Non-Surgical Adjunctive Interventions For Accelerating Tooth Movement in Patients Undergoing Orthodontic Treatment CR

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Non-surgical adjunctive interventions for accelerating tooth
movement in patients undergoing orthodontic treatment (Review)
El-Angbawi A, McIntyre G, Fleming PS, Bearn D
El-Angbawi A, McIntyre G, Fleming PS, Bearn D.

Non-surgical adjunctive interventions for accelerating tooth movement in patients undergoing orthodontic treatment.
Cochrane Database of Systematic Reviews 2023, Issue 6. Art. No.: CD010887.
DOI: 10.1002/14651858.CD010887.pub3.
www.cochranelibrary.com

Non-surgical adjunctive interventions for accelerating tooth movement in patients undergoing orthodontic
treatment (Review)
Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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TABLE OF CONTENTS
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
SUMMARY OF FINDINGS.............................................................................................................................................................................. 4
BACKGROUND.............................................................................................................................................................................................. 13
OBJECTIVES.................................................................................................................................................................................................. 13
METHODS..................................................................................................................................................................................................... 14
RESULTS........................................................................................................................................................................................................ 16
Figure 1.................................................................................................................................................................................................. 17
Figure 2.................................................................................................................................................................................................. 24
Figure 3.................................................................................................................................................................................................. 25
DISCUSSION.................................................................................................................................................................................................. 33
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 35
ACKNOWLEDGEMENTS................................................................................................................................................................................ 35
REFERENCES................................................................................................................................................................................................ 36
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 42
WHAT'S NEW................................................................................................................................................................................................. 84
HISTORY........................................................................................................................................................................................................ 85
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 85
DECLARATIONS OF INTEREST..................................................................................................................................................................... 85
SOURCES OF SUPPORT............................................................................................................................................................................... 85
DIFFERENCES BETWEEN PROTOCOL AND REVIEW.................................................................................................................................... 85
NOTES........................................................................................................................................................................................................... 85
INDEX TERMS............................................................................................................................................................................................... 85
Non-surgical adjunctive interventions for accelerating tooth movement in patients undergoing orthodontic treatment (Review) i
Informed decisions.

[Intervention Review]
Non-surgical adjunctive interventions for accelerating tooth movement

in patients undergoing orthodontic treatment
Ahmed El-Angbawi1, Grant McIntyre2, Padhraig S Fleming3, David Bearn2
1Division of Dentistry, The University of Manchester, Manchester, UK. 2School of Dentistry, University of Dundee, Dundee, UK. 3School of
Dental Science, The University of Dublin, Dublin , Ireland
Contact: Ahmed El-Angbawi, aelangbawi@outlook.com.
Editorial group: Cochrane Oral Health Group.

Publication status and date: New search for studies and content updated (conclusions changed), published in Issue 6, 2023.
Citation: El-Angbawi A, McIntyre G, Fleming PS, Bearn D. Non-surgical adjunctive interventions for accelerating tooth movement
in patients undergoing orthodontic treatment. Cochrane Database of Systematic Reviews 2023, Issue 6. Art. No.: CD010887. DOI:
10.1002/14651858.CD010887.pub3.
ABSTRACT
Background
Deviation from a normal bite can be defined as malocclusion. Orthodontic treatment takes 20 months on average to correct malocclusion.
Accelerating the rate of tooth movement may help to reduce the duration of orthodontic treatment and associated unwanted
effects including orthodontically induced inflammatory root resorption (OIIRR), demineralisation and reduced patient motivation and
compliance. Several non-surgical adjuncts have been advocated with the aim of accelerating the rate of orthodontic tooth movement
(OTM).
Objectives
To assess the effect of non-surgical adjunctive interventions on the rate of orthodontic tooth movement and the overall duration of
treatment.
Search methods
An information specialist searched five bibliographic databases up to 6 September 2022 and used additional search methods to identify
published, unpublished and ongoing studies.
Selection criteria
We included randomised controlled trials (RCTs) of people receiving orthodontic treatment using fixed or removable appliances along with
non-surgical adjunctive interventions to accelerate tooth movement. We excluded split-mouth studies and studies that involved people
who were treated with orthognathic surgery, or who had cleft lip or palate, or other craniofacial syndromes or deformities.
Data collection and analysis

Two review authors were responsible for study selection, risk of bias assessment and data extraction; they carried out these tasks
independently. Disagreements were resolved by discussion amongst the review team to reach consensus.
Main results
We included 23 studies, none of which were rated as low risk of bias overall. We categorised the included studies as testing light
vibrational forces or photobiomodulation, the latter including low level laser therapy and light emitting diode. The studies assessed non-
surgical interventions added to fixed or removable orthodontic appliances compared to treatment without the adjunct. A total of 1027
participants (children and adults) were recruited with loss to follow-up ranging from 0% to 27% of the original samples.
Non-surgical adjunctive interventions for accelerating tooth movement in patients undergoing orthodontic treatment (Review) 1
Informed decisions.

Certainty of the evidence
For all comparisons and outcomes presented below, the certainty of the evidence is low to very low.
Light vibrational forces
Eleven studies assessed how applying light vibrational forces (LVF) affected orthodontic tooth movement (OTM). There was no evidence
of a difference between the intervention and control groups for duration of orthodontic treatment (MD -0.61 months, 95% confidence
interval (CI) -2.44 to 1.22; 2 studies, 77 participants); total number of orthodontic appliance adjustment visits (MD -0.32 visits, 95% CI -1.69
to 1.05; 2 studies, 77 participants); orthodontic tooth movement during the early alignment stage (reduction of lower incisor irregularity
(LII)) at 4-6 weeks (MD 0.12 mm, 95% CI -1.77 to 2.01; 3 studies, 144 participants), or 10-16 weeks (MD -0.18 mm, 95% CI -1.20 to 0.83; 4
studies, 175 participants); rate of canine distalisation (MD -0.01 mm/month, 95% CI -0.20 to 0.18; 2 studies, 40 participants); or rate of OTM
during en masse space closure (MD 0.10 mm per month, 95% CI -0.08 to 0.29; 2 studies, 81 participants). No evidence of a difference was
found between LVF and control groups in rate of OTM when using removable orthodontic aligners. Nor did the studies show evidence of
a difference between groups for our secondary outcomes, including patient perception of pain, patient-reported need for analgesics at
different stages of treatment and harms or side effects.
Photobiomodulation
Ten studies assessed the effect of applying low level laser therapy (LLLT) on rate of OTM. We found that participants in the LLLT group
had a statistically significantly shorter length of time for the teeth to align in the early stages of treatment (MD -50 days, 95% CI -58 to -42;
2 studies, 62 participants) and required fewer appointments (-2.3, 95% CI -2.5 to -2.0; 2 studies, 125 participants). There was no evidence
of a difference between the LLLT and control groups in OTM when assessed as percentage reduction in LII in the first month of alignment
(1.63%, 95% CI -2.60 to 5.86; 2 studies, 56 participants) or in the second month (percentage reduction MD 3.75%, 95% CI -1.74 to 9.24; 2
studies, 56 participants). However, LLLT resulted in an increase in OTM during the space closure stage in the maxillary arch (MD 0.18 mm/
month, 95% CI 0.05 to 0.33; 1 study; 65 participants; very low level of certainty) and the mandibular arch (right side MD 0.16 mm/month,
95% CI 0.12 to 0.19; 1 study; 65 participants). In addition, LLLT resulted in an increased rate of OTM during maxillary canine retraction (MD
0.01 mm/month, 95% CI 0 to 0.02; 1 study, 37 participants). These findings were not clinically significant. The studies showed no evidence
of a difference between groups for our secondary outcomes, including OIIRR, periodontal health and patient perception of pain at early
stages of treatment.
Two studies assessed the influence of applying light-emitting diode (LED) on OTM. Participants in the LED group required a significantly
shorter time to align the mandibular arch compared to the control group (MD -24.50 days, 95% CI -42.45 to -6.55, 1 study, 34 participants).
There is no evidence that LED application increased the rate of OTM during maxillary canine retraction (MD 0.01 mm/month, 95% CI 0 to
0.02; P = 0.28; 1 study, 39 participants ). In terms of secondary outcomes, one study assessed patient perception of pain and found no
evidence of a difference between groups.
Authors' conclusions
The evidence from randomised controlled trials concerning the effectiveness of non-surgical interventions to accelerate orthodontic
treatment is of low to very low certainty. It suggests that there is no additional benefit of light vibrational forces or photobiomodulation
for reducing the duration of orthodontic treatment. Although there may be a limited benefit from photobiomodulation application for
accelerating discrete treatment phases, these results have to be interpreted with caution due to their questionable clinical significance.
Further well-designed, rigorous RCTs with longer follow-up periods spanning from start to completion of orthodontic treatment are
required to determine whether non-surgical interventions may reduce the duration of orthodontic treatment by a clinically significant
amount, with minimal adverse effects.
PLAIN LANGUAGE SUMMARY
Additional, non-surgical treatments for accelerating tooth movement in dental patients being treated with fixed braces
Review question
Do additional non-surgical procedures that claim to accelerate orthodontic tooth movement reduce the overall length of orthodontic
treatment?
Background
Throughout the world, orthodontic treatment is used to correct the position of teeth in adolescents and adults when they experience
problems with their teeth and bite. Orthodontic appliances can vary in type, and include fixed braces (made up of brackets glued to the
teeth and then connected by wires) and removable appliances, e.g. clear aligners, which are a set of clear plastic removable gum shields
that fit closely over the teeth. Depending on the tooth and bite problem, the length of time for orthodontic treatment may range from
several months to several years. However, most full orthodontic treatments take typically around 20 months. Orthodontic treatment is
known to improve how a smile looks, which in turn has a positive impact on patients; however, orthodontic treatment can carry some
unwanted risks, such as tooth decay and shortening of tooth roots. Accelerating the rate of tooth movement may help to reduce the length
of time needed for a course of treatment and may reduce the unwanted effects of orthodontic treatment that can sometimes occur. Several
Informed decisions.

methods, including surgical and non-surgical treatments, have been suggested to accelerate orthodontic tooth movement. The evidence
relating to non-surgical treatments to accelerate orthodontic tooth movement is assessed in this review.
Authors for Cochrane Oral Health carried out this update of the systematic review of existing studies. The evidence on which it is based
is current up to September 2022.
Study characteristics
We included 23 studies involving a total of 1027 participants, both males and females, and children and adults. These investigated light
vibrational force appliances, low level laser therapy and light-emitting diode (LED) therapy as extras to orthodontic treatment in both
private practice and university hospital settings. The trials evaluated different aspects of orthodontic tooth movement and side effects. In
the studies, participants were being treated either with fixed orthodontic appliances or orthodontic removable aligners. The participants
in all studies had dental (tooth) crowding in one or both arches. Some studies included participants requiring tooth extractions for relief
of dental crowding and correction of their bite with space closure, while other studies included participants who did not require dental
extractions. The percentage of participants lost to follow-up in the studies included in this review ranged from 0% to 27% of the original
samples.
The studies evaluated seven outcomes: duration of orthodontic treatment; number of appointments required to adjust orthodontic
appliance, the rate of orthodontic tooth movement at different stages, patient perception of pain and discomfort, patient reported need
for painkillers, and unwanted side effects. There were substantial differences between some of the studies; however, it was possible to
combine the results of some studies for the light vibrational forces and low level laser therapy.
Key results
There is low-certainty evidence to suggest that applying light vibrational forces during orthodontic treatment (fixed or removable
appliances) has no significant advantage for any of the outcomes assessed.
There is very low-certainty evidence to suggest that applying low level laser and LED therapy can reduce the duration of the early stage
of orthodontic fixed brace treatment (alignment), but it is difficult to estimate the impact of this outcome on the full comprehensive
orthodontic treatment duration.
Conclusion
From the limited evidence available, we did not find a benefit from the use of light vibrational forces or photobiomodulation for the
reduction of orthodontic treatment duration. However, there could be a potential benefit from photobiomodulation to reduce the length
of the early stage of orthodontic treatment only and increase the speed of orthodontic tooth movement; it is important to realise that
the results from discrete phases do not necessarily have similar impact on the full orthodontic treatment duration. Further well-designed
studies with longer follow-up are needed.
Certainty of the evidence
Our certainty about the evidence is low to very low.
Non-surgical adjunctive interventions for accelerating tooth movement in patients undergoing orthodontic treatment (Review)
SUMMARY OF FINDINGS

Summary of findings 1. Summary of findings 1: adjunctive light vibrational forces versus conventional orthodontic treatment
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Light vibrational forces as an adjunctive to conventional orthodontic treatment compared with conventional orthodontic treatment
Population: adolescents and adults with malocclusion undergoing orthodontic treatment
Settings: teaching university hospitals and private practice
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Trusted evidence.
Intervention: orthodontic appliance treatment with vibrational light forces
Comparison: conventional orthodontic appliance treatment
Outcomes Anticipated absolute effects Relative effect No of partici- Certainty of Comments

(95% CI) (95% CI) pants the evidence
(studies) (GRADE)
Absolute Mean differ-
effect in ence (MD) with
control
Convention- Non-surgical
al orthodontic adjunctive in-
treatment tervention
Duration of or- Mean duration Mean dura- - 77 participants ⊕⊕⊝⊝ There was no evidence to suggest that LVF can either
thodontic treat- tion was 0.61 low 1 increase or decrease the total duration of orthodontic
ment ranged across months fewer (2 RCTs) treatment.
groups from (2.44 fewer to
19.7 to 20.71 1.22 more)
months

Total number of Mean number Mean number 77 participants ⊕⊕⊝⊝ There was no evidence to suggest that LVF can either
orthodontic ap- of visits ranged of visits was increase or decrease the total number of appoint-
pliance adjust- across groups 0.32 less (1.05 (2 RCTs) low 2 ments required for orthodontic appliance adjust-
ment appoint- from 12.92 to fewer to 1.69 ment.
ments during 14.12 more)
treatment
Orthodontic Mean reduction Mean reduc- - 54 participants ⊕⊕⊝⊝ There was no evidence to suggest that OTM during the
tooth movement in LII score was tion in LII score (1 RCT) alignment stage was either increased or decreased in
8.6 mm was 0.20 mm low 3 the LVF group compared to the control.
4

(OTM) during less (7.02 less to
alignment stage 6.62 more)
OTM also assessed at other time points during align-
During full alignment stage: at first 4-6 weeks (3 RCTs; 144 partici-
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ment stage (re- pants) mean reduction in LII 0.12 mm more (1.77 less
duction in Little to 2.01 more); at 10-16 weeks from the start of treat-
Irregularity Index ment (4 RCTs; 175 participants) mean reduction in LII
(LII) in mm) score 0.18 mm less (1.20 less to 0.83 more).
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Orthodontic Mean rate of Mean rate of - 81 participants ⊕⊕⊝⊝ There was no evidence to suggest that LVF can in-
tooth move- tooth move- space closure (2 RCTs) crease or decrease OTM during the space closure
ment (OTM) dur- ment ranged was low4 stage.
ing space clo- from 0.76 to 1.3 0.10 mm/
sure stage (mm/ mm/month month higher
month) (0.08 lower to
When assessed in the maxillary or mandibular arch
0.29 higher)
During en masse only, there was also no evidence to suggest that LVF
space closure can increase or decrease OTM during the space clo-
(maxillary and sure stage (1 RCT; 40 and 41 participants, respective-
mandibular arch ly). Likewise, when assessed through canine distalisa-
combined) tion (2 RCTs, 40 participants).
Patient percep- Mean pain and Mean pain and - 153 partici- ⊕⊕⊝⊝ low5 There was no evidence to suggest that LVF can in-
tion of pain and discomfort discomfort pants crease or decrease patient's perception of pain follow-
discomfort using score in the score was 2.56 (3 RCTs) ing ligation of the initial aligning archwire.
VAS 0 to 100 mm control groups higher (2.35
ranged from 8.1 lower to 7.47
Immediately after to 28.27 mm higher)
ligation of initial Patient's perception of pain was assessed after the
archwire ligation of the first aligning arch wire at several time
points: 4-8 hours, 1 day, 3 days and 7 days (3 RCTs; 153
participants). There was no evidence that pain percep-
tion was greater or lower in the LVF group compared
to the control group.

Pain perception after fitting the second aligning arch-

wire was assessed by one study (Woodhouse 2015) (53
participants). There was no evidence that pain percep-
tion was greater or lower in the LVF group compared
to the control group, except after 1 day where the pain
perception was higher in the LVF group (MD 18.66 mm,
95% CI 3.41 to 33.91).
Patient-report- Percentage of Percentage was OR 1.64 (lower 76 participants ⊕⊕⊝⊝ There was no evidence to suggest that the patient-re-
ed need for anal- patients who lower in inter- 0.60 and higher ported need for analgesics following fitting the ini-
(2 RCTs) low 6
5
gesics reported need 4.53)

During first week for analgesics vention groups tial aligning archwire was greater or lower in the LVF
of the initial in control group by 7.59% group compared to the control group.
aligning archwire was 76.08%

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The patient-reported need for analgesics was as-
sessed after fitting the second archwire by one
study (Woodhouse 2015) (53 participants) and was not
greater or lower in the LVF group compared to the con-
trol group (OR 1.01, 95% CI -0.32 to 3.20).
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Trusted evidence.
Harms and side Mean amount Mean amount 50 participants ⊕⊕⊝⊝ low 7 There was no evidence to suggest that OIIRR was re-
effects: OIIRR of OIIRR in con- of OIIRR in in- (1 RCT) duced, or increased, due to the use of LVF when com-
trol group was tervention pared to the control group.
1 mm (95% CI groups was
0.61 to 1.38) 0.09 mm higher
(95% CI -0.35 to
0.53)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is
based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; LED: light-emitting diode; LII: Little's irregularity index; LLLT: low level laser therapy; mm: millimetres; OTM: orthodontic tooth movement; OIIRR:
orthodontically induced inflammatory root resorption; RR: risk ratio; VAS: visual analogue scale
GRADE Working Group grades of evidence

High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is
substantially different.
Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.
1 Downgraded one level for limitation in design and implementation due to overall high risk of bias. Downgraded one level for imprecision of evidence due to small sample size.

2 Downgraded one level for limitation in design and implementation due to overall high risk of bias. Also downgraded one level for imprecision of evidence due to small sample
size.
3 Downgraded two levels for imprecision of evidence due to small sample size and single study involving only mandibular arch with extraction treatment plan. Although the study
was rated as unclear risk of reporting bias, this does not have a direct impact on this outcome.
4 Downgraded one level for limitation in design and implementation due to overall high risk of bias. Also downgraded one level for imprecision of evidence due to inconsistency
as the space closure for both the maxillary and mandibular arch were combined.
5 Downgraded one level for limitation in design and implementation due to 2 studies out of 3 at high risk of bias. Downgraded one level for imprecision
6 Downgraded one level for limitation in design and implementation due to one study rated as high risk of bias. Downgraded one level for imprecision of evidence due to wide
confidence intervals. Also downgraded one level for indirectness due to short duration period assessed which does not represent the full treatment duration (surrogate results).
7 Downgraded one level for imprecision due to small sample size and single study rated unclear risk of bias. Also downgraded one level for indirectness due to short duration
period assessed which does not represent the full treatment duration (surrogate results).
6


Summary of findings 2. Summary of findings 2: adjunctive low level laser therapy versus conventional orthodontic treatment
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Low level laser therapy as an adjunctive intervention to conventional orthodontic treatment compared with conventional orthodontic treatment
Settings: teaching university hospitals
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Trusted evidence.
Intervention: LLLT as an adjunctive intervention to conventional orthodontic treatment
Comparison: conventional orthodontic treatment
Outcomes Illustrative comparative risks* Relative effect No of partici- Certainty of Comments

(studies) (GRADE)
Assumed risk Corresponding
risk
Control Experimental
Duration of or- Mean duration Mean duration 92 ⊕⊝⊝⊝ There was very low-certainty evidence to suggest that
thodontic treat- ranged from was 48.87 days very low1 the duration of the orthodontic alignment stage was
ment during 109.23 to 284.1 fewer (56.48 (3 RCTs) reduced due to the use of LLLT when compared to the
alignment stage days fewer to 41.26 control group.
only fewer)
Alignment dura-
tion from start
of orthodontic
treatment until

end of alignment
stage

Total number of Median num- Median num- 36 ⊕⊝⊝⊝ There was very low-certainty evidence to suggest that
orthodontic ap- ber of visits was ber of visits was very low2 the total number of orthodontic appliance adjustment
pliance adjust- 9.5 (lower 6.7 to 2.5 fewer ( 2.52 (1 RCT) visits required during alignment stage was reduced
ment appoint- higher 7.2) fewer to fewer due to the use of LLLT when compared to the control
ments required 1.97 fewer) group.
during treat-
ment: alignment
stage only
7

Orthodontic Mean reduction Mean percent- - 56 (2 RCTs) ⊕⊝⊝⊝ There was no evidence that OTM during the first 4
tooth movement in LII ranged age reduction very low3 weeks of the alignment stage was either increased or
(OTM) during from 41.40% to in LII was 1.63% decreased in the LLLT group compared to the control.
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alignment stage 48.85% greater (2.60
less to 5.86
(percentage re- greater)
duction in LII in OTM was assessed at different time points by the same
mm) studies during the alignment stage: at first 8 weeks (2
RCTs; 56 participants) mean percentage reduction in
During first 4 LII (mm) in the LLLT group was 3.75% greater (-1.74
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Trusted evidence.
weeks of align- less to 9.24 greater) than in the control group.
ment stage

Orthodontic Mean rate of Mean rate of 45 (1 RCT) ⊕⊝⊝⊝ There was very low-certainty evidence to suggest that
tooth move- space closure OTM was 0.18 very low4 rate of OTM during space closure stage in the maxillary
ment (OTM) dur- ranged from higher (0.10 arch was increased due to the use of LLLT when com-
ing space clo- 0.48 to 0.50 greater to 0.26 pared to the control group.

sure stage mm/ mm/month greater)
month

(maxillary arch) OTM was assessed in the mandibular arch by the

same study (Lalnunpuii 2020) during the space closure

stage: mean rate of space closure in the LLLT was 0.16

mm/months

greater mm/month ( 0.13 to greater 0.19). There was

very low certainty evidence to suggest that rate of
OTM during space closure stage in the mandibular

arch was increased, due to the use of LLLT when com-
pared to the control group

OTM was assessed during canine distalization/space

closure Farhadian 2021 (1 RCTs; 37 participants). The
8

mean rate of OTM was 0.01 mm/day higher (0 greater
to 0.02 greater). There was insufficent evidence to sug-
gest that LLLT can increased or decrease the rate of
OTM during canine distalisation/space closure stage.
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Patient percep- Mean pain and Mean pain 37 (1 RCT) ⊕⊝⊝⊝ There was insufficent evidence to suggest that LLLT
tion of pain and discomfort and discom- very low5 can increase or decrease patient's perception of pain
discomfort using score in the fort score was during fixed orthodontic apppliance treatment.
VAS 0 to 100 mm control groups 0.4 mm lower
was 3.5 mm (-1.87 lower to
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Trusted evidence.
1.07 higher)
Alam 2019; Ghaffer 2022 (high risk of bias) both as-
sessed pain and discomfort using VAS during the early
7 days with the initial aligning archwires.
Ghaffer 2022 reporetd no increase or decrease in pain

pereception except in the 5th day where the pain was
reduced in the laser group.
Alam 2019 using a mix of different types of orthodon-

tic bracket systems (self ligating and conventional lig-
ation) with reported reducecd pain score at several
time points, mainly in combinatioin with self-ligating
bracket system.
Patient-report- Not reported

ed need for anal-
gesics
Harms and side Not reported

effects


CI: confidence interval; LII: Little's irregularity index; LLLT: low level laser therapy; mm: millimetres;OTM: orthodontic tooth movement; RR: risk ratio; VAS: visual analogue
scale

9

1 Downgraded one level for limitation in design and implementation due to overall high risk of bias. Downgraded one level for imprecision of evidence due to wide
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confidence intervals with high heterogenity; also clinical heterogeneity among included studies resulted from different LLLT devices used. Downgraded one level for indirectness
due to short duration period assessed, which does not represent the full treatment duration (surrogate results).
2 Downgraded one level for limitation in design and implementation due to overall high risk of bias. Downgraded one level for imprecision of evidence due to single study.
Downgraded one level for indirectness due to short duration period assessed, which does not represent the full treatment duration (surrogate results).
3 Downgraded one level for limitation in design and implementation due to overall high risk of bias. Downgraded one level for imprecision of evidence due to small sample.
Better health.
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Trusted evidence.

Summary of findings 3. Summary of findings 3: adjunctive light emitting diode versus conventional orthodontic treatment
Light emitting diode as an adjunctive intervention to conventional orthodontic treatment compared with conventional orthodontic treatment
Settings: teaching university hospitals
Intervention: LED as an adjunctive intervention to conventional orthodontic treatement
Comparison: conventional orthodontic treatment
Outcomes Illustrative comparative risks* Relative effect No of partici- Certainty of Comments

(studies) (GRADE)
Assumed risk Corresponding
risk

Control Experimental
Duration of orthodon- Mean duration Mean duration - 34 participants ⊕⊝⊝⊝ There is very low-certainty evidence to
tic treatment: alignment of orthodontic was 24.5 days (1 RCT) very low1 suggest that the duration of the orthodon-
stage only alignment stage fewer (6.55 fewer tic alignment stage was reduced due to
was 87.8 days to 42.45 fewer) the use of LED when compared to the con-
Alignment duration from trol group.
start of orthodontic treat-
ment until end of alignment
stage
10

Total number of orthodon- Not reported
tic appliance adjustment
appointments required
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during treatment stage
Orthodontic tooth move- Not reported

ment (OTM) during align-
ment stage
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Trusted evidence.
Orthodontic tooth move- Mean rate of ca- Mean rate of OTM - 39 (1 RCT) ⊕⊝⊝⊝ There is very low-certainty evidence to
ment (OTM) during space nine distalisa- was 0.006 mm/ very low2 suggest that the rate of OTM during canine
closure stage mm/month tion was 0.023 day higher (0 low- distalisation/space closure stage in the
mm/day er to 0.02 higher) maxillary arch was increased due to the
(canine distalisation) use of LED when compared to the control
group.
One study (Farhadian 2021) found LED in-

creases the OTM, but difference was not
clinically significant.
Patient perception of pain Mean pain and Mean pain and - 39 (1 RCT) ⊕⊝⊝⊝ There was insufficent evidence to sug-
and discomfort using VAS discomfort discomfort score very low3 gest that LED can increase or decrease
0 to 100 mm score in the was 0.80 mm patient's perception of pain during fixed
control groups lower (-2.20 lower orthodontic apppliance treatment. One
was 3.5 mm to 0.62 higher) study (Farhadian 2021)
Patient-reported need for Not reported

analgesics
Harms and side effects Not reported

CI: confidence interval;LED: light-emitting diode; LII: Little's irregularity index; mm: millimetres; OTM: orthodontic tooth movement; RR: risk ratio; VAS: visual analogue
scale

11

1Downgraded one level for limitation in design and implementation due to overall high risk of bias. Downgraded one level as single study. Also downgraded one
level for indirectness due to short duration period assessed, which does not represent the full treatment duration (surrogate results).
2Downgraded one level for limitation in design and implementation due to overall high risk of bias. Downgraded one level as single study. Also downgraded one level for
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indirectness due to short duration period assessed, which does not represent the full treatment duration (surrogate results).
3Downgraded one level for limitation in design and implementation due to overall high risk of bias. Downgraded one level as single study. Also downgraded one level for
indirectness due to short duration period assessed, which does not represent the full treatment duration (surrogate results).

Better health.
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Trusted evidence.
12

Informed decisions.

BACKGROUND appliance and used by the patient on a daily or weekly basis

following the clinician's prescription (e.g. pulsed electromagnetic
Description of the condition waves and intermittent electrical vibration).
Discrepancies in the arrangement of the teeth and the bite are How the intervention might work
called malocclusion (Andrews 1972). It is a common dental problem
with a range of prevalence amongst different ethnic populations, Orthodontic tooth movement occurs due to a sterile inflammatory
with more than a quarter of adolescents classified as being in process that results in bone resorption and deposition, which is
need of orthodontic treatment (Migale 2009; Mtaya 2009; Tausche known as bone remodelling (Zainal 2011). Bone cells (osteoclasts
2004). Malocclusion can cause aesthetic and functional problems, and osteoblasts) responsible for remodelling are the main target
which can lead to negative impacts on an individual’s emotional of non-surgical interventions for accelerating tooth movement
and social well-being (Dimberg 2015). This is normally corrected through upregulation of the inflammation process. This is because
using orthodontic treatment, which aims for dentoalveolar and/ it has been proposed that such interventions can act as a bio-
or orthopaedic outcomes using fixed or removable appliances, or stimulus to increase the activity of bone cells (Tortamano 2009). The
both. In the current review the focus will be on dentoalveolar Photobiomodulation has a biostimulatory effect which stimulates
orthodontic tooth movement (OTM). remodelling cells by the production of ATP and activation of
cytochrome C, via RANK/RANKL and the macrophage colony-
There are clear benefits to patients of effective orthodontic stimulating factor and its receptor expression (Nimeri 2013 ).
treatment accomplished by delivering the planned treatment The light vibrational forces work according to the bioelectrical
goals over the shortest time possible with high levels of patient potential theory which originated from the bone bending theory
satisfaction, minimal biological side effects and low financial in orthodontic tooth movement (Zainal 2011). The increased bone
cost. The duration of comprehensive orthodontic treatment may remodelling rate can increase the rate of tooth movement, which
range from several months to several years, with an average may lead to a reduction in the overall duration of orthodontic
treatment duration of approximately 20 months reported in a treatment.
recent systematic review (Tsichlaki 2016). This can be extended for
patients with a severe malocclusion. Reducing treatment duration Why it is important to do this review
can limit the risk of undesirable effects (e.g. root shortening or
Duration of treatment is an important aspect of successful
demineralisation) and associated cost, which can increase patient
and effective orthodontic treatment. Comprehensive orthodontic
satisfaction (Riedmann 1999; Segal 2004).
treatment typically takes nearly two years to complete and
Many factors can influence the duration of orthodontic treatment, can be influenced by different factors, including patient-related
including both patient-related and treatment-related factors and treatment-related aspects. Reduction in the duration of
(Fisher 2010; Mavreas 2008). Several conventional treatment orthodontic treatment can reduce the exposure of patients
modalities have been suggested aiming to reduce the duration to risks associated with treatment and related cost, and can
of orthodontic treatment including brackets design and archwires increase patient satisfaction. Increased orthodontic treatment
however with no sound evidence to support those claims (Germec duration can increase the risk of the severity of OIIRR and
2008; Maizeray 2021; Sebastian 2012; Yassir 2019). Similarly, in demineralisation (Weltman 2010). In addition, increased treatment
the last few decades, alternative techniques have been developed duration can lead to lack of patient's motivation and compliance
aiming to reduce treatment duration by accelerating the rate of with treatment (Fleming 2007).
tooth movement. These alternative techniques include surgical
This systematic review assessed the available evidence for the
interventions (Fleming 2015) such as surgical corticotomy and non-
effect of non-surgical adjunctive interventions on the reduction of
surgical interventions such as low level energy laser therapy and
orthodontic treatment duration by accelerating orthodontic tooth
light vibrational forces (Caccianiga 2017; Miles 2016; Nahas 2017).
movement. However, the acceleration of orthodontic treatment
Description of the intervention during a short phase of treatment does not necessarily have a
significant influence on the overall treatment duration which is
The proposed non-surgical adjunctive interventions to accelerate the primary outcome of this review. In addition, the effect on
orthodontic tooth movement include: treatment outcome, biological side effects and patient perception
of treatment were evaluated. This will provide the orthodontic
• Low energy laser radiation directed to the mucosa of the clinician with evidence about the effectiveness and safety of non-
targeted teeth; surgical adjunctive interventions for accelerating orthodontic tooth
• Light vibrational forces (LVF) using an electrical appliance fitted movement.
into the orthodontic appliance or applied to the teeth;
• Light-emitting diode LED Several systematic reviews have been published in the last few
years with different study inclusion criteria, which has led to various
• Pulsed electromagnetic waves using integrated circuits placed
conclusions. The first version of this review was originally published
in an oral appliance;
in 2015 and the current review is an update due to the increased
• Chewing gum or muscle exercise; and relevant published studies in the last five years that necessitate
• Novel methods as they are described by authors. assessment of the new evidence.
These interventions are used during conventional orthodontic OBJECTIVES
appliance treatment, and are undertaken by the clinician in a
clinical setting during additional scheduled visits (e.g. low energy To assess the influence of non-surgical adjunctive interventions
laser radiation), or can be fitted in an intra-oral or extra-oral for accelerating the rate of orthodontic tooth movement on
Informed decisions.

the effectiveness of orthodontic treatment including treatment • Patient-centred outcomes: impact of fixed or removable
duration, treatment outcome, patient centred outcomes and side orthodontic appliances and the adjunctive interventions on
effects. daily life, quality of life and pain experience
• Harms arising during the course of orthodontic treatment
METHODS including periodontal problems, anchorage loss, and iatrogenic
damage to teeth (e.g. caries or decalcification, root resorption)
Criteria for considering studies for this review including any additional adverse events arising from the
Types of studies adjunctive intervention.
• Cost of treatment including the additional costs in terms
We included randomised controlled trials (RCTs), irrespective
of time and other resources in administering the additional
of publication status or language of publication. The split-
intervention.
mouth study design was determined to be inappropriate for
this type of investigation. This is because this type of study We did not include studies had measured only patient-reported
design may introduce 'carry-across effects', which potentially allow outcomes, harms or costs; studies had to measure some aspect of
interventions to have effects on experimental units other than tooth movement.
those to which they were assigned. There was no restriction in the
length of follow-up. Search methods for identification of studies
Types of participants Electronic searches
We included studies involving individuals, of any age, receiving Cochrane Oral Health’s Information Specialist conducted
orthodontic treatment with fixed or removable orthodontic systematic searches in the following databases for randomised
appliances that incorporated the adjunctive use of non-surgical controlled trials and controlled clinical trials. There were no
interventions to accelerate tooth movement. We excluded studies language, publication year or publication status restrictions:
that included patients who were treated with orthognathic surgery,
participants with cleft lip or palate, or with other craniofacial • Cochrane Oral Health’s Trials Register (searched 6 September
syndromes or deformities, as these patients would routinely have 2022) (Appendix 1);
a combination of orthodontic and surgical treatment, which can • Cochrane Central Register of Controlled Trials (CENTRAL; 2022,
influence the outcome, duration and side effects of the treatment. Issue 8) in the Cochrane Library (searched 6 September 2022)
(Appendix 2);
Types of interventions • MEDLINE Ovid (1946 to 6 September 2022) (Appendix 3);
• Active interventions: any form of fixed or removable orthodontic • Embase Ovid (1980 to 6 September 2022) (Appendix 4);
appliance treatment incorporating the use of non-surgical • LILACS BIREME Virtual Health Library (Latin American and
adjunctive interventions to accelerate orthodontic tooth Caribbean Health Science Information database; from 1982 to 6
movement September 2022) (Appendix 5).
• Control: any form of fixed or removable orthodontic
appliance treatment without the use of non-surgical adjunctive Subject strategies were modelled on the search strategy designed
interventions to accelerate orthodontic tooth movement or for MEDLINE Ovid. Where appropriate, they were combined
with the use of a different type of non-surgical adjunctive with subject strategy adaptations of the highly sensitive search
intervention to accelerate orthodontic tooth movement strategies designed by Cochrane for identifying randomised
controlled trials and controlled clinical trials (as described in
Types of outcome measures the Cochrane Handbook for Systematic Reviews of Interventions,
Version 6.1 (Lefebvre 2022)).
Primary and secondary outcomes
Searching other resources
Primary outcomes
The following trial registries were searched for ongoing studies:
• Duration of active orthodontic treatment from the day the
active appliance is fitted until it is removed at the end of active • US National Institutes of Health Ongoing Trials Register
treatment. ClinicalTrials.gov (clinicaltrials.gov; searched 6 September 2022)
(Appendix 6);
Secondary outcomes
• World Health Organisation International Clinical Trials Registry
• The number of visits required for activation of orthodontic Platform (apps.who.int/trialsearch; searched 8 September
appliance during active treatment (scheduled and unscheduled) 2022) (Appendix 6).
• Rate of reduction in the severity of dental arch malalignment
through treatment using validated indices, e.g. Little's The metaRegister of controlled trials (mRCT) was searched in
irregularity index (LII). November 2014, however this resource is no longer available. The
search strategy is reported in Appendix 6.
• Rate of orthodontic tooth movement (OTM) determined by
millimetres of tooth movement per week or month. We examined the reference lists of relevant articles and contacted
• Improvement in occlusion, as judged using a validated index e.g. the investigators of included studies by electronic mail to ask for
Peer Assessment Rating (PAR), recorded at the completion of details of additional published and unpublished trials if needed.
active orthodontic treatment
Informed decisions.

We checked that none of the included studies in this review were We produced a 'Risk of Bias' table for each included study. For each
retracted due to error or fraud. domain, we provided a description of what was reported. We then
used this information to judge whether the risk of bias was low, high
We did not perform a separate search for adverse effects of or unclear. The two review authors compared their assessments;
interventions used, we considered adverse effects described in any inconsistencies between them were discussed and resolved.
included studies only.
We assessed the following domains as being at low, high or unclear
Data collection and analysis risk of bias:
Selection of studies • random sequence generation (selection bias);
Two review authors (AE and PSF) independently assessed the • allocation concealment (selection bias);
titles and abstracts of studies identified by the searches. The • blinding of participants and personnel (performance bias);
search was designed to be sensitive and include controlled clinical • blinding of outcome assessors (detection bias);
trials, these were filtered out early in the selection process if they
were not randomised. Full copies were obtained of all relevant • incomplete outcome data addressed (attrition bias);
and potentially relevant studies, and for studies that appeared to • selective outcome reporting (reporting bias);
meet the inclusion criteria but for which there were insufficient • other bias.
data in the title and abstract to make a clear decision. The full-
text papers were independently assessed by two review authors We categorised and reported the overall risk of bias of each
(AE and DB). Any disagreement on the eligibility of an included included study according to the following:
study was resolved through discussion and consensus. Consulting
• low risk of bias (plausible bias unlikely to seriously alter the
with a third review author if needed. From this group of full-text
results) if all domains were considered to be at low risk of bias;
papers, we recorded the studies not meeting the inclusion criteria,
with reasons for exclusion, in the Characteristics of excluded • unclear risk of bias (plausible bias that raises some doubt about
studies section of the review. the results) if one or more domains were assessed at unclear risk
of bias; or
Data extraction and management • high risk of bias (plausible bias that seriously weakens
confidence in the results), if one or more domains were assessed
Two review authors (AE and GM) independently extracted data.
at high risk of bias.
We used data extraction forms recording the year of publication,
country of origin and details of the participants including Measures of treatment effect
demographic characteristics and the criteria for inclusion. We
entered the study details into the Characteristics of included We calculated mean differences (MD) with 95% confidence intervals
studies tables in Review Manager (RevMan) 5.4.1 (RevMan 2014). (CI) for continuous data, and risk ratios (RR) with 95% CI for
Any disagreements were resolved by consulting with a third review dichotomous data. We contacted the corresponding authors of
author. trials for original data where necessary.
The following details were also extracted if reported. Unit of analysis issues
1. Trial methods: (a) allocation method; (b) sample size We had anticipated that some included studies may have presented
calculation; (c) masking of participants, trial staff and outcome participant data from repeated or multiple site observations, or
assessors; (d) exclusion of participants after randomisation and both, which may have led to unit of analysis errors. Had this been
the proportion and reasons for sample attrition at follow-up. the case, we would have followed the advice provided in section 5.6
of the Cochrane Handbook for Systematic Reviews of Interventions
2. Participants: (a) country of origin and study setting; (b) sample
(Higgins 2020).
size; (c) age; (d) gender; (e) inclusion and exclusion criteria.
3. Intervention: (a) type; (b) materials and techniques used; (c) Dealing with missing data
time of follow-up.
In studies where data were unclear or missing, we contacted
4. Control: (a) type; (b) materials and techniques used; (c) time of the principal investigators. If missing data were unavailable,
follow-up. we followed the advice given in section 10.12 of the Cochrane
5. Outcomes: (a) primary and secondary outcomes mentioned in Handbook for SystematicReviews of Interventions (Higgins 2020).
the Types of outcome measures section of this review.
Assessment of heterogeneity
Where stated, we recorded sources of funding. We used this
information to aid assessment of investigator reporting bias and We assessed clinical heterogeneity by examining the characteristics
the validity of included trials. of the studies, the similarity between the types of participants,
the interventions and the outcomes, as specified in the criteria
Assessment of risk of bias in included studies for included studies. We had intended to assess statistical
heterogeneity using a Chi2 test and the I2 statistic. We considered
Two review authors (AE and GM) independently assessed the risk of
heterogeneity to be significant for the Chi2 test when the P value
bias for the selected trials using Cochrane's tool for assessing risk of
was less than 0.10, with I2 values of 30% to 60% indicating moderate
bias (RoB 1), as described in section 8.5 of the Cochrane Handbook
heterogeneity, and over 60%, substantial heterogeneity (Higgins
for Systematic Reviews of Interventions (Higgins 2011a; Sterne 2011).
2020).
Informed decisions.

Assessment of reporting biases Summary of findings and assessment of the certainty of the
evidence
We had intended to assess publication bias according to the
recommendations on testing for funnel plot asymmetry if a We produced summary of findings tables (Summary of findings
sufficient number of studies assessing similar interventions were 1, Summary of findings 2) for the following outcomes, listed by
identified for inclusion in this review, as described in the Cochrane priority.
Handbook for Systematic Reviews of Interventions (Higgins 2020). If
asymmetry had been identified, we had planned to assess other 1. Duration of orthodontic treatment, number of visits during
possible causes and explore these in the discussion. active treatment (scheduled and unscheduled)
2. Rate of tooth movement
Data synthesis 3. Improvement in occlusion
We pooled data from studies with similar participants, 4. Patient-centred outcomes: impact of fixed appliances on daily
interventions and outcomes. We calculated a weighted treatment life, quality of life and pain experience
effect with the results expressed as mean difference for continuous 5. Harm arising during the course of orthodontic treatment:
data and odds ratio for dichotomous data. We carried out meta- including gingival and other periodontal problems, anchorage
analyses where there were studies relating to similar comparisons loss and iatrogenic damage to teeth (e.g. caries or
reporting the same outcomes. We used the fixed-effect model for demineralisation and root resorption)
meta-analyses. We used additional tables to present the results
from the included studies (Deeks 2011). We assessed the certainty of the evidence according to GRADE as
high, moderate, low or very low, with reference to the overall risk
Subgroup analysis and investigation of heterogeneity of bias for included studies, directness of evidence, consistency of
Where we found a sufficient number of studies included results, precision of estimates and risk of publication bias.
with moderate, substantial or considerable heterogeneity
(see Assessment of heterogeneity), we had planned to carry out the
RESULTS
following subgroup analyses.
Description of studies
• Type of non-surgical method used See Characteristics of excluded studies and Characteristics of
• Age category (adolescents versus adults) included studies.
• Type of orthodontic appliance
Results of the search
Sensitivity analysis The initial review was published in 2015 and had two included
We undertook sensitivity analysis based on risk of bias (low risk of studies. Electronic searches to date (September 2022) identified a
bias versus high or unclear risk of bias) to investigate the robustness total of 6521 references. After removal of duplicates, 1902 records
of conclusions. remained. We discarded 1771 of these and assessed the full text
of 131 records. Of these 131, we rejected 55 and excluded 35 (33
studies) with reasons presented (see Characteristics of excluded
studies). We included a total of 41 records in this review, reporting
on 23 studies. Figure 1 shows the study selection process.

Informed decisions.

Figure 1. Study flow diagram
6521 records
identified through
database searching
1902 records left

after duplicates
removed
1902 records 1771 records

screened rejected
55 records rejected
131 records full 35 records (33
text screened studies) excluded
with reasons

41 records (from
23 studies)
included in
qualitative
synthesis
13 studies included
in quantitative
synthesis
(meta-analysis)
Informed decisions.

Characteristics of design Most studies involved treatment with fixed orthodontic

appliances, while Katchooi 2018, NCT02868554 and Lombardo
This review included 23 parallel-group RCTs reported in 41
2018 used removable orthodontic aligners. The participants in
articles (Abellán 2021; Alam 2019; AlSayed 2017; Caccianiga 2017;
most studies presented with dental crowding in one or both
El Shehawy 2020; Farhadian 2021; Ghaffer 2022; Hasan 2022;
arches. Some studies included participants who required dental
Katchooi 2018; Kumar 2020; Lalnunpuii 2020; Lo Giudice 2020;
extraction to relieve dental crowding and correct the malocclusion
Lombardo 2018; Miles 2012; Miles 2016; Nahas 2017; NCT02868554;
with space closure (AlSayed 2017; Kumar 2020; Lalnunpuii 2020;
Pavlin 2015; Reiss 2020; Siriphan 2019; Taha 2020; Telatar 2020;
Lo Giudice 2020; Miles 2016; Pavlin 2015; Siriphan 2019; Taha
Woodhouse 2015). NCT02868554 was not published in a peer
2020; Telatar 2020; Woodhouse 2015), while other studies included
reviewed journal by the time the current review was submitted
participants who did not require dental extractions (Caccianiga
for publication; however, review authors extracted data from the
2017; El Shehawy 2020; Ghaffer 2022; Katchooi 2018; Lo Giudice
trial registration webpage. Ethical approval was obtained in all
2020; Lombardo 2018; Miles 2012; Nahas 2017; Reiss 2020). Alam
studies prior to commencement and recruitment of participants.
2019 included participants being treated both with and without
Fourteen of the studies compared two groups (Abellán 2021;
dental extractions. Two studies recruited participants for the
AlSayed 2017; Caccianiga 2017; El Shehawy 2020; Ghaffer 2022;
treatment of anterior open bite (Abellán 2021; Hasan 2022).
Katchooi 2018; Lo Giudice 2020; Miles 2012; Miles 2016; Nahas 2017;
Pavlin 2015; Reiss 2020; Taha 2020; Telatar 2020), eight compared The percentage of participants lost to follow-up ranged from 0% to
three groups (Farhadian 2021; Hasan 2022; Kumar 2020; Lalnunpuii 27%, with the maximum dropout being in Woodhouse 2015 for the
2020; Lombardo 2018; NCT02868554; Siriphan 2019; Woodhouse secondary outcomes.
2015) and one compared four groups (Alam 2019).
Characteristics of interventions
Characteristics of settings and investigators
In this review, we classified the non-surgical interventions for
Of the 23 included studies in this review, four studies were accelerating orthodontic tooth movement into two categories:
conducted in the United States of America (NCT02868554; Pavlin light vibrational forces (LVF) and photobiomodulation therapy
2015; Reiss 2020; Taha 2020), three in Italy (Caccianiga 2017; Lo (low level laser therapy (LLLT) and light emitting diode (LED)).
Giudice 2020; Lombardo 2018), two each in Australia (Miles 2012; All trials provided a clear description of the treatment protocols
Miles 2016), India (Kumar 2020; Lalnunpuii 2020), Syria (AlSayed except Alam 2019. Twelve studies (reported in 16 publications)
2017; Hasan 2022), and Egypt (El Shehawy 2020; Ghaffer 2022), assessed appliances delivering LVF (Katchooi 2018; Kumar 2020;
and one each in the United Kingdom (Woodhouse 2015), United Lombardo 2018; Miles 2012; Miles 2016; NCT02868554; Pavlin 2015;
Arab Emirates (Nahas 2017), Saudi Arabia (Alam 2019), Turkey Reiss 2020; Siriphan 2019; Taha 2020; Telatar 2020; Woodhouse
(Telatar 2020), Iran (Farhadian 2021), Spain (Abellán 2021), Thailand 2015); 10 studies (reported in 12 publications) assessed low
(Siriphan 2019), and the USA and Canada (Katchooi 2018). level laser therapy (LLLT) (Abellán 2021; Alam 2019; AlSayed
2017; Caccianiga 2017; El Shehawy 2020; Farhadian 2021; Ghaffer
Nineteen studies were conducted in university hospital settings
2022; Hasan 2022; Lalnunpuii 2020; Lo Giudice 2020) and two
(Abellán 2021; Alam 2019; AlSayed 2017; Caccianiga 2017; El
studies assessed light-emitting diode (LED) (Farhadian 2021; Nahas
Shehawy 2020; Farhadian 2021; Ghaffer 2022; Hasan 2022; Kumar
2017) as an adjunct to increase the rate of orthodontic tooth
2020; Lalnunpuii 2020; Lombardo 2018; Nahas 2017; NCT02868554;
movement (OTM). Some studies had more than one intervention
Pavlin 2015; Reiss 2020; Siriphan 2019; Taha 2020; Telatar 2020;
group in addition to the control. Kumar 2020 and Lalnunpuii
Woodhouse 2015), with orthodontists as well as postgraduate
2020 both had two intervention groups receiving non-surgical
students treating participants under supervision; only four studies
adjunctive intervention with the stratification based on the ligation
were conducted in an orthodontic practice setting (Katchooi 2018;
method of the fixed appliance, i.e. self-ligation or conventional
Lo Giudice 2020; Miles 2012; Miles 2016).
brackets. Farhadian 2021 had two intervention groups (LED and
Characteristics of participants laser) in addition to the placebo control group.
The trials involved a total of 1027 participants with various types Light vibrational forces (LVF)
of malocclusion. The recruited participants had a wide age range
Three different types of vibrational appliances were used in the
from 8 to 50 years. The age range in most studies spanned both
12 studies that assessed the influence of light vibrational forces
childhood/adolescence and adulthood. One study recruited only
on the rate of orthodontic tooth movement. Most studies used
children (Hasan 2022, 42 participants aged 8 to 10 years old); two
the Acceledent device with vibrational frequency of 30 Hz and
studies recruited only adolescents (Miles 2012, 66 participants aged
0.25N (Katchooi 2018; Lombardo 2018; Miles 2016; NCT02868554;
from 11 to 15 years; Miles 2016, 40 participants up to the age of
Pavlin 2015; Reiss 2020; Taha 2020; Telatar 2020; Woodhouse
16 years), and three studies recruited only adults only (Katchooi
2015); however, Miles 2012 used the Tooth Masseusse device with
2018, 27 participants aged 18 years and older; NCT02868554, 33
vibration frequency of 11 Hz and 0.06N, while Siriphan 2019 used
participants aged 18 to 65 years old). Nahas 2017 did not specify
modified electric tooth brushes with 0.60N and two different
chronological age, although 40 participants in the permanent
vibration frequencies (30 and 60 Hz). Kumar 2020 used a custom-
dentition were included, while Alam 2019 did not report the age of
made oral vibration device with vibration frequency of 30 Hz. The
the recruited participants.
devices had a mouthpiece for the patient to lightly bite into with a
All but one study recruited participants of both sexes; Ghaffer linked extraoral enclosure. In all the included studies, participants
2022 included only adult female participants. were instructed to use the vibrational appliance for 20 minutes
daily.
Informed decisions.

Nine studies used vibrational appliances as an adjunct to fixed stainless steel archwire. The working archwire choice varied in
orthodontic appliances (Kumar 2020; Miles 2012; Miles 2016; the included studies which used 0.022 x 0.028-inch bracket slot
Pavlin 2015; Reiss 2020; Siriphan 2019; Taha 2020; Telatar 2020; system depending on the space closure mechanics with most of
Woodhouse 2015), with three studies using the pre-adjusted 0.018 the studies using 0.019 x 0.025-inch stainless steel archwire for en
x 0.025-inch orthodontic bracket slot system (Miles 2012; Miles masse space closure and for canine distalisation, some studies used
2016; Pavlin 2015), while six used the pre-adjusted 0.022 x 0.028- 0.018-stainless steel archwire (Taha 2020) while others used 0.016 x
inch orthodontic bracket slot system (Kumar 2020; Reiss 2020; 0.022-inch stainless steel archwire (Siriphan 2019).
Siriphan 2019; Taha 2020; Telatar 2020; Woodhouse 2015). Three
studies assessed the influence of vibrational forces on orthodontic Three of the seven studies applied en masse space closure
treatment during the alignment stage (Miles 2012; Miles 2016; mechanics (Kumar 2020; Miles 2016; Woodhouse 2015), three
Woodhouse 2015), seven studies assessed the space closure stage studies involved canine distalisation (Siriphan 2019; Taha 2020;
(Kumar 2020; Miles 2016; Pavlin 2015; Siriphan 2019; Taha 2020; Telatar 2020), while Pavlin 2015 used anchorage reinforcement
Telatar 2020; Woodhouse 2015) and four studies assessed the full with orthodontic mini-implants with the randomisation stratified
duration of treatment (Katchooi 2018; Lombardo 2018; Miles 2016; according to space closure mechanics into either en masse
Woodhouse 2015). retraction or canine distalisation. The orthodontic force applied
for space closure varied in the included studies depending on the
Three studies used removable orthodontic aligners to assess the biomechanics used. Three studies applied en masse space closure
influence of adjunctive light vibrational forces on orthodontic with the use of 9 mm nickel titanium coil to deliver approximately
treatment over the full treatment duration (Katchooi 2018; 150 g of force bilaterally (Kumar 2020; Miles 2016; Woodhouse
Lombardo 2018; NCT02868554). 2015). Siriphan 2019, Taha 2020 and Telatar 2020 applied 60 g, 180
g and 200 g, respectively, for canine retraction. Pavlin 2015 applied
Fixed orthodontic appliances a retraction force of 180 g from the orthodontic miniscrew to the
Alignment stage canine bracket; however, it was not specified if a different force
magnitude was used with canine retraction compared to en masse
Four studies assessed the influence of light vibrational forces on retraction.
OTM during the alignment stage (Miles 2012; Miles 2016; Reiss 2020;
Woodhouse 2015). All four studies included the mandibular arch Four of the seven studies assessed the full space closure stage,
only. Both Miles 2012 and Miles 2016 investigated the influence of while three studies assessed space closure for a specified duration
light vibrational forces on the early alignment stage for a period of (Kumar 2020; Miles 2016; Pavlin 2015; Woodhouse 2015).
up to 10 weeks (5, 8 and 10 weeks) using the same initial (0.014- In particular, Siriphan 2019 and Taha 2020 evaluated a three-month
inch nickel-titanium) archwire in combination with a 0.018 x 0.025- period and Telatar 2020 considered a time frame of six months of
inch bracket slot system. Reiss 2020 investigated the influence of canine distalisation. All seven studies used a series of study models
light vibrational forces on the alignment stage for up to three visits to calculate the rate of space closure. In addition, Siriphan 2019 also
(4 to 6-week intervals) using a standardised archwire sequence reported using lateral cephalometric radiographs to assess the
(0.014-inch followed by 0.014 x 0.025-inch copper nickel titanium) angulation of the canines and molars.
in combination with a 0.022 x 0.028-inch bracket slot. Woodhouse
2015 investigated the full alignment in two stages using 0.022 Full treatment duration
x 0.028-inch bracket slot system with a standardised archwire Woodhouse 2015, Miles 2016 and Kumar 2020 were the only three
system. The initial alignment stage was described as the alignment studies to investigate the influence of vibrational forces on OTM for
achieved with the 0.014-inch nickel titanium archwire and the final the full duration of orthodontic treatment. All three studies used
alignment stage was described as the end of alignment with the a standardised archwire sequence; however, with different bracket
ligation of the working 0.019 x 0.025- inch stainless steel arch slot dimension systems. Woodhouse 2015 and Kumar 2020 used
wire (Woodhouse 2015). The four included studies used Little's 0.022 x 0.028-inch slots and Miles 2016 used 0.018 x 0.025-inch.
Irregularity index (LII) applied on study models to assess the
improvement in the alignment of the mandibular teeth during the Removable orthodontic aligners
specified intervention period.
Three studies assessed the effectiveness of light vibrational forces
Space closure stage appliances on the rate of OTM using removable orthodontic
aligners (Invisalign) for the full duration of treatment (Katchooi
Seven studies assessed the influence of light vibrational forces on 2018; Lombardo 2018; NCT02868554). Lombardo 2018 had two
the rate of OTM during the space closure stage (Miles 2016; Pavlin intervention groups in addition to the control. The two intervention
2015; Siriphan 2019; Taha 2020; Telatar 2020; Woodhouse 2015). groups used vibrational forces similarly; however, one group
Four studies assessed the rate of space closure in the maxillary arch changed aligners every 14 days while the other group changed
only (Miles 2016; Pavlin 2015; Siriphan 2019; Taha 2020), one study aligners every 7 days. NCT02868554 had one intervention group
assessed space closure in the mandibular arch only (Woodhouse where the vibrational appliance was used with aligners changed
2015), while two studies assessed space closure in both arches every 4 days and two control groups with different duration for
(Kumar 2020; Telatar 2020). aligners changing at 14 days and 4 days. Katchooi 2018 had only
All studies used conventional preadjusted fixed bracket systems one intervention group in addition to the control group.
except Kumar 2020 who used a self-ligating bracket system
(SmartClip). Most of the studies used a 0.022 x 0.028-inch bracket
slot system except Miles 2016 who used 0.018 x 0.025-inch
bracket slot dimension in combination with 0.016 x 0.022-inch
Informed decisions.

Photobiomodulation therapy month. Two irradiations were done both buccally and palatally/
lingually from canine to canine. To ensure complete irradiation of
Low level laser therapy (LLLT)
the periodontium, the following protocol was followed: two doses
Ten studies assessed the influence of LLLT on OTM (Abellán 2021; were given in the cervical third (1 mesial/1 distal); two doses in
Alam 2019; AlSayed 2017; Caccianiga 2017; El Shehawy 2020; the apical third (1 mesial/1 distal); and a single dose directed at
Farhadian 2021; Ghaffer 2022; Hasan 2022; Lalnunpuii 2020; Lo the centre of the root. A similar process was repeated for the
Giudice 2020). Eight out of ten studies used fixed devices with palatal/lingual side. The tip was held in contact with the tissue
0.022 x 0.028-inch bracket dimensions with AlSayed 2017, El during application. This procedure was followed for all subsequent
Shehawy 2020 and Ghaffer 2022 using conventional pre-adjusted appointments.
brackets, and Caccianiga 2017, Lalnunpuii 2020 and Lo Giudice
2020 using self-ligating brackets. Alam 2019 used both self-ligation El Shehawy 2020 used gallium aluminium arsenide (Ga-Al-As)
and conventional preadjusted brackets within subgroups. Two semiconductor diode laser (SMART™ PRO, LASOTRONIX, Poland)
studies did not use the multibracket orthodontic appliances; Hasan with a wavelength of 635 nm with the following set parameters;
2022 used posterior bite blocks for molars intrusion while Abellán continuous mode, power output of 20 mW, fibre optic tip diameter
2021 used orthodontic mini-implants and auxiliaries to intrude of 2 mm, energy density of 6.5 J/cm2, exposure time of 10 s per
maxillary molars. point resulting in dose of 0.2 J per point, 2 J per tooth, and total
energy of 12 J per session. The laser beam was applied to six
All the studies assessed the influence of LLLT on OTM during the mandibular anterior teeth where each root area was divided into 3
alignment stage except Lalnunpuii 2020 and Farhadian 2021 who thirds; cervical, middle and apical. Laser was applied directly and
assessed OTM during the space closure stage, and Abellán perpendicular to target points on mesial and distal of cervical and
2021 and Hasan 2022 who assessed OTM during the correction of apical thirds and on centre of middle third at 10 points, 5 facially
anterior open bite with maxillary molar intrusion. and 5 lingually. The laser protocol was held on days 0, 3, 7, and 14
of first month and repeated for an additional two months.
Low level laser devices
AlSayed 2017 applied a LLLT dose in the intervention group using an Lo Giudice 2020 used the ATP38 (Biotech Dental, Allee de Craponne,
830-nm wavelength laser device (CMS Dental ApS, 55 Wildersgade, Salon de Provence, France). This device features a multi-panel
system emitting cold polychromatic lights with a combination of
1408 Copenhagen K, Denmark) with a 2.25-J/cm2 irradiation dose.
wavelengths from 450 to 835 nm depending on the field of action.
The laser beam was applied to each root of the six maxillary
incisors. Each root was divided into two halves: cervical and This module provided six minutes of irradiation producing 48 J/cm2
apical. The LLLT device tip was applied to the centre of each half, of fluency, calculated as the sum of the fluency produced by each
perpendicular to the root and in direct contact with the mucosa light source (16 J/cm2) multiplied for the three active panels (16 J/
from both the buccal and palatal sides so that there were four cm2 3 = 48 J/cm2). Three consecutive stages of irradiation in each
application points for each tooth with an exposure time of 1 session, for a total duration of 18 minutes and 144 J/cm2 of fluency
minute/tooth. The LLLT application was repeated on days 3, 7, administered (i.e. 48 J/cm2 x 3 stages). A rest time of 1 minute was
and 14 after the first application and every 15 days starting from set between each stage. Each LLLT session was performed every 14
the second month until the levelling and the alignment stage was days, including the date of bracket bonding, up to the end of the
completed. alignment stage.
Caccianiga 2017 applied LLLT in the intervention group using a Alam 2019 used the Epic-x Biolase device to apply LLLT. No details
diode laser emitting infrared radiation at 980 nm (Wiser; Doctor were published about the radiation dose, frequency or duration.
Smile–Lambda Spa, Brendola, VI). The plane wave optical fibre (AB
2799; Doctor Smile Lambda Spa) delivered a beam spot size of 1 cm2 Abellán 2021 used a low-power diode laser (Periowave; Ondine
and irradiation was administered by positioning the optical fibre tip BioPharma) emitting at a wavelength of 670 nm, with a power
along the mandibular dental arch. Four dental segments (right first of 150mW (measured with a Gentec XLP power detector in
premolar-canine, right lateral-central incisors, left central-lateral combination with a Gentec console. The radiation was applied
incisors, left canine-first premolar) were consecutively irradiated through a flexible optical fibre connected to an autoclavable
for 8 seconds and two dental segments (right first molar-second stainless steel handpiece designed by the user. This handpiece
premolar, left second premolar-first molar) for nine seconds, for accommodates a light diffuser tip configured as a periodontal
a total of 50 seconds. The procedure was repeated three times at probe to allow access to the periodontal pocket. The diffuser tip
two-minute intervals. All irradiation was performed with an output moved smoothly around the gum on each of the dental surfaces
power of 1W using a continuous wave. The total energy density for (distal, mesial, vestibular, and palatal) of the molar to be intruded
the entire mandibular dental arch, corresponding to an exposure for three minutes for each surface (total 12 minutes) on days 0, 1,
time of 150 seconds, was 150 J/cm2, (1 J/cm2 per second) including 2, 3, 4, and 7 of the beginning of the intrusion and in each monthly
follow-up.
27 J/cm2 for each of the two first molar-second premolar segments
and 24 J/cm2 for each of the remaining four dental segments. In Farhadian 2021, LLLT was performed using a Cheese II
dental diode laser device (Wuhan Gigaa Optronics Technology
Lalnunpuii 2020 used a 658 nm (Aluminium Gallium Arsenide)
Corporation, Wuhan, China). The Ga Al As diode laser was used with
Semiconductor Diode laser (the Silberbauer CL mini 8-658 EN
a wavelength of 810 nm and a power of 100 mW. The diameter of
60601-1-2:2007-07, Vienna, Austria, EU). The dose of irradiation was
the laser tip was 3.1 mm, and the energy density was 4 j/cm2. LLLT
2.29 J/cm2 at 2.2 J and an output of 8mW. The duration of exposure
was performed on days 0 (at the beginning of canine retraction), 3,
was 10 seconds being delivered by direct contact on days 0, 3, 7 and
30 and, 60. The laser was irradiated to three points on the buccal
14 for the first month followed by every 15 days from the second
Informed decisions.

and three points on the canine's palatal surface (cervical, mid-root palatal mucosa to avoid being embedded in the palatal mucosa
and apical), three seconds each point. during the posterior teeth intrusion. An acrylic posterior bite-block
covered the occlusal surfaces of the primary upper first and second
Hasan 2022 used a gallium aluminium arsenide (Ga-Al-As) laser molars and the permanent first upper molar. The thickness of the
with a continuous wavelength of 808 nm applied on the first day bite block was 2 mm greater than the freeway space. Also, the
and on days 3, 7, and 14 of the first month, then every 15 days device had a tongue crib which was manufactured from a stainless-
until the end of the treatment. The laser was applied in contact steel round wire with a diameter of 0.9 mm. Cementation was
with the mucosa of the buccal (3 points) and palatal (3 points) performed using Glass Ionomer Cement (Vivaglass CEM PL, Ivoclar
sides of the permanent upper first molar and the first and second Vivadent).
upper primary molars root tips on each side. The location of the
LLLT on the primary upper molars was determined according to Light-emitting diode LED
the location of the root tips of these molars on the panorama. The Two studies investigated the influence of LED compared to control
irradiation parameters of the LLLT were standard is through the on OTM using fixed orthodontic appliances (Farhadian 2021; Nahas
whole treatment period and were set as follows: the power of 250 2017).
MW, the energy at 4 J, and the application time was 16 seconds per
point. Participants were followed up in the same manner as what In Nahas 2017, the intervention group received an OrthoPulse
was performed in the FPBB (flat posterior bite blocks) group. device from Biolux Ltd (Vancouver, Canada). Participants
were instructed to use the device daily for 20 minutes producing
Ghaffer 2022 used an Epic 10 diode laser machine (BIOLASE,
light at a wavelength of 850 nm and a power output of 90 mW/cm2.
Foothill Ranch, California, USA). This operates on continuous power
The estimated irradiation dose per session on the surface of the
mode with wavelength 940 +/- 10 nm, energy density 25.7 J cm2
cheek was 108 J/cm2. Tracking software was integrated into the LED
and power output 2.5 W, using an application tool (tooth-whitening
device to evaluate the compliance rate based on recording of the
handpiece ((35 mm x 8 mm) = (2.8 cm2))), where the application site number of sessions performed by each patient. A self-ligating 0.022
and duration is labially at the vestibule for 30 seconds. LLLT was x 0.028-inch system was used with participants who required no
applied on days 3, 7, and 14, then at one month, followed by every dental extractions to relieve mandibular arch crowding. The entire
two weeks until alignment completion. alignment stage for the mandibular arch was assessed in this study.
Alignment stage
Farhadian 2021 used an intraoral LED device named Biolight, with
Two studies assessed the influence of LLLT on the alignment of the a wavelength of 640 nm, energy density of 10 j/cm2, and 40 mW/
maxillary arch (Alam 2019; AlSayed 2017), while four investigated cm2 power density. The inner part of the device has 2 pairs of diodes
the mandibular arch alignment (Caccianiga 2017; El Shehawy 2020; bilaterally located, irradiating the buccal surface of the canine and
Ghaffer 2022; Lo Giudice 2020). AlSayed 2017 included participants extraction site. At the beginning of canine retraction, participants
that required dental extraction in the maxillary arch to relieve were educated to use the device in the maxillary dental arch for five
crowding. Caccianiga 2017, El Shehawy 2020, Ghaffer 2022 and Lo minutes a day.
Giudice 2020 included cases that did not require extraction in the
mandibular arch, while Alam 2019 included both extraction and Control conditions
non-extraction cases.
In all studies, control group participants received either
Space closure stage orthodontic fixed appliance or removable aligners without the use
of adjunctive non-surgical interventions. Katchooi 2018, Farhadian
Only one study assessed the influence of laser therapy on OTM 2021 and Pavlin 2015 had the control group using a sham device,
during the space closure stage (Lalnunpuii 2020). The authors used which was an inactive device that was held in the mouth and
a self-ligating (Smartclip) bracket system with 0.022 x 0.028-inch looked identical to the active devices, but did not deliver any non-
bracket slot with a working 0.019 x 0.025 stainless steel wire. En surgical intervention. Woodhouse 2015 was the only study to have
masse space closure mechanics was used with bilateral force of 150 a sham group in addition to the control group.
g for the entire space closure stage.
Characteristics of outcomes
Molar intrusion for the correction of anterior open bite
Outcomes assessed primarily included objective assessments of
Two studies assessed the influence of LLLT on the correction of the rate of OTM as well as duration of treatment, in addition to
anterior open bite by the intrusion of maxillary molars (Abellán secondary outcomes: orthodontically-induced inflammatory root
2021; Hasan 2022). Abellán 2021 used orthodontic mini-implants resorption, occlusal outcome evaluated using PAR scoring and
(1.6 mm in diameter and 10 mm in length). One in the buccal region subjective pain experience, as well as the reported use of analgesics
mesial to the super-erupted molar, and another in the palatal during treatment.
region distal to this molar. Auxiliary buttons were used to intrude
the maxillary molars with the use of elastomeric power chain Specific clinical outcomes included the following.
placed between the screw head and the button, a force of 75 g was
applied. Rate of orthodontic tooth movement (with fixed or removable
orthodontic appliances)
Hasan 2022 used acrylic posterior bite blocks for intrusion of
maxillary molars. The appliance consisted of transpalatal arch The rate of OTM during the alignment stage was assessed by
that connected the two acrylic blocks, extending across the palate measuring the rate of the reduction in malalignment using Little's
between the primary second and the permanent first molars from Irregularity Index (LII) during part or all of the orthodontic
the right side to the left side. This arch was 4 mm away from the alignment stage (Alam 2019; AlSayed 2017; Caccianiga 2017; El
Informed decisions.

Shehawy 2020; Ghaffer 2022; Lalnunpuii 2020; Miles 2012; Miles pain perception after the ligation of the first aligning archwire
2016; Nahas 2017; Reiss 2020; Woodhouse 2015). The rate of OTM during the first week at different time points; Woodhouse
was assessed during the space closure stage by measuring the 2015 also assessed pain after the ligation of the second aligning
rate of space closure for either canine retraction or en masse archwire. NCT02868554 used VAS to assess pain levels with clear
retraction (anterior segment) during part or all of the orthodontic aligners at several time points: 4 days, 2 weeks, 6 weeks and 12
space closure stage (Farhadian 2021; Kumar 2020; Lalnunpuii 2020; weeks. Farhadian 2021 used McGill pain questionnaire to assess
Miles 2016; Pavlin 2015; Siriphan 2019; Taha 2020; Telatar 2020; patient discomfort and pain.
Woodhouse 2015). The rate of OTM was assessed by measuring the
amount of intrusion in the maxillary molars during the anterior Participants' reported need of analgesics (painkillers)
open bite correction (Abellán 2021; Hasan 2022). Three studies assessed the need for analgesia during orthodontic
treatment to control pain associated with OTM (Miles 2016;
Overall duration of orthodontic treatment NCT02868554; Woodhouse 2015). Miles 2016 assessed the
The overall orthodontic treatment duration was assessed in reported need for analgesics at several time points during
months from the start of orthodontic treatment marked by the the first week after the ligation of the first (0.014-inch NiTi)
ligation of the first archwire until the orthodontic appliance was aligning archwire. Woodhouse 2015 assessed the overall reported
debonded (Miles 2016; Woodhouse 2015). consumption of analgesics during the first week after the ligation
of the first (0.014-inch NiTi) as well as the second (0.018-inch NiTi)
Duration of the full orthodontic alignment stage aligning archwires.
The full duration of the orthodontic alignment stage treatment was Oral health-related quality of life
assessed in months from the start of orthodontic treatment from
the ligation of the first archwire ending with the ligation of the Katchooi 2018 was the only study to assess the impact of applying
orthodontic working archwire, e.g. 0.019 x 0.025-inch stainless light vibrational light forces compared to control group on reported
steel archwire (AlSayed 2017; Caccianiga 2017; Ghaffer 2022; Lo oral health related quality of life. A customised questionnaire was
Giudice 2020; Woodhouse 2015). used in this study, which was completed by the participants at three
time points (at the start, middle and end of treatment).
Orthodontic treatment outcome
Side effects of treatment
The orthodontic treatment outcome was assessed by measuring
the improvement in the occlusion or tooth position using specified Orthodontically-induced inflammatory root resorption (OIIRR)
indices by comparing the tooth position before and after a specified Woodhouse 2015 investigated OIIRR using 2-dimensional
period of time in treatment or at the completion of treatment. The radiographic assessment of the amount of maxillary central incisor
measures used include: evaluation of the change or outcome based root shortening by comparing the root length in millimetres before
on the use of a recognised occlusal index, the accuracy of OTM and treatment and towards the end of the alignment stage. Pavlin
successful completion of a set of orthodontic aligners. 2015 also mentioned in the published article that OIIRR was
assessed; however, no data were published. We tried to contact
Treatment outcome index
the authors for more information with no success. Abellán
Woodhouse 2015 used the Peer Assessment Rating (PAR) index 2021 used 3-dimensional radiographic CBCT technology to assess
to assess improvement in the occlusal outcome at the end of the volumetric OIIRR after intrusion of maxillary molars.
treatment. Several studies (Katchooi 2018) used Little's irregularity
index (LII) to assess the improvement in the alignment of the teeth Harm from treatment
after a course of orthodontic treatment. Pavlin 2015, Katchooi 2018, Ghaffer 2022 and Lombardo
2018 reported on serious and non-serious harm or safety-
Several studies assessed treatment outcomes using related side effects throughout the treatment including headache
different methods and indices: Lombardo 2018 used and loosening of fixed appliance auxiliaries, e.g. temporary
validated software (VAM) to access accuracy of tooth anchorage devices.
movement; NCT02868554 assessed the percent reduction in
Proximal Contact Point Discrepancy Index (PCPDI); Siriphan Orthodontic inflammation markers
2019 assessed the angulation and rotation of the canines and
molars during space closure using study models and a lateral Reiss 2020 and Siriphan 2019 assessed the level of several oral
cephalometric radiograph. None of these outcome measurements inflammatory markers using a salivary sample or a sample from
were included in the current review as they did not meet the the gingival cervical fluid (GCF) at different time points. Siriphan
inclusion criteria. 2019 assessed the levels of receptor activator of nuclear factor
kappa-B ligand (RANKL) and osteoprotegerin (OPG) during the first
Patient-centred outcomes week of canine distalisation. Reiss 2020 assessed a wider range
of inflammatory markers with 17 biomarkers analysed with the
Participants' perception of pain and discomfort
Multiplex analysis during the first three to four months of initial
Participants' perception of pain during orthodontic treatment was alignment.
assessed in nine studies by asking participants to record pain
and discomfort levels using a scoring system (visual analogue Excluded studies
scale (VAS) or a numeric rating scale (NRS)) (Alam 2019; AlSayed After removal of duplicates, 1902 unique records were identified.
2017; Farhadian 2021; Ghaffer 2022; Miles 2012; Miles 2016; We discarded 1771 of these and assessed the full text of 131
NCT02868554; Taha 2020; Woodhouse 2015). Eight studies assessed records. Of these 131, we rejected 46 and excluded 44 with reasons
Informed decisions.

presented (see Characteristics of excluded studies). We included a table corresponding to each study in the Characteristics of included
total of 41 records in this review, reporting on 23 studies. studies section. Overall ratings are also presented in the 'Risk of
bias' summaries in Figure 2 and Figure 3.
Risk of bias in included studies
None of the included studies had a low risk of bias in all domains.
Further details of these assessments are given in the 'Risk of bias'

Informed decisions.

Figure 2. Risk of bias summary: review authors' judgements about each risk of bias item for each included study
Blinding of participants and personnel (performance bias): All outcomes

Blinding of outcome assessment (detection bias): All outcomes
Incomplete outcome data (attrition bias): All outcomes
Random sequence generation (selection bias)
Allocation concealment (selection bias)
Selective reporting (reporting bias)

Other bias
Abellán 2021 + ? − − + ? ?
Alam 2019 − − − − + − −
AlSayed 2017 + ? − − + + ?
Caccianiga 2017 + ? − − + ? +
El Shehawy 2020 + − − + − + +
Farhadian 2021 ? + + + − + −
Ghaffer 2022 + + − + ? ? +
Hasan 2022 + + − − + + +
Katchooi 2018 + + + + + + ?
Kumar 2020 + ? − + + − +
Lalnunpuii 2020 + ? − + + − +
Lo Giudice 2020 + + − + − − +
Lombardo 2018 + ? − + + + ?
Miles 2012 + ? − + ? ? +
Miles 2016 + + − + + ? +
Nahas 2017 + ? − + − ? +
NCT02868554 + + − + − + +

Informed decisions.

Figure 2. (Continued)
NCT02868554 + + − + − + +
Pavlin 2015 + ? + + + − −
Reiss 2020 + ? − + + − ?
Siriphan 2019 + ? − + − + +
Taha 2020 + ? − − − − +
Telatar 2020 ? ? − − − + +
Woodhouse 2015 + + + + + ? +

Figure 3. Risk of bias summary: each domain for all included studies
Random sequence generation (selection bias)

Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias): All outcomes
Blinding of outcome assessment (detection bias): All outcomes
Incomplete outcome data (attrition bias): All outcomes
Selective reporting (reporting bias)
Other bias
0% 25% 50% 75% 100%
Low risk of bias Unclear risk of bias High risk of bias

Allocation space closure; Reiss 2020 stratified according to gender; Farhadian
2021 stratified according to gender and bracket slot size, while Lo
Selection bias can be minimised when participants and study
Giudice 2020 applied stratification according to both gender and
personnel cannot foresee the upcoming assignment. This can
the severity of crowding.
be achieved by proper sequence generation and allocation
concealment. Although Miles 2012 did not clearly describe the sequence
generation method, the authors were contacted and confirmed
Sequence generation
that statistical software was used for sequence generation.
In 20 out of the 23 included studies, the randomisation sequence Accordingly, it was rated as low risk of bias.
generation procedure was described clearly and therefore these
studies were assessed as low risk of bias for this domain (AlSayed Farhadian 2021 was rated as unclear risk of bias as it was not clear
2017; Caccianiga 2017; Katchooi 2018; Lombardo 2018; Miles 2016; how the sequence generation or the stratification were done.
Nahas 2017; Pavlin 2015; Siriphan 2019; Woodhouse 2015 Abellán
Both Alam 2019 and Telatar 2020 were rated as high risk
2021; Ghaffer 2022; Hasan 2022; NCT02868554; Reiss 2020). In
of bias. Telatar 2020 used coin tossing for random sequence
15 of these studies, computer statistics software programmes were
generation, which may result in an imbalanced sample size and
used to generate the randomisation sequence (Abellán 2021;
baseline characteristics in the study groups especially because the
Caccianiga 2017; El Shehawy 2020; Ghaffer 2022; Hasan 2022;
sample size is considered relatively small (20 participants). Alam
Katchooi 2018; Kumar 2020; Lalnunpuii 2020; Lo Giudice 2020;
2019 was rated as high risk of bias because the authors did
Lombardo 2018; Miles 2016; NCT02868554; Pavlin 2015; Taha 2020;
not include enough details of the randomisation sequence
Woodhouse 2015), while four studies used selection of cards or
generation with conflicting reports in two different peer-reviewed
envelopes for simple randomisation (AlSayed 2017; Nahas 2017;
journals. Although the study, Alam 2019, was published in the
Siriphan 2019, Reiss 2020). Eight studies used block randomisation
Bangladesh Journal of Medical Science as a "randomised clinical
involving two (Katchooi 2018), four (Pavlin 2015), six (Miles 2012;
trial", the results were also published in the Pain Research
NCT02868554) or 15 (Lombardo 2018) blocks. However, Farhadian
and Management Journal in 2019 with the authors mentioning
2021; Reiss 2020 and Lo Giudice 2020 did not mention how
that the "study was designed and conducted according to the
the block randomisation was performed. Stratification was
guidelines of Strengthening the Reporting of Observational Studies
applied in the randomisation procedure in five studies: Katchooi
in Epidemiology (STROBE)".
2018 applied stratification according to gender and age; Pavlin
2015 applied stratification according to age and mechanics of
Informed decisions.

Allocation concealment Lalnunpuii 2020; Lombardo 2018; Miles 2016; Siriphan 2019), and
in the other four studies, loss of follow-up was reported (Katchooi
In nine studies (Farhadian 2021; Ghaffer 2022; Hasan 2022;
2018 1/27; Pavlin 2015 6/45, Reiss 2020 3/40; Woodhouse 2015 up to
Katchooi 2018; Lo Giudice 2020; Miles 2016; NCT02868554;
21/81), and the authors demonstrated an appropriate rationale for
Reiss 2020; Woodhouse 2015), the allocation concealment was
the dropouts with the use of either intention-to-treat or sensitivity
described clearly and were therefore assessed as low risk of
analysis.
bias. In three studies, the allocation concealment was undertaken
remotely (Katchooi 2018, NCT02868554; Woodhouse 2015). Six For two studies, the risk of attrition bias was unclear (Miles 2012;
studies used sealed opaque envelopes to conceal the group NCT02868554). In Miles 2012, the authors reported incomplete
allocation (Farhadian 2021; Ghaffer 2022; Hasan 2022; Lo Giudice outcome data with no clear description of how the missing
2020; Miles 2016; Reiss 2020). data were dealt with. For the outcome rate of orthodontic tooth
movement, two of 66 participants were lost to follow-up; both the
We assessed 12 studies as having unclear risk of bias as the authors
dropouts were from the experimental group. For the discomfort
did not provide enough details to ensure safeguarding of the
and pain outcome, eight of 66 did not complete the VAS at the
allocation process (AlSayed 2017; Caccianiga 2017; Kumar 2020;
five time points, five from the control group and three from
Lalnunpuii 2020; Lombardo 2018; Miles 2012; Nahas 2017; Pavlin
the experimental group. It was unclear if the authors applied
2015; Siriphan 2019 Abellán 2021; Taha 2020; Telatar 2020).
an intention-to-treat analysis. We also assessed NCT02868554 as
Two studies were assessed as having high risk of bias (Alam 2019; having unclear risk of bias. The results presented on the trials
El Shehawy 2020). Alam 2019 did not report information about register indicate three of 10 participants in the control group
allocation concealment. El Shehawy 2020 reported that the clinical dropped out and one of 12 in the second intervention group. It does
assistants arbitrarily allocated patients into the study groups with not seem intention-to-treat analysis was applied, but the results
no allocation concealment described. have not yet been published fully.
Performance bias We assessed seven studies as having high risk of attrition bias
(El Shehawy 2020; Farhadian 2021; Ghaffer 2022; Lo Giudice 2020;
Performance bias can be reduced by blinding both participants and Nahas 2017; Taha 2020; Telatar 2020). The authors reported no
study personnel to the type of intervention allocated; however, evidence of account for loss to follow-up of participants and per-
performance bias can sometimes be unavoidable according to the protocol analysis was applied.
nature of the intervention. Four studies were assessed as having
low risk of bias with detailed reporting of the use of a sham Selective reporting
(inactive) device that was held in the mouth and looked identical
We assessed 10 studies as low risk of reporting bias as the studies
to the active devices without delivering any vibration (Farhadian
were registered in a clinical trial registry, with all the planned
2021; Katchooi 2018; Pavlin 2015; Woodhouse 2015). Nineteen
outcomes reported clearly in the published peer-reviewed articles
studies were assessed as having high risk of bias with no measures
(AlSayed 2017; El Shehawy 2020; Farhadian 2021; Hasan 2022;
detailed about blinding participants nor clinicians (Alam 2019;
Katchooi 2018; Kumar 2020; Lalnunpuii 2020; Lombardo 2018;
AlSayed 2017; Caccianiga 2017; Katchooi 2018; Miles 2012; Miles
NCT02868554; Siriphan 2019).
2016; Nahas 2017; Siriphan 2019, Abellán 2021; El Shehawy 2020;
Ghaffer 2022; Hasan 2022; Kumar 2020; Lalnunpuii 2020; Lo Giudice We assessed eight studies as having unclear risk of reporting bias as
2020; NCT02868554; Reiss 2020; Taha 2020; Telatar 2020). these studies had no protocol published nor were they registered in
a clinical trial registry or platform (Abellán 2021; Caccianiga 2017;
Detection bias
Ghaffer 2022; Lo Giudice 2020; Miles 2012; Miles 2016; Nahas 2017;
Detection bias can be reduced by blinding the outcome assessors Taha 2020). Woodhouse 2015 was also assessed as at unclear risk
to the type of intervention allocated. Sixteen studies clearly of bias as, according to the study registration, the trial authors had
described the details of the assessor blinding for the different planned to assess OIIRR in relation to the mandibular incisors as a
studies outcomes and were assessed as low risk of bias (El secondary outcome; however, the published data for the OIIRR was
Shehawy 2020; Farhadian 2021; Ghaffer 2022; Katchooi 2018; for the maxillary central incisors. The authors were contacted and
Kumar 2020; Lalnunpuii 2020; Lo Giudice 2020; Lombardo 2018; confirmed that only the maxillary incisors were assessed with no
Miles 2012; Miles 2016; Nahas 2017; NCT02868554; Pavlin 2015; additional radiographs taken for any other teeth (Appendix 7).
Reiss 2020; Siriphan 2019; Woodhouse 2015). Seven studies did not
report enough information regarding the blinding of the assessors We assessed three studies as having high risk of reporting bias
and were assessed as high risk of bias (Abellán 2021; Alam 2019; (Alam 2019; Pavlin 2015; Reiss 2020). Alam 2019 published the
AlSayed 2017; Caccianiga 2017; Hasan 2022; Taha 2020; Telatar outcomes in two-peer reviewed journals with lack of consistency
2020). as the study was published as an RCT in the Bangladesh Journal
of Medical Science in 2019 and then published as an observational
Incomplete outcome data study in another peer-reviewed journal (Pain Research and
Management Journal) in the same year. Reiss 2020 did not publish
We assessed 14 studies as having low risk of attrition bias (Abellán
data about orthodontic pain, tooth mobility, and oral health and
2021; Alam 2019; AlSayed 2017; Caccianiga 2017; Hasan 2022;
quality of life; however, these outcomes were listed in the study
Katchooi 2018; Kumar 2020; Lalnunpuii 2020; Lombardo 2018; Miles
registry entry. In Pavlin 2015, we noticed that the authors used
2016; Pavlin 2015; Reiss 2020; Siriphan 2019; Woodhouse 2015). In
different measurement units to report the rate of canine retraction
10 of these studies, all the randomised participants were included
(mm per month) in the peer-reviewed published article compared
in the final analysis with no reported dropouts (Abellán 2021; Alam
to the reported results in the clinical trial registry (mm per week).
2019; AlSayed 2017; Caccianiga 2017; Hasan 2022; Kumar 2020;
Informed decisions.

Other potential sources of bias Summary of findings 3 Summary of findings 3: adjunctive light
emitting diode versus conventional orthodontic treatment
There was no reason for concern for other risk of bias in 15 studies
(Caccianiga 2017; El Shehawy 2020; Kumar 2020; Lalnunpuii 2020; A total of 23 studies (involving 1027 participants) assessing
Lo Giudice 2020; Miles 2012; Miles 2016; Nahas 2017; Siriphan the effectiveness of non-surgical adjunctive interventions for
2019; Taha 2020; Telatar 2020; Woodhouse 2015; ; Ghaffer 2022; accelerating orthodontic tooth movement were included in this
Hasan 2022; NCT02868554). Although not a source of bias per se, it review: 12 studies assessed the influence of vibrational light forces
should be noted we had concerns about inaccurate data reporting on orthodontic tooth movement (OTM) compared with control or
in Kumar 2020. placebo group (Katchooi 2018; Kumar 2020; Lombardo 2018; Miles
2012; Miles 2016; NCT02868554; Pavlin 2015; Reiss 2020; Siriphan
The risk of bias for other potential causes was assessed as
2019; Taha 2020; Telatar 2020; Woodhouse 2015), 10 studies
unclear in five studies. In AlSayed 2017, it was noticed that
compared the influence of LLLT with control groups (Abellán 2021;
the level of malalignment in the maxillary arch was higher
Alam 2019; AlSayed 2017; Caccianiga 2017; El Shehawy 2020;
in the control group compared to the intervention group (LLI
Farhadian 2021; Ghaffer 2022; Hasan 2022; Lalnunpuii 2020; Lo
10.8 and 8.91, respectively). The authors did not report if
Giudice 2020) and one study compared the influence of LED with
this difference was statistically significant. Three studies had
control groups (Nahas 2017). Farhadian 2021 compared LED to LLLT
funding from the company manufacturing the vibrational devices
as well as the control.
(OrthoAccel Technologies) (Katchooi 2018; Lombardo 2018; Reiss
2020). Lombardo 2018 reported that the funding manufacturer was We classified the non-surgical interventions for accelerating
allowed to have access to the results; however, the final decision on orthodontic tooth movement as light vibrational forces (LVF) or
publication was retained by the study authors. Katchooi 2018 did photobiomodulation therapy (low level laser therapy (LLLT) and
not publish details regarding the level of involvement of the light-emitting diode (LED)).
funding manufacturer in the study. Reiss 2020 clearly mentioned
that OrthoAccel Technologies had no contribution in relation to Light vibrational forces as an adjunct to orthodontic appliance
the conduct of the study. In addition, the study registry of Reiss treatment versus placebo or conventional orthodontic
2020 suggested that two investigators would assess the models; appliance treatment (control)
however, in the published article it appeared that only one
Twelve studies (involving 554 participants) assessed the effect
investigator assessed the models. In Abellán 2021, there was no
of vibrational forces on the acceleration of orthodontic tooth
mention of relatability of the results.
movement (Katchooi 2018; Kumar 2020; Lombardo 2018; Miles
The risk of bias for other potential causes was assessed as high 2012; Miles 2016; NCT02868554; Pavlin 2015; Reiss 2020; Siriphan
in three studies (Alam 2019; Pavlin 2015). There were significant 2019; Taha 2020; Telatar 2020; Woodhouse 2015). All studies
concerns about the design and presentation of the Alam 2019 study were assessed as having high risk of bias except two (Katchooi
as the investigators included conventional ligation and self-ligating 2018; Woodhouse 2015), which were unclear. OTM was assessed
systems, and moreover used an unusual archwire sequence. Pavlin during the alignment and space closure stages as well as the
2015 was sponsored by OrthoAccel Technologies Inc, which is the overall orthodontic treatment. The participants were treated with
manufacturer of the intervention appliance. The clinicaltrial.gov fixed orthodontic appliances except in two studies (Katchooi
website mentions a time-limited agreement between the principal 2018; Lombardo 2018; NCT02868554), which used removable
investigators and the sponsor to review results before release to orthodontic aligners.
the public: "...the sponsor can review results communications prior
Primary outcomes
to public release and can embargo communications regarding trial
results for a period that is less than or equal to 60 days. The Overall duration of active orthodontic treatment and total number of
sponsor cannot require changes to the communication and cannot orthodontic appliance adjustment visits
extend the embargo." Moreover, it was not clear if the primary Two included studies (Miles 2016 assessed as high risk of bias and
outcome measure for the rate of orthodontic tooth movement was Woodhouse 2015 assessed as unclear risk of bias) involving 121
for the canines only or for en masse retraction of the six anterior recruited participants investigated the influence of applying light
teeth. Although stratification was done according to age and the vibrational forces during orthodontic treatment on the duration
technique of space closure (canine versus en masse retraction), of the overall orthodontic treatment as well as the total number
the authors did not present the outcome for the technique of of orthodontic appliance adjustment visits. Both studies used
space closure subgroups. This may have influenced the rate of Acceladent to deliver light vibrational forces. Although both
space closure in both groups. In the Farhadian 2021 study it was studies included only participants whose orthodontic treatment
mentioned in the methods section mentioned that stratification plan required extractions to correct the malocclusion, they used
was done based on gender and bracket prescription; however, how different orthodontic bracket slot systems (0.022 x 0.028-inch
was this done was not explained, other than "according to clinicians slot; Woodhouse 2015 and 0.018 x 0.025-inch slot; Miles 2016).
preference", nor was it reported clearly in the results.
Meta-analysis was conducted that showed no evidence that
Effects of interventions duration of active orthodontic treatment was reduced, or
See: Summary of findings 1 Summary of findings 1: adjunctive increased, for application of light vibrational forces compared
light vibrational forces versus conventional orthodontic treatment; to the control: mean difference (MD) of 0.61 months (95% CI
Summary of findings 2 Summary of findings 2: adjunctive low -2.44 to 1.22; P = 0.51; 2 studies, 73 participants; low-certainty
level laser therapy versus conventional orthodontic treatment; evidence; Analysis 1.1). In addition, there was no evidence that total
number of orthodontic appliance adjustment visits was decreased
Informed decisions.

or increased for application of light vibrational forces compared to 2019 Kumar 2020; Taha 2020; Telatar 2020) and mandibular
the control: MD 0.32 visits (95% CI -1.69 to 1.05; P = 0.65; 2 studies, arch (Kumar 2020; Telatar 2020; Woodhouse 2015). One of these
73 participants; low-certainty evidence; Analysis 1.2). We assessed was rated as unclear risk (Woodhouse 2015) and six as high risk of
the certainty of evidence for this comparison as low owing to the bias (Kumar 2020; Miles 2012; Pavlin 2015; Siriphan 2019; Taha 2020;
high risk of bias and imprecision (Summary of findings 1). Telatar 2020).
Rate of tooth movement during alignment stage Five studies used Acceledent as the vibrational device; Siriphan
Four studies involving 221 participants assessed the influence of 2019 used vibrational forces generated from an electric tooth brush;
light vibrational forces on the rate of OTM during fixed orthodontic and Kumar 2020 used a custom-made vibrational device. Four
appliance tooth alignment in the mandibular arch. We assessed studies assessed the rate of OTM during space closure by measuring
one at unclear risk of bias (Woodhouse 2015) and three as high the space closed per month on study models for the whole
risk (Miles 2012; Miles 2016; Reiss 2020). Three studies used space closure stage; Taha 2020 and Siriphan 2019 assessed space
Acceledent as the vibrational device and one (Miles 2012) used closure for three months and Telatar 2020 for six months. Siriphan
Tooth Masseusse. The rate of OTM was assessed during the 2019 used lateral cephalometric radiographs to assess the
alignment stage by quantifying the reduction in LII per arch at angulation of the teeth adjacent to the space during the space
different time points: Miles 2012 and Miles 2016 assessed at 5, 8 closure stage. We assessed the certainty of evidence for this
and 10 weeks with the same aligning (0.014-inch NiTi) archwire comparison as low to very low (Summary of findings 1).
in combination with 0.018 x 0.025-inch bracket slot system; Reiss En masse space closure
2020 considered the first three fixed appliance adjustment visits
during the alignment stage with 4 to 6 week intervals using two Three studies assessed space closure through en masse
consecutive archwires 0.014-inch NiTi and 0.014 x 0.025-inch NiTi retraction (Kumar 2020; Miles 2016; Woodhouse 2015). Meta-
archwires in combination with 0.022 x 0.028-inch bracket slot analysis of two of the studies was conducted for en masse retraction
system; and Woodhouse 2015 assessed the full alignment stage space closure (Analysis 1.6), which suggested that there is no
by dividing it into an early alignment stage, which the authors evidence of reduced or increased OTM in the intervention group
described as the visit where the 0.018-inch NiTi was ligated, and the when compared to the control group (MD 0.10 mm per month, 95%
full alignment stage, which was described as the period that starts CI -0.08 to 0.29; P = 0.27; 2 studies, 81 participants; low certainty).
from the ligation of the first archwire and ends with the ligation
Additional analyses were conducted to assess studies
of the working (0.019 x 0.025-inch SS) archwire. All four studies
that investigated the maxillary and mandibular arches
assessed the rate of OTM by measuring the reduction in LII in the
separately, which again suggested no difference between
mandibular arch.
interventions (Analysis 1.7; Analysis 1.8).
All four studies reported no evidence that the rate of OTM during
Kumar 2020 reported a small but clinically insignificant difference
the alignment stage was reduced, or increased, for application
between interventions for each outcome; however, we did not
of light vibrational forces compared to the control at any of the
include data from Kumar 2020 due to concerns about inaccuracy in
time points assessed during the orthodontic alignment stage. Meta-
the reported data (see Characteristics of included studies).
analysis was conducted showing the comparison between groups
by assessing the reduction in the LII at two time stages of alignment: Canine distalisation
early alignment (4 to 6 weeks) with a mean difference of 0.12
mm (95% CI 1.77 to -2.01; P = 0.90; 3 studies, 144 participants; Three studies assessed space closure through
low certainty) and mid-alignment (8 to 12 weeks) reflecting a canine distalisation (Siriphan 2019; Taha 2020; Telatar 2020). All
difference of 0.18 mm (95% CI 0.83 to -1.20; P = 0.72; 4 studies, three studies reported no evidence of a difference in the
175 participants; low certainty (Analysis 1.3; Analysis 1.4)). In intervention group compared to the control. Meta-analysis was
addition, Reiss 2020 reported no evidence that OTM was reduced or conducted including two studies only showing there is no evidence
increased for application of light vibrational forces compared to the that the rate of canine distalisation was reduced, or increased
control by measuring the rate of LII reduction at 12 to 16 weeks. due to the use of light vibrational forces when compared to the
control group (Taha 2020; Telatar 2020): MD 0.01 mm/month (95%
Woodhouse 2015 was the only study amongst the included studies CI 0.20 to -0.18; P = 0.92; 2 studies, 40 participants; very low
to publish data for the full alignment stage. The authors reported certainty; Analysis 1.9). Siriphan 2019 assessed the influence of two
no evidence that the rate of OTM, by assessing the reduction, in different vibrational force frequencies (30 and 60 Hz) on the rate of
the LII was reduced, or increased, for application of light vibrational space closure with two intervention groups as well as the control
forces compared to the control (P = 0.60). group for 3 months. The authors did not find a significant difference
in the rate of space closure between the two groups (P < 0.05). The
The available low-certainty evidence does not support the use authors stated that the data was not normally distributed and they
of light vibrational forces to increase the rate of OTM during presented the data as median and IQR hence the reason this study
the alignment stage of fixed orthodontic treatment (Summary of data was not included in the meta-analysis.
findings 1).
Pavlin 2015 stratified the study sample according to space
Rate of tooth movement during space closure closure mechanics (en masse and canine distalisation) reporting
Seven studies involving 233 participants investigated the influence that the intervention group experienced more efficient space
of light vibrational forces on the rate of OTM during the space closure (MD 0.36 mm/month, 95% CI -0.01 to 0.73; P = 0.02).
closure stage with orthodontic extraction of either first or second However, the published confidence intervals for the mean
premolars in the maxillary arch (Miles 2016; Pavlin 2015; Siriphan differences indicate imprecision in the reported results, which
Informed decisions.

suggest interpreting the reported mean difference with caution. Secondary outcomes
The data extracted from Pavlin 2015 was not included in the meta-
Patient-centred outcome: patient perception of pain and
analyses as the subgroup data was not presented in the published
discomfort
article.
Five studies (four rated as high risk of bias and one as unclear
Based on the low level of certainty, there is no evidence to support risk of bias) involving 208 participants assessed patient perception
the suggestion that light vibrational forces can increase the rate of pain and discomfort using a 100 mm VAS while assessing the
of OTM during canine distalisation. There is a very low level of effectiveness of light vibrational forces on rate of OTM (Miles
evidence to suggest that OTM during en masse space closure may 2012; Miles 2016; NCT02868554; Taha 2020; Woodhouse 2015).
be increased; however, any possible difference does not appear to Three studies assessed pain perception during the alignment stage.
be clinically significant. We assessed the certainty of evidence for In the first week (at different time points) after the ligation of
this comparison as low to very low (Summary of findings 1). a 0.014-inch NiTi in the maxillary or mandibular arches with
either 0.018 x 0.025-inch bracket slot system (Miles 2012; Miles
Change in angulation of the teeth adjacent to the space
2016) or 0.022 x 0.028-inch bracket slot system (Woodhouse 2015.)
Siriphan 2019 was the only study to assess the change in In addition, Woodhouse 2015 assessed pain perception after the
angulation of the teeth adjacent to the space closed using lateral ligation of the second aligning archwire (0.018-inch NiTi). Taha
cephalometric radiographs. The rate of molar movement and 2020 assessed patient perception of pain and discomfort during the
tipping, and canine rotation and tipping were not significantly canine distalisation stage at different time points within the first
different between groups (P > 0.05). week. NCT02868554 assessed patient's perception of pain and
discomfort during aligner treatment.
Aligners
Pain and discomfort during treatment: the first aligning archwire
Three studies (one with unclear and two with high risk of
bias) involving 105 participants assessed the influence of light Pain and discomfort increased 4 to 6 hours after archwire
vibrational forces on OTM using removable orthodontic aligners ligation and declined gradually after 3 to 7 days with minimal
(Katchooi 2018; Lombardo 2018; NCT02868554). All three studies difference between the intervention and control groups. None of
used Invisalign aligners; however, with different aligner change the three studies reported differences between the control and
interval regimens. Katchooi 2018 used 7-day changes for both experimental groups in perception of pain during the first week
study groups, while Lombardo 2018 used 14-day changes for two of the initial aligning archwire. Meta-analysis demonstrated no
study groups (one with light vibrational force and one control) evidence that patient's perception of pain and discomfort was
and 7-day changes for the third study group (with light vibrational reduced, or increased, due to the use of the light vibrational forces
force). NCT02868554 had two non-intervention groups with 14-day when compared with control at any of the time points assessed.
routine wear and another with shortened 4-day aligner wear, as
well as one intervention study group with shortened 4-day aligner There was no evidence that light vibrational forces reduced, or
wear and light vibrational force. increased, pain and discomfort at any of the time points assessed
with the first aligning archwire. Immediately after ligating the first
The three studies used different criteria to measure changes in OTM aligning archwire, the mean difference on the 100 mm VAS was -2.56
with some reported outcomes that did not meet the current review mm (95% CI -2.35 to 7.47; P = 0.31; 3 studies; 153 participants; low-
inclusion criteria; hence, it was deemed inappropriate to combine certainty evidence; I2 = 0%; Analysis 1.10). Similar findings were
the results of the three studies. observed at 4 to 6 hours (MD 0.99 mm, 95% CI -8.83 to 6.85; P = 0.80;
3 studies; 153 participants; low-certainty evidence; I2 = 0%; Analysis
Katchooi 2018 used the reduction in the LII at the end of treatment 1.11), one day (MD 2.93 mm, 95% CI -11.25 to 5.39; P = 0.49; 3
compared to the start of the treatment. No evidence of a difference
trials, 153 participants; I2 = 0%; Analysis 1.12), three days (MD 0.48
was found between the light vibrational and the control groups in
mm; 95% CI -7.13 to 6.18; P = 0.89; 3 trials, 153 participants; I2 =
the mean reduction of the LII in the maxillary arch (MD 0.2, 95%
0%; Analysis 1.13) and seven days (MD -0.04 mm, 95% CI -2.97 to
CI -1.51 to 1.10; P = 0.74) and the mandibular arch (MD -0.18, 95% CI
-17.7 to 2.12; P = 0.85). NCT02868554 assessed several outcomes to 3.05; P = 0.98; 3 trials, 153 participants; I2 = 9%; Analysis 1.14).
compare between the non-intervention group and the intervention Pain and discomfort during treatment: the second aligning archwire
with both having shortened aligner wear 4-day changes. The rate
of OTM during the first 12 weeks was increased in the intervention Woodhouse 2015 was the only study to extend the assessment of
group compared to the non-intervention group: 0.0243 (SD +/- pain and discomfort to the first week after ligation of the second
0.0163) and 0.0202 (SD +/-0.0135), respectively. However, this aligning archwire (0.018 NiTi). The authors reported no benefit from
reported difference was not statistically significant. The percentage the vibrational forces in reducing pain and discomfort. There was
reduction in the proximal contact point discrepancy was increased no evidence of a difference between the intervention, control and
in the intervention group compared to the non-intervention group: placebo groups at assessed time points except after the first day
29.12 (SD +/- 10.77) and 23.71 (SD+/- 11.02), respectively. However, when more pain and discomfort were reported in the intervention
this reported difference was not statistically significant. group (mean 53.18, SD 31.18) compared to both the control (mean
34.52, SD 25.39) and placebo group (mean 34.96, SD 28.13). This
difference was found to be statistically significant (P = 0.028)
(Analysis 1.18).
Informed decisions.

Pain and discomfort during treatment: space closure Quality of life

Taha 2020 assessed patient perception of pain and discomfort Katchooi 2018 (unclear risk of bias) was the only study to assess the
during maxillary canine distalisation. The authors reported that impact of applying light vibrational forces on patient-reported oral
there is no evidence that light vibrational forces can reduce, or health related quality of life (OHRQoL). The use of light vibrational
increase, pain and discomfort when compared to a control group. forces had no statistically significant (P > 0.05) effect on OHRQoL
No statistical analysis was published. when used in conjunction with orthodontic aligners.
Pain and discomfort during treatment: aligners Orthodontic treatment occlusal outcome
NCT02868554 assessed patient perception of pain and discomfort Woodhouse 2015 (unclear risk of bias) involving 81 participants
during aligner treatment for 12 weeks. The pain score was higher with 22 dropouts, was the only study to report on the orthodontic
in the intervention group compared to non-intervention group; treatment occlusal outcome at the end of treatment. This was
1.58 SD+/- 1.38 and 0.68 SD +/- 1.23, respectively. The authors assessed by comparing reduction in the Peer Assessment Rating
reported that there is no evidence that light vibrational forces (PAR) index. Both the absolute and percentage improvement in the
can significantly reduce, or increase, pain and discomfort when PAR index were reported for the intervention group (median 28.0,
compared to a control group. IQR 21.0, 38.0 and median 88.9, IQR 80.9, 94.4, respectively), control
group (median 29.0, IQR 24.0, 31.0 and median 91.2, IQR 85.0, 93.5,
Patient-centred outcome: reported consumption of analgesics
(painkillers)
respectively) and placebo group (median 27.0, IQR 20.0, 35.0 and
median 90.0, IQR 87.5, 92.0, respectively). There is no evidence that
Three studies (two at high risk of bias and the other at occlusal outcomes was reduced, or increased due to the use of light
unclear risk) assessed the influence of light vibrational forces vibrational forces when compared to the control or the placebo
on patient-reported analgesic consumption following engagement groups (P = 0.91 and P =0.71, respectively).
of initial archwires during the alignment stage (Miles 2016;
Woodhouse 2015). NCT02868554 assessed patient-reported Orthodontically-induced inflammatory root resorption (OIIRR)
analgesic consumption during the aligners' treatment.
Woodhouse 2015 was the only included study (involving 81
The first aligning archwire participants with 9 dropouts) to assess the influence of light
vibrational forces on the severity of OIIRR when compared to
Both Miles 2016 and Woodhouse 2015 assessed the overall reported control and placebo groups. The authors investigated OIIRR by
analgesic consumption during the first week after the ligation comparing the root length reduction in the upper central incisors
of the initial archwire. There was no evidence that patient using long-cone periapical radiographs taken before the start of
consumption of analgesics was reduced, or increased, due to the orthodontic treatment and at the end of the alignment stage. OIIRR
use of light vibrational forces when compared to control (RR 1.64, of the upper central incisors was measured for the intervention
95% CI 0.60 to 4.53; P = 0.34; 2 studies, 95 participants; low- (mean 1.09 mm, SD 0.64), control (mean 1.00 mm, SD 0.90) and
certainty evidence; Analysis 1.15). placebo (mean 1.16 mm, SD 0.94). There is no evidence to suggest
that OIIRR was reduced, or increased, due to the use of light
In addition, Miles 2016 assessed analgesic consumption at specific
vibrational forces when compared to the control groups (MD 0.09
time points (immediately after ligation and at 6 to 8 hours, 1
mm, 95% CI -0.35 to 0.53; P = 0.69; 1 study, 50 participants).
day, 3 days and 7 days). The authors reported no reduction in
We assessed the certainty of evidence as low (Summary of findings
patient-reported consumption of analgesics between intervention
1).
and control groups at any time points assessed except 24 hours (RR
0.63, 95% CI 0.44 to 0.92; P < 0.01). Harms arising during the course of orthodontic treatment
The second aligning archwire Five studies assessed other harms arising during the
intervention (Katchooi 2018; Lombardo 2018; Pavlin 2015; Reiss
Woodhouse 2015 was the only study to assess reported analgesic
2020; Taha 2020). No serious adverse effects were reported. Pavlin
consumption following the ligation of the second aligning archwire.
2015 reported a similar number of minimal non-serious adverse
Although, the prevalence of analgesic consumption for the whole
effects in the intervention (5/23; 21.7%) and control (5/22; 22.7%)
study sample was significantly reduced after the second visit
groups, with a RR of 0.96 (95% CI 0.32 to 2.85). The non-serious
compared with the first visits (34% and 69%, respectively), there
adverse effects included headache, discomfort and loosening of
was no evidence of a difference (P = 0.90) between study
temporary anchorage devices.
groups after the second visit, with a similar proportion (35%) of
participants in both groups reporting consumption of analgesics Other outcomes
(9/28 in the intervention group and 8/25 in the control group).
Cost of treatment was not investigated in any of the included
We assessed the certainty of evidence for patient-centred outcomes studies.
as low (Summary of findings 1).
Low level laser therapy (LLLT) as an adjunct to orthodontic
During aligner treatment appliance treatment versus conventional orthodontic
NCT02868554 assessed the need for analgesics during 12 weeks of appliance treatment (control)
aligner wear. The authors reported that there is no evidence that Ten studies, involving 423 participants, assessed the influence of
light vibrational forces can significantly reduce, or increase, pain LLLT as an adjunctive intervention to accelerate OTM compared to
and discomfort when compared to a control group. control group with conventional orthodontic appliances (Abellán
2021; Alam 2019; AlSayed 2017; Caccianiga 2017; El Shehawy 2020;
Informed decisions.

Farhadian 2021; Ghaffer 2022; Hasan 2022; Lalnunpuii 2020; Lo Ghaffer 2022). AlSayed 2017 assessed maxillary arch alignment
Giudice 2020). All 10 studies used fixed orthodontic appliance. Six for participants with premolar extractions by quantifying the
studies assessed the influence of LLLT on OTM during the alignment percentage improvement in the LII at several time points from
stage, Lalnunpuii 2020 and Farhadian 2021 assessed the space the start of treatment, 1 month, 2 months and at the end
closure stage, while Abellán 2021 and Hasan 2022 assessed the of alignment. El Shehawy 2020 and Ghaffer 2022 assessed the
correction of anterior open bite by intrusion of maxillary molars. We mandibular arch alignment on non-extraction cases for several
rated all studies as high risk of bias. months.
Primary outcome Meta-analysis was conducted including only two studies (El
Shehawy 2020; Ghaffer 2022) based on percentage reduction of
Duration of total overall orthodontic treatment and total number of
orthodontic appliance adjustment visits the LII in the mandibular arch at the end of the first (Analysis
2.3) and second month (Analysis 2.4) of initial alignment. There is
No study included in this systematic review was found to report no evidence to suggest that rate of OTM was reduced, or increased,
on the influence of LLLT on the total overall orthodontic treatment with the application of LLLT compared to the control by the end
duration nor the total number of orthodontic appliance adjustment of the first month: MD 1.63 %, 95% CI -2.60 to 5.86; P = 0.45; 2
visits to complete a course of orthodontic treatment. studies, 56 participants; very low level of certainty) nor the end
of the second month: MD 3.75%, 95% CI -1.74 to 9.24; P = 0.18;
Duration of orthodontic alignment stage
2 studies, 56 participants; very low level of certainty; Summary
Four studies (all assessed as high risk of bias) assessed the of findings 2). It is important to interpret the outcome from this
influence of LLLT on the duration of the fixed orthodontic analysis with caution as the heterogeneity was found to be high.
appliance alignment stage with a total sample of 172 participants
(AlSayed 2017; Caccianiga 2017; Ghaffer 2022; Lo Giudice 2020). AlSayed 2017 reported increase in the maxillary LII percentage
All four studies reported shorter orthodontic alignment duration improvement in the LLLT group compared to the control group.
in the LLLT groups compared to the control groups. Caccianiga The differences in the first and second months were found to
2017 reported a mean difference of 72.30 days (95% CI -83.80 to be statistically significant (P = 0.004 and P = 0.001, respectively).
-60.80); AlSayed 2017, a mean difference of 28 days (95% CI -39.34 to However, at the end of the alignment stage there was no evidence of
-16.66), Lo Giudice 2020, a 57-day reduction in the median duration a difference between the LLLT group (mean 94.24% SD +/- 3.65) and
with LLLT compared to the control group (P < 0.001), and Ghaffer control group (mean 94.20% SD+/- 2.81; P = 0.973). Due to the poor
2022, a mean difference of 41.3 days (95% CI -70.30 to -12.30). quality design and high risk of bias, the results from Alam 2019 were
not included in quantitative or qualitative analysis.
Meta-analysis was conducted showing that there is some evidence
to suggest that the duration of the orthodontic alignment stage Space closure stage
can be reduced by use of LLLT when compared to control group: Only two studies (assessed as high risk of bias) involving 105
MD -48.87 days, 95% CI -56.48 to -41.26; P < 0.001; 3 studies, 92 participants assessed the influence of LLLT on the rate of OTM
participants; I2 = 97%; very low level of certainty; Analysis 2.1; during the space closure stage (Farhadian 2021; Lalnunpuii
Summary of findings 2). The study by Lo Giudice 2020 was not 2020). The first premolars were extracted with the rate of OTM
included in the meta-analysis as the outcomes were reported as assessed in both the maxillary and mandibular arches in Lalnunpuii
medians; however, the authors also reported a statistically and 2020 using en masse retraction mechanics, while Farhadian
clinically significant difference favouring the LLLT group. 2021 assessed canine retraction in the maxillary arch only. Due to
the different biomechanics in space closure used in the two studies,
Number of visits during the alignment stage
it was deemed impossible to combine data for meta-analysis.
Only two studies (assessed as high risk of bias) with 136 participants
were included assessing the influence of LLLT on the number of Lalnunpuii 2020 reported increased rate of space closure with the
visits required during the alignment stage in the mandibular arch LLLT with conventional brackets group when compared to the
involving non-extraction cases (Caccianiga 2017; Lo Giudice 2020). control in the maxillary arch. There is a little evidence to suggest
that rate of OTM during space closure can be increased on the
Meta-analysis was conducted showing that there is some evidence application of LLLT compared to control (right side MD 0.18 mm/
to suggest that the use of LLLT can reduce the number of month, 95% CI 0.10 to 0.26, P < 0.001; left side MD: 0.18 MM/month,
visits required for fixed orthodontic appliance adjustment when 95% CI 0.08 to 0.28, P < 0.001; 1 study, 65 participants; very low level
compared to control: median difference of -2.25 visits (95% CI -2.52 of certainty) as well as the mandibular arch (right side MD 0.16 mm/
to -1.97; P < 0.00001; 2 studies, 136 participants; I2 = 69%; very month, 95%CI 0.13 to 0.19, P < 0.001; left side MD 0.18 mm/month,
low level of certainty; Analysis 2.2; Summary of findings 2). It is 95% CI 0.16 to 0.20, P < 0.001; 1 study; 65 participants; very low level
important to interpret the outcome from this analysis with caution of certainty; Summary of findings 2).
as the heterogeneity was found to be high though not statistically
Farhadian 2021 reported an increased rate of maxillary canine
significant (I2 = 69%; P = 0.07).
retraction with the LLLT with conventional bracket group when
Rate of orthodontic tooth movement compared to the control in the maxillary arch. Although the authors
reported P = 0.01, the 95% confidence intervals included zero (MD
Alignment stage 0.01 mm/day, 95% CI 0 to 0.02; P = 0.01; 1 study, 37 participants; very
Four studies (all rated as of high risk of bias) with 114 participants low level of certainty). There was insufficient evidence to suggest
assessed the influence of LLLT on the rate of OTM during the that LLLT can increase or decrease the rate of OTM during canine
alignment stage (AlSayed 2017; Alam 2019; El Shehawy 2020; distalisation/space closure stage.
Informed decisions.

Maxillary molar intrusion for the correction of anterior open Farhadian 2021 used a modified McGill pain questionnaire, along
Two studies (both rated as high risk of bias) involving 62 with a VAS to assess the pain during the first visit with no specific
participants assessed maxillary molars intrusion for the correction time point. Based on the VAS, the authors reported no significant
of anterior open bite. The two studies applied different difference between the LLLT group mean (3.1, SD+/- 2.4) and the
mechanics for maxillary molar's intrusion; Abellán 2021 used control group mean (3.5, SD+/-2.1). It was deemed impossible to
orthodontic mini-implants, bondable buttons and elastomeric pool the data from the two studies in meta-analysis due to the high
chain, while Hasan 2022 used acrylic flat posterior bite blocks clinical heterogeneity with each study assessing pain in a different
(FPBB). It was deemed inappropriate to pool the data from the two treatment stage.
studies into meta-analysis due to the difference in appliances and Alam 2019 used a VAS to assess the pain during the first week (at
biomechanics applied. 4 hours, 24 hours, 3 days and 7 days) of the alignment of ectopic
Abellán 2021 assessed the amount of maxillary molar intrusion canines. The authors reported that patient perception of pain and
using 3D intra oral scanner at two point intervals, 3 and 6 months. discomfort was significantly less in the LLLT group compared to the
The authors reported there is no evidence to suggest that the control group in the self-ligating bracket subgroup for three out
amount of molar intrusion was significantly increased or reduced of four time points assessed. Due to the poor quality design and
with the application of LLLT compared to the control at 3 months high risk of bias, the results from Alam 2019 were not included in
(mean 1.25 mm, SD +/- 0.72, and 1.72 mm, SD +/- 0.75, respectively) quantitative or qualitative an analysis.
and 6 months (mean 1.09 mm, SD +/- 0.54, and 1.28 mm, SD +/- Harms arising during the course of orthodontic treatment
0.46, respectively). In addition, there is no evidence to suggest that
the rate of maxillary molar intrusion per months was significantly Ghaffer 2022 was the only study to assess harms arising during
increased or reduced with the application of LLLT compared to the LLLT intervention. No serious harms were reported other than
the control at 3 months (mean 0.42 mm/month, SD +/- 0.24, and gingivitis associated with plaque accumulation.
0.58 mm, SD +/- 0.25, respectively), and 6 months (mean 0.43 mm/
month, SD +/- 0.23, and 0.44 mm/month, SD +/- 0.13, respectively). Light-emitting diode (LED) as an adjunct to orthodontic
appliance treatment versus conventional orthodontic
Hasan 2022 assessed radiographically the amount of maxillary appliance treatment (control)
molar's intrusion using acrylic FPBB. The authors reported an
Two studies (both assessed as high risk of bias) involving 80
increased molar intrusion in the FPBB + LLLT compared to FPBB
participants evaluated the influence of the use of LED as an adjunct
(mean 1.251 mm, SD +/- 0.32 and 0.82 mm SD +/- 0.37, respectively;
to accelerate OTM with conventional orthodontic appliances
P = 0.018). In addition, the duration required for the correction of
(Farhadian 2021; Nahas 2017).
anterior open bite was reduced in the FPBB + LLLT compared to
FPBB (mean 7.07 months, SD +/- 1.54, and 9.42 months, SD +/- 2.31, Duration of orthodontic alignment stage
respectively; P = 0.001).
Nahas 2017 assessed the influence of LED during the full treatment
Secondary outcomes duration. Although 40 participants were recruited, only 85% were
analysed, with six participants excluded with no accounting for
Orthodontically-induced inflammatory root resorption (OIIRR)
the dropouts. The study suggests that the duration of orthodontic
Abellán 2021 assessed OIIRR using CBCT after the intrusion of the treatment for mandibular arch alignment was reduced by the
maxillary molars. There is no evidence to suggest that OIIRR volume application of LED compared to the control (MD 24.5 days, 95%
during molar intrusion was significantly increased or reduced with CI 6.55 to 42.45; P = 0.043; 1 study, 34 participants; very low
the application of LLLT compared to the control group. The authors certainty). See Summary of findings 3.
did not publish the statistical test results.
Rate of orthodontic tooth movement
Periodontal health Space closure stage
Abellán 2021 assessed periodontal health after the intrusion of Farhadian 2021 assessed the influence of LED on OTM during
maxillary molars using clinical parameters such as plaque index, the canine retraction phase using fixed appliances. The authors
pocket depth, and bleeding of probing. There is no evidence to reported slight increase in the rate of maxillary canine retraction
suggest that the periodontal health was significantly increased with the LLLT with the conventional brackets group when compared
or reduced with the application of LLLT compared to the control to the control in the maxillary arch (mean 0.029 mm/day, 95%
group. The authors did not publish the statistical test results. CI 0.02 to 0.03 and mean 0.023 mm/day, 95% CI 0.02 to 0.03,
respectively). There is no evidence to suggest that OTM during
Patient-centred outcome: perception of pain and discomfort
canine retraction was reduced, or increased, due to the use of
Only three studies (rated as at high risk of bias) evaluated the LED when compared to the control groups (P = 0.17; 1 study, 39
influence of LLLT on the perception of pain and discomfort in the participants; very low level of certainty).
maxillary arch alignment (Alam 2019), mandibular arch alignment
(Ghaffer 2022) and space closure (Farhadian 2021) stages. Patient-centred outcome: perception of pain and discomfort
Farhadian 2021 used a modified McGill pain questionnaire, along
Ghaffer 2022 assessed pain perception using VAS for the first 7 days
with a VAS to assess pain during the first visit with no specific time
during the alignment stage. They reported no increase or decrease
point. Based on the VAS, the trial authors reported no significant
in the pain and discomfort when using LLLT compared to control in
difference between the LED group mean 4.3 (SD+/- 2.4) and the
all 7 days except the 5th day (MD 1.6; 95% CI 3.1 to 0.1; P = 0.035).
control group mean 3.5 (SD+/-2.1).
Informed decisions.

Harms arising during the course of orthodontic treatment during orthodontic treatment (fixed or removable appliances)
has no significant advantage for all the outcomes assessed
None of the included studies assessed harms arising during the LED
including the duration of orthodontic treatment, number of
intervention.
routine orthodontic appliance adjustment visits, the rate of
DISCUSSION orthodontic tooth movement during the alignment and space
closure stages, OIIRR, patient perception of pain and the reported
Summary of main results need for analgesics at different time points early in treatment.
Although Pavlin 2015 reported accelerated OTM during the
See Summary of findings 1, Summary of findings 2 and Summary space closure stage, Lombardo 2018 reported higher accuracy of
of findings 3 for a summary of the main results. alignment in one tooth only (maxillary incisor rotation) and Miles
2016 reported a reduced requirement for analgesics at 24 hours
A total of 23 RCTs met the inclusion criteria for this review. only after the ligation of the first aligning archwire (Miles 2016),
The studies involved 1027 participants. We judged 21 of the the differences were too small to have clinical significance. Those
studies to be at high risk of bias overall; the other two studies were all judged to be at high risk of bias (Lombardo 2018;
we judged to be unclear (Katchooi 2018; Woodhouse 2015). Miles 2016; Pavlin 2015).
The studies investigated the influence of three different types
of non-surgical adjunctive interventions on orthodontic tooth LLLT versus placebo or control during orthodontic treatment
movement (OTM). Twelve studies assessed the influence of light
vibrational forces (Katchooi 2018; Kumar 2020; Lombardo 2018; This comparison included 10 RCTs (Abellán 2021; Alam 2019;
Miles 2012; Miles 2016; NCT02868554; Pavlin 2015; Reiss 2020; AlSayed 2017; Caccianiga 2017; El Shehawy 2020; Farhadian 2021;
Siriphan 2019; Taha 2020; Telatar 2020; Woodhouse 2015), nine Ghaffer 2022; Hasan 2022; Lalnunpuii 2020; Lo Giudice 2020), with
assessed the influence of low level laser therapy (LLLT) (Abellán a total of 423 participants recruited to assess the influence of LLLT
2021; Alam 2019; AlSayed 2017; Caccianiga 2017; El Shehawy 2020; on OTM. All studies were rated as having high risk of bias. The
Farhadian 2021; Hasan 2022; Lalnunpuii 2020; Lo Giudice 2020) and outcome from this review indicates that there is very low-certainty
two assessed the influence of light-emitting diode (LED) (Farhadian evidence to suggest that the application of LLLT can reduce the
2021; Nahas 2017). To assess the influence of light vibrational duration of the alignment stage with fixed orthodontic appliances
forces, we conducted meta-analyses for the duration of orthodontic (MD -48.87 days, 95% CI -56.48 to -41.26) as well as the number
treatment, number of appointments required to adjust the fixed of visits required to adjust the orthodontic appliance (median
orthodontic appliance, rate of orthodontic tooth movement during difference -2.25 visits, 95% CI -2.52 to -1.97). This reduction was
the alignment and space closure, patient perception of pain at found to be statistically significant when compared to the control
different time points and patient-reported need for analgesics groups. However, no statistical increase in the rate of (by assessing
at different time points during the first week of treatment. To the percentage reduction in the LII) was detected in the LLLT groups
assess the influence of LLLT, we conducted meta-analyses for during the first or the second month of the alignment stage. The
the alignment stage and number of appointments, and rate of meta-analyses presented in the form of four forest plots have to
orthodontic tooth movement during the alignment stage. Only two be interpreted with caution due to the significant statistical and
studies investigated the influence of LED and no meta-analysis was clinical heterogeneity amongst the included studies. Furthermore,
conducted. The certainty of evidence for each outcome was also it is important to note that, although the difference reported in the
assessed. duration and number of visits during the alignment stage can be
considered clinically significant for that specific stage of treatment,
Light vibrational forces versus placebo or control during it does not necessarily reflect the same significance on the full
orthodontic treatment treatment duration.
This comparison included 12 RCTs, with a total of 554 participants, There is little evidence to suggest that rate of OTM during space
(Katchooi 2018; Kumar 2020; Lombardo 2018; Miles 2012; Miles closure (en masse retraction) can be increased on the application
2016; NCT02868554; Pavlin 2015; Reiss 2020; Siriphan 2019; of LLLT compared to control (right side MD 0.18 mm/month, 95%
Taha 2020; Telatar 2020; Woodhouse 2015), which assessed the CI 0.10 to 0.26, P < 0.001; 1 study; 65 participants; very low level
effectiveness of light vibrational forces on OTM (9 studies used fixed of certainty) (Lalnunpuii 2020). Moreover, there is little evidence to
orthodontic appliances and 3 studies used aligners for orthodontic suggest that OTM during canine retraction can be increased on the
treatment). All but two studies were rated as high risk of bias; these application of LLLT compared to control (MD 0.01 mm/day, 95%
were judged to be unclear (Katchooi 2018; Woodhouse 2015). Three CI 0 to 0.02; P = 0.01; 1 study, 37 participants; very low level of
different types of light vibrational devices were used in the 11 certainty) (Farhadian 2021). The differences reported in OTM with
included RCTs. Most studies used the Acceledent device with the LLLT seems to be clinically insignificant and do not represent
vibrational frequency 30 Hz and force of 0.25N (Katchooi 2018; the full treatment duration.
Lombardo 2018; Miles 2016; NCT02868554; Pavlin 2015; Taha 2020;
Telatar 2020; Woodhouse 2015). Miles 2012 used the Tooth Mousse There is very low-certainty evidence to suggest that the application
device with vibration frequency of 11 Hz and force of 0.06N; LLLT does not influence the patient's perception of pain and
while Siriphan 2019 and Kumar 2020 used customised devices with discomfort during orthodontic treatment.
vibrational frequencies 30 to 60 Hz and force of 0.6 N. In all studies,
they instructed participants to use the vibrational appliance for 20 LED versus control during orthodontic treatment
minutes daily. This comparison included only two studies (both assessed as
having high risk of bias) involving 80 participants to assess the
The results from this review indicate that there is low-certainty
influence of LED on OTM. There is very low-certainty of the evidence
evidence to suggest that the application of light vibrational forces
to suggest that LED can significantly reduce the fixed appliance
Informed decisions.

orthodontic alignment duration in the mandibular arch. However, aligner therapy. Different biomechanical principles are applied with
LED did not influence the rate of canine distalisation. It is important each of these orthodontic appliances. We decided to assess each
to note that the assessed stage of orthodontic alignment does type of appliance in this review separately to limit the effect of
not necessarily represent the overall total orthodontic treatment associated confounding.
duration.
In relation to the multi-bracket fixed appliance systems used, there
There is very low-certainty evidence to suggest that the application was variation in slot dimensions, ligation systems and sequence
of LED does not influence patient perception of pain and discomfort of archwires. Given that there is no evidence that these variations
during orthodontic treatment. have a significant impact on any of the investigated outcomes, we
decided to collate data from these studies without the need for
Overall completeness and applicability of evidence subgroup analysis (El-Angbawi 2019; Fleming 2010, Papageorgiou
2014). It was deemed difficult to assess the rate of OTM in the
The primary objective of this review was to assess the influence
studies that used aligners (e.g. Invisalign) for treatment due to the
of non-surgical adjunctive interventions on the duration of
different methods of assessing OTM, such as the reduction of LII
orthodontic treatment and the rate of OTM. Only two studies
during treatment or use of a customised formula to assess the
investigated the full treatment duration (Miles 2016; Woodhouse
accuracy of tooth movement.
2015); however, most of the other included studies assessed
the influence of the interventions on the duration of different Finally, there was great variation in the outcome measures that
stages of orthodontic treatment, representing proxy measures were adopted by the investigators. This was particularly marked
of treatment efficiency. It is important to note that the rate when assessing rate of OTM in the different stages of treatment,
of OTM during a specified stage of orthodontic treatment does with some studies involving study models while others used
not necessarily represent the overall rate of OTM or the total radiographs and others used customised formulas. We would
orthodontic treatment duration. suggest that uniformly applied outcomes are used when future
studies are planned so that adequate comparisons between trials
Some studies assessed secondary outcomes including side effects
can be achieved.
of orthodontic treatment, e.g. OIIRR and patient-centred outcomes
including self-reported pain and self-reported need for analgesics.
Quality of the evidence
This was only reported for the light vibrational forces and was
not reported for the photobiomodulation interventions. Patient- Limitations in study design and applicability of evidence
centred outcomes were mainly assessed at different time
A total of 23 RCTs involving 1027 participants meeting the inclusion
points following the first and second visits of orthodontic
criteria were included in this review. The overall certainty of
treatment. These time points do not represent the full orthodontic
evidence is low with all the studies rated as high risk of bias
treatment duration; however, it is reasonable to assert that this
except two studies that we judged to be unclear (Katchooi 2018;
early stage of treatment is the most relevant when assessing pain
Woodhouse 2015). The sample size was relatively small in all
and discomfort as a side effect of OTM (Ngan 1994). No other harms
studies, ranging from 13 to 33 participants per study group.
were noted in any of the studies.
Most of the studies had selection bias issues with clinicians and
It is important to note that there were five studies identified participants not blinded however, the detection bias in most
through our search strategy that assessed the influence of non- studies was low risk.
surgical interventions on some of the secondary outcomes but
Several included studies recruited participants young and adults
did not report the rate of OTM or the duration of treatment;
with no subgroup analysis to demonstrate if the rate OTM is similar
these studies were excluded from this review as they did not
with different age groups. In addition, most of the included studies
meet the inclusion criteria. The secondary outcome data in this
had two groups (control and intervention) with clear explanation
review were only reported within the context of their relevance
about the sample size calculation, however, there were a few
to the rate of OTM. Some of those secondary outcomes related
included studies that had 3 or 4 arms where the authors did not
to non-surgical interventions, e.g patient-centred outcomes,
account for the sample size calculation with multiple comparisons
are addressed comprehensively in another Cochrane systematic
required for the multiple study groups especially with longitudinal
review (Fleming 2016).
time point outcomes. Moreover, a limited number of the included
We consider the participants in the included studies to be studies used stratification according to bracket ligation type to
representative of the patient groups that would be treated ensure equal distribution of these variables in the comparison
in the majority of orthodontic settings in terms of age, sex, group (Kumar 2020; Lalnunpuii 2020). This stratification would
and type of malocclusion, although in some studies only the require subgroup analysis; however, the authors did not account for
maxillary or mandibular dental arch was assessed. The severity the reduced sample size in the subgroups, which could potentially
and complexity of the malocclusion can dictate the need for have reduced the power of the statistical tests used.
dental extractions during orthodontic treatment, with some studies
The methods of assessing OTM for specified periods or stages
recruiting extraction cases and others involving non-extraction
of treatment were not standardised in the included studies, with
cases or a combination of both. This can make the comparison
different criteria described. This could be a source of error that
between the reported outcomes problematic due to high levels of
could have influenced the results. Only two of the included studies
heterogeneity in relation to some of the outcomes.
assessed the influence of the interventions on the full orthodontic
Two main types of orthodontic appliances were used in the treatment duration (Miles 2016; Woodhouse 2015). All the other
included studies - multi-bracket fixed orthodontic appliances and included studies assessed stages of the orthodontic treatment
ranging from a few weeks to a few months. It is important to
Informed decisions.

emphasise that the outcomes from those periods of treatment do vibrational forces, Jing 2017 reported weak evidence that light
not necessarily represent the full treatment duration. vibrational forces are effective in accelerating canine retraction but
not orthodontic alignment. The inconsistencies between reviews
The certainty of the evidence, as assessed using GRADE, on the can be explained by the difference in the studies included and
effectiveness of non-surgical interventions to influence OTM was the certainty of evidence: Long 2013 and Gkantidis 2014 included
low to very low. The available evidence suggest that there is RCTs and controlled clinical trials, while Kalemaj 2015, Jing
no additional benefit from the use of light vibrational forces for 2017 and Baghizadeh 2020 included RCTs with split-mouth design.
accelerating the rate of OTM. The limited and incomplete evidence
available suggests that LLLT and LED can potentially increase We decided to include only RCTs in this review to ensure high-
the rate of OTM in the short term during the alignment stage quality methodology and limit selection bias. In addition, we
of orthodontic treatment. It would be inappropriate to assume excluded split-mouth design RCTs due to the potential for cross-
that the reported short-term outcomes will be reflected in the full over effects. This explains the difference between our conclusion
treatment duration. and the previous reviews.
Potential biases in the review process A systematic review of systematic reviews was published in 2017
assessing the quality of most of the reviews published related to
Every possible effort was made to reduce selection and reporting non-surgical and surgical interventions for acceleration of OTM (Yi
bias by ensuring a comprehensive search for potentially eligible 2017). The review used the AMSTAR tool for quality assessment
studies. We used a broad search strategy with no language of the included reviews with an average score of 6.3 out of 11,
restrictions, and assessments were made independently by indicating moderate quality of systematic review methodology.
multiple authors. We are not aware of any biases in the review However, all the included systematic reviews assessed the quality
process. We excluded several published and ongoing studies of evidence from included studies as either low or very low
because they were split-mouth in design. At this time, we believe using GRADE. The authors reported that LLLT is effective in
that the potential cross-over effects in this design introduces too promoting OTM in the short term.
great a risk of bias if they were to be included in this review. The
authors will continue to review this decision as evidence emerges AUTHORS' CONCLUSIONS
from these ongoing studies.
Implications for practice
It is important to note that several studies assessed the influence
of non-surgical interventions on some of the secondary outcomes There is low-certainty evidence to suggest that neither the
without reporting on the rate of OTM or the duration of treatment. application of light vibrational forces nor photobiomodulation
Those studies were excluded from this review as they did not meet reduce the duration of orthodontic treatment (with fixed or
the inclusion criteria. This indicates that reported data for the removable appliances). While there is very low certainty evidence to
secondary outcomes were only reported within the context of their suggest that the application of photobiomodulation (low level laser
relevance to the rate of OTM. However, some of those secondary therapy and light-emitting diode (LED)) can reduce the duration
outcomes related to non-surgical interventions, e.g patient-centred of the orthodontic alignment stage as well as the number of visits
outcomes, were addressed comprehensively in another Cochrane required to adjust the orthodontic appliance during the alignment
systematic review (Fleming 2016). stage, these results have to be interpreted with caution as it is
difficult to estimate the clinical significance of this reduction on the
Agreements and disagreements with other studies or full orthodontic treatment duration.
reviews
Implications for research
In the last decade, several systematic reviews have been conducted
to assess the effectiveness of several types of non-surgical There is a clear need for well-designed randomised clinical studies
interventions in accelerating OTM (Baghizadeh 2020; De Almeida with standardised outcome reporting for the proposed non-
2016; Gkantidis 2014; Jing 2017; Kalemaj 2015; Long 2013; Long surgical adjunctive methods to accelerate tooth movement. Future
2015; Yi 2017). There is a lack of agreement amongst the reviews studies need to have sufficient participants to detect any clinically
in regard to the reported effectiveness of some of the non-surgical and statistically significant differences, involve the full orthodontic
interventions and the certainty of the evidence assessed. treatment duration rather than just limited stages of treatment, and
assess additional cost enquired to determine whether non-surgical
Gkantidis 2014 reported that there is moderate to weak interventions can result in a clinically important reduction in the
evidence that non-surgical interventions (low energy laser, duration of orthodontic treatment, with minimal adverse effects.
photobiomodulation or pulsed electromagnetic fields) can
accelerate tooth movement. In contrast, De Almeida 2016 reported ACKNOWLEDGEMENTS
that there is no evidence that laser therapy can accelerate
OTM. Long 2013 suggested that LLLT is safe but unable to The review authors would like to thank Anne Littlewood
accelerate orthodontic tooth movement; however, the same (Information Specialist), Laura MacDonald (Managing Editor) and
research group published another systematic review that reported Cochrane Oral Health for their help and support. We thank editors
that LLLT could accelerate OTM during the first three months Helen Worthington and Fang Hua, and peer reviewers Philip
of treatment (Long 2015). Kalemaj 2015 reported that there is Benson, Dirk Bister and Sarah Rolland for their feedback on drafts
some evidence that LLLT can accelerate OTM to a limited but of the review. We thank Anne Lethaby for copy editing before
clinically insignificant degree. In a systematic review concerning publication.
Informed decisions.

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Miles P, Pandis N. AcceleDent Aura does not influence treatment Journal of Orofacial Orthopedics 2020;82:288-94.
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Woodhouse 2015 {published data only}
2020;36(1):2-8.
DiBiase AT, Woodhouse NR, Papageorgiou SN, Johnson N,
Nahas 2017 {published data only} Slipper C, Grant J, et al. Effect of supplemental vibrational force
Nahas AZ, Samara SA, Rastegar-Lari TA. Decrowding of lower on orthodontically induced inflammatory root resorption:
anterior segment with and without photobiomodulation: a a multicenter randomized clinical trial. American Journal of
single center, randomized clinical trial. Lasers in Medical Science Orthodontics and Dentofacial Orthopedics 2016;150(6):918-27.
2017;32(1):129-35.
DiBiase AT, Woodhouse NR, Papageorgiou SN, Johnson N,
NCT02868554 {published data only} Slipper C, Grant J, et al. Effects of supplemental vibrational
force on space closure, treatment duration, and occlusal
NCT02868554. Accelerated Invisalign therapy in conjunction
outcome: a multicenter randomized clinical trial. American
with Acceledent aura. clinicaltrials.gov/ct2/show/NCT02868554
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Pavlin 2015 {published data only}
Dibiase A. Re: Effect of supplemental vibrational force on
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Informed decisions.

NCT02314975. Intermittent vibrational force and orthodontic Cronshaw 2019 {published data only}
tooth movement. clinicaltrials.gov/ct2/show/NCT02314975 Cronshaw M, Parker S, Anagnostaki E, Lynch E. Systematic
(first received 11 December 2014). review of orthodontic treatment management with
photobiomodulation therapy. Photobiomodulation
* Woodhouse NR, Dibiase AT, Johnson N, Slipper C, Grant J,
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Celebi F, Turk T, Bicakci AA. Effects of low-level laser therapy IRCT2015030921406N1. Evaluation the effect of low energy
and mechanical vibration on orthodontic pain caused by initial laser irradiation on the rate of mandibular molar protraction
archwire. American Journal of Orthodontics and Dentofacial in orthodontic patients. trialsearch.who.int/Trial2.aspx?
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en.irct.ir/trial/20555 (first received 25 June 2016).
Mistry 2020 {published data only}
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et al. Effectiveness of low-level laser therapy during tooth of low-level laser therapy on the rate of orthodontic tooth
movement: a randomized clinical trial. Materials (Basel, movement: a triple-blind, split-mouth, randomized controlled
Switzerland) 2019;12(13):2187. trial. American Journal of Orthodontic and Dentofacial
Orthopedics 2020;157(4):444-53.
JPRN-UMIN000013722 {published data only}
JPRN-UMIN000013722. The effect of vibration on acceleration NCT02181439 {published data only}
of orthodontic tooth movement. apps.who.int/trialsearch/ NCT02181439. Study evaluating the laser diode effect on the
Trial2.aspx?TrialID=JPRN-UMIN000013722 (first received 18 kinetics of orthodontic tooth movement (Protocol CINELASER)
April 2014). (CINELASER). clinicaltrials.gov/ct2/show/NCT02181439 (fiirst
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Kansel 2014 {published data only}
CTRI/2012/03/002488. Effects of low intensity laser therapy NCT02606331 {published data only}
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www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=3681 (first in accelerating orthodontic treatment. clinicaltrials.gov/ct2/
received 9 March 2012). show/NCT02606331 (first received 17 November 2015).
* Kansal A, Kittur N, Kumbhojkar V, Mahabaleshwar Keluskar K, Prasad 2019 {published data only}
Dahiya P. Effects of low-intensity laser therapy on the rate of
Prasad SMV, Prasanna TR, Kumaran V, Venkatachalam N,
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Kau 2013 {published and unpublished data} randomized controlled clinical trial. Journal of Pharmacy and
Bioallied Sciences 2019;11:S228-31.
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de la Fuente A, et al. Photobiomodulation accelerates Shipley 2019 {published data only}
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Shipley T, Farouk K, El-Bialy T. Effect of high-frequency vibration
in Orthodontics 2013;19:14-30.
on orthodontic tooth movement and bone density. Journal of
Lobre 2016 {published data only} Orthodontic Science 2019;8:15.
Lobre WD, Callegari BJ, Gardner G, Marsh CM, Bush AC, Yang 2019 {published data only}
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* Indicates the major publication for the study

CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]

Abellán 2021
Methods • Study design: parallel RCT, 2 arms

• Setting: Teaching Dental Hospital, Universidad Complutense de Madrid (UCM), Spain
• Sample size calculation: by IBM SPSS Sample-Power (v3.0) based on detecting a difference between
groups of 1 mm or more in the primary outcome variable: intruded distance, assuming SD of 0.7, error
a = 0.05, and statistical power of 80%. A sample of 20 participants (10 per group) was judged to be
adequate, taking into account potential dropouts.
Participants • 20 participants with fixed orthodontic appliance

• Less than 18 years of age
Inclusion criteria
• First upper molar extruded, without curved roots

• Permanent dentition
• Presence of adjacent teeth of molar to intrude
• Adequate oral hygiene
• No previous orthodontic treatment
• No trauma or dental and congenital anomalies
• No reconstructions
• No periodontal disease
• No severe crowding on the back of the jaw or rotated teeth
• Alveolar bone loss < 30%
Exclusion criteria
• > 18 years old

• Diabetes mellitus, cancer, HIV
• Congenital craniofacial malformations
• Taking medications that can alter the response to orthodontic treatment (nonsteroidal anti-inflam-
matory drugs)
• Metabolic or endocrine disorders
• Health conditions contraindicated for orthodontic treatment or laser treatment (pregnancy and lac-
tation)
• Osteoporosis
• Immunological disorders
• Alterations of connective tissue
• Antibiotics use
Interventions Experimental group: intrusion + laser
Informed decisions.

Abellán 2021 (Continued)
Control group: intrusion
Appliance: fixed appliance with TADS and elastic bands. Force 75 g
Laser: low-power diode laser (Periowave; Ondine BioPharma) emitting at a wavelength of 670 nm, with
a power of 150 mW (measured with a Gentec XLP power detector in combination with a Gentec con-
sole—ONLY 2). Radiation applied through a flexible optical fibre connected to an autoclavable stain-
less steel handpiece designed by the user. Handpiece has a light diffuser tip configured as a periodontal
probe to allow access to the periodontal pocket. The diffuser tip moved smoothly around the gum on
each of the dental surfaces (distal, mesial, vestibular, and palatal) of the molar to be intruded for 3 min
for each surface (total 12 min) on days 0, 1, 2, 3, 4 and 7 of the beginning of the intrusion and in each
monthly follow-up.
Outcomes Primary
• Molar intrusion amount assessed by scanning days 0, 90 and 180 with an intraoral scanner (3Shape
Trios) and CBCT day 0 and day 180
Secondary
• Root resorption assessed using CBCT day 0 and day 180

• Periodontal health assessed using plaque index, probing depth, and bleeding of probing at 0, 1, 2, 3,
and 6 months
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence genera- Low risk Simple randomisation: done using online computer software (Research Ran-
tion (selection bias) domizer)
Allocation concealment Unclear risk No mention of allocation method

(selection bias)
Blinding of participants High risk No blinding of participants nor clinicians

and personnel (perfor-
mance bias)
All outcomes
Blinding of outcome as- High risk No blinding of assessors

sessment (detection bias)
All outcomes
Incomplete outcome data Low risk No dropouts

(attrition bias)
All outcomes
Selective reporting (re- Unclear risk Study registered but no access to the registration
porting bias)
Other bias Unclear risk Reliability of measurements not done

Alam 2019
Informed decisions.

Alam 2019 (Continued)
• Setting: Teaching Dental Hospital, Division of Orthodontics, College of Dentistry, Jouf University, Sau-
di Arabia
• Sample size calculation: power 80%, α 0.05, and effect size (d) 0.22 was used. Hence, total sample size
intended was 32; each group required a minimum of 8 participants.
Participants • 32 participants with fixed orthodontic appliance

• Age 14 to 24 years
Inclusion criteria
• Angle class I or II or III malocclusion with ectopic maxillary canine requiring space creation or extrac-
tion of first premolar
Exclusion criteria
• On medications such as non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, bisphos-

phonates that disturb the bone metabolism or tooth movement
• Presence of parafunctional habits
• Temporomandibular joint (TMJ) dysfunction
• Craniofacial malformation
• Multiple missing teeth
• Impacted teeth
• Periodontally compromised
Interventions 4 groups: 2 intervention groups having LLLI (one with self ligating and the other with conventional
brackets) and another 2 control groups (one with self ligating and the other with conventional brack-
ets).
All participants had upper orthodontic fixed appliance 0.022 inch bracket slot system. Archwire se-
quence 0.012-inch super-elastic nickel-titanium (NiTi) wire was used for alignment and levelling, which
was followed by 0.014, 0.016 and 0.018 NiTi wires at 4-week intervals between each wire.
Intervention groups (LLLT)
• LLLT + self-ligating brackets

• No LLLT + self-ligating brackets
Laser unit was a 940 nm aluminum-gallium-arsenide (Al-Ga-As) diode laser (iLase; Biolase, Irvine, CA,
USA) set on continuous mode with power at 100 mW) diameter of the optical fibre tip was 0.04 cm2,
the energy density was calculated to be 7.5 J/cm2 for each point, and total energy density was 75 J per
tooth.
Laser applied on gingival mucosa for 3 sec each on 5 points labially/buccally and palatally per tooth,
starting from central incisor to the first molar. These points were mesial and distal over the cervi-
cal-third of the root and the middle of the root and also mesial and distal over the apical-third of the
root. The fibre tip of the laser was in close but light contact with the surface of the gingival tissues and
held perpendicular to the mucosa overlying the roots of teeth.
Control groups: no LLLT application of any form
• No LLLT + self-ligating brackets

• No LLLT + conventional brackets
Outcomes Primary
• Rate of orthodontic teeth movement with the maxillary canine tooth aligning for 28 days. Unit of mea-
surement not mentioned, but photos and cone beam CT used
Secondary
Informed decisions.

Alam 2019 (Continued)
• Patient perception of pain using NRS questionnaire to measure pain intensity. Participants asked to
record pain after 4 hours, 24 hours, 3 days and 7 days
Notes Study data published in 2 journal articles with conflicting information about the randomisation process
Risk of bias
Random sequence genera- High risk "...enrolled and randomly allocated to the 4 groups..."
tion (selection bias)
No information provided about random sequence generation. Eight partici-
pants in each group. See 'other bias' below
Allocation concealment High risk Not described, probably not done

(selection bias)
Blinding of participants High risk "The intervention provider and the patient were not blinded to the interven-
and personnel (perfor- tion"
mance bias)
All outcomes
Blinding of outcome as- High risk No blinding of assessor mentioned

All outcomes
Incomplete outcome data Low risk No dropouts reported

(attrition bias)
All outcomes
Selective reporting (re- High risk Study not registered; no protocol published
porting bias)
The same study outcomes were published in two separate peer reviewed jour-
nals. Some statistical analysis results were published in one article but not in
the other although reporting on the same outcome.
Other bias High risk Poor study design; reliability of the data were not assessed.
Although the study was published in the Bangladesh Journal of Medical

Science Vol. 18 No. 02 April 2019 as "randomised clinical trial", the results were
also published in another journal in the same year Pain Research and Manage-
ment Journal volume 2019 with authors mentioning "study was designed and
conducted according to the guidelines of Strengthening the Reporting of Ob-
servational Studies in Epidemiology (STROBE)"

AlSayed 2017

• Setting: Teaching Dental Hospital, Department of Orthodontics at Damascus University, Syria
• Sample size calculation: power 80% and significance level of 0.05 to detect a 40% reduction in time
to align teeth (97.2 days) with SD 82.5 days
• Reliability: evaluated using intraclass correlation coefficient. 10 dental casts (of the T1 casts) were
randomly chosen, and LII was re-measured 1 month after the first measurement.
Participants 26 participants with fixed orthodontic appliance 0.022-inch bracket slot system (MBT)
Informed decisions.

AlSayed 2017 (Continued)
Inclusion criteria
• Age 16 to 24 years old

• Moderate crowding (tooth-size arch-length discrepancy of 3 to 5 mm) in the anterior maxilla with LII
of 7 mm or more
• Extraction of first maxillary premolars
• Feasibility of bonding brackets on all maxillary teeth
• No systemic diseases
• Good oral hygiene
• Severe tooth displacement (e.g. ectopic canine)
• Those reporting the use of medications throughout the study
Interventions All study participants had fixed orthodontic appliance treatment with bracket slot 0.022-inch MBT pre-
scription. Archwire sequence 0.014-inch NiTi, 0.016 x 0.016-inch, 0.0173 0.025-inch NiTi, and finally
0.0193 0.025-inch stainless steel
Intervention group
Laser
• After inserting the first archwire, a laser dose was applied using an 830-nm wavelength laser device
(CMS Dental ApS, 55 Wildersgade, 1408 Copenhagen K, Denmark) with a 2.25-J/cm2 irradiation dose.
The laser beam was applied to each root of the six maxillary incisors roots. Each root was divided into
two halves: cervical and apical.
• The laser device tip was applied to the centre of each half, perpendicular to the root and in direct
contact with the mucosa from both the buccal and palatal sides so that there were four application
points for each tooth with an exposure time of 1 minute/tooth.
• The laser application was repeated on days 3, 7 and 14 after the first application and every 15 days
starting from the second month until the levelling and the alignment stage was complete.
Control group
No laser application of any form
Outcomes Primary
• Duration (days) of levelling and alignment of the maxillary arch measured before treatment, at 1
month, at 2 months and at the end of alignment. Treatment was considered finished when LII was
less than 1 mm, indicating complete alignment of the teeth, and it was feasible to insert the final arch-
wire passively into all brackets, indicating complete levelling of the teeth. Measurements of alignment
were done using LLI done on study models from alginate impressions.
Secondary
• Levelling and alignment improvement percentage (LAIP) of the maxillary teeth throughout the level-
ling and alignment stage, calculated by dividing change in LII value at the relevant timepoint by LII
value at baseline.
Notes Maxillary arch alignment only
Extraction of first maxillary premolars
Study duration July 2015 to March 2016
Risk of bias
Informed decisions.

AlSayed 2017 (Continued)
Random sequence genera- Low risk Simple 2-arm randomisation technique 1:1
Page 500: "each patient was asked to select a folded piece of paper from a box
containing 26 pieces of paper on 13 of which the word ‘‘laser’’ was written; on
the other 13, the word ‘‘control’’ was written"
Allocation concealment Unclear risk No measures mentioned by the authors to ensure allocation concealment. No
(selection bias) mention if the folded piece of paper was safeguarded, e.g. stapled or tapped.
"...each patient was asked to select a folded piece of paper from a box contain-
ing 26 pieces of paper on 13 of which the word ‘‘laser’’ was written; on the oth-
er 13, the word ‘‘control’’ was written"
Blinding of participants High risk No blinding of participants or clinicians described

mance bias)
All outcomes
Blinding of outcome as- High risk No blinding of the assessor during measurements from study models
All outcomes

(attrition bias)
All outcomes
Selective reporting (re- Low risk RCT registered in Clinical Trials database (NCT02568436)
porting bias)
Other bias Unclear risk Control group started with high LLI compared to experimental group. Not
shown if the difference was statistically significant

Caccianiga 2017
Methods • Study design: parallel RCT, 2 arms (described by trial authors as a pilot study)
• Setting: Department of Surgery and Translational Medicine, Section of Orthodontics, Milano-Bicocca
University, Italy
• Sample size calculation: none
• Reliability: 15 randomly selected dental casts were re-measured by the same operator 4 weeks later. A
paired sample t-test was applied to the first and second measurements and no differences were found.
Participants 36 participants planned for fixed appliance orthodontic treatment non-extraction
Inclusion criteria
• Age 13 to 30 years
• Completely erupted mandibular teeth
• Angle class I malocclusion
• Lower 6–6 mild crowding measured on dental cast
• No spaces or diastema in the lower arch
• No ectopic teeth
• No treatment plan, including extractions or the use of intraoral or extraoral auxiliary device
Informed decisions.

Caccianiga 2017 (Continued)
Interventions Participants treated by single operator with 0.022-in slot Empower self-ligating appliances (Ameri-
can Orthodontics, Sheboygan, WI) and Low Profile tubes (American Orthodontics) with MBT prescrip-
tion. Archwire sequence 0.014-in thermal NiTi archwire, (Thermal-Ti Lite, Form I; American Orthodon-
tics) followed by 0.016-in, 0.022-in and 0.017 x 0.025-in thermal NiTi archwires (Thermal-Ti Lite, Form I;
American Orthodontics).
Intervention group
Laser
• LLLT administered to test group using a diode laser emitting infrared radiation at 980 nm (Wiser; Doc-
tor Smile–Lambda Spa, Brendola, VI). The plane wave optical fibre (AB 2799; Doctor Smile–Lambda
Spa) dispensed a beam spot size of 1 cm2 and irradiation was administered by positioning the optical
fibre tip along the mandibular dental arch (1.5 cm as minimum on defocalisation, as prescribed by
the producer).
• Four dental segments (right first premolar-canine, right lateralcentral incisors, left central-lateral in-
cisors, left canine-first premolar) consecutively irradiated for 8 sec and two dental segments (right
first molar-second premolar, left second premolar-first molar) for 9 sec, for a total of 50 sec.
• Procedure repeated 3 times at intervals of 2 min. All irradiations done with an output power of 1W
at a continuous wave. Total energy density for entire mandibular dental arch, corresponding to an
exposure time of 150 sec, was 150 J/cm2, (1 J/cm2 per second) including 27 J/cm2 for each of the two
first molar-second premolar segments and 24 J/cm2 for each of the remaining four dental segments.
• Intervention mentioned above every 4 weeks
Control group
Outcomes Primary
• Duration (days) of mandibular arch levelling and alignment from T1 (before start of treatment) to T2
(end of alignment - not precisely defined). Measurements of arch alignment was done using LLI on
study models with digital calliper.
Secondary
• Number of visits from T1 to T2
Notes Mandibular arch alignment only
Non-extraction
Study duration: January 2014 to March 2016
Risk of bias
Random sequence genera- Low risk 2-arm simple randomisation done

Page 2 "SPSS Statistics software (IBM Corporation, Armonk, NY) was used to
generate an allocation sequence"
Allocation concealment Unclear risk No clear description of the allocation concealment

(selection bias)
"each subject was assigned a study number that was concealed until the date
of bonding the fixed appliance"
Blinding of participants High risk No blinding of participants or clinicians described

mance bias)
Informed decisions.

Caccianiga 2017 (Continued)
All outcomes
Blinding of outcome as- High risk No blinding of the assessor described

All outcomes

(attrition bias)
All outcomes
Selective reporting (re- Unclear risk Study not registered and no protocol published
porting bias)
Other bias Low risk No concerns

El Shehawy 2020

• Setting: outpatient clinic, Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-
AzharUniversity, Cairo, Egypt
• Sample size calculation: done but details not explained
• Reliability: 4 randomly selected dental casts were re-measured by the same operator 4 weeks later.
A paired sample t -test was applied to the first and second measurements and no differences were
found.
Participants 30 participants planned for fixed appliance orthodontic treatment non-extraction
Inclusion criteria
• Complete permanent dentition (third molars not included)

• Moderate mandibular anterior crowding (with Little's irregularity index score greater than 4 mm) who
required non-extraction approach in the mandibular arch
• No tooth size, shape or root abnormalities visible on the patient's radiographic records
• No spaces in the mandibular arch; no blocked out tooth that did not allow for placement of the bracket
at the initial bonding appointment
• No required management with interproximal stripping, intermaxillary elastics, open NiTi springs, and
removable or extraoral devices
Exclusion criteria
• Severe dental crowding that necessitates an extraction approach

• Abnormal anteroposterior and vertical relationships
• Cleft lip and palate, anomalies, and syndromes
• Previous orthodontic treatment
• Regular medication intake that could interfere with OTM
Interventions All participants enrolled in the study received Roth pre-adjusted metallic brackets (3M Unitek, Mon-
rovia, CA) with a 0.022 ~ 0.028-inch slot and treated with conventional NiTi archwires (Ortho Organiz-
er, Super Elastic Nitanium Archwiress, USA) in a standardised sequence of 0.012-, 0.014- and 0.016-inch
during the leveling and alignment phase for 12 weeks.
Intervention group
Laser
Informed decisions.

El Shehawy 2020 (Continued)
"Methylene blue-mediated PDT was delivered through gallium aluminum arsenide (Ga-Al-As) semicon-
ductor diode laser (SMART PRO, LASOTRONIX, Poland) with a wavelength of 635 nm with the follow-
ing set parameters: continuous mode, power output of 20 mW, fiber optic tip diameter of 2 mm, ener-
gy density of 6.5 J/cm2, exposure time of 10 sec per point resulting in dose of 0.2 J per point, 2 J per
tooth and total energy of 12 J per session. The laser beam was applied to six mandibular anterior teeth
where each root area was divided into 3 thirds; cervical, middle and apical. Laser was applied directly
and perpendicular to target points on mesial and distal of cervical and apical thirds and on centre of
middle third at 10 points, 5 facially and 5 lingually. The laser protocol was held on days 0, 3, 7 and 14
of first month and repeated for an additional 2 months. Both operator and participant wore protective
eyeglasses appropriated with the utilised wavelength according to standard safety rules and all clinical
procedures and laser irradiations were performed by the same investigator."
Control group
Outcomes Routine orthodontic records were obtained for each participant before treatment. In addition,
mandibular orthodontic study models and intraoral photographs were obtained before and at every 4-
week interval during observation period of the study.
Study casts were fabricated at T0 (before treatment), T1 (after 4 weeks), T2 (after 8 weeks) and T3 (after
12 weeks) intervals.
Primary
• Difference in reduction in LII and percentage change in the LII between the study groups through T1-
T2-T3
Secondary: none
Notes
Risk of bias
Random sequence genera- Low risk Simple randomisation - "allocation ratio of 1:1...clinical assistants arbitrari-
tion (selection bias) ly allocated patients into two groups with 15 patients each, using a comput-
erised simple generated randomisation plan via an online software (http://
www.graphpad com/quickcalcs/index.com)".
Allocation concealment High risk Allocation not concealed - "clinical assistants arbitrarily allocated patients in-
(selection bias) to two groups with 15 patients each"
Blinding of participants High risk Participants were not blinded to the intervention.
mance bias)
All outcomes
Blinding of outcome as- Low risk Single assessor who was blinded to study groups.
All outcomes "LII scores by the same examiner, who was unaware about the nature of the
studied groups"
Incomplete outcome data High risk The authors did not use intention-to-treat analysis with 4/30 dropouts.
(attrition bias)
All outcomes
Selective reporting (re- Low risk Study registered on ClinicalTrials.gov (NCT04376164)

porting bias)
Informed decisions.

El Shehawy 2020 (Continued)
Other bias Low risk None

Farhadian 2021

• Setting: Orthodontics Department, Hamadan University of Medical Sciences, United Arab Emirates
• Sample size calculation: based on smallest difference in OTM mean rate between groups being about
0.014 mm/day or 0.42 mm/month, number of participants needed for 80% power was 18.
• Reliability: measurements carried out by two observers with high inter-examiner correlation (intra-
class correlation coefficient 0.97)
Participants 60 participants were recruited.
Inclusion criteria
• Patients scheduled for fixed orthodontic treatment of the upper arch with bilateral or unilateral ex-
traction of the maxillary first premolar, followed by canine retraction
• Patients should have their teeth extracted at least three months before the beginning of canine re-
traction
• Age range from 15 to 30 years
Exclusion criteria
• Inappropriate periodontal health

• History of previous orthodontic treatment
• Systemic diseases that could affect the bone structure or density
• Long-term intake of non-steroidal anti-inflammatory drugs and hormonal supplements
• Pregnancy and breastfeeding
• Severe canine root dilacerations
Interventions All participants enroled in the study received MBT system brackets with 0.022 -0.028-inch slots (Ortho
Technology, Lutz, USA) or Roth system with 0.018 to 0.030-inch slots (Dentaurum, Ispringen, Germany)
based on clinician preference.
"After completion of levelling and alignment, a 0.019 x 0.025-inch stainless steel wire (Dentaurum,
Ispringen, Germany) for participants with MBT bracket system and 0.016 _ 0.022-inch stainless steel
wire (Dentaurum, Ispringen, Germany) for participants with Roth system was used for canine retraction
phase. "
"A 6-mm nickel-titanium closed-coil spring (Ortho Technology, Lutz, USA) was used for canine retrac-
tion. Springs were activated using a ligature wire to exert a force of 150 g. The force was adjusted at
each visit. The anchorage was reinforced by transpalatal arch or bonding maxillary second molars, if
necessary. "
Intervention groups
Laser group
LLLT was performed using a Cheese II dental diode laser device (Wuhan Gigaa Optronics Technology
Corporation, Wuhan, China). "Ga Al As diode laser was used with a wavelength of 810 nm and a pow-
er of 100 mW. Laser tip diameter was 3.1 mm, and energy density was 4 j/cm2. LLLT was performed
on days 0 (at the beginning of canine retraction), 3, 30 and 60. The laser was irradiated to 3 points on
the buccal and 3 points on the canine's palatal surface (cervical, mid-root and apical), 3 seconds each
point."
Informed decisions.

Farhadian 2021 (Continued)
LED group
An intraoral LED device named Biolight, similar to Ortho-pulse, with a wavelength of 640 nm, energy
density of 10 j/cm2, and 40 mW/cm2 power density was used. The inner part of the device has 2 pairs of
diodes bilaterally located, irradiating the buccal surface of the canine and extraction site. At the begin-
ning of canine retraction, participants were educated to use the device for maxillary dental arch 5 min
per day.
Control group
Placebo, no laser application using a coated light cure device
Outcomes • Rate of canine retraction and canine rotation
T1-T4 monthly
Alginate impressions were taken monthly during canine retraction.
Alginate impressions were made for each participant at baseline and monthly thereafter until the end
of canine retraction. The obtained models were scanned with an Emerald scanner (Planmeca, Helsinki,
Finland), and 3D models were prepared for each participant.
"The measurements of canine retraction and canine rotation were performed by Dolphin Imaging soft-
ware version 11.9 (Patterson Dental Supply, Chatsworth, USA). At first, 3D models were oriented alike.
Midpalatal raphe (MPR) was drawn as a reference line, and then the rugae line (RL) was drawn perpen-
dicular to MPR from the medial end of the third palatal rugae. The canine retraction was measured by
the distance from the tip of the canine to RL in millimetres at different time intervals. The angle be-
tween the line connecting the mesial and distal edges of canine and the MPR in occlusal view was con-
sidered as canine rotation."
• Pain perception
Patient-centred outcomes were recorded with a modified McGill pain questionnaire, along with a VAS.
In the first session, all participants were given the questionnaire and asked to complete and return it at
the next appointment. The questionnaire included questions about the onset of pain, description, lo-
cality, duration, intensity, triggers and analgesic consumption following orthodontic appliance place-
ment.
Notes It is not clear if questionnaire was done monthly or just once.
Risk of bias
Random sequence genera- Unclear risk "Someone outside the research team performed the randomisation." Not clear
tion (selection bias) how was this done.
"...allocated to three groups using the stratified block randomization

method..."
Allocation concealment Low risk Therapeutic interventions were placed in opaque envelopes.
(selection bias)
Blinding of participants Low risk Placebo was used "using a coated light cure device".
mance bias)
All outcomes
Blinding of outcome as- Low risk Assessor blinded

All outcomes
Informed decisions.

Farhadian 2021 (Continued)
Incomplete outcome data High risk 4 dropouts. No account for the dropouts. No intention-to-treat analysis
(attrition bias)
All outcomes
Selective reporting (re- Low risk Study registered on the Iranian Registry of Clinical Trials, www.irct.ir (IRC-
porting bias) T20120220009086N4)
Other bias High risk Study described the block randomisation stratification was done based on slot
size; however, later the text states that this was done according to clinician
preference.

Ghaffer 2022
Methods • Study design: parallel RCT, 2 arms, 1:1 allocation ratio

• Setting: Orthodontic Department, Faculty of Dentistry, Ain-Shams University, Cairo, Egypt
• Sample size calculation: yes, 13 per group
• Reliability: strong - ICC from 0.825 to 0.924 and 0.806 to 0.914 for intra- and inter-examiner agreements,
respectively
Participants 32 females (mean age 21.5 ± 3.5 years) with mandibular anterior crowding. Preoperative LII mean of
5.85 ± 1.75 mm and 6.4 ± 2.7 mm for intervention and control groups, respectively (no statistically sig-
nificant difference)
Inclusion criteria
• Female, 18 to 25 years
• Fully erupted permanent dentition
• Angle Class I malocclusion
• Little's irregularity index (LII) from 4 to 10 mm
• Good oral and general health
Exclusion criteria
• Pregnancy
• Systemic disease/condition
• Skeletal discrepancy in any of three planes
• Extracted/missing/badly decayed permanent teeth (excluding third molars)
• History of orthodontic treatment
• Treatment plan involving mandibular extractions
• Spacing in the mandibular arch
• Impediment to bracket placement on the mandibular anterior teeth
Interventions 2 groups. Both had fixed orthodontic appliance (0.022-inch Roth Mini Diamond). 0.014-inch cop-
per-nickel-titanium wire inserted immediately after bonding followed by 0.016-inch copper-nickel-tita-
nium wire, 0.016 × 0.022-inch NiTi then 0.017 × 0.025-inch stainless steel wire after alignment comple-
tion.
Intervention group
Low-level laser therapy (LLLT) - In-Ga-As laser applied to mandibular anterior segment on days 3, 7 and
14, at 1 month and then every 2 weeks until completion of levelling and alignment
Control group
Informed decisions.

Ghaffer 2022 (Continued)
No adjunct to orthodontic treatment
Outcomes Primary
• Overall levelling and alignment time (OLAT) of mandibular anterior crowding (digital models used to
monitor changes in LII) at day 3, weeks 1, 2, 4, 6, 8, 10, 12 and 14
Secondary
• Alignment improvement percentage at day 3, weeks 1, 2, 4, 6, 8, 10, 12 and 14

• Pain in the 7 days after initial archwire placement (assessed by VAS questionnaires)
Adverse effects were also mentioned.
Notes "The study methodology was approved by the Ethical Committee review board at the Faculty of Den-
tistry, Ain Shams University (FDASU-RecM071403)."
Risk of bias
Random sequence genera- Low risk Simple randomisation: computer-generated random list, no block randomisa-
tion (selection bias) tion.
"Thirty-two patients were randomized in a 1:1 ratio to laser or control groups."
"A generated randomization sequence was prepared using Microsoft Excel

software (Redmond, Washington, USA). The first 16 random numbers were as-
signed to the intervention group while the others were assigned to the con-
trol..."
Allocation concealment Low risk 1:1 allocation ratio

(selection bias)
"...Each number was placed in a sealed opaque envelope. Envelopes and the
generated sequence were held by the department secretary."
Blinding of participants High risk "Blinding of the patient and operator was not applicable due to the nature of
and personnel (perfor- this study."
mance bias)
All outcomes
Blinding of outcome as- Low risk "...data concealment and blinding of the outcome assessor and the statistician
sessment (detection bias) were established to minimize possible risk of bias."
All outcomes
Incomplete outcome data Unclear risk 2 participants not included in analysis - 1 from intervention group (missed sev-
(attrition bias) eral appointments) and 1 from control group (removed fixed appliance for
All outcomes wedding)
Selective reporting (re- Unclear risk Study not registered. No protocol published.
porting bias)
Other bias Low risk No other potential biases identified

Hasan 2022
Informed decisions.

Hasan 2022 (Continued)
• Setting: Department of Orthodontics and Dentofacial Orthopedics and the Laser Research Unit of
Damascus University
• Sample size calculation: using G*Power 3.1.9.2 software (University of Kiel, Germany) with level of
significance set at 0.05, and statistical power set at 90%, 13 and 12 participants in each group were
needed for the "treatment time'' and "overbite'' variables, respectively. In order to compensate for
dropout, one was added to each group (i.e. 14), with a total required sample size of 42
• Reliability: lateral cephalometric radiograph measurement. ICC ranged from 0.970 to 0.999. Paired-
sample t-tests showed that there were no significant differences between the two assessment times
(P > 0.05).
Participants 42 participants were recruited.
Inclusion criteria
• Between 8 and 10 years of age

• Fully erupted upper and lower permanent incisors
• Class I or class II skeletal
• A 1 mm (minimum) anterior open bite
• Good oral health
Exclusion criteria
• Unilateral or bilateral crossbite, craniofacial syndromes, systemic diseases or previous facial traumas
Interventions Three groups with a total of 42 students
Intervention group with bite blocks
The fixed posterior bite block (FPBB) used was a modification of the posterior bite block presented
by Turkkahraman and Cetin. This device consisted of the transpalatal arch that connected two acrylic
blocks.
Intervention group with bite blocks and laser
FPBB as above. Gallium aluminum arse-nide (Ga-Al-As) laser with a continuous wavelength of 808 nm
applied on first day and on days 3, 7 and 14 of the first month, then every 15 days until end of treat-
ment. Irradiation parameters of the LLL standardised throughout treatment as power of 250 MW, ener-
gy at 4 J, and application time 16 sec per point.
Control group
No intervention. Monitored for 9 months
Outcomes • Duration taken to correct anterior open bite. Active treatment period ended when a positive overbite
of 1 to 2 mm achieved
• Skeletal and dental changes from lateral cephalometric radiographs
Notes
Risk of bias
Random sequence genera- Low risk Using mini-tab software

Allocation concealment Low risk The allocation sequence was concealed using opaque numbered and sealed
(selection bias) envelopes. To prevent subversion of the allocation sequence, the name and
Informed decisions.

Hasan 2022 (Continued)
the date of birth of each participant were written on the envelope, and these
data were transferred onto the allocation card inside each envelope. Corre-
sponding envelopes were only opened after completing all baseline assess-
ments.
Blinding of participants High risk No blinding of clinicians or participants

mance bias)
All outcomes
Blinding of outcome as- High risk No mention of blinding assessors

All outcomes

(attrition bias)
All outcomes
Selective reporting (re- Low risk RCT registered in Australian New Zealand Clinical Trials Registry (ANZCTR) (AC-
porting bias) TRN12619001740189)

Katchooi 2018

• Setting: private practice in North America. Two centres (Vancouver and Seattle)
• Sample size calculation: "power calculations were a 99% completion rate in patients with an active
device, compared with a 50% completion rate with the control device. These estimates indicated that
12 subjects were required in each arm." A 1.5-mm difference in LII between test and control groups
was considered clinically meaningful.
• Reliability: error analysis showed that ICC was 0.98 for rater 1 (95% CI 0.93 to 0.99), 0.96 for rater 2
(95% CI 0.87 to 0.99) and ICC for average assessments between raters was 0.94 (95% CI 0.80 to 0.98),
indicating no significant intra-rater and inter-rater difference.
Participants 27 orthodontic patients who were beginning Invisalign (Align Technology, San Jose, Calif)
Inclusion criteria
• Adults (18 years or older) with malocclusions whose treatment involved fewer than 25 sets of aligners
Exclusion criteria
• No significant anteroposterior or transverse movements were planned, e.g correction from Class II to
Class I molar relationships
• Patients whose treatment plans included correction of posterior crossbites
• People with systemic diseases or syndromes, a history or current use of bisphosphonates, current
use of prostaglandin inhibitors, generalised moderate to severe periodontitis, active oral hard or soft
tissue lesions
Interventions All study participants received Invisalign (Align Technology, San Jose, California). The aligners were
fabricated using the usual approach and prescription of the treating orthodontist, with respect to se-
quencing of treatment, use of attachments or other treatment features, use of interproximal reduction,
and so on. Tooth movement was limited to no more than 0.25 mm per aligner.
Informed decisions.

Katchooi 2018 (Continued)
Compliance in groups A and B (active and control arms) was monitored using 3 methods: (1) self re-
ported data from questionnaires, (2) objective wear time of the aligners by the blue-dot indicators, and
(3) AcceleDent use time obtained from the device.
Intervention group
• AcceleDent Aura device vibration appliance 30 Hz and 0.25 N for 20 min per day
Control group
• No vibration appliance
Outcomes Primary outcome
• Number of participants who are able to successfully complete a set of aligners
Secondary outcomes
• Reduction in LII in the upper and lower arches

• Participant pain experience. Two time points (during first and middle aligners)
• Quality of life questionnaire (completed at 3 time points: immediately after distribution of first aligner,
at the midpoint of treatment and at study completion visit)
Notes Orthodontic aligners
Non-extraction
Risk of bias
Random sequence genera- Low risk Done: 2-arm block stratified randomisation scheme of 2 was used in this study
tion (selection bias) with stratification based on sex and age.
Page 340 "The study statistician created the randomisation list by using R soft-
ware (version 3.1.1; R Foundation for Statistical Computing, Vienna, Austria)".
Allocation concealment Low risk Remote allocation. A randomisation chart was kept at the University of Wash-
(selection bias) ington, at the time of enrolment, the orthodontist contacted the study coordi-
nator by phone or text to receive the assignment based on age and sex.
Blinding of participants Low risk Clinician was blinded.

mance bias) Participants were blinded as the control group had an inactive Aura appliance.
All outcomes
Blinding of outcome as- Low risk Investigator and statistician were blinded.
All outcomes
Incomplete outcome data Low risk 1 exclusion. Intention-to-treat analysis as well as per-protocol analysis
(attrition bias)
All outcomes
Selective reporting (re- Low risk Study registered in clinical trial.gov (clinicaltrials.gov/ct2/show/NCT02438280)
porting bias)
Other bias Unclear risk Study funded by Acceldent but results did not favour the Aura appliance.
Study registered as a pilot study
Informed decisions.


Kumar 2020
Methods • Study design: RCT, multi-arm, single-centre, with an allocation ratio of 1:1:1.32
• Setting: Department of Orthodontics and Dentofacial Orthopaedics in a nationally accredited dental
college, India
• Sample size calculation: "...similar study on the rate of orthodontic tooth movement was conducted
in the department, which was a 2-arm parallel RCT with an equal allocation ratio. The sample size
estimation for that study yielded a sample size of 17 participants per group (minimum power of 80%
and an α error of 0.05 and Cohen's effect size of 0.8). By designing the present trial as a multiple arm
trial, we can have a reduction of 25% in the sample size. Keeping that in mind a sample size of 20
was chosen for the experimental groups and 25 for the control group keeping the allocation ratio of
1:1:1.32 for the multi-arm trial"
• Reliability: 20 randomly selected participants (10 from each group) were re-measured by the same
assessor after 2 weeks for repeatability and re-test reliability. Intraclass coefficient was 0.88 and stan-
dard error of the mean was tabulated using paired t-test; the findings were not statistically significant.
Participants 65 patients in fixed orthodontic appliance treatment
Inclusion criteria
• Age group of 13–20 years

• With permanent dentition
• LII of < 5 mm
• Extraction of all first bicuspids as a treatment plan
• Periodontally sound dentition
• Good general health and not under any medication (acetylsalicylic acid [ASA] or nonsteroidal anti-in-
flammatory drugs [NSAIDs])
• FMA between 20–25
Exclusion criteria
• Orthognathic surgery as treatment plan

• History of systemic illness (affecting the calcium metabolism, or any other causing the patient to take
any medication which may alter the rate of tooth movement)
• Periodontally compromised dentition; congenital orofacial deformity
• Previous history of orthodontic therapy
Interventions All participants in the trial were treated by a single orthodontist and in accordance with the MBT treat-
ment philosophy. In total, 150 g of force was used for the en masse closure. Participants were randomly
allocated to one of three groups.
Group 1: passive self-ligating brackets (Smartclip SL3 3M Unitek 0.02200 Slot, MBT prescription) treated
using low-frequency vibrations
Group 2: conventional MBT brackets (Gemini 3M Unitek 0.02200 Slot, MBT prescription) treated using
low-frequency vibrations
Group 3: conventional MBT brackets (Gemini 3M Unitek 0.02200 Slot, MBT prescription) treated without
Vibration device
The low-frequency vibrations were provided by a custom-made vibratory device. The device was ad-
justed to produce a frequency of 30 Hz in the mouthpiece. The participants were instructed to us the
device 20 min daily.
Outcomes Primary
Informed decisions.

Kumar 2020 (Continued)
Rate of space closure (mm/months)
Measurements on digital models were made before, at the beginning of space closure and at the end of
space closure. Three-dimensional scanning of plaster models was performed using White light technol-
ogy (Solutionix C500) with a 3D reverse modelling software programme.
Perpendicular lines were drawn towards the distal surface of canine to the mesial surface of the second
premolar in the pre-retraction model.
Notes National Trial Registry (CTRI/2018/04/013009)
We contacted the trial authors as the SEs presented in the publication were larger than the SDs (which
cannot be accurate, given that SE = SD/sqroot (n)). We wondered if the SE and SD column headings had
been inverted, but even if this were the case, the numbers still did not add up; however, the column
headed SE provided numbers that would be sensible as SDs. We contacted the trial author who replied
that the SDs in the paper were accurate and reflect the homogeneity in the data. We conducted sensi-
tivity analysis as we still had concerns about the data. As a consequence of this, we opted to present
the meta-analysis excluding Kumar.
Risk of bias
Random sequence genera- Low risk "Randomization was carried out using a computer-generated random alloca-
tion (selection bias) tion sequence"
Allocation concealment Unclear risk No enough information provided about the concealment process. "The se-
(selection bias) quences were concealed and were chosen by the patient".
Blinding of participants High risk Blinding of the participants and the primary investigator was not possible due
and personnel (perfor- to the nature of the trial.
mance bias)
All outcomes
Blinding of outcome as- Low risk Only the data analyser was blinded to the groups and the digital models pre-
sessment (detection bias) sented were coded.
All outcomes

(attrition bias)
All outcomes
Selective reporting (re- High risk Registered at the National Trial Registry (CTRI/2018/04/013009)
porting bias)
1) registration retrospective
2) age inclusion is different (17-20 years)
3) Sample size calculation was only 30

Lalnunpuii 2020
Methods • Study design: RCT multi-arm, single-centre, with an allocation ratio of 1:1:1.32
• Setting: Institutional Department of Orthodontics and Dentofacial Orthopaedics
Informed decisions.

Lalnunpuii 2020 (Continued)
• Sample size calculation: based on a previous study (minimum power of 80%, error of 0.05 and Cohen's
effect size of 0.8). A sample size of 20 was chosen for experimental groups and 25 for control group,
keeping the allocation ratio of 1:1:1.32 for the multi-arm trial.
• Reliability: 20 randomly selected participants (10 from each group) were re-measured by the same
assessor after 2 weeks for repeatability and re-test reliability. Intraclass coefficient was 0.88 and stan-
dard error of the mean was tabulated using paired t-test: the findings were not statistically significant.
Participants 65 patients in fixed orthodontic appliance treatment
Inclusion criteria
• 13 to 20 years of age
• Little's Irregularity Index of < 5 mm
• Extraction of all first bicuspid as a treatment plan
• Periodontally sound dentition
• Sound general health and not under any medication (ASA I)
• Frankfurt mandibular angle (FMA) between 20–25 degrees
Exclusion criteria
• Orthognathic surgery as treatment plan

• History of systemic illness (systemic illnesses primarily affecting the calcium metabolism, or any other
due to which the patient might be on any medication that may alter the rate of tooth movement)
• Periodontally compromised dentition
• Congenital orofacial deformity
• Previous history of orthodontic therapy
• Little's Irregularity Index > 5 mm
Interventions All participants in the trial were treated by a single orthodontist using preadjusted MBT brackets sys-
tem. In total, 150 g of force was used for the en masse closure (active Tied Back and en-mass retrac-
tion). Extraction of all first bicuspids in the three groups was done prior to levelling and alignment by
the same surgeon. Conventional anchorage (second molar banding and cross archwire stabilisation)
was used for the three groups. All participants were instructed not to take any NSAIDs during the course
of space closure and inform the primary investigator if a need arose for any other medication before
taking the medication.
Participants were randomly allocated to one of three groups.
Group 1: passive self-ligating brackets (Smartclip SL3 3M Unitek 0.02200 Slot, MBT prescription) treated
Group 2: conventional MBT brackets (Gemini 3M Unitek 0.02200 Slot, MBT prescription) treated using
low-frequency vibrations
Group 3: conventional MBT brackets (Gemini 3M Unitek 0.02200 Slot, MBT prescription) treated without
Laser device
Laser device used was a 658 nm (Aluminium Gallium Arsenide) Semiconductor Diode laser (The Silber-
bauer CL mini 8-658 EN 60601-1-2:2007-07, Vienna, Austria, EU).
"Laser parameters used in the trial: active medium – Aluminium Gallium Arsenide; emission type – con-
tinuous; wavelength – 658 nm; dose of irradiation – 2.29 J/cm2; energy/point – 2.2 J; output – 8mW; ex-
posure time/point – 10 s; application – direct contact; sessions – first month, 4 times (day 0, 3, 7, 14),
from second month, every 15th day; laser classification – class 2M."
Two irradiations were done both buccally and palatally/lingually from canine to canine. To ensure com-
plete irradiation of the periodontium, the protocol was: 2 doses – cervical third (1 mesial/1 distal); 2
doses – apical third (1 mesial/1 distal); 1 dose – centre of the root. Similar process repeated for the
Informed decisions.

Lalnunpuii 2020 (Continued)
palatal/lingual side. The tip was held in contact with the tissue during application. This procedure was
followed for all subsequent appointments.
Outcomes Primary
Rate of space closure (mm/months)
Measurements on digital models were made before, at the beginning of space closure and at the end
of space closure. Three-dimensional scanning of plaster models was performed using White light tech-
nology (Solutionix C500) with a 3D reverse modelling software programme. The mid-palatine line was
used as a reference for measurement of available space, which was drawn in the software. Perpendicu-
lar lines were drawn towards the distal surface of canine to the mesial surface of the second premolar
in the pre-retraction model.
The average monthly rate of space closure was calculated as available extraction space/total number
of days 28 days.
Notes National Trial Registry (CTRI/2018/04/013156)
Risk of bias
Random sequence genera- Low risk "Randomization was carried out using a computer-generated random alloca-
tion (selection bias) tion sequence" to ensure equivalent distribution amongst the 3 groups. The
primary investigator had no role in the randomisation process.
Allocation concealment Unclear risk Not enough information provided about the concealment process. The au-
(selection bias) thors mentioned that the allocation was concealed but did not describe the
details "sequences were concealed and were chosen by the patient".
Blinding of participants High risk Blinding of the participants and the primary investigator was not possible due
and personnel (perfor- to the nature of the trial.
mance bias)
All outcomes
Blinding of outcome as- Low risk Only the data analyst was blinded to the groups and the digital models pre-
sessment (detection bias) sented were coded.
All outcomes

(attrition bias)
All outcomes
Selective reporting (re- High risk National Trial Registry (CTRI/2018/04/013156) - registration retrospective, dif-
porting bias) ferent age inclusion criteria (17-30 years), sample size calculation only 30

Lo Giudice 2020
Methods • Study design: RCT (1:1), single-operator

• Setting: an orthodontic private clinic in Bergamo, Italy
Informed decisions.

Lo Giudice 2020 (Continued)
• Sample size calculation: a minimum sample size of 80 participants (40 for each group) was considered
to obtain 90% power at a 95% CI to demonstrate a difference of 56 days in treatment time between
PBM and control groups
• Reliability: 20 dental casts were randomly selected and remeasured 4 weeks later. A paired sample t-
test was applied to the first and second measurements and no differences were found. All measure-
ments were done by one calibrated operator.
Participants 100 orthodontic patients
• Age between 13 and 30 years

• Permanent mandibular dentition
• Angle class I malocclusion
• Lower 6–6 mild crowding measured on dental cast
• No diastema or spaces in the lower arch
• No ectopic teeth
• No extractions required or intraoral or extraoral auxiliary devices
Interventions Both groups used the Empower self-ligating appliance (American Orthodontics, Sheboygan, WI) with
0.022-in slot and MBT prescription. The arch-wire sequence included 0.014-in thermal NiTi arch-wire
followed by 0.016 x 0.022-in and 0.019 x 0.025-in thermal NiTi archwires (Thermal-Ti Lite, Form I; Amer-
ican Orthodontics). Review visits were scheduled at 28-day intervals to check clinical progress and ad-
just the appliance if necessary by a single operator.
Intervention group
"Photobiomodulation (PBM) was administered to the PBM group using the ATP38 (Biotech Dental, Alle
´e de Craponne, Salon de Provence, France). This device features a multi-panel system emitting cold
polychromatic lights with a combination of wavelengths from 450 to 835 nm depending on the field of
action. The module provided 6 min of irradiation producing 48 J/cm2 of fluency, calculated as the sum
of the fluency produced by each light source (16 J/cm2) multiplied for the three active panels." A total
duration of 18 min and 144 J/cm2 of fluency administered (i.e. 48 J/cm2 x 3 stages).
Each PBM session was performed every 14 days, including the date of bracket bonding, up to the end
of the alignment stage. Thus, the fluency administered to participants was 288 J/cm2 per month (144 J/
cm2 x 2 sessions).
Control group
No PBM exposure
Outcomes Primary
Assessment of dental alignment treatment time
A digital calliper (Absolute Digimatic IP67; Mitutoyo Europe GMBH) was used to quantify the Little’s ir-
regularity index in the lower arch (6–6) on the pretreatment (T0) dental casts only.
The assessment of dental alignment (T2) was based on the visual examination of correction of the 11
mandibular interproximal contacts. The date of appliance bonding (T1) and the date when complete
resolution of crowding was established (T2) were recorded, and alignment treatment time was defined
in days as T2–T1.
Secondary
None
Notes Authors mentioned that randomisation was stratified according to sex and amount of crowding; how-
ever, the ratio of F:M was not kept equal.
Informed decisions.

Lo Giudice 2020 (Continued)
Risk of bias
Random sequence genera- Low risk "a randomized balanced block protocol using sex and the amount of crowd-
tion (selection bias) ing as stratification factors. The SPSS Statistics software (IBM Corporation, Ar-
monk, New York) was used to generate the allocation sequence"
Allocation concealment Low risk "Assignments were enclosed in sequentially numbered, sealed, and opaque
(selection bias) envelopes and were unveiled the date of bonding the fixed appliance".
Blinding of participants High risk No blinding of participants or clinicians

mance bias)
All outcomes
Blinding of outcome as- Low risk "The assessment of dental alignment and the relative data registration were
sessment (detection bias) entrusted to one expert operator (M.B.) who was unaware of whether the sub-
All outcomes jects being assessed were within the PBM or control groups".
Incomplete outcome data High risk Dropout: 7 participants from intervention group and 4 from control group. No
(attrition bias) Intention-to-treat analysis
All outcomes
Selective reporting (re- High risk The study was not registered. No protocol published
porting bias)
Other bias Low risk Study authors stated that randomisation was stratified according to sex and
amount of crowding, but the ratio of F:M was not kept equal. This puts a ques-
tion mark over how the stratification was done.

Lombardo 2018

• Setting: University of Ferrara Postgraduate School of Orthodontics clinic
• Sample size calculation: "for comparison of three parallel groups via one-way analysis of variance
(ANOVA) and to achieve a type 1 error with α = 0.05 (5 per cent) and objective power 0.8 (80 per cent)
—and therefore a type 2 error of 20 per cent—a minimum of 79 teeth for each tooth per arch would
be necessary. Considering that the least numerous tooth type is the canine—two per arch in each pa-
tient the minimum number of patients to be recruited was 40, which was increased to 45 to take into
account a possible dropout rate of 10 per cent."
• Reliability: "one month after completion of the analysis of all 270 arches, a random sample of 28.8 per
cent of the total sample. Dahlberg’s D was calculated to evaluate the random error, and Student’s t-
test for dependent samples to determine whether or not there was any systematic error." Measure-
ment analysis for paired samples confirmed the absence of systematic error in the measurements of
MD tip, VL tip, and rotation.
Participants Orthodontic patients who were beginning their aligners treatment with the sole aim of correcting den-
tal alignment
Inclusion criteria
• Age between 14 and 50 years
Informed decisions.

Lombardo 2018 (Continued)
• Complete dentition, or at most 1 missing tooth per quadrant (excluding third molars)
• No supernumerary teeth
• No tooth shape anomalies
• No tooth rotation > 35°
• No diastema > 5 mm
• Crowding < 5 mm per arch
Exlsion criteria
• Systemic pathologies
• Ongoing pharmacological treatment able to influence orthodontic movement (e.g. prostaglandin in-
hibitors or biphosphonates)
• Active periodontal disease
• Need for treatment for extraction space closure, distalisation, or sagittal correction
Interventions "Treatment staging, i.e. maximum movement planned for each tooth per aligner, was as follows: up
to 2-degree rotation, 2.5-degree each labio lingual and mesiodistal tip, and 0.2-mm linear displace-
ment. No auxiliaries of any kind (intra-oral elastics, buttons, chains, etc) were prescribed, but the sys-
tem attachments (Grip Points) were used, in addition to anterior and/or posterior interproximal reduc-
tion (IPR). The maximum IPR included in the prescription was 0.3 mm per interproximal space, from the
mesial sides of the second premolar to the mesial side of the opposite second premolar. The maximum
total IPR planned was 2 mm per arch."
Group A: conventional protocol with aligners replaced every 14 days
Group B: conventional protocol with aligners replaced every 14 days, and use of a low-frequency vibra-
tion device (AcceleDent; OrthoAccel Technologies, Houston, Texas, USA) for 20 min per day throughout
treatment
Group C: 7-day aligners replacement protocol, and use of a low-frequency vibration device (Accele-
Dent; OrthoAccel Technologies, Houston, Texas, USA) for 20 min per day throughout treatment
"All patients were instructed to wear their aligners for 22 hours per day, taking them out only during
meals and oral hygiene procedures. All patients were examined at monthly check-ups until comple-
tion of aligner treatment. During these monthly check-ups, compliance with the vibration protocol was
checked via the data recorded on their AcceleDent device. Patients who failed to reach the target 20
minutes were verbally motivated to do so."
Outcomes • Absolute value of prescription, i.e. difference between ‘ideal outcome’ and ‘pre-treatment’ measure-
ments, as a measure of the degree of planned movement (prescription = ideal outcome/pre-treat-
ment)
• Absolute value of imprecision, i.e. difference between ‘ideal’ and ‘post-treatment’ outcomes, as a
measure of the degree to which the movement achieved differed from the planned movement (im-
precision = ideal outcome/post-treatment)
• To determine the degree of tooth movement achieved with respect to the prescription, the following
formula was applied to each movement of each tooth: accuracy = 1 - imprecision/prescription values
Prescription and imprecision values were categorised according to tooth types (i.e. upper incisors, up-
per canines, upper premolars, upper molars, lower incisors, lower canines, lower premolars, lower mo-
lars) and type of movement (mesiodistal tipping, vestibulolingual tipping, and rotation). Movements
with a prescription of less than 2 degrees (determined a priori) were excluded from the analysis.
Notes Randomisation was done per participant, but statistical analysis was done per tooth.
Risk of bias
Random sequence genera- Low risk 3-arm block randomisation to ensure equal number of participants in each
tion (selection bias) study group.
Informed decisions.

Lombardo 2018 (Continued)
Page 2 "Stata statistical software (StataCorp LLC, College Station, Texas, USA)
was used to randomly allocate recruited patients to one of the three treatment
arms".
Allocation concealment Unclear risk No clear description of the allocation concealment

(selection bias)
Blinding of participants High risk Participants and clinicians were not blinded. This study used removable or-
and personnel (perfor- thodontic appliance, so compliance was essential; if the participants are not
mance bias) blinded that can lead to performance bias.
All outcomes
Blinding of outcome as- Low risk The investigator was blinded.

All outcomes

(attrition bias)
All outcomes
Selective reporting (re- Low risk Study registered in German Clinical Trials Register and all outcomes reported
porting bias)
Other bias Unclear risk "This study was supported by a research grant from the OrthoAccel Technolo-
gies, Inc. [(OATI), Bellaire, Texas]; the company was permitted to review this
manuscript, but the right to a final decision on the content was retained exclu-
sively by the authors."

Miles 2012

• Setting: private practice, Pennsylvania, United States of America
• Sample size calculation: calculated as 90% at 0.05 level to detect 20% faster alignment and reduction
in irregularity
Participants 66 participants with fixed orthodontic appliance 0.018 inch bracket slot system
• Age 11 to 15 years old

• Non-extraction treatment plan in the lower arch
• No impacted or unerupted teeth
• Participants living close to the orthodontic practice
Interventions Initial alignment of the lower anterior teeth using 0.018 x 0.025-inch bracket slot system brackets and
0.014-inch nickel titanium arch wire for 10 weeks.
Intervention
Vibration appliance (Tooth Masseuse), which provided a vibrational frequency of 11 Hz and 0.06N
(~6.1 g), applied immediately after the initial arch wire was placed, to accelerate the alignment of the
mandibular teeth. Participants instructed to use vibrational appliance daily for 20 minutes each ses-
sion.
Control
No vibration appliance
Informed decisions.

Miles 2012 (Continued)
Outcomes Improvement in alignment of mandibular teeth measured using LII at 4 time points (0, 5, 8 and 10
weeks)
Pain and discomfort measured on a VAS at 5 time points (0, 6-8 hours, 1 day, 3 days and 7 days)
Notes
Risk of bias
Random sequence genera- Low risk Randomly allocated in blocks of 6 as mentioned in page 214 "randomly as-
tion (selection bias) signed in blocks of six"

(selection bias)
Blinding of participants High risk Clinician and investigator blinded but not the participants as mentioned in
and personnel (perfor- page 216: "The clinician was blinded to the study participants at all appoint-
mance bias) ments. Identification numbers were assigned to the models prior to the mea-
All outcomes surements to ensure blinding". Lack of participant blinding could have influ-
enced their scoring on a VAS for discomfort.
Blinding of outcome as- Low risk Outcome assessors were blinded during assessment, as mentioned on page
sessment (detection bias) 216: "Identification numbers were assigned to the models prior to the mea-
All outcomes surements to ensure blinding"
Incomplete outcome data Unclear risk Dropouts: 2 out of 66 participants did not complete the trial. No mention of
(attrition bias) how missing data from participants who dropped out were dealt with, e.g. in-
All outcomes tention-to-treat analysis. We emailed study authors but received no response.
Selective reporting (re- Unclear risk No protocol published nor was the study registered
porting bias)
Although planned outcomes were reported, neither the P value for statistical
testing of data nor the confidence intervals were reported.

Miles 2016
Methods
• Study design: 2-arm parallel RCT

• Setting: private practice in Australia
• Sample size calculation: "a power analysis based on the arch perimeter data from an unpublished
study from the University of Texas Health Science Center at San Antonio (means, 1.32 mm per week
[SD, 1] vs 2.71 mm per week [SD, 1.42]) indicated that a sample size of 17 subjects per group (n = 34)
would be required to have 90% power at P = 0.05. A total of 20 subjects per group(n = 40) were recruited
to allow for approximately 10% dropouts from the study sample."
• Reliability: "10 randomly selected baseline models of subjects were measured again after a 2-week
interval. There were mean differences between measurements of 0.07 mm in arch perimeter, 0.10 mm
for the irregularity index, and 0.05 mm for the visual analog scale. The intra-class correlation coeffi-
cients were 0.98, 1.00, and1.00, respectively, indicating excellent measurement agreement."
Informed decisions.


Participants
• 40 participants (20 in each group) with fixed orthodontic appliance 0.018 inch bracket slot system
Inclusion criteria
• Children up to age 16
• Fully erupted dentition from first molar forward
• Erupted or erupting second molars
• No missing or previously extracted permanent teeth
• Undergoing comprehensive orthodontic treatment with full fixed appliances
• Class II malocclusion requiring extraction of 2 maxillary premolars but no mandibular extractions
Interventions From Miles 2016 article: "All patients were indirectly bonded with conventional 0.018-in slot, MBT pre-
scription brackets (Victory Series; 3M Unitek, Monrovia, Calif) on all mandibular teeth and the maxillary
premolars and molars, whereas the maxillary incisors and canines were bonded with MBT equivalent
prescription self-ligating In-Ovation C ceramic brackets (GAC International, Bohemia, NY)."
Mandibular arch alignment (Miles 2016):
"The archwires were identical in the 2 groups during the 10-week experimental period: a 0.014-in M5
Heaters thermal nickel-titanium wire (G&H Wire, Franklin, Ind)."
Maxillary arch space closure (Miles 2018):
"The maxillary first or second premolars were extracted after the brackets were placed but before
placement of the second 0.016x 0.022-inM5 Heaters thermal nickel-titanium wire (G&H Wire, Franklin,
Ind). Approximately 10 weeks later, a 0.016 x 0.022-in stainless steel wire with soldered posts (G&H
Wire) was placed and allowed to align for 5 weeks, and an elastomeric chain was placed to consolidate
the anterior 6 or 8 teeth. At the next visit, photos and alginate impressions of the maxillary arch were
taken for the baseline data. In subjects having extractions of first premolars, the second premolar was
tied with a stainless steel ligature that was left in place until the extraction space was closed.
A 9-mm nickel-titanium medium Sentalloy coil spring (GAC International) was placed across the extrac-
tion sites from the bracket hook on the first molar, and the spring was activated between 6 and 9 mm
and then ligated with a stainless steel ligature to the archwire hook mesial to the canine as per a pre-
vious study to deliver approximately 150 g, confirmed with a Dontrix gauge (E.T.M. Corporation, Mon-
rovia, CA). Based on how much space remained to be closed, patients were recalled at 5- to 8-week in-
tervals to reactivate the coil spring. New alginate impressions were taken when the spaces on 1 side
or both sides of the arch were almost but not fully closed; this was considered the end-point for this
study."
Intervention
Vibration forces to accelerate mandibular teeth alignment - AcceleDent Aura appliance for 20 minutes
per day
Control
No AcceleDent Aura appliance
Outcomes Miles 2016 article
• Change in the mandibular arch perimeter - measured from the distal contact of the mandibular ca-
nines and then to the labiolingual centres of each tooth (canine to canine) according to the unpub-
lished study from the University of Texas Health Science Center at San Antonio
• Change in the LII for the mandibular arch - LII measured at baseline, 5, 8 and 10 weeks
Informed decisions.

• Discomfort - participant-reported pain and discomfort VAS score at 5 time points (0, 6-8 hours, 1 day,
3 days and 7 days)
Miles 2018 article
• Rate of space closure in the maxillary arch
Miles 2020 article
• Full duration of treatment
Notes This study has 3 published articles reporting different outcomes.
Risk of bias
Random sequence genera- Low risk 2-arm block randomisation of 10

Page 930 "Randomization was performed using permuted blocks of 10 ran-
domly generated numbers with the random generation function in Excel (Mi-
crosoft, Redmond, Wash)".
Allocation concealment Low risk The allocation numbers were sealed in opaque envelopes and shuffled by a
(selection bias) staff member.
Blinding of participants High risk Study participants were not blinded to the intervention. Outcome measures
and personnel (perfor- included a patient-focused questionnaire regarding pain and discomfort,
mance bias) scored on a VAS by participants.
All outcomes
Blinding of outcome as- Low risk Outcome assessors were blinded during assessment.
All outcomes

(attrition bias)
All outcomes
porting bias)

Nahas 2017
Methods
• Study design: 2-arm parallel RCT

• Setting: university teaching hospital in Dubai, United Arab Emirates
• Sample size calculation: not mentioned
• Reliability: measurement error was evaluated by re-measuring the LII of 10 randomly selected casts on
two occasions separated by a 2-week interval. Both measurements performed by a single operator. A
Dahlberg test for reliability revealed no significant differences between the measurements (P > 0.05).
Informed decisions.

Nahas 2017 (Continued)

Participants 40 participants due to receive fixed orthodontic appliance treatment were recruited
Inclusion criteria: permanent dentition; requiring comprehensive orthodontic treatment, non-extrac-

tion treatment plan, a LII of ≥ 2 mm and ≤ 10 mm score (lower anterior crowding); medically fit with
good oral hygiene and healthy periodontium
Exclusion criteria: active periodontal disease, taking any medication that might affect bone metabo-
lism
Interventions All study participants had the following.
• Self-ligating bracket appliance (Empower; American Orthodontics, Inc.) with an MBT prescription and
slot size of 0.022 × 028 inches
• Orthodontic treatment without teeth extraction
• 0.016-in Heat Activated NiTi (HANT) initially placed and followed by a 0.018-in NiTi until alignment of
lower anterior teeth
• Recall every 2 weeks until good alignment of lower six anterior teeth was achieved
Intervention group
OrthoPulse LED device
"...received OrthoPulse device (LED source) from Biolux® Ltd (Vancouver, Canada) and were instructed
to use it daily for 20 min. The fitting procedures were performed by a single operator. The OrthoPulse
device produced light at a wavelength of 850 nm and a power output of 90 mW/cm2. The estimated ir-
radiation dose per session on the surface of the cheek was 108 J/cm2. Tracking software was integrat-
ed into the LED device to evaluate the compliance rate based on recordings of the numbers of sessions
performed by each participant. A minimum compliance rate of 80% was required."
Control group
No OrthoPlus
Outcomes Primary
• LII measured before and after alignment of the lower teeth. End of alignment defined as LII 0-1 mm
Notes Mandibular arch alignment only

Non-extraction
Study duration: March to December 2012
Measurements for LII done on study models
Risk of bias
Random sequence genera- Low risk Simple randomisation - participants asked to draw a sealed envelope that in-
tion (selection bias) dicated their allocation to a test or control group (each with 20 participants)
Paper page 131: "simple randomization by asking them to draw a sealed enve-
lope (n = 40) that indicated their allocation to a test group (n = 20) in which LED
photobiomodulation was delivered from an OrthoPulse device (Biolux® Ltd.,
Vancouver, Canada) or a control group (n = 20)"
Allocation concealment Unclear risk Paper stated that envelopes were sealed but did not mention if envelopes
(selection bias) were opaque.
Informed decisions.

Nahas 2017 (Continued)
Blinding of participants High risk Clinicians and participants were not blinded.
mance bias)
All outcomes
Blinding of outcome as- Low risk Single-blinded investigator

All outcomes
Incomplete outcome data High risk Dropouts: 2 from intervention group and 4 from control group. Intention-to-
(attrition bias) treat analysis was not applied.
All outcomes
porting bias)

NCT02868554
Methods Study design: single-blind parallel RCT, 3 arms

Setting: University of North Carolina Orthodontics, Chapel Hill, NC, USA
Sample size calculation: none mentioned
Participants Up to 30 orthodontic patients of the University of North Carolina Orthodontic Residency Program
People older than 18 years old, otherwise healthy, previously diagnosed with malocclusion
"Inclusion criteria:
1. Males or females over the age of 18 years old desiring orthodontic treatment.
2. Adult dentition with all upper and lower front teeth present and any premolar and molar combination
in the upper posterior of two teeth on each side.
3. Normal pulp vitality and healthy periodontal tissues as determined by intraoral exam.
4. Good health as determined by medical history.
5. Willingness and ability to comply with study procedures, attend study visits, and complete the study.
6. The ability to understand and sign a written informed consent form, which must be signed prior to
initiation of study procedures.
Exclusion criteria:
1. Patient under the age of 18 years old

2. Women may not be pregnant. Negative urine pregnancy tests prior to exposure to cone beam imaging
is required to verify pregnancy status.
3. Patients diagnosed with systemic diseases such as diabetes, hypertension (high blood pressure), tem-
poromandibular disorders (jaw disorders), or craniofacial syndromes.
4. Severe malocclusions that would require adjunctive procedures other than Invisalign. These include
impacted teeth, closure of extractions spaces.
5. Significant periodontal disease (> 4mm pocket depth or > 2 mm of recession on upper anterior teeth).
6. Active caries not under care of either a dentist or periodontist.
7. Chronic daily use of any non-steroidal anti-inflammatory medication, oestrogen, calcitonin, or corti-
costeroids.
8. History of use or current use of any bisphosphonate medication or other medication for treatment of
osteoporosis.
Informed decisions.

NCT02868554 (Continued)
9. Current smoker (must not have smoked in the last 6 months).
10.Failing to comply with research protocols"
Interventions 3 groups
Experimental: accelerated Invisalign
Participants receiving accelerated Invisalign therapy instructed to wear each aligner 24 hours day. Par-
ticipants permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
Experimental: accelerated Invisalign and vibration
In addition to the accelerated Invisalign protocol as above, participants undergo intraoral vibration
therapy using an AcceleDent Aura mouthpiece, which vibrates at 0.25 N (25 g) force level with a 30 Hz
frequency, for 20 min per day.
Control: standard Invisalign therapy
Participants receiving standard Invisalign therapy instructed to wear each aligner 24 h per day. Partici-
pants permitted to progress to the subsequent aligner after 14 days of compliant aligner wear.
Outcomes Primary
• LLI at baseline
• LLI at end of study, approx. 12 weeks
• Rate of OTM (difference in LII, mm/day at baseline and 12 weeks)
• Rate of OTM (total % change of LII at baseline and 12 weeks)
Secondary
• Activity of bone turnover markers during orthodontic tooth movement (quantitative polymerase
chain reaction, cycle threshold values (at 12 weeks)). Gingival crevicular fluid sampled to determine if
vibratory stimulation during orthodontic tooth movement increases activity of the Receptor Activator
of Nuclear Factor-KappaB (RANK), Receptor Activator of Nuclear Factor-KappaB Ligand (RANKL) and
Osteoprotegerin (OPG) cell signalling pathway.
• Mean patient discomfort score (at week 12) Research participants asked to complete questionnaire
at week 12. The FACES Pain Visual Analogue Pain Scale was used to assess pain on a 0 (no pain) to 10
(worst pain) grading scale.
Notes
Risk of bias
Random sequence genera- Low risk "An independent, third party biostatistician, using an electronic program, R
tion (selection bias) 3.4.2, completed randomisation of the subject allocation sequence. All sub-
jects enrolled within the study were randomised in blocks of 6 to the 3 groups
that correspond to one of the 3 treatment options to be studied."
Allocation concealment Low risk Allocation concealment was done by contacting the sequence generator for
(selection bias) assignment.
Blinding of participants High risk No placebo or sham device

mance bias)
All outcomes
Blinding of outcome as- Low risk Outcome assessors were blinded.

Informed decisions.

NCT02868554 (Continued)
All outcomes
Incomplete outcome data High risk 3 of the standard Invisalign group and 1 of the plus vibration group were lost
(attrition bias) to follow-up. It does not seem intention-to-treat analysis was used.
All outcomes
Selective reporting (re- Low risk Peer reviewed article not published yet
porting bias)

Pavlin 2015
Methods Study design: parallel RCT, 2 arms

Setting: unknown
Sample size calculation: "two-sided alpha of 0.05, and 80% power, a sample size of 16 subjects per
group (total of 32) was required to detect a statistically significant difference between the groups".
Participants 45 male and female participants
Inclusion criteria
• Aged between 12 and 40 years

• Participants had maxillary first premolars extracted as part of the orthodontic treatment
• Minimum of 3 mm of extraction space to be closed by distal movement of all 6 anterior teeth from
canine to canine or by distal movement of the canines
• Good oral hygiene and compliance
Exclusion criteria
• Any compromised medical or dental condition

• Participant currently involved in any other study, lives significantly outside San Antonio, or both
• Use of bisphosphonates
• Pregnant females
Interventions "45 participants were bonded 0.022 x 0.028 in twin brackets (MBT, 3M Unitek, St. Paul, MN). After initial
alignment, a mini-implant was inserted and immediately loaded with 180g of force, which produced
a predominantly translator canine movement, thus avoiding an unstable posterior dental anchorage
that would compromise accurate measurements. To avoid excessive occlusal interferences, the bite
was opened when necessary using composite build-ups. Separate canine retraction was performed on
0.018 in stainless steel (SS) archwire and en masse retraction with a 0.019 x 0.025 SS archwire."
Intervention group: OrthoAccel device provides a light vibration at 0.25 N and 30 Hz frequency for 20
min daily
Control group: inactive sham device that was held in the mouth for 20 min daily
Outcomes Primary
• Rate of orthodontic movement of a maxillary canine tooth being distalised to close an extraction space
Secondary
• Adverse effects during treatment
Informed decisions.

Pavlin 2015 (Continued)
Notes
Risk of bias
Random sequence genera- Low risk "A third-party vendor provided a computer-generated randomization schedule
tion (selection bias) with a block size of 4 and stratified to ensure that the number of subjects aged
12–19 years and aged 20–40 years, as well as the number of subjects with “sep-
arate canine retraction” versus “en masse retraction” were equally distributed
between the groups".

(selection bias)
Blinding of participants Low risk Participant blinding: intervention and sham device nearly identical
mance bias) Operator blinding: "both the investigators and the subjects remained blinded
All outcomes to treatment".
Blinding of outcome as- Low risk Outcome assessor blinding: "Masking: Single Blind (Outcomes Assessor)"
All outcomes "The device was programmed to the assigned treatment by independent site
personnel and both the investigators and the subjects remained blinded to
treatment".
Incomplete outcome data Low risk 9 out of 45 participants did not complete the trial. Intention-to-treat analysis
(attrition bias) was done. From the data, the authors state the number analysed as N = 45,
All outcomes with mention of the number of dropouts in each group.
Selective reporting (re- High risk We noticed that there was a disagreement in the reported outcome measures
porting bias) in the published article and results on ClinicalTrials.gov.
Other bias High risk The study was sponsored by OrthoAccel Technologies Inc, which is the manu-
facturer of the intervention appliance. The clinicaltrial.gov registration refers
to a time-limited agreement between the principal investigator and the spon-
sor to review results before release to public: "There is an agreement between
Principal Investigators and the Sponsor that the sponsor can review results
communications prior to public release and can embargo communications re-
garding trial results for a period that is less than or equal to 60 days. The spon-
sor cannot require changes to the communication and cannot extend the em-
bargo."

Reiss 2020
Methods
• Study design: parallel RCT, 2 arms

• Setting: university hospital
• Sample size calculation: post hoc power calculation based on biomarkers - 20 participants per group
would allow detection of a 0.91 SD difference between groups using a 2-sided 2-sample t-test with
80% power at the 5% significance level
Informed decisions.

Reiss 2020 (Continued)
• Reliability: one assessor. Two LII measurements for each cast were taken 1 week apart and averaged.
Intraclass correlation coefficients calculated to assess reliability were above 0.85, which suggests
good reliability.
Participants 40 participants (20 in each group) with fixed orthodontic appliance self-ligating 0.022 inch bracket slot
system
Inclusion criteria: healthy, non-smoker with no systemic medical conditions and taking no routine
medications; 15 to 35 years of age at the time of bonding; non-extraction treatment plan or no extrac-
tions required during the first 6 months of treatment; at least 5 mm of crowding in the mandibular arch;
full-complement dentition: first molar to first molar; good oral hygiene
Exclusion criteria: requiring extractions as part of their treatment plan; smoking or excessive alco-
hol consumption; with edentulous areas (missing teeth); evidence of periodontal disease (any pock-
et depths > 4 mm); use of anti-inflammatory drugs within 2 days of bonding; uncontrolled diabetes;
dentofacial deformities (cleft palate, hemifacial microsomia, etc); routinely taking any of the following
medications: corticosteroids (including for asthma), bisphosphonates, anti-inflammatory drugs such
as Ibuprofen, nicotine patch, oestrogen, opioids, growth hormone, relaxin, anti-coagulants, stimulants
(ADHD), diseases that could affect bone metabolism: parathyroid or thyroid dysfunction, osteoporosis
or, osteomalacia, vitamin D deficiency, fibrous dysplasia, Paget’s disease, multiple myeloma, osteogen-
esis imperfecta, history of bone metastasis
Interventions Intervention group
AcceleDent device use, according to manufacturer's instructions, for 20 min a day throughout study
Control group
No AcceleDent device
"Participants were bonded with Carriere passive self-ligating brackets (Henry Schein, Melville, New
York, USA), featuring a 0.022 Å~ 0.028-inch slot. After the initial bonding appointment (T0), participants
were scheduled for trial time points T1, T2, and T3 in conjunction with their regular orthodontic adjust-
ments with their primary orthodontic provider every 4 to 6 weeks.
At the bonding appointment (T0), a 0.014-inch copper–nickel–titanium wire was engaged into the
mandibular arch brackets and was re-engaged at the T1 appointment. Before the 0.014-inch cop-
per–nickel–titanium wire was retied at the T1 appointment, it was removed from the participant’s
mouth to verify that there was no permanent deformation that could confound the potential for low-
er incisor alignment. At T2, a 0.014 x 0.025-inch copper–nickel–titanium wire was engaged. After data
were collected at the T3 appointment, future wire size decisions were made by the primary orthodontic
provider as the participant was no longer considered to be part of the trial."
Outcomes
• Changes in expression of salivary biomarkers of bone remodelling. Saliva collected at T0 (baseline),

T1 (5-6 weeks), T2 (10-12 weeks), T3 (15-17 weeks). Saliva analysed for a variety of biomarkers (n = 17)
with protein quantified by ELISA assay at each time point for each participant
• Alignment of mandibular anterior teeth. At each study visit, alginate impressions taken. These models
analysed by 2 examiners to calculate the alignment based on LII, which measures the interproximal
contact displacement in mm between the anterior teeth segment from the mesial canine on one side
to the mesial aspect of the contralateral canine.
Notes Results missing for other outcomes mentioned in the study register on ClinicalTrials.gov, e.g. ortho-
dontic pain, oral health quality of life, tooth mobility
Risk of bias
Informed decisions.

Reiss 2020 (Continued)
Random sequence genera- Low risk Block randomisation stratification according to sex and intervention
"...randomization into the AcceleDent® or control group was performed sepa-
rately for male and female subjects..."
Allocation concealment Unclear risk Participants were asked to select from 40 opaque envelopes with allocation
(selection bias) group assignments inside; however, no description of allocation process safe-
guarding was mentioned.
Blinding of participants High risk No blinding of study participants or clinicians

mance bias)
All outcomes
Blinding of outcome as- Low risk Single assessor blinded to the study groups
All outcomes
Incomplete outcome data Low risk 3 dropouts. Intention-to-treat analysis

(attrition bias)
All outcomes
Selective reporting (re- High risk Study registered on ClinicalTrials.gov, but some planned outcomes not report-
porting bias) ed including orthodontic pain, tooth mobility and oral health quality of life
Other bias Unclear risk Study registry stated that two investigators will assess the models, but in the
published article, only one investigator was reported to have assessed the
models.
Post hoc sample size

Siriphan 2019
Methods
• Study design: parallel RCT, 3 arms

• Setting: Orthodontic Clinic, Faculty of Dentistry, Prince of Songkla University
• Sample size calculation: "based on the results of a RCT that investigated the effects of three difference
interventions on the rate of canine distalization (mean differences between methods = 0.35, 0.58 and
0.81 mm/month, difference in standard deviations = 0.34 mm/months, significance level = 0.05, power
= 0.90). A minimum of 15 individuals/group was required. We recruited 20 subjects/group to compen-
sate for dropout." The calculation was done using data from a study that did not use vibration forces.
• Reliability: measurements of 10 randomly selected records were repeated after a 4-week interval. The
level of significance was set at 0.05 for all analysis. Method error did not exceed 0.5 mm for linear vari-
ables and 0.5° for angular variables. Repeatability of measurement was acceptable (ICC = 0.86-0.99).
Participants 60 male and female participants aged between 8 and 24 years
Inclusion criteria
• Planning to have maxillary first premolar extraction followed by canine distalisation
Informed decisions.

Siriphan 2019 (Continued)
• Good general health
• Good oral health, no signs of periodontal disease
Exclusion criteria
• Excessive overbite
• History of immunosuppressive or bisphosphonate drugs ever
• History of anti-inflammatory or steroid drug use within the 6 months before beginning treatment
• Unable to continue treatment or presented periodontal problems during the study
Interventions Group 1: 30 Hz vibration
Group 2: 60 Hz vibration
Group 3: control
"...each patient was fitted with fixed orthodontic appliance 0.022- inch slot Roth's prescription pre-ad-
justed edgewise brackets (Roth system; Ormco Corporation, Orange, CA)...Arch wire 16x22 SS Force for
canine distalization 60 cN force was used to distalize the maxillary canine using a NiTi closed-coil spring
that was calibrated and reactivated every 4 weeks. Only one canine (left or right) per subject was ran-
domly selected for the study."
"Vibratory devices were fabricated from electric toothbrushes...The magnitude of vibration was 0.1 cN;
amplitude, 3.85 μm and acceleration, 9.81 m/s2...The average percentage coefficients of variation for
the 30 and 60 Hz devices were 0.06 ± 0.01 and 0.03 ± 0.01, respectively."
"From day 1 to day 7, all subjects were requested to attend the first investigator clinic daily. The maxil-
lary archwire was removed, and the tip of the vibratory stimulus device was lightly placed at the mesial
aspect of the cusp tip of the canine and switched on for 20 minutes. This procedure was also repeated
for the subjects in the control group, except the device was not switched on.
From day 8 to day 90, each subject was trained in self-administration of vibratory stimulus and provid-
ed a vibratory device of the allocated frequency. A daily reminder message was sent to the subjects’
mobile phones. Subjects were requested to attend the first investigator clinic every 4 weeks for appli-
ance activation and data collection."
Outcomes Primary
• Space closure canine distalisation in mm/month; measured digitally on scanned models. Rates of ca-
nine and first molar movement were calculated as distance between cusp tips and between central
pits, respectively, at T1 and T5 divided by treatment time
Secondary
• RANKL and OPG secretion T1-T5

• Canine rotation was calculated as the angle between the mid-sagittal line and a line passing through
the mesio-labio-incisal point angle to disto-labio-incisal point angle of the canine on the digital study
models. Angular changes between T1 and T5 were compared.
• Upper canines and molars tipping and angulation were measured using lateral cephalometric radi-
ograph T1 and T5.
T1: immediately before starting canine distalisation
T2: 24 hours from the start of canine distalisation
T3: 48 hours from the start of canine distalisation
T4: 7 days from the start of canine distalisation
T5: 3 months canine distalisation
Intraclass correlation ranged from 0.993 to 0.995.
Informed decisions.

Siriphan 2019 (Continued)
Notes Only 3 months of canine distalisation
No dropouts for the primary outcome but dropouts in the secondary outcome (8/60) RANKL and OPG
with per-protocol analysis
Risk of bias
Random sequence genera- Low risk 3-arm simple randomisation

Page 132 "a randomization schedule was generated by a card shuffling
method to randomly allocate the subjects into three groups".
Allocation concealment Unclear risk Not mentioned

(selection bias)
Blinding of participants High risk "The subjects and first investigator were not blinded to control/intervention
and personnel (perfor- group allocation. The subjects in the intervention groups were not aware of
mance bias) the frequency of vibration they were allocated to."
All outcomes
Blinding of outcome as- Low risk "All records collected were coded and shuffled to blind the co-researcher who
sessment (detection bias) performed data measurements."
All outcomes
Incomplete outcome data High risk No dropouts for the primary outcome. Dropouts in the secondary outcome
(attrition bias) (8/60) RANKL and OPG with per-protocol analysis.
All outcomes
Selective reporting (re- Low risk Study registered TCTR20170707004 in International Clinical Trial Registry Plat-
porting bias) form

Taha 2020
Methods
• Study design: single-centre parallel RCT, 2 arms

• Setting: university orthodontic clinic; Department of Orthodontics, School of Dental Medicine, Uni-
versity at Buffalo, NY
• Sample size calculation: calculated with reference to a prior study that reported a mean tooth move-
ment per 28 days with conventional brackets over a 0.018-in SS archwire as 1.17 ± 0.28 mm. To achieve
power of 80%, with significance level 0.05, a minimum of 20 participants per group was required.
• Reliability: to assess intra- and inter-examiner reliability, the same measurements on 10 participants
(5 control, 5 experimental) were repeated at a 1-week interval by the main investigator and by a tech-
nical specialist. Interclass correlation coefficients were calculated.
Participants 22 participants (11 in intervention group and 11 in control group) with fixed orthodontic appliance
0.022 inch MBT bracket slot system
Informed decisions.

Taha 2020 (Continued)
Inclusion criteria
• Healthy females and males between 12 and 17 years of age who were undergoing comprehensive
orthodontic treatment on both arches
• Cases treated with unilateral or bilateral maxillary first-premolar extraction; available canine retrac-
tion space of at least 3 mm
• Healthy teeth without any active caries or untreated lesions; healthy periodontal tissue (Modified Gin-
gival Index grades 0 or 1); normal pulp vitality of the teeth undergoing retraction force
• Good ability to understand and sign the informed consent form
Exclusion criteria
• Moderate-to-severe root resorption during orthodontic treatment

• Active periodontal disease
• Significant systemic condition, or used medications that may impact the study outcomes
Interventions "Participants had comprehensive treatment by banding and bonding all teeth using 0.022-in. slot edge-
wise (MBT) prescription. Once the provider prepared the case for maxillary unilateral or bilateral first-
premolar extraction (by levelling and aligning the teeth and/or by setting up anchorage methods), they
referred the subjects to oral surgery for tooth extractions. Within 1–2 weeks after extraction, canine re-
traction mechanics were applied using 0.018-in. stainless steel round wires (Ormco Corp., Orange, Cali-
fornia). NiTi closed coil springs (Dentos Inc., Daegu, South Korea) were attached from the band hook on
the first molar to the bracket hook on the canine and secured with a 0.010-in. stainless steel single tie.
The coil spring was activated to deliver 180 g of force measured by a Correx gauge (Haag-Streit, Bern,
Switzerland)".
Intervention group
AcceleDent Aura (OrthoAccel Technologies, Bellaire, TX, USA) generates small vibrations at 30 Hz and
0.2 N
Participants given direct instructions on operation and usage, being instructed to use their device for
20 min per day at around 7 pm
Control group
No vibrational appliance
Outcomes Rate of maxillary canine retraction per month and amount of tooth displacement at each time point. All
assessments and data collection were performed by the same investigator.
Time points: assessed at 4-week intervals. Follow-up time points: T0 = day of NiTi coil-spring delivery
and initial canine retraction; first three-dimensional (3D) intraoral scan; T1 = second intraoral scan, 4
weeks after T0; T2 = third intraoral scan, 8 weeks after T0; T3 = fourth intraoral scan, 12 weeks after T0.
"The maxillary dental arch and the palate, including all rugae, were digitally scanned using an intra-
oral 3D scanner (i-Tero Element II, Align Technology Inc., San Jose, California). Superimpositions and
measurements of canine movement were conducted using OrthoAnalyzer software (3Shape Orthodon-
tics System, Copenhagen, Denmark). For superimposition, three reference points were selected on the
third palatal rugae on the T0 maxillary digital model and on each follow-up scan magnified to 200%.
The sequence of points’ selection started systematically from the upper left quadrant to the right one
on each model. When the reference points were confirmed, the superimposition procedure was initiat-
ed using “dual view both sides on the same window” in the superimposition tool. Measurements were
then made between the tips of the canine cusps on the superimposed models."
Pain perception on day of activation, and every day at the same time for a period of 1 week using the
VAS from 1 to 10. In the experimental group, participants were specifically asked to report level of per-
ceived pain 1 h after using the device.
Compliance data on device use were collected at each visit by downloading tracking information on
the device.
Informed decisions.

Taha 2020 (Continued)
Notes Pain perception was assessed during canine retraction and not early in treatment.
Study not registered
Risk of bias
Random sequence genera- Low risk Using a simple randomisation method, random table generation in GraphPad
tion (selection bias) software (GraphPad, CA, USA) was carried out.
Allocation concealment Unclear risk No mention of the allocation process

(selection bias)
Blinding of participants High risk No blinding for participants nor the clinicians
mance bias)
All outcomes
Blinding of outcome as- High risk No blinding of assessor

All outcomes
Incomplete outcome data High risk 1 from intervention group. No intention-to-treat analysis
(attrition bias)
All outcomes
Selective reporting (re- High risk Study not registered; no protocol published
porting bias)

Telatar 2020
Methods Study design: parallel RCT
• Setting: Orthodonic Department of the Faculty of Dentistry at Akdeniz University, Turkey

• Sample size calculation: based on a prior study, which reported average monthly rate of tooth move-
ment as 1.16 mm/month (95% CI 0.86 to 1.46) in the AcceleDent Aura group and 0.79 mm/month (95%
CI 0.49 to 1.09) in the control group. Also, Miles 2018 suggested that a sample size of 7 participants
per group would be required. Based on these data, G*Power package software was used to determine
that at least 14 participants were required for control and case groups, with α = 0.05 type I error rate
for 80% power in d = 1.70 impact width.
• Reliability: correlation between measurements described with Spearman correlation coefficient. In-
terclass correlation (ICC) was 95%, which represents excellent measurement agreement.
Participants 20 participants aged 13–18 years and whose treatment also included first premolar extraction (10 fe-
males, 10 males), 12 in intervention group and 8 in control group, with fixed orthodontic appliance
0.022-inch MBT bracket slot system
Inclusion criteria: individuals referred to the Orthodonic Department of the Faculty of Dentistry at Ak-
deniz University between March 2016 and November 2016
Informed decisions.

Telatar 2020 (Continued)
Exclusion criteria: no details
Interventions "Each patient received MBT (technique according to McLaughlin, Bennett and Trevisi) preadjusted
edgewise brackets (Mini Master Series, American Orthodontics, Sheboygan, WI, USA) with 0.022 inch
slots on the canines and posterior teeth with a predetermined sequence of 0.014 inch, 0.016 inch, 0.018
inch, 0.016 x 0.022 inch, 0.017 x 0.025 inch, and 0.019 x 00.25 inch nickel–titanium (NiTi) wires inserted
and ligated. After the initial alignment stage, a 0.019 x 0.025-inch stainless steel wire was engaged pas-
sively to the buccal tubes and brackets and left in place for 1 month before commencing canine distal-
ization. Miniscrews were used for direct anchorage and were inserted between first molars and second
premolars.
NiTi coil springs were used to apply 200 retraction force immediately. To avoid excessive occlusal in-
terference, the bite was opened when necessary using composite build-ups. The total study duration
was 6 months and appointments were scheduled approximately every 4 weeks. The NiTi coil springs
were reactivated at each appointment."
Intervention group
AcceleDent Aura (OrthoAccel Technologies, Bellaire, TX, USA) generates small vibrations at 30 Hz and
0.2 N. Direct verbal and written instructions given on operation and usage, instructed to use device for
20 min per day
Control group
No vibrational appliance
Outcomes Rate of canine retraction (upper and lower)
"All linear measurements were recorded digitally with the 3D Trios® System (3Shape Inc., Copenhagen,
Denmark). Initial measurements were conducted after the levelling stage and prior to retraction of the
canine tooth. Linear measurements were performed between mesial edges of molar tubes and distal
edges of canine brackets."
Notes Orthodontic mini-screws were used for anchorage reinforcement.
Trial registration NCT04206267
Risk of bias
Random sequence genera- Unclear risk Simple randomisation was achieved by coin tossing. This is not recommended
tion (selection bias) in small sample studies.
Allocation concealment Unclear risk No mention of the allocation process

(selection bias)
Blinding of participants High risk No blinding

mance bias) "One investigator assigned the patients to study or control group and con-
All outcomes ducted the linear measurements with the 3D Trios® System, while another in-
vestigator treated the samples"
Blinding of outcome as- High risk "One investigator assigned the patients to study or control group and con-
sessment (detection bias) ducted the linear measurements"
All outcomes
Incomplete outcome data High risk No intention-to-treat analysis. Dropouts: 1 from intervention group
(attrition bias)
All outcomes
Informed decisions.

Telatar 2020 (Continued)
Selective reporting (re- Low risk Study registered at ClinicalTrials.gov (NCT04206267)
porting bias)

Woodhouse 2015
Methods • Study design: multi-centre 3-arm parallel RCT

• Setting: hospital: university teaching hospital King’s Dental Hospital, Brighton Hospital and William
Harvey Hospital
• Sample size calculation: done for primary outcome alignment rate based on previous data relating to
initial rate of orthodontic tooth movement using a Titanol aligning archwire (O'Brien 1990). Post hoc
power calculations were done for the secondary outcome pain, OIIRR and space closure.
• Reliability: reproducibility of OIIRR measurements determined by repeated measurements of 20 sets
of radiographs made 2 weeks apart from the same outcome assessor by calculating the intraclass cor-
relation coefficient (range 0.998-0.0976). For the study models LII measurements, 10 sets of baseline
models were selected and remeasured after 2 wk. Analysis of variance with random effects showed
high consistency in replications (F = 40.6; P < 0.0001). Intraclass correlation was 95% (CI, 91% to 99%).
For space closure and PAR measurements, agreement of repeated measurements was excellent by
the Bland-Altman limits of agreement (mean difference 0.05 mm) and the concordance correlation
coefficient (0.990). For pain, "each VAS score was measured on two separate occasions by the same
operator; with the mean taken as the representative value".
Participants 81 participants
Inclusion criteria
• Less than 20 years of age at start of treatment

• Medically fit and well
• In the permanent dentition
• Mandibular incisor irregularity
• Bilateral mandibular first premolar extractions as part of the treatment plan
Interventions Bonding method and fixed appliance standardised between groups (MBT prescription pre-coated 3M
Victory series, 3M Unitek, Monrovia, USA)
"After bracket bonding, a pre-determined sequence of 0.014-inch and 0.018-inch nickel titanium arch-
wires was used during the period of study. Archwire progression occurred only if full bracket engage-
ment was achievable, which required the relevant archwire to be fully tied into the base of the bracket
slot adjacent to each tie wing using elastomeric ligation".
"Space closure was initiated at the first visit after placement of a 0.019 x 0.025- in stainless steel work-
ing archwire and undertaken using 9-mm nickel-titanium coil springs attached from the first molar to
hooks placed on the archwire between lateral incisor and canine, and stretched to no more than twice
their length, as per the manufacturer's instructions".
Data were collected at the start of mandibular space closure, first visit after initiation of space closure,
end of space closure in the mandibular arch, and completion of treatment on removal of the fixed ap-
pliances. During the study, no bite planes, auxiliary arches, inter-maxillary elastics, headgears or tem-
porary anchorage devices were used. All participants were treated by consultant orthodontists or spe-
cialist registrars under their direct supervision.
Interventions
Group 1
Informed decisions.

Woodhouse 2015 (Continued)
Preadjusted edgewise fixed appliance treatment with 20 min daily use of an AcceleDent vibrational de-
vice (Accel group), a vibrational frequency of 30Hz and force of 0.2N to the dentition
Group 2
Preadjusted edgewise fixed appliance treatment with daily use of a nonfunctional AcceleDent device
(sham group)
Group 3
Preadjusted edgewise fixed appliance treatment alone (fixed only group)
Outcomes Primary
• Rate of tooth alignment in the mandibular arch using LII/day
Secondary
• Number of visits
• Rate of mandibular space closure mm/month
• Severity of OIIRR in mm
• Patient perception of pain using VAS
• Duration of full treatment in months
• Peer Assessment Rating (PAR) score reduction
Notes This study has four published articles reporting different outcomes.
Risk of bias
Random sequence genera- Low risk Simple randomisation: computer-generated randomisation sequence. No re-
tion (selection bias) stricted randomisation or stratification was used.
"The randomization sequence was generated by one investigator (MTC) us-

ing GraphPad online software with unrestricted equal participant allocation
(1:1:1)"
Allocation concealment Low risk Participant allocation undertaken centrally at King's College London, indepen-
(selection bias) dently from the clinical operators after recruitment.
Blinding of participants Low risk Clinicians were blinded as well as the study participants with the use of a sham
and personnel (perfor- appliance in one of the study groups.
mance bias)
All outcomes
Blinding of outcome as- Low risk Outcome assessor blinded

All outcomes Page 4: "The pain questionnaires and extracted data were coded appropriate-
ly, so that both outcome assessor (NRW) and statistician (SNP) were blinded
to subject allocation. The coding of the data was broken after the end of the
analysis and no breach of blinding was identified."
Incomplete outcome data Low risk The dropouts were minimal in most outcomes other than space closure (n =
(attrition bias) 21), treatment duration (n = 20) and PAR score (n = 22). Although the analy-
All outcomes sis was done "per-protocol", the authors reported that a separate sensitivity
analysis was performed with the intention-to-treat sample, by including all ex-
cluded participants with available data, and compared with the main analysis
for robustness, with no significant difference.
Informed decisions.

Woodhouse 2015 (Continued)
Selective reporting (re- Unclear risk According to the study registration NCT02314975, OIIRR was planned for
porting bias) mandibular incisors but published data was for maxillary central incisors. We
contacted the author who responded that he is unsure why the study registra-
tion states that mandibular incisors will be assessed.
ADHD: attention deficit hyperactivity disorder; ANOVA: analysis of variance; AOB: anterior open bite; ASA: acetylsalicylic acid; CBCT:
cone beam computerised tomography; CI: confidence interval; cm: centimetres; CT: computerised tomography; e.g.: for example; ELISA:
enzyme-linked immunosorbent assay;F: female; FMA: Frankfort-mandibular plane angle; FPBB: fixed posterior bite block; g: grams;
Gp: group; h: hour; HANT: heat activated nickel titanium; HIV: human immunodeficiency virus; Hz: hertz; ICC: intraclass correlation
coefficient; in: inches; IPR: interproximal reduction; J/cm2: joules per square centimetre; LED: light emitting diode; LII: Little's Irregularity
Index; LLL: low level laser; LLLI: low level laser irradiation; LLLT: low level laser therapy; LAIP: levelling and alignment improvement; M;
male; min: minutes; MBT: McLaughlin-Bennet-Trevisi; MD: mean difference; mm: millimetres; MPR: midpalatal raphe; mW: megawatt; n:
number; N: newtons; NiTi: nickel titanium; nm: nanometre; NRS: numerical rating scale; NSAIDs: non-steroidal anti-inflammatory drugs;
OIIRR: orthodontically induced inflammatory root resorption; OLAT: overall levelling and alignment time; OPG: osteoprotegerin; OTM:
orthodontic tooth movement; PFBB: posterior fixed bite blocks; PBM: photobiomodulation; PDT: photodynamic therapy; RANK: receptor
activator of nuclear factor-kappaB; RANKL: receptor activator of nuclear factor kappa-B ligand; RCT: randomised controlled trial; sec:
seconds; SD: standard deviation; SS: stainless steel; T: time point; TMJ: temporomandibular joint; VAS: visual analogue scale; v: version;
W: watt; wk: weeks; 3D: three-dimensional.

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion
Abd 2019 Systematic review
Abellan 2016 Split-mouth study design
ACTRN12616000829415 Split-mouth study design
ACTRN12619001237178 Split-mouth study design
Al-Jundi 2018 The laser therapy was used for an invasive procedure, which involved cutting tunnels in the at-
tached gingiva.
AlShahrani 2019 Systematic review
Celebi 2019 Did not assess orthodontic tooth movement
Cronshaw 2019 Systematic review
CTRI201804013228 Split-mouth study design. The intervention (laser) was applied as part of a split-mouth RCT com-
paring self-ligating brackets versus conventional brackets.
CTRI201804013520 Split-mouth study design
Dalaie 2015 Split-mouth study design
Elmotaleb 2019 Systematic review
Fernandes 2019 Not an RCT
Goymen 2020 Not an RCT
Informed decisions.

Study Reason for exclusion
IRCT138804022066N1 Split-mouth study design
Isola 2019 Split-mouth study design
JPRN-UMIN000013722 Split-mouth study design - mentioned cross-over design. The authors were contacted to confirm
but with no response.
Kansel 2014 Split-mouth study design
Kau 2013 Not clear from the published article if the study was an RCT. The main author was contacted who
confirmed that it was not.
Lo Giudice 2019 Did not assess orthodontic tooth movement
Lobre 2016 Did not assess orthodontic tooth movement
Lyu 2019 Systematic review
Matys 2020 Did not assess orthodontic tooth movement
Michelogiannakis 2019 Systematic review
Mistry 2020 Split-mouth study design
NCT02181439 Split-mouth study design
NCT02606331 Split-mouth study design
Prasad 2019 Did not assess orthodontic tooth movement
Shipley 2019 Retrospective study
Yang 2019 Animal study
Yassaei 2019 Systematic review

WHAT'S NEW

Date Event Description
20 June 2023 New search has been performed Search updated, search date 6 September 2022.
20 June 2023 New citation required and conclusions 4 new studies included. There is slight change in the conclusions
have changed - we have concluded "there may be benefit from photobiomodu-
lation application for accelerating discrete treatment phases".
Informed decisions.

HISTORY
Protocol first published: Issue 12, 2013
Review first published: Issue 11, 2015
CONTRIBUTIONS OF AUTHORS
Identifying relevant titles and abstracts from searches: Ahmed El-Angbawi (AE), Grant T McIntyre (GM), David R Bearn (DB)
Obtaining copies of trials: AE, GM
Selection of trials: AE, PF, DB
Extracting data from trials: AE, GM
Entering data into RevMan: AE
Carrying out risk of bias assessment: AE, GM
Carrying out analysis: AE
Interpreting the data: all review authors
Drafting the final review: all review authors
DECLARATIONS OF INTEREST
There are no financial conflicts of interest; the review authors declare that they do not have any association with any parties who may
have vested interests in the results of this review.
SOURCES OF SUPPORT
Internal sources
• Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester; Manchester
Academic Health Sciences Centre (MAHSC); and the NIHR Manchester Biomedical Research Centre, UK
Support from Cochrane Oral Health at the University of Manchester
External sources
• National Institute for Health Research (NIHR), UK
This project was supported by the NIHR, via Cochrane Infrastructure funding to Cochrane Oral Health. The views and opinions expressed
herein are those of the review authors and do not necessarily reflect those of the Evidence Synthesis Programme, the NIHR, the National
Health Service, or the Department of Health and Social Care.
• Cochrane Oral Health Global Alliance, UK
The production of Cochrane Oral Health reviews has been supported financially by our Global Alliance since 2011 (ohg.cochrane.org/
partnerships-alliances). Contributors over recent years have been: British Association for the Study of Community Dentistry, UK; British
Society of Paediatric Dentistry, UK; the Canadian Dental Hygienists Association, Canada; Centre for Dental Education and Research at
All India Institute of Medical Sciences, India; National Center for Dental Hygiene Research & Practice, USA; New York University College
of Dentistry, USA; NHS Education for Scotland, UK; Swiss Society for Endodontology, Switzerland.
DIFFERENCES BETWEEN PROTOCOL AND REVIEW
The search strategy was revised and re-run from scratch in September 2022; it was expanded to include more interventions (light-emitting
diodes, chewing gums and muscle training).
There are no significant changes in the current review methodology compared to the methodology published in the protocol in 2013.
However, the primary outcomes were described in more detail. We clarified that our SoF tables would report on pain as a patient-centred
outcome (rather than oral health related quality of life).
NOTES
This is an update of a previously published review (El-Angbawi 2013; El-Angbawi 2016).
INDEX TERMS
Medical Subject Headings (MeSH)

Cuspid; Pain Measurement; Randomized Controlled Trials as Topic [instrumentation]; Time Factors; Tooth Movement Techniques
[adverse effects] [*methods]; Vibration [*therapeutic use]
Informed decisions.

MeSH check words

Adolescent; Child; Female; Humans; Male; Young Adult

Non-Surgical Adjunctive Interventions For Accelerating Tooth Movement in Patients Undergoing Orthodontic Treatment CR

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El-Angbawi A, McIntyre G, Fleming PS, Bearn D

El-Angbawi A, McIntyre G, Fleming PS, Bearn D.

Non-surgical adjunctive interventions for accelerating tooth movement

Ahmed El-Angbawi1, Grant McIntyre2, Padhraig S Fleming3, David Bearn2

Contact: Ahmed El-Angbawi, aelangbawi@outlook.com.

Editorial group: Cochrane Oral Health Group.

Data collection and analysis

Certainty of the evidence

Certainty of the evidence

Our certainty about the evidence is low to very low.

Population: adolescents and adults with malocclusion undergoing orthodontic treatment

Settings: teaching university hospitals and private practice

Comparison: conventional orthodontic appliance treatment

Outcomes Anticipated absolute effects Relative effect No of partici- Certainty of Comments

Cochrane Database of Systematic Reviews

Cochrane Database of Systematic Reviews

Pain perception after fitting the second aligning arch-

gesics reported need 4.53)

GRADE Working Group grades of evidence

Cochrane Database of Systematic Reviews

Population: adolescents and adults with malocclusion undergoing orthodontic treatment

Settings: teaching university hospitals

Comparison: conventional orthodontic treatment

Outcomes Illustrative comparative risks* Relative effect No of partici- Certainty of Comments

Cochrane Database of Systematic Reviews

Cochrane Database of Systematic Reviews

OTM was assessed during canine distalization/space

Ghaffer 2022 reporetd no increase or decrease in pain

Alam 2019 using a mix of different types of orthodon-

Patient-report- Not reported

Harms and side Not reported

Cochrane Database of Systematic Reviews

GRADE Working Group grades of evidence

Population: adolescents and adults with malocclusion undergoing orthodontic treatment

Settings: teaching university hospitals

Intervention: LED as an adjunctive intervention to conventional orthodontic treatement

Comparison: conventional orthodontic treatment

Outcomes Illustrative comparative risks* Relative effect No of partici- Certainty of Comments

Cochrane Database of Systematic Reviews

Orthodontic tooth move- Not reported

One study (Farhadian 2021) found LED in-

Patient-reported need for Not reported

Harms and side effects Not reported

Cochrane Database of Systematic Reviews

GRADE Working Group grades of evidence

BACKGROUND appliance and used by the patient on a daily or weekly basis

Figure 1. Study flow diagram

1902 records left

1902 records 1771 records

Characteristics of design Most studies involved treatment with fixed orthodontic

Blinding of participants and personnel (performance bias): All outcomes

Selective reporting (reporting bias)

Random sequence generation (selection bias)

0% 25% 50% 75% 100%

Low risk of bias Unclear risk of bias High risk of bias

Pain and discomfort during treatment: space closure Quality of life

a randomized controlled trial. International Orthodontics movement. clinicaltrials.gov/ct2/show/NCT00830947 (first

ACTRN12616000829415 {published data only} Elmotaleb 2019 {published data only}

AlShahrani 2019 {published data only} IRCT138804022066N1 {published data only}

Celebi 2019 {published data only} IRCT2015030921406N1 {published data only}

TrialID=IRCT2015072923401N1 (first received 16 June Michelogiannakis 2019 {published data only}

De Almeida 2016 postadolescent borderline patients. American Journal of

Germec 2008 Maizeray 2021