlined system to apply for permissions for health


and social care research in the UK is called the:
Q3 ADAM, FLETT AND SANDLER 12: 134–139 A. Integrated Research Application System (IRAS).
B. Medicines and Healthcare Products Regulatory Agency (MHRA).
Which of the following is NOT an advantage of using rare-earth C. Independent Research Advanced System (IRAS).
magnets in the method described?: D. Research Ethics Committee (REC).
A. Less dependent on patient and operator dexterity.
B. Faster tooth movement.
C. More physiological, slowly-increasing forces.
D. Palatally directed forces are more readily applied.

Q4 HARLOW, PARKER AND HODGES 12: 140–142 Q7 PREMKUMAR AND PETER 12: 151–156

Primary failure of eruption: The concept of component approach to dentofacial orthopaedics


A. Usually involves anterior teeth. was introduced by:
B. Can only be diagnosed if it occurs bilaterally. A. Clark WJ.
C. Is often associated with a PTH1R mutation. B. Vig PS and Vig KWL.
D. Always presents in conjunction with other systemic factors. C. McNamara JA.
D. Pancherz H.

DEADLINE FOR SUBMISSION: 24 JANUARY 2020


CPD in Orthodontic Update in partnership with
ANSWERS FOR JULY 2019 ON PAGE 133

7 QUESTIONS REPRESENT 4 HOURS OF CPD


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