Accepted: 25 February 2017

DOI: 10.1111/ocr.12177

ORIGINAL ARTICLE

Efficiency, effectiveness and treatment stability of clear

aligners: A systematic review and meta-­analysis

M. Zheng1 | R. Liu2 | Z. Ni1 | Z. Yu1

1
Department of Orthodontics, Hospital of
Stomatology, Wenzhou Medical University, Structured Abstract
Wenzhou, China Objectives: The objective of this study was to perform a systematic review of the or-
2
Wenzhou Medical University, Wenzhou,
thodontic literature with regard to efficiency, effectiveness and stability of treatment
China
outcome with clear aligners compared with treatment with conventional brackets.
Correspondence
Methods: An electronic search without time or language restrictions was undertaken
Z. Yu, Department of Orthodontics, Hospital
of Stomatology, Wenzhou Medical University, in October 2014 in the following electronic databases: Google Scholar, the Cochrane
Wenzhou, China.
Oral Health Group’s Trials Register, Scopus, CENTRAL, MEDLINE via OVID, EMBASE
Email: wzmczy@126.com
via OVID and Web of Science. We also searched the reference lists of relevant arti-
cles. Quality assessment of the included articles was performed. Two authors were
responsible for study selection, validity assessment and data extraction.
Results: Four controlled clinical trials including a total of 252 participants satisfied the
inclusion criteria. We grouped the trials into four main comparisons. One randomized
controlled trial was classified as level 1B evidence, and three cohort studies were clas-
sified as level 2B evidence. Clear aligners appear to have a significant advantage with
regard to chair time and treatment duration in mild-­to-­moderate cases based on sev-
eral cross-­sectional studies. No other differences in stability and occlusal characteris-
tics after treatment were found between the two systems.
Conclusions: Despite claims about the effectiveness of clear aligners, evidence is gen-
erally lacking. Shortened treatment duration and chair time in mild-­to-­moderate cases
appear to be the only significant effectiveness of clear aligners over conventional sys-
tems that are supported by the current evidence.

KEYWORDS
clear aligner, comparative effectiveness research, orthodontic appliances, systematic review,
treatment outcome

1 | INTRODUCTION
The first clear aligner was introduced by Kesling1 in the early 1940s.
However, it did not gain much popularity because of scepticism and
the lack of promotion at that time. With the development of dental
materials and 3D technology, clear aligners became more popular.
Many advantages have been claimed of this type of appliance over
conventional edgewise appliances. The greatest advantage of this ap-
pliance, compared to fixed orthodontic appliances, is improved aes-
thetics and comfort for the patient. For these reasons, patients who
care about their appearance or their speech are good candidates for
treatment with clear aligners. However, clear aligners have some dis-
advantages, including higher costs and the inability to treat certain
types of malocclusion.2-4
Few clinical studies have been published that adequately assessed
the effectiveness of treatment with clear aligners leaving uncertainty
among clinicians about the effectiveness of the appliance. McNamara
and others stated that more studies are needed to expand the under-
standing of the clinical applicability of clear aligners.2-4 Additionally,
there is a paucity outcome studies in a case-­controlled research design.

Orthod Craniofac Res. 2017;1–7. wileyonlinelibrary.com/journal/ocr © 2017 John Wiley & Sons A/S. | 1
Published by John Wiley & Sons Ltd
2 | ZHENG et al.

Published articles are mainly case reports and case series studies and TABLE 2 Search strategy
5-9
descriptions of the use of the system. This made it difficult for clini- 1. exp clear aligners
cians to objectively compare the efficiency and effectiveness of clear
2. “conventional brackets”.mp.
aligners as well as treatment outcome relative to standard fixed appli-
3. clear aligners or invisalign.mp.
ances. Thus, clinicians who plan to use clear aligners on their patients
4. “effect* or effic*”.mp.
have to rely on their clinical experience, the opinions of experts and
5. (clear aligners adj3 clear aligners effect) or (conventional brackets
limited published evidence.10
adj3 conventional brackets effect*) or (clear aligners adj3 (clear
The aim of this systematic review was to identify and review the aligners effic*).mp.
orthodontic literature with regard to the efficiency (treatment time, 6. Or/1-­5
chair time), effectiveness (occlusal indices) and long-­
term stability
The above subject search was linked to the Cochrane Highly Sensitive
of treatment with clear aligners. If the data allowed, a meta-­analysis Search Strategy (CHSSS) for identifying randomised trials in
would be performed. MEDLINE: sensitivity maximising version (2008 revision) as
referenced in Chapter 6.4.11.1 and detailed in box 6.4.c of the
Cochrane Handbook for Systematic Reviews of Interventions,
Version 5.1.0 [updated March 2011]:
2 | MATERIAL AND METHODS
1. randomized controlled trial.pt.
2. controlled clinical trial.pt.
This systematic review and meta-­analysis were conducted accord- 3. randomized.ab.
ing to the guidelines of the Preferred Reporting Items for Systematic 4. placebo.ab.
reviews and Meta-­Analyses (PRISMA) statement and the Cochrane 5. drug therapy.fs.
6. randomly.ab.
Handbook. A review protocol does not exist.
7. trial.ab.
The inclusion and exclusion criteria for admittance in the system- 8. groups.ab.
atic review are presented in Table 1. 9. or/1-8
An electronic search without time or language restrictions was 10. exp animals/not humans.sh.
11. 9 not 10
undertake in October 2014 in the following electronic databases:
Google Scholar, the Cochrane Oral Health Group’s Trials Register,
Scopus, CENTRAL, MEDLINE via OVID, EMBASE via OVID and Web Papers included in the final review were assessed using the fol-
of Science. Detailed search strategies were developed for each data- lowing parameters: (i) study design; (ii) sample details; (iii) outcome
base searched. These were based on the search strategy developed for measures; (iv) author’s conclusions; and (v) level of scientific evi-
MEDLINE (OVID) but revised appropriately for each database (Table 2). dence based on the criteria of the Oxford Centre for Evidence-­based
A manual search of orthodontic journals including American Medicine11 (see Table 3).
Journal of Orthodontics and Dentofacial Orthopedics, European At least two review authors assessed all included studies, to con-
Journal of Orthodontics, Angle Orthodontist, Journal of Orthodontics firm eligibility, assess risk of bias and extract data. The following data
and World Journal of Orthodontics were also performed. were extracted: study design, participants, intervention, outcome
We checked the bibliographies of included papers and relevant re- measure.
view articles for studies not identified by the search strategies above. Meta-­
analyses would also be possible only on studies report-
We contacted the authors of identified and included studies to iden- ing the same outcome measures. A meta-­
analysis was performed
tify unpublished or ongoing trials. to combine comparable results in each category using Review
At least two review authors independently scanned the list of titles Manager (version 5.2.11, The Nordic Cochrane Centre, The Cochrane
and abstracts of potentially eligible studies. For studies appearing to Collaboration, Copenhagen, Denmark, 2014). Heterogeneity was as-
meet the inclusion criteria, for which there were insufficient data in sessed among the included studies. Results with less heterogeneity (I2
the title and/or abstract to make a clear decision, the full paper was statistics<50%) were presented with a fixed-­effects model, whereas
obtained. Disagreements were resolved by discussion or judged by a results with I2>50% utilized a random-­effects model. Weighted mean
third reviewer. differences were used to construct forest plots of continuous data.

TABLE 1 Inclusion and exclusion criteria

Inclusion criteria Exclusion criteria

Study design: Prospective and retrospective original studies on human (1) Animal studies; (2) studies with no comparison group; and (3)
subjects with permanent dentition (minimum chronological age of 15 y). editorials, opinions, or treatment philosophy articles with no subjects.
Participants: Patients treated with clear aligners or conventional brackets.
Interventions: Treatment involving clear aligners or conventional brackets.
Outcome measures: Treatment duration, occlusal indices and stability of
treatment related to both clear aligners and conventional brackets.

TABLE 3 Oxford centre for evidence-­based medicine levels of evidence
Therapy/prevention, aetiology/
Level harm
1a SR (with homogeneity) of RCTs
1b Individual RCT (with narrow
Confidence Interval)
1c All or none
2a SR (with homogeneity) of cohort
studies
2b Individual cohort study (including
low quality RCT; e.g., <80%
follow-­up)
2c “Outcomes” Research; Ecological
studies
3a SR (with homogeneitya) of
case-­control studies
3b Individual Case-­Control Study
4 Case-­series (and poor quality
cohort and case-­control studies)
5 Expert opinion without explicit
critical appraisal, or based on
physiology, bench research or
“first principles”
Produced by Bob Phillips, Chris Ball, Dave Sackett, Doug Badenoch, Sharon Straus, Brian Haynes, Martin Dawes since November 1998. Updated by Jeremy Howick March 2009.
Prognosis
SR (with homogeneity) of
inception cohort studies;
validated in different populations
Individual inception cohort study
with > 80% follow-­up; validated
in a single population
All or none case-­series
SR (with homogeneity) of either
retrospective cohort studies or
untreated control groups in RCTs
Retrospective cohort study or
follow-­up of untreated control
patients in an RCT; Derivation of
RCT or validated on split-­samples
only
“Outcomes” Research
Case-­series (and poor quality
prognostic cohort studiesb)
Expert opinion without explicit
critical appraisal, or based on
physiology, bench research or
“first principles”
Diagnosis
SR (with homogeneity) of Level 1
diagnostic studies; with 1b studies from
different clinical centres
Validating cohort study with good
reference standards; or tested within
one clinical centre
SR (with homogeneity) of Level >2
diagnostic studies
Exploratory cohort study with good
reference standards; after derivation, or
validated only on split-­samples or
databases
SR (with homogeneity) of 3b and better
studies
Non-­consecutive study; or without
consistently applied reference standards
Case-­control study, poor or non-­
independent reference standard
Expert opinion without explicit critical
appraisal, or based on physiology, bench
research or “first principles”
Differential diagnosis/
symptom prevalence study
SR (with homogeneity) of
prospective cohort studies
Prospective cohort study with
good follow-­up
All or none case-­series
SR (with homogeneity) of 2b
and better studies
Retrospective cohort study, or
poor follow-­up
Ecological studies
SR (with homogeneity) of 3b
and better studies
Non-­consecutive cohort
study, or very limited
population
Case-­series or superseded
reference standards
Expert opinion without
explicit critical appraisal, or
based on physiology, bench
research or “first principles”
ZHENG et al.
Economic and decision analyses
SR (with homogeneity) of Level 1
economic studies
Analysis based on clinically sensible
costs or alternatives; systematic
review(s) of the evidence; and including
multi-­way sensitivity analyses
Absolute better-­value or worse-­value
analyses
SR (with homogeneity) of Level >2
economic studies
Analysis based on clinically sensible
costs or alternatives; limited review(s)
of the evidence, or single studies; and
including multi-­way sensitivity analyses
Audit or outcomes research
SR (with homogeneity) of 3b and better
studies
Analysis based on limited alternatives or
costs, poor quality estimates of data,
but including sensitivity analyses
incorporating clinically sensible
variations.
Analysis with no sensitivity analysis
Expert opinion without explicit critical
appraisal, or based on economic theory
or “first principles”
|
3
4 | ZHENG et al.

Identification
Records identified through Additional records identified
database searching through other sources
(n=239) (n=0)

Records after duplicates removed

(n=226)
Screening

Records screened Records excluded

(n=226) (n=201)

Full-text articles assessed Full-text articles excluded,

for eligibility with reasons
Eligibility

(n=25) (n=21)

Reasons: case report, no

controlled trial, no control
Studies included in group, animal study
qualitative synthesis
(n=4)
Included

Studies included in
quantitative synthesis
(meta-analysis)
(n=2) F I G U R E 1 Identification screening
eligibility included

Odds ratios were used for dichotomous data. If there were enough was randomized and was judged as 1B evidence level due to the small
trials (more than 10) included in any meta-­analysis, publication bias sample size. Thus, conclusions with a limited level of evidence could
was to be assessed according to the recommendations on testing for be drawn from the review process.
funnel plot asymmetry as described in the Cochrane Handbook.

3.3 | Effects of interventions

3 | RESULTS
3.1 | Description of studies
We initially identified a total of 239 references and 25 reports of trials
as eligible according to the defined inclusion criteria for this review.
The full text of 25 articles led to the exclusion of 21 because they did
not meet the inclusion criteria (15 were case reports, four were not
including a control group and two were laboratory studies). Additional
handsearching of the reference lists of selected studies did not yield
additional papers. Thus, a total of four studies were included in the
review.12-15 The article selection process is illustrated in the PRISMA
Flow Diagram (Figure 1). The details of each study are presented in
Table 4.
3.2 | Quality analysis
Among the four included papers, three were cohort studies with a
good follow-­up and were classified as level 2B evidence according to
the Oxford Centre for Evidence-­Based Medicine criteria. One study
3.3.1 | Total treatment time
Three studies12-14 compared total treatment time. When analysing the
average treatment duration for the two groups, Figure 2 shows the
results of the meta-­analysis from the three eligible studies. The treat-
ment duration of the braces group was significantly longer than that
of the Invisalign group.
3.3.2 | Chair time, appointments and emergency
visits time
One study13 compared the time efficiency of aligner therapy and con-
ventional edgewise braces based on a large sample of patients treated
by the same highly experienced orthodontist, with the same treat-
ment goals for both groups of patients. They found that treatment
with conventional edgewise brackets required significantly more vis-
its (approximately 4.0), more emergency visits (1.0), more emergency
chair time (7.0 minutes) and a greater total chair time (93.4 minutes),
compared to aligner therapy.
ZHENG et al. | 5

3.3.3 | Treatment outcomes

Evidence
Only one study14 that included a control group assesses the treatment

Level

2B

1B

2B

2B
outcome of Invisalign relative to conventional braces. The American
Board of Orthodontics Objective Grading System (OGS) was used

Treatment with conventional edgewise brackets required significantly more

inclination, occlusal contacts, occlusal relationships and overjet. According

chair time (7.0 minutes) and a greater total chair time (93.4 minutes), than
to the OGS, Invisalign did not treat malocclusions as well as braces in this
Aligner scores were consistently lower than braces scores for buccolingual

visits (approximately 4.0), more emergency visits (1.0), more emergency

Invisalign were its ability to close spaces and correct anterior rotations
to systematically grade post-­treatment records in this study. It was

sample. The latter was especially deficient in its ability to correct large

Patients treated with Invisalign relapsed more than those treated with
Aligner treatment followed by treatment with fixed appliances might
found that the Invisalign group lost 13 OGS points more than the

anteroposterior discrepancies and occlusal contacts. Strengths of

require more time than treatment with fixed appliances alone.

braces group on average. Invisalign scores were consistently lower
than braces scores for buccolingual inclination, occlusal contacts, oc-
clusal relationships and overjet. According to the OGS, Invisalign did
not treat malocclusions as well as braces in this sample.

3.3.4 | Stability
Outcome and authors conclusions

Only one study15 compared the post-­retention dental changes between

conventional fixed appliances.

and marginal ridge heights.

patients treated with Invisalign and those treated with conventional

fixed appliances. They found that the change in the total alignment score
in the Invisalign group was significantly larger than that for the Braces
aligner therapy.

group. There were significantly larger changes in maxillary anterior align-

ment in the Invisalign group than in the conventional bracket group.

4 | DISCUSSION
treatment with fixed appliances
American Board of Orthodontics

American Board of Orthodontics

Treatment duration, chair time
Objective Grading System

Objective Grading System

In this systematic review, we aimed to provide data on the efficiency (treat-

Time required for aligner
treatment followed by

ment time, chair time), effectiveness (occlusal indices) and stability of treat-
Outcome measure

ment with clear aligners compared with conventional brackets. We hoped

to give clinicians a better understanding how well clear aligners work.

4.1 | Quality of the studies in this review

follow-­up time

We identified three cohort studies with 2B evidence according to the

Length of

Oxford Centre for Evidence-­Based Medicine criteria and one rand-

19 mo

17 mo

omized controlled trial with 1B evidence level. The evidence for each
2y

3y

outcome of interest, however, was sparse, with only one analysis

combining data from more than three studies. Many of the trials were
23-­33 y

18-­54 y

16-­29 y

26-­36 y
sample
Age of

small (mean number of participants 63, range 24-­150) and may have
had insufficient participants to determine a statistically significant
difference between interventions, or between intervention and con-
Sample

trol, if in fact this was present. Furthermore, not any study reported a
48

24

48
150
size

power analysis. We intended to assess publication bias, but only four

Sample type

Consecutive

Consecutive

Consecutive
Randomized

studies for each outcome were too few to do so.

Summary of included studies

4.2 | Summary of main results

Cohort study

Cohort study

Cohort study
Study design

Four controlled clinical trials including a total of 252 participants satis-

fied the inclusion criteria for this review. We grouped the trials into
RCT

four main comparisons.

Buschang201413
Baldwin 200812

Kuncio 200715

4.2.1 | Total treatment time

Djeu 200514
First author
TABLE 4

Meta-­analysis of the influence of bracket type on total treatment

time confirmed that clear aligners have clinically significant shorter
6 |
FIGURE 2 The meta-­analysis of total treatment time
treatment duration. Djeu14 found that the treatment time for the
braces group (1.7 years) was significantly longer than that for the
13
Invisalign group (1.4 years). Buschang found that Invisalign treatment
duration was 67% shorter than treatment with conventional edgewise
braces. Aligner treatment lasted 11.5 months, whereas treatment with
conventional edgewise braces required 17 months, but this could be
the result of having more severe cases in the conventional appliance
group. Baldwin12 found for premolar extraction cases that clear aligner
treatment followed fixed appliance treatment required more time than
treatment with fixed appliances alone. Thus, on the basis of the exist-
ing literature, the duration of treatment was shorter in CAT only when
applied to mild-­to-­moderate case.
4.2.2 | Chair time, appointments and emergency
visits time
13
Only one study compared the time efficiency of aligner therapy and
conventional edgewise braces. It was found that patients with aligner
therapy spent 50% less time in the chair, had 67% fewer appointments
and needed more emergency visits than patients treated with conven-
tional edgewise appliances. This difference can be explained by the fact
that aligner patients who had a good compliance were often seen at
10-­to 12-­week intervals, compared to a 6-­week standard interval for
conventional braces. The patients with conventional edgewise brack-
ets required more appointment time due to the detailing and finishing
phase of treatment. The total chair time for aligner patients was less
due to fewer adjustment appointments during treatment. Patients with
fixed appliances required adjustments of arch wires and/or brackets at
each appointment, which significantly increased the total chair time.
Emergency visits are not common with aligner treatment because
there are few auxiliary parts that are likely to break and there are no
bands and brackets that could come loose. Also, the aligners are re-
moved during eating, which eliminates the risk of breakage during
mastication.
4.2.3 | Treatment outcomes
Only one trial14 assessed the treatment outcome between two groups.
The comparison based on the American Board of Orthodontics
Objective Grading System showed that aligner therapy did not cor-
rect malocclusions as well as conventional braces.14 Furthermore with
aligner therapy, it was hard to correct severe malocclusions especially
extraction cases. However, there is still much to learn regarding the
ZHENG et al.
biomechanics and efficacy of the aligner system.16 Kassas found simi-
lar results,17 but this study was excluded because it lacked a control
group. Based on these small sample trials, there is insufficient evi-
dence that clear aligner treatment is better or worse than conventional
fixed appliances regarding treatment outcome.
4.2.4 | Stability
Only one study15 comparing the stability of treatment outcome with
clear aligners to conventional brackets was identified. It was found
that patients treated with Invisalign relapsed more than those treated
with conventional fixed appliances. Both groups underwent a similar
retention protocol, which means that gingival and periodontal fibres
were equally reorganized. One difference in the treatment protocol of
the two groups was that the patients treated with Invisalign inserted
new aligners introducing new forces every 2 weeks. There is no re-
search supporting the 2-­week interval recommendation. The braces
group, on the other hand, was adjusted usually every 4-­6 weeks. Even
under ideal orthodontic forces, some undermining resorption of the
alveolar bone will occur. Undermining resorption requires 7-­14 days,
with equal time needed for periodontal ligament (PDL) regeneration
and repair. Activating an appliance too frequently can produce damage
to the teeth or bone by cutting short the repair process.18,19 It could be
postulated that the 2-­week interval of aligners in the Invisalign system
is too short and is leading to poor bone formation and more relapse.
In addition, the current concept of an optimal force in orthodontics
is based on the theory that a force of a certain magnitude and duration
would be capable of producing a maximum rate of tooth movement
without tissue damage.20,21 Tooth movement with the Invisalign system
is distance-­based, as opposed to forced-­based with the fixed appliance
systems. Due to static constraints, it is impossible to know exactly what
forces are being created by continuous arch mechanics with fixed appli-
ances, but material properties and stress/strain relationships of orthodon-
tic wires and springs are known.19 Even though both fixed appliances and
Invisalign can move teeth to clinically acceptable positions, there is no
literature on the force magnitude that is being created by aligner therapy.
4.3 | Agreements and disagreements with other
studies or reviews
Only two published systematic reviews were identified.10,22 These
reviews only focused on treatment effects of the Invisalign system,
while treatment duration, chair time and stability were also evaluated
ZHENG et al.
in our review. It should be noted that, due to a lack of homogeneity
among the included studies, meta-­analyses could not be undertaken
in the earlier reviews,10,22 while by meta-­analysis only one outcome
parameter was included in this study. In similarity with our review,
the earlier reviews also identified substantial bias, which reduced the
quality of the evidence.
4.4 | Limitations
First, as in all systematic reviews we may have missed studies. We
searched electronic databases and ongoing trials and performed a
manual search, which could restrict this bias to some extent. Second,
the sample size of the included studies was generally small. Therefore,
statistical power was lacking. Third, only four studies were included,
and funnel plots and the Begg’s rank correlation test were not con-
ducted. Therefore, some publication bias might exist, such as funding
support for published studies. Furthermore, the unexplained statisti-
cal heterogeneity and lack of randomized controlled trial studies lim-
ited the overall conclusions, which call for future high-­quality studies
to obtain more stable conclusions. Finally, none of the trials in this
review reported both the benefits (periodontal status and/or quality
of life) and the possible adverse effects (pain and/or root resorption)
associated with the two systems.
5 | CONCLUSIONS
1. This review suggests that future studies in this field should include
RCTs with rigorous methodology and proper sample size to in-
crease the power of the studies for estimating the effects.
2. Aligner therapy appears to have a significant advantage with regard
to efficiency (treatment time, chair time) in mild-to-moderate cases,
based on several cross-sectional studies.
3. There is insufficient evidence with regard to the effectiveness and
stability of treatment with clear aligners compared with conven-
tional brackets.
ACKNOWLE DG E MEN TS
We would like to acknowledge the assistance of Jerry Wood in devel-
oping the search strategy and also Jayne Cook in editing the review.
CO NFLI CT OF I NTE RE ST
The authors have stated explicitly that there are no conflict of ­interests
in connection with this article.
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How to cite this article: Zheng M, Liu R, Ni Z, Yu Z. Efficiency,
effectiveness and treatment stability of clear aligners: A
systematic review and meta-­analysis. Orthod Craniofac Res.
2017;00:1–7. https://doi.org/10.1111/ocr.12177