The Journal of EVIDENCE-BASED DENTAL PRACTICE

ORIGINAL ARTICLE

SKELETAL AND DENTAL EFFECTIVENESS OF

TREATMENT OF CLASS II MALOCCLUSION
WITH HEADGEAR: A SYSTEMATIC REVIEW
AND META-ANALYSIS

RICCARDO NUCERA, DDS, PhD, MSca, ANGELA MILITI, DDS, PhDa,

ANTONINO LO GIUDICE, DDS, PhD, MSca, VANESSA LONGO, DDSa,
ROSAMARIA FASTUCA, DDS, MSca, ALBERTO CAPRIOGLIO, MD, DDSb,
GIANCARLO CORDASCO, MD, DDSa, AND MOSCHOS A. PAPADOPOULOS, DDS, MScc
a
Department of Biomedical and Dental Sciences and Morphofunctional Imaging, Section of Orthodontics, School of Dentistry, University of Messina,
Policlinico Universitario “G. Martino,” Messina, Italy
b
Orthodontic Unit, Department of Surgical and Morphological Sciences, Section of Orthodontics, School of Medicine, University of Insubria, Clinica
Odontostomatologica, Varese, Italy
c
Department of Orthodontics, Faculty of Dentistry, School of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece

ABSTRACT CORRESPONDING AUTHOR:

Antonino Lo Giudice, Department of
Objective
Biomedical and Dental Sciences and
To evaluate the skeletal and dental effects of headgear treatment by systemati-
Morphofunctional Imaging, Section of
cally reviewing the best available scientific evidence.
Orthodontics, School of Dentistry,
Materials and Methods University of Messina, Policlinico
A survey of articles published up to February 2017 investigating the effects of Universitario “G. Martino”, Via
headgear in the treatment of patients with class II malocclusion was performed Consolare Valeria 98123 Messina, Italy.
using 19 electronic databases. Only randomized clinical trials and prospective E-mail: nino.logiudice@gmail.com
controlled clinical trials investigating growing patients with class II malocclusion
treated with headgear were included. Two authors performed independently study KEYWORDS
selection, data extraction, and risk of bias assessment. All pooled data analyses Class II malocclusion, Headgear,
were performed using the random-effect model. Statistical heterogeneity was Meta-analysis
evaluated.

Results
In total, 6 trials were included (4 randomized clinical trials and 2 prospective
controlled clinical trials), grouping data from 337 patients (170 treated patients
and 167 untreated controls). The ages of the patients varied across the studies, Conflict of Interest: The authors have no
but the majority of the trials had a sample with an age range between 8 and actual or potential conflicts of interest.
9 years. The times of daily wear of the appliance varied across studies from 8 to Funding: The current research
14 h/d. The significant mean differences in treatment effects compared with the project received no funding.
untreated controls were 21.41
per year for SNA angle cephalometric parameter Received 17 June 2017; revised 25
(95% confidence interval [CI]: 22.25
to 20.56
), 20.57 mm/y for anterior July 2017; accepted 25 July 2017
maxillary displacement (95% CI: 20.75 to 20.40 mm), 21.42
per year for ANB
angle cephalometric parameter (95% CI: 22.12
to 20.72
), and 21.31 mm/y for J Evid Base Dent Pract 2018: [41-58]
the overjet cephalometric parameter (95% CI: 22.34 to 20.29 mm). 1532-3382/$36.00
ª 2017 Elsevier Inc.
Conclusion
All rights reserved.
Headgear treatment is effective in restricting sagittal maxillary growth and doi: http://dx.doi.org/10.1016/
reducing the overjet in the short term. j.jebdp.2017.07.008

March 2018 41
 The Journal of EVIDENCE-BASED DENTAL PRACTICE
INTRODUCTION
C lass II malocclusion is the most prevalent sagittal skel-
etal discrepancy.1-3 It can be dental and/or skeletal,
involving mandibular deficiency, maxillary excess, or a
combination of both.4,5 The extraoral headgear is success-
fully used to treat class II malocclusions.6-9 The effects of
headgear on the craniofacial complex were studied in
experimental10,11 and clinical studies.12-17 Headgear seems
to both inhibit maxillary growth and distalize upper mo-
lars.6-9 To evaluate the effects of headgear, some systematic
reviews with meta-analysis have been performed18,19;
however, one review was dated18 and the other review19
mentioned was conducted by evaluating only skeletal
effects of headgear and including, in the final sample,
some clinical trials with different biases such as: “historic
control group” or “unclear control group.” The use of
historic control groups in orthodontic clinical research was
correlated with a reduction of treatment effects; caution is
necessary when interpreting clinical studies with historic
untreated control groups or when interpreting systematic
reviews that include such studies.20 According to the
GRADE Working Group,21 different levels of quality of a
body of evidence exist for meta-analysis according to the
level of evidence of the included studies. Only meta-
analyses performed by including prospective unbiased tri-
als can reach the highest level of evidence.22
Thus, the aim of this systematic review and meta-analysis
was to evaluate the skeletal and dental effects of head-
gear treatment on growing class II patients including only
prospective trials with prospective control group to evaluate
the treatment effects of headgear with the best available
scientific evidence.
MATERIALS AND METHODS
Protocol and Registration
This systematic review and meta-analysis was conducted
according to the guidelines of the Cochrane Handbook for
Systematic Reviews of Interventions (version 5.1.0) and is
reported according to the PRISMA statement.23,24 This
study was registered on the PROSPERO international pro-
spective register of systematic reviews (Protocol
CRD42016033947, http://www.crd.york.ac.uk/PROSPERO/
display_record.asp?ID5CRD42016033947).
Information Sources and Search
A survey of articles published up to February 2017 about the
effects of headgear in the treatment of class II malocclusion
was performed using 19 electronic databases (Table 1). The
searched databases were selected to try and find all
possible evidence including gray literature, thesis
dissertations, and conference proceedings. All electronic
searches were performed in the period between January
42 Volume 18, Number 1
24 and February 4, 2017. Full electronic search strategies
and electronic search results for every database are
reported in Table 1. No language restriction was applied
during the research. Reference lists of the articles eligible
for inclusion were also manually reviewed. Systematic
reviews and meta-analyses on this subject were also iden-
tified and their reference lists scanned for additional trials.
Eligibility Criteria and Selection of Studies
Duplicate reports were preliminarily excluded. Two review
authors (V.L. and R.F.) screened all retrieved records after
removal of duplicates on the basis of titles and abstracts.
Afterward, the same authors assessed full text of the
remaining articles for eligibility in the final analysis. Articles
were considered eligible if they meet criteria defined with
PICO format in Table 2. Table 3 reports the number of
excluded studies and the reasons for exclusion. Screening
for eligibility of the trials was performed independently,
and any disagreement was resolved after consulting
another author (A.L.G.). The level of agreement between
the 2 reviewers was assessed by Cohen kappa statistics.
Data Collection Process and Extraction
Two authors (R.N. and A.M.) independently extracted study
characteristics (study design, type of appliance, sample size,
age, sex, setting, observation period, time of daily appli-
ance wear, evaluation of cephalometric parameters, and
follow-up) and outcomes from the selected studies using
predefined data extraction forms. Any disagreements were
resolved by discussion with another author (A.C.). Cohen
kappa statistics were used to assess the agreement between
the 2 authors.
In total, 7 variables were investigated. For the evaluation of
maxillary anterior growth, SNA^ was used along with the “A
point to N perpendicular,” a linear cephalometric parameter
(distance between point A and a vertical reference line
passing through the N point and perpendicular to the
Frankfort plane) that evaluates the horizontal displacement
of the anterior maxilla compared with a vertical reference
line of the cranial base.
The changes in “palatal plane inclination” were reported in
all considered trials as the angle obtained between a line
passing through anterior nasal spine and posterior nasal
spine and a line identifying cranial base skeletal structures:
Sella–Nasion plane or Frankfort horizontal plane.
For the evaluation of anteroposterior mandibular projection
and the intermaxillary sagittal jaw relationships, the angular
cephalometric parameters SNB and ANB were respectively
considered.
Finally, the overjet and overbite were used for the evalua-
tion of the anterior dental relationships in the sagittal and
vertical planes.

Table 1. Consulted databases, search strategies, and the number of retrieved articles.
Consulted database
MEDLINE searched via PubMed on January 24,
2017, via www.ncbi.nlm.nih.gov/sites/entrez/
OvidSP searched on January 24, 2017, via https://
ovidsp.tx.ovid.com/
EMBASE searched via ScienceDirect on January 24,
2017, via www.embase.com
Cochrane Database of Systematic Reviews
searched via The Cochrane Library on January 26,
2017, via www.thecochranelibrary.com
Cochrane Central Register of Controlled Trials
searched via The Cochrane Library on January 26,
2017, via www.thecochranelibrary.com
Google Scholar searched on January 26, 2017, via
www.scholar.google.com
Web of Science searched on January 31, 2017, via
www.webofknowledge.com
The Journal of EVIDENCE-BASED DENTAL PRACTICE
Search strategy used Hits
(((((((((((randomized controlled trial [pt]) OR 216
controlled clinical trial [pt]) OR randomized [tiab])
OR placebo [tiab]) OR drug therapy [sh]) OR
randomly [tiab]) OR trial [tiab]) OR groups [tiab]))
AND ((class II malocclusion) AND (((((((((Extraoral
Traction Appliances [mh]) OR Extraoral traction
[tiab]) OR Extraoral traction [tiab]) OR Extra oral
traction [tiab]) OR Headgear [tiab]) OR Cervical
headgear [tiab]) OR Highpull headgear [tiab]) OR
Facebow [tiab]) OR Facebow [tiab])))) NOT ((animals
[mh] not (humans [mh] and animals [mh])))
(randomized controlled trial OR controlled clinical 154
trial OR randomized OR placebo OR drug therapy
OR randomly OR trial OR groups) AND (Class II
Malocclusion) AND (Extraoral Traction Appliances
OR Extraoral traction OR Extra-oral traction OR
Extra oral traction OR Headgear OR Cervical
headgear OR High-pull headgear OR Facebow OR
Face-bow)
(randomized controlled trial OR controlled clinical 44
trial OR randomized OR placebo OR drug therapy
OR randomly OR trial OR groups) AND (Class II
Malocclusion) AND (Extraoral Traction Appliances
OR Extraoral traction OR Extra-oral traction OR
Extra oral traction OR Headgear OR Cervical
headgear OR High-pull headgear OR Facebow OR
Face-bow)
(Class II Malocclusion) AND (Extraoral Traction 10
Appliances OR Extraoral traction OR Extra-oral
traction OR Extra oral traction OR Headgear OR
Cervical headgear OR High-pull headgear OR
Facebow OR Face-bow)
(Class II Malocclusion) AND (Extraoral Traction 98
Appliances OR Extraoral traction OR Extra-oral
traction OR Extra oral traction OR Headgear OR
Cervical headgear OR High-pull headgear OR
Facebow OR Face-bow)
randomized OR controlled OR clinical OR trial OR 980
randomly OR groups AND “Class II Malocclusion”
AND Extraoral OR Extra-oral OR “Extra oral” OR
Traction OR Headgear OR Cervical OR High-pull
OR Facebow OR Face-bow
(randomized controlled trial OR controlled clinical 189
trial OR randomized OR placebo OR drug therapy
OR randomly OR trial OR groups) AND (Class II
Malocclusion) AND (Extraoral Traction Appliances
OR Extraoral traction OR Extra-oral traction OR
Extra oral traction OR Headgear OR Cervical
headgear OR High-pull headgear OR Facebow OR
Face-bow)
(continued )
March 2018 43
 The Journal of EVIDENCE-BASED DENTAL PRACTICE
Table 1. Continued
Consulted database
Scopus searched on January 31, 2017, via
www.scopus.com
African Journal Online Database searched on
January 31, 2017, via www.ajol.info
LILACS searched on February 2, 2017, via http://
bvsalud.org/en/
Bandolier searched on February 2, 2017, via http://
www.medicine.ox.ac.uk/bandolier/
Evidence-Based Medicine searched on February 2,
2017, via https://www.tripdatabase.com/
Databases of dissertations and conference proceedings
Digital dissertation searched via UMI ProQuest on
February 3, 2017, via http://search.proquest.com/
pqdtft/dissertations/fromBasicHomePage
Conference Proceedings Citation Index searched
on February 3, 2017, searched via Web of Science,
http://thomsonreuters.com/conference-
proceedings-citation-index/
Conference Paper Index searched via Cambridge
Scientific Abstracts Search Strategy on February 4,
2017, via http://journals.cambridge.org/action/
search
Databases of research registers
German Library of Medicine (ZB Med) searched on
February 4, 2016, via http://www.medpilot.de
44 Volume 18, Number 1
Search strategy used Hits
(randomized controlled trial OR controlled clinical 64
trial OR randomized OR placebo OR drug therapy
OR randomly OR trial OR groups) AND (Class II
Malocclusion) AND (Extraoral Traction Appliances
OR Extraoral traction OR Extra-oral traction OR
Extra oral traction OR Headgear OR Cervical
headgear OR High-pull headgear OR Facebow OR
Face-bow)
(Class II Malocclusion) AND (Randomized 0
Controlled Trial*)
(tw:(Class II Malocclusion)) AND (tw:(Randomized 52
Controlled Trial$)) AND (tw:(Extraoral Traction
Appliance$))
(Class II Malocclusion) AND (Randomized 0
Controlled Trial*) AND (Extraoral Traction
Appliance*)
(orthodont* OR Class II Malocclusion*) AND 58
(Randomized Controlled Trial*) AND (Extraoral
Traction Appliance)
(Class II Malocclusion) AND (Extraoral Traction 40
Appliance* or Extraoral traction or Extra-oral
traction* or Extra oral traction* or Headgear or
Cervical headgear or High-pull headgear or
Facebow or Face-bow)
((Extraoral Traction Appliance* OR Extraoral traction 101
OR Extra-oral traction* OR Extra oral traction* OR
Headgear OR Cervical headgear OR High-pull
headgear OR Facebow OR Face-bow))
(randomized controlled trial OR controlled clinical 3
trial OR randomized OR placebo OR drug therapy
OR randomly OR trial OR groups) AND (Class II
Malocclusion) AND (Extraoral Traction Appliance*
OR Extraoral traction OR Extra-oral traction* OR
Extra oral traction* OR Headgear OR Cervical
headgear OR High-pull headgear OR Facebow OR
Face-bow)
(randomized controlled trial OR controlled clinical 1345
trial OR randomized OR placebo OR drug therapy OR
randomly OR trial OR groups) AND (Class II
Malocclusion) AND (Extraoral Traction Appliance* OR
Extraoral traction OR Extra-oral traction* OR Extra
oral traction* OR Headgear OR Cervical headgear OR
High-pull headgear OR Facebow OR Face-bow)
(continued )
 The Journal of EVIDENCE-BASED DENTAL PRACTICE

Table 1. Continued

Consulted database Search strategy used Hits

Metaregister of Controlled Clinical Trials searched (Class II Malocclusion) AND (Extraoral Traction 0
on February 4, 2017, via www.controlled-trials.com Appliance* OR Extraoral traction OR Extra-oral
traction* OR Extra oral traction* OR Headgear OR
Cervical headgear OR High-pull headgear OR
Facebow OR Face-bow)

Clinical Trials.Gov searched on February 4, 2017, (Class II Malocclusion) AND (Extraoral Traction 3
via http://clinicaltrials.gov/ct2/home Appliance* OR Extraoral traction OR Extra-oral
traction* OR Extra oral traction* OR Headgear OR
Cervical headgear OR High-pull headgear OR
Facebow OR Face-bow)

“International Clinical Trials Registry Platform
searched on February 4, 2017, via http://www.who.
int/ictrp/en/”
(Class II Malocclusion) AND (Extraoral Traction 0
Appliance* OR Extraoral traction OR Extra-oral
traction* OR Extra oral traction* OR Headgear OR
Cervical headgear OR High-pull headgear OR
Facebow OR Face-bow)

Total 3357

Table 2. Eligibility criteria used for study selection according to the PICO format.

Domain Inclusion criteria Exclusion criteria

Participants Related human clinical trials on growing patients with Craniofacial deformity, congenital syndromes,
class II malocclusion periodontal diseases, orofacial inflammatory
conditions, and tooth agenesis

Intervention Orthodontic treatment conducted using headgear Previous, additional and concomitant procedures
(functional appliances, orthognathic surgery,
extractions, fixed appliances, etc.)

Comparison Comparable untreated control group Studies without untreated control group

Outcome Linear and angular cephalometric parameters

assessing maxillary anterior growth and angular
cephalometric parameters assessing palatal plane
inclination
Linear and angular cephalometric parameters
assessing mandibular anterior growth and
cephalometric parameters assessing overjet and
overbite

Study design Randomized clinical trials and prospective controlled Abstracts, in vitro studies, descriptive studies,
clinical trials individual case reports, series of cases, reviews, studies
on adult subjects, retrospective longitudinal studies,
and meta-analyses

March 2018 45
 The Journal of EVIDENCE-BASED DENTAL PRACTICE

Copenhagen, Denmark, 2012). For each article, the

Table 3. Number of excluded studies and the reasons for following domains were examined: (1) sequence genera-
exclusion. tion; (2) allocation concealment; (3) blinding of participants,
personnel, and outcome assessors; (4) incomplete outcome
Excluded
Excluded articles articles after data; (5) selective outcome reporting; and (6) other sources
after evaluation of full-text of bias. The risk of bias for each domain was judged as low,
Reason for exclusion title and abstract evaluation high, or unclear risk. Each RCT was assigned an overall risk
Methodology not 57 37
of bias rating: low risk (low for all key domains), high risk
compatible with the (high for $1 key domain), or unclear risk (unclear for $1 key
subject of the study domain).

Expert opinions 4 The risk of bias of the included nonrandomized prospective

controlled clinical trials (pCCTs) was independently assessed
Replies to authors or 3 1 by 2 authors (V.L. and A.L.G.) using the Downs and Black
editor
scale.25 The Downs and Black scale consisted of 27
questions evaluating (1) reporting [10 questions]; (2)
Abstracts 4
external validity [3 questions]; (3) internal validity or bias [7
Retrospective clinical 25 15
questions]; (4) internal validity, confounding, or selection
trials bias [6 questions]; and (5) power [1 question]. According
to this scale, answers were scored from 0 to 1 point,
Systematic reviews 8 2 except for 2 items: reporting domain (question number 5)
and meta-analyses scored from 0 to 2 points and power analysis (last
question) scored from 0 to 5 points. Consequently, the
Absence of control 22 16
total maximum score that a pCCT could receive was 32
group
points. Any disagreement on the risk of bias assessments
Different topic 1872 6 was resolved after consulting another author (R.N.). The
level of agreement between the 2 authors was assessed
Different outcomes 52 6 with the Cohen’s kappa.
evaluated
Summary Measures and Data Analysis
Case reports 7 4 The data extracted from each trial were preliminarily annu-
alized to minimize heterogeneity related to the observation
Animal studies 1
period variability. For each continuous outcome under
investigation, to combine and summarize data, the mean
Descriptive studies 1 3
difference and the corresponding 95% confidence interval
Case series 3 were calculated. The random-effects model was used to
estimate all pooled data.
Control group 8
obtained from Assessment of Heterogeneity
longitudinal growth
study
Clinical heterogeneity was evaluated by examining the
characteristics of the subjects and the interventions for the
Incomplete outcomes 1 outcome in each included study. For all analyses, hetero-
geneity was assessed by the I2 index. A value of 0% in-
Total 2056 102 dicates no observed heterogeneity, and greater values show
increasing heterogeneity, with 25% indicating low, 50%
moderate, and 75% high heterogeneity.

Assessment of Quality of Evidence

Risk of Bias Assessment
Two authors (V.L. and A.L.G.) independently performed a
qualitative evaluation to assess the risk of bias of the
included randomized clinical trial (RCTs) using the Cochrane
Collaboration’s risk of bias tool (Review Manager ver. 5.2;
Nordic Cochrane Centre, Cochrane Collaboration,
The quality of evidence was assessed using the Grades of
Recommendation, Assessment, Development and Evalua-
tion Pro software (GRADEPro).21 This consists of 5 aspects
for overall risk of bias: directness of the evidence,
consistency of the results, precision of the estimates, risk
of publication bias, and magnitude of the effect.21 The

46 Volume 18, Number 1


Figure 1. Flow diagram for the selection of studies according to the PRISMA statement.
quality of the body of evidence was categorized as high,
moderate, low, or very low.
Moreover, the Strength of Recommendation Taxonomy
(SORT) Grading system was used to assess the strength of
recommendation for each outcome investigated.26 This tool
explicitly addresses the issue of patient-oriented (effective-
ness) vs disease-oriented evidence (efficacy), and it is based
on the assessment of the quality of the individual studies
and the consistency of evidence across the studies included
in the meta-analyses. The SORT system furnishes 3 levels of
quality. The strength of recommendation was graded as A
The Journal of EVIDENCE-BASED DENTAL PRACTICE
(good-quality patient-oriented evidence), B (limited-quality
patient-oriented), and C (disease-oriented evidence).
POEM, or “patient-oriented evidence that matters,” allows
clinicians to filter information from the medical literature and
focus only on what is in fact important for the patient.26
Additional Analyses
In meta-analyses of at least 10 studies (n . 10), reporting biases
across studies (small-study effects or publication bias) were
planned to be assessed through the inspection of a contour-
enhanced funnel plot,27 Begg’s rank correlation test,28 and
Egger’s weighted regression test.29 If the tests hinted toward
March 2018 47
48
Volume 18, Number 1

The Journal of EVIDENCE-BASED DENTAL PRACTICE

Table 4. Characteristics of included clinical trials.

Time of
daily
Study Type of Mean Observation appliance Cephalometric Follow-
Study design appliance Sample size age 6 SD (y) Sex Setting period (mo) wear (h/d) parameters up

Jakobsson RCT Cervical headgear Headgear, 9; Overall sample, Treated and Karolinska 18 mo 12 A point (mm), No
et al control, 10 8.5 y controls: 33 M, Institutet, Solna, overbite (mm),
(1967)31 27 F Sweden overjet (mm)

Keeling RCT Cervical Headgear/bite Headgear/bite Headgear/bite University of Headgear/bite 14 Maxillary anterior Yes
et al headgear 1 bite plane, 51; control, plane, 10 6 0.9; plane, 57% male; Michigan, Ann plane, 1.5 6 0.6; horizontal
(1995)32 plane 38 control, 9.6 6 0.8 control, 66% male Arbor control, 1.7 6 0.5 displacement
(mm), overjet
(mm)

Tulloch RCT Cervical headgear Headgear, 52; Headgear, Headgear: male, University of 18 mo Not SNA (
), SNB (
), No
et al control, 61 9.4 6 1.0; control, 31, female, 21; North Carolina reported ANB (
), A to N
(1997)33 9.4 6 1.2 control: male, 35, perp (mm),
female, 26 overbite (mm),
overjet (mm)

Mäntysaari RCT Cervical headgear Overall sample, Overall sample, 40 boys; 28 girls University of Oulu, 16 mo 8-10 SNA (
), ANB (
), Yes
et al 68 7.6 6 0.3 Finland SN/NL (
),
(2004)34 overbite (mm),
overjet (mm)

Firouz CCT High-pull Headgear, 12; Overall sample, Not reported University of Overall sample, 12 (ANS-PNS)/FH (
), No
et al headgear control, 12 between 9.5 and Connecticut 6 mo N-A (mm)
(1992)35 12.5 y Health Center,
Farmington,
Connecticut

Ulger et al CCT Cervical headgear Cervical headgear, Cervical Cervical Turkey, University Cervical 12-14 SNA (
), SNB (
), No
(2006)36 12; control, 12 headgear: headgear: 6 girls, of Yeditepe headgear: ANB (
), SN-PP (
),
7.89 6 0.47 (girls), 6 boys; control: 8 1.42 6 0.11; N perp A (mm),
9.82 6 0.81 girls, 4 boys control: overbite (mm),
(boys); control: 1.42 6 0.11 overjet (mm)
8.68 6 0.79 (girls),
8.50 6 0.84 (boys)
 The Journal of EVIDENCE-BASED DENTAL PRACTICE

Table 5. The risk of bias evaluation of the included RCTs performed with the Cochrane Collaboration’s tool

Random Blinding of Blinding of Incomplete

sequence Allocation participants and outcome outcome Selective Other
generation concealment personnel assessment data reporting bias

Jakobsson 196731 ? ? ? ? 1 1 ?

Keeling 199532 - ? 1 1 1 1 1

Tulloch 199733 1 1 1 1 1 1 1

Mäntysaari 1 1 ? - 1 ? ?
200434

The 1 symbol indicates low risk of bias, ? indicates unclear risk of bias, and - indicates high risk of bias.

the existence of publication bias, the Duval and Tweedie’s trim
and fill procedure30 was planned to be performed.
Subgroup analyses were planned to evaluate the source of
heterogeneity. In this respect, early vs late treatment and
high-pull vs cervical headgear appliance design were
compared, if at least 3 studies were found for each sub-
group. The cutoff used to differentiate early and late treat-
ment was the mean age of 11 years at the beginning of
treatment. Sensitivity analysis was performed to compare
RCTs and controlled clinical trials for the most relevant
outcomes and to evaluate treatment timing and appliance
design in case of inability to perform subgroup analysis due
to the inadequate number of studies per group.
RESULTS
Study Selection
From the initially identified 3357 records, 2164 remained
after exclusion of duplicates and 2056 additional records
were excluded on the basis of screening. A total of 108 full
texts were assessed for eligibility, and 102 articles were
excluded for not fulfilling the eligibility criteria. Thus, 6 trials
were identified as eligible and were included in the final
qualitative and quantitative synthesis.31-36 Figure 1 shows
the PRISMA flow diagram for the selection of studies. The
number of excluded studies and the reasons for exclusion
are reported in Table 3. The kappa score before
reconciliation for selection of studies was 0.821 (with
asymptotic standard error 0.115).
Study Characteristics
The characteristics of the 6 prospective trials included in the
meta-analysis are reported in Table 4.31-36 All selected
clinical trials evaluated headgear treatment in growing
patients with a class II malocclusion; the majority of trials
took place in university settings. Four trials were RCTs,31-34
and 2 were pCCTs.35,36 The total number of pooled
treated patients was 170, whereas the overall control
sample consisted of 167 untreated individuals. All studies
included both male and female participants, except 1
study35 that did not report the gender of the participants.
The ages of the patients varied across the studies, but the
majority of the trials had samples with ages ranging
between 8 and 9 years. The times of daily wear of the
appliance varied across studies from 8 to 14 h/d, except
for 1 study33 that did not report wear time. The
observation period varied from 6 to 18 months. Only 2
studies reported follow-up outcomes.32,34 The kappa score
for data extraction was 0.914 (with asymptotic standard error
0.092).

Table 6. Risk of bias evaluation of the included nonrandomized prospective controlled clinical trials (Downs and Black scale).

Study Reporting, 0-11 External validity, 0-3 Bias, 0-7 Confounding, 0-6 Power, 0/5 Overall, 0-32
35
Firouz 1992 5 2 3 2 0 12

Ulger 200636 7 1 3 2 0 13

March 2018 49
 The Journal of EVIDENCE-BASED DENTAL PRACTICE

Figure 2. Forest plot of the meta-analysis of the primary outcome (mean difference and the 95% confidence intervals
[CIs] of the annualized change of the SNA angle between the headgear and the control groups) based on the random-
effects model together.

Figure 3. Forest plot of the meta-analysis of the primary outcome (mean difference and the 95% confidence intervals
[CIs] of the annualized change of the variable “A point to N perpendicular” between the headgear and the control
groups) based on the random-effects model together.

Figure 4. Forest plot of the meta-analysis of the primary outcome (mean difference and the 95% confidence intervals
[CIs] of the annualized change of the SNB angle between the headgear and the control groups) based on the random-
effects model together.

Risk of Bias Assessment cephalometric variables: SNA^, “A point to N perpendic-

Two RCTs 32,34 33
showed a high risk of bias (Table 5). In 1 RCT,
the risk of bias was low, and in 1 RCT,31 the risk of bias was
unclear. The risk of bias of the 2 included nonrandomized
pCCTs35,36 identified using the Downs and Black scale was
medium (Table 6). The kappa score for the risk of bias
assessment was 0.851 (with asymptotic standard error 0.105).
Quantitative Data Synthesis
Meta-analyses could be performed regarding only the short-
term effectiveness of headgear for the following
ular,” “palatal plane inclination,” SNB^, ANB^, overjet, and
overbite. Figures 2-8 present the forest plots derived from
the quantitative analysis of these variables. Each forest plot
reports the trials included in the meta-analysis, the number
of treated and control subjects for each trial, the mean dif-
ference of the headgear treatment effects, and the 95%
confidence intervals, the significance (P), and the hetero-
geneity (I2%).
Only the quantitative analysis related to the following
cephalometric parameters showed statistically significant

50 Volume 18, Number 1

 The Journal of EVIDENCE-BASED DENTAL PRACTICE

Figure 5. Forest plot of the meta-analysis of the primary outcome (mean difference and the 95% confidence intervals
[CIs] of the annualized change of the ANB angle between the headgear and the control groups) based on the random-
effects model together.

results: SNA^ (21.41
, P , .001), “A point to N perpen- Additional Analyses

dicular” (20.57 mm, P , .001), ANB^ (21.42
, P , .001),
and overjet (21.31 mm, P , .01). Only the quantitative
analyses related to the “A point to N perpendicular” and
overjet were able to combine data from at least 5 clinical
trials and can be considered as definitive meta-analysis.
Quantitative analysis with less than 5 trials was consid-
ered as exploratory analyses and should be interpreted
with caution because of the fewer number of considered
trials.
Fewer than 10 trials were included in the final analysis; as a
consequence, no publication analysis and subgroup ana-
lyses were performed. To test the robustness of the results
of this meta-analysis, a sensitivity analysis was performed
comparing the anterior maxillary displacement outcomes of
RCTs and pCCTs (Figure 9). Because 1 study35 was
conducted evaluating the effects of high-pull headgear, a
sensitivity analysis was also performed excluding this trial
(Figure 10).

Assessment of Quality of Evidence DISCUSSION

21
According to the GRADE, there was a very low level of
evidence that headgear inhibits maxillary growth, reduces
overjet, and affects the overbite and the “palatal plane
inclination”. Moderate evidence was found that headgear
does not affect mandibular growth (Table 7).
According to SORT approach,26 the strength of
recommendation was classified as B (limited-quality
patient-oriented) for SNA^, SNB^, “A point to N perpen-
dicular,” ANB^, overbite, and overjet outcomes and was
classified as C (disease-oriented evidence) for “palate plane
inclination” because this outcome does not directly affect
smile and esthetic and facial appearance (Table 8).
To the best of our knowledge, this is the first meta-analysis
evaluating the best clinical evidence (using data derived
exclusively from prospective randomized and non-
randomized trials) about the treatment effects of headgear
on the craniofacial complex and on the occlusion charac-
teristics in growing patients in the short term. Moreover, the
quantitative analysis of this review demonstrates, for the first
time, a significant overjet reduction as a consequence of
headgear treatment. Despite a wide and accurate biblio-
graphic search, we found only 6 eligible trials to be included
in this systematic review.
The results of the current meta-analysis showed that head-
gear is effective in inhibiting sagittal maxillary growth. In this

Figure 6. Forest plot of the meta-analysis of the primary outcome (mean difference and the 95% confidence intervals
[CIs] of the annualized change of the overbite between the headgear and the control groups) based on the random-
effects model together.

March 2018 51
 The Journal of EVIDENCE-BASED DENTAL PRACTICE

Figure 7. Forest plot of the meta-analysis of the primary outcome (mean difference and the 95% confidence intervals
[CIs] of the annualized change of the overjet between the headgear and the control groups) based on the random-
effects model together.

regard, treated patients exhibited, when compared with
untreated controls, annual statistically significant mean
reduction of the SNA^ (21.41
) and restricted maxillary
anterior displacement (20.57 mm). These results confirm
findings of a previous meta-analytic review18 performed
with different methodology and by including, in the final
trial samples, clinical studies with different biases: “unclear
intervention and unclear control group,” “unclear
intervention and historic control group,” and “prospective
intervention and historic control group.”
Moreover, surprisingly these results show that headgear is
able to inhibit sagittal maxillary growth in a comparable
linear amount compared to removable functional appliances
originally designed to stimulate mandibular growth.37
The present meta-analysis shows that headgear is not able
to affect sagittal mandibular growth. This conclusion can be
drawn from the analysis of ANB^ and SNB^: no significant
difference was observed evaluating the effects of headgear
on the SNB angle, while the significant reduction of ANB^
(21.42
) can be contributed to the effect on the SNA^
(21.41
), which was almost of the same amount. However,
the effects of headgear on the mandible should be
considered with caution because they are supported by a
limited number of clinical trials.
Although a previous meta-analysis18 did not report a
statistically significant effect of headgear on the overjet,
we obtained, evaluating the same outcome and for the
first time in the literature, a significant overjet reduction in
patients treated with headgear compared to untreated
control subjects. According to our findings, the headgear
is able to reduce overjet by 21.31 mm/y. Because incisor
prominence is considered as a risk factor for anterior
dental trauma,38 headgear treatment can be regarded as
an approach able to reduce this risk of trauma on the
anterior teeth. Moreover, patients are particularly
conscious of the upper-incisor prominence39,40 that is
strictly related to the overjet increase. For this reason, we
considered overjet as a patient-oriented cephalometric
outcome according to the SORT approach (Table 8) along
with the different evaluated skeletal outcomes that affect
craniofacial skeletal harmony and soft-tissue facial profile.41

Figure 8. Forest plot of the meta-analysis of the primary outcome (mean difference and the 95% confidence intervals
[CIs] of the annualized change of the “palatal plane inclination” between the headgear and the control groups) based
on the random-effects model together.

52 Volume 18, Number 1

 Table 7. Should orthopedic treatment with headgear vs no treatment be used for correction of class II malocclusion?

Quality assessment No of patients Effect

Other Relative
No of studies Study design Risk of bias Inconsistency Indirectness Imprecision considerations Headgear Control (95% CI) Absolute (95% CI) Quality Importance

SNA

3 Randomized Very seriousa Very seriousb Not serious Not serious None 98 107 – MD 1.41 lower (2.25 4 Critical
trials lower to 0.56 lower) Very low

N per A

5 Randomized Very seriousc Very seriousb Not serious Not serious None 136 133 – MD 0.57 lower (0.75 4 Critical
trials lower to 0.4 lower) Very low

SNB

2 Randomized Seriousd Not serious Not serious Not serious None 64 73 – MD 0.17 lower (0.44 444 Important
trials lower to 0.1 higher) Moderate

ANB

3 Randomized Very seriouse Very seriousb Not serious Not serious None 98 107 – MD 1.42 lower (2.12 4 Critical
trials lower to 0.72 lower) very low

The Journal of EVIDENCE-BASED DENTAL PRACTICE

Overjet

5 Randomized Very seriousf Very seriousb Not serious Not serious None 158 155 – MD 1.31 lower (2.34 4 Critical
trials lower to 0.29 lower) Very low

Overbite

4 Randomized Very seriousg Very serioush Not serious Not serious None 107 117 – MD 0.28 lower (0.6 4 Important
trials lower to 0.05 higher) Very low

(continued )
March 2018
53
54
Volume 18, Number 1

The Journal of EVIDENCE-BASED DENTAL PRACTICE

Table 7. Continued

Quality assessment No of patients Effect

Other Relative
No of studies Study design Risk of bias Inconsistency Indirectness Imprecision considerations Headgear Control (95% CI) Absolute (95% CI) Quality Importance

Palatal plane inclination

3 Randomized Very seriousi Very seriousb Not serious Not serious None 58 58 – MD 0.94 higher (1.63 4 Important
trials lower to 3.51 higher) Very low

CI, confidence interval; MD, mean difference.

a
In 1 study, the risk of bias was high for “blinding of outcome assessment.” In 1 study, the risk of bias was high for “random sequence generation.”
b
Heterogeneity .75%.
c
In 1 study, the risk of bias was high for “random sequence generation.” In 1 study, the risk of bias was unclear for “random sequence generation,” “allocation concealment,” “blinding of participants and
personnel,” and “blinding of outcome assessment.”
d
In 1 study, blinding and allocation concealment were not described.
e
In 1 study, the risk of bias was high for “blinding of outcome assessment.” In 1 study, blinding and allocation concealment were not described.
f
In 1 study, the risk of bias was high for “blinding of outcome assessment.” In 1 study, the risk of bias was high for “random sequence generation.” In 1 study, the risk of bias was unclear for “random
sequence generation,” “allocation concealment,” “blinding of participants and personnel,” and “blinding of outcome assessment.”
g
In 1 study, the risk of bias was high for “blinding of outcome assessment.” In 1 study, the risk of bias was unclear for “random sequence generation,” “allocation concealment,” “blinding of participants
and personnel,” “blinding of outcome assessment.”
h
Heterogeneity ,75%.
i
In 1 study, the risk of bias was high for “blinding of outcome assessment.”
 The Journal of EVIDENCE-BASED DENTAL PRACTICE

Table 8. Strength of recommendation for each outcome investigated in the present study.

Study Strength of
Outcomes qualitya Consistencya recommendationa Explanation
^
SNA Level 2 Yes B Patient-oriented outcome; meta-analysis including 2 RCTs
and 1 CCT

A to N perp Level 2 Yes B Patient-oriented outcome; meta-analysis including 3 RCTs

and 2 CCTs

SNB^ Level 2 Yes B Disease-oriented outcome; meta-analysis including 1 RCT

and 1 CCT

ANB^ Level 2 Yes B Patient-oriented outcome; meta-analysis including 2 RCTs

and 1 CCT

Overbite Level 2 Yes B Patient-oriented outcome; meta-analysis including 3 RCTs

and 1 CCT

Overjet Level 2 Yes B Patient-oriented outcome; meta-analysis including 4 RCTs

and 1 CCT

Palatal plane Level 3 No C Disease-oriented outcome; meta-analysis including 1 RCT

inclination and 2 CCTs

a
Reports of levels of study quality, consistency of measured outcomes, and strength of recommendation according to the Strength of Recommendation
Taxonomy (SORT) system.

Finally, headgear showed no significant effects on the
overbite and on the “palatal plane inclination.” The absence
of significant vertical treatment effect could be related to
the few clinical trials included in the analysis and conse-
quently to the low statistical power and to the potential
heterogeneity of the trials in terms of appliance design. In
fact, the quantitative assessment of the effect of the head-
gear on the “palatal plane inclination” was performed
including only 2 studies that used different appliance design
(cervical and high-pull headgear).

Figure 9. Sensitivity analysis of the comparison of the anterior maxillary displacement outcomes between RCTs and
pCCTs.

March 2018 55
 The Journal of EVIDENCE-BASED DENTAL PRACTICE

Figure 10. Sensitivity analysis of the comparison of the anterior maxillary displacement outcomes between trials using
cervical headgear.

Additional Analyses Currently, there is no consensus by the dental community on

One limitation of this meta-analysis was the small number which system is the most suitable method (GRADE vs SORT)
of clinical trials; this aspect affected the I2 index, under- for assessing the quality of evidence and the strength of rec-
estimating the extent of between-study heterogeneity. The ommendations in clinical dentistry. They essentially evaluate
I2 values reported total variations across the studies from different aspects, and for this reason, we decided to evaluate
low to moderate, with a mean value and a standard devi- the results of this meta-analysis with both approaches.
ation equal to 83.9% and 19.2%, respectively. This variation
The sensitivity analysis (Figure 9) showed significant
was assumed to be due to clinical heterogeneity. The
differences between the results obtained from RCTs and
headgear designs, the observation period, and the time of
pCCTs, potentially indicating that nonrandomized studies
daily use of the appliances were different among the trials,
could overestimate the skeletal effects of headgear
which potentially affected heterogeneity. Data annual-
inhibiting sagittal maxillary development in growing class
ization was specifically performed to minimize the hetero-
II patients. This finding clearly demonstrates the necessity
geneity related to the observation period. Moreover, the I2
of further RCTs to better elucidate the effects of headgear
values affected the level of evidence of the present find-
on the whole craniofacial complex. The sensitivity analysis
ings, which ranges from very low to moderate, according to
performed excluding the only prospective trial conducted
the GRADE approach.21 Although we selected only the
with high-pull headgear35 (Figure 10) showed a similar
published trials offering the highest level of evidence, the
amount of maxillary growth inhibition (20.44 mm)
GRADE score showed that the included studies provided,
compared with the ultimate result of this meta-analysis for
in most cases, very low quality of evidence (Table 7), this
the same parameter (20.57 mm), thus confirming the val-
result should be evaluated considering the difficulties of
idity of the obtained results.
conducting RCTs in orthodontics.42,43 In fact, in
orthodontics, ethical concerns limit the possibility to have
adequate long-term control groups; it is almost impos- CONCLUSIONS
sible to execute a double-blind trail design; wide and
 Headgear treatment in growing subjects with class II
stratified samples are necessary to reach significant results
malocclusion is effective in the short term to restrict
considering the small effect size of orthopedic jaw treat-
sagittal maxillary growth.
ments; efficacy and efficiency of the orthodontic treatment
strictly depend on the expertise level and education of the  The use of headgear produces a significant reduction in
clinicians.42,43 overjet and thus may contribute in reducing the risk of
dental trauma in growing patients.
All these aspects increase the heterogeneity of different
clinical trials and consequently contribute to limit the  Additional RCTs performed with unbiased methodol-
methodological GRADE score of orthodontic trials. ogy are needed to better elucidate the effects of
headgear on the craniofacial complex.
The SORT approach (Table 8), used to evaluate the quality
of evidence and the strength of recommendations,
revealed a better score compared with GRADE; this result REFERENCES
was essentially related to the methodological choice to 1. Kelly JE, Harvey CR. An assessment of the occlusion of the
evaluate patient-oriented outcomes. teeth of youths 12-17 years. Vital Health Stat 1977;11:1-65.

56 Volume 18, Number 1


2. McLain JB, Proffitt WR. Oral health status in the United States:
prevalence of malocclusion. J Dent Educ 1985;49:386-97.
3. Proffit WR, Fields HW Jr, Moray LJ. Prevalence of malocclusion
and orthodontic treatment need in the United States: estimates
from the NHANES III survey. Int J Adult Orthod Orthognath
Surg 1998;13:97-106.
4. McNamara JA Jr. Components of Class II malocclusion in chil-
dren 8-10 years of age. Angle Orthod 1981;51:177-202.
5. Proffit WR, Fields HW, Ackerman JL, Sinclair PM, Thomas PM,
Tulloch JFC. Contemporary Orthodontics. St. Louis: Mosby-
Year Book; 1993.
6. Ricketts RM. The influence of orthodontic treatment on facial
growth and development. Angle Orthod 1960;30:103-33.
7. Poulton DR. A three-year survey of Class II malocclusions with
and without headgear therapy. Angle Orthod 1964;34:181-93.
8. Brandt S, Root TL. Interview: Dr Terrell Root on headgear. J Clin
Orthod 1975;9:20-31.
9. Baumrind S, Molthen R, West EE, Miller MD. Mandibular plane
changes during maxillary retraction. Part 1. Am J Orthod Den-
tofacial Orthop 1978;74:32-40.
10. Triftshauser R, Walters RD. Cervical retraction of the maxillae in
the Macaca mulatta monkey using heavy orthopedic force.
Angle Orthod 1976;46:37-46.
11. Droschi H. The effect of heavy orthopedic forces on the maxilla
in the growing Saimiri sciureus (squirrel monkey). Am J Orthod
Dentofacial Orthop 1973;63:449-61.
12. Melsen B. Effects of cervical anchorage during and after treat-
ment: an implant study. Am J Orthod Dentofacial Orthop
1978;73:526-40.
13. Gianelly AA, Valentini V. The role of “orthopedics” and ortho-
dontics in the treatment of Class II, division 1 malocclusions.
Am J Orthod Dentofacial Orthop 1976;69:668-78.
14. Baumrind S, Molthen R, West EE, Miller MD. Mandibular plane
changes during maxillary retraction. Part 2. Am J Orthod
Dentofacial Orthop 1978;74:603-20.
15. Lima Filho RM, Lima AL, de Oliveira Ruellas AC. Mandibular
changes in skeletal Class II patients treated with Kloehn cervical
headgear. Am J Orthod Dentofacial Orthop 2003;12:83-90.
16. Lima Filho RM, Lima AL, de Oliveira Ruellas AC. Longitudinal
study of anteroposterior and vertical maxillary changes in
skeletal Class II patients treated with Kloehn cervical headgear.
Angle Orthod 2003;73:187-93.
17. Kim KR, Muhl ZF. Changes in mandibular growth direction
during and after cervical headgear treatment. Am J Orthod
Dentofacial Orthop 2001;119:522-30.
18. Antonarakis GS, Kiliaridis S. Short-term anteroposterior treatment
effects of functional appliances and extraoral traction on class II
malocclusion. A meta-analysis. Angle Orthod 2007;77:907-14.
The Journal of EVIDENCE-BASED DENTAL PRACTICE
19. Papageorgiou SN, Kutschera E, Memmert S, et al. Effectiveness
of early orthopaedic treatment with headgear: a systematic
review and meta-analysis. Eur J Orthod 2017;39:176-87.
20. Papageorgiou SN, Koretsi V, Jäger A. Bias from historical con-
trol groups used in orthodontic research: a meta-
epidemiological study. Eur J Orthod 2017;39:98-105.
21. Guyatt GH, Oxman AD, Vist G, et al. Rating quality of evidence
and strength of recommendations GRADE: an emerging
consensus on rating quality of evidence and strength of rec-
ommendations. BMJ 2008;336:924-6.
22. Papadopoulos MA. Meta-analysis in evidence-based ortho-
dontics. Orthod Craniofac Res 2003;6:112-26.
23. Higgins JPT, Green S, eds. Cochrane Handbook for Systematic
Reviews of Interventions (Version 5.1.0, Updated March 2016).
The Cochrane Collaboration. Available at: http://www.
cochrane-handbook.org.
24. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement
for reporting systematic reviews and meta-analyses of studies
that evaluate health care interventions: explanation and elab-
oration. J Clin Epidemiol 2009;62:e1-34.
25. Downs SH, Black N. The feasibility of creating a checklist for the
assessment of the methodological quality both of randomized
and non-randomised studies of health care interventions.
J Epidemiol Commun Health 1998;52:377-84.
26. Newman MG, Weyant R, Hujoel P. JEBDP improves grading
system and adopts strength of recommendation taxonomy
grading (SORT) for guidelines and systematic reviews. J Evid
Based Dent Pract 2007;7(4):147-50.
27. Peters JL, Sutton AJ, Jones DR, Abrams KR, Rushton L. Con-
tour-enhanced meta-analysis funnel plots help distinguish
publication bias from other causes of asymmetry. J Clin Epi-
demiol 2008;61:991-6.
28. Begg CB, Mazumdar M. Operating characteristics of a rank
correlation test for publication bias. Biometrics 1994;50:
1088-101.
29. Egger M, Smith GD, Schneider M, Minder C. Bias in meta-
analysis detected by a simple, graphical test. BMJ 1997;315:
629-34.
30. Duval S, Tweedie R. Trim and fill: a simple funnel-plot-based
method of testing and adjusting for publication bias in meta-
analysis. Biometrics 2000;56:455-63.
31. Jakobsson SO. Cephalometric evaluation of treatment effect on
Class II, division 1 malocclusions. Am J Orthod Dentofacial
Orthop 1967;53:446-57.
32. Keeling SD, Wheeler TT, King GJ, et al. Anteroposterior skel-
etal and dental changes after early Class II treatment with
bionators and headgear. Am J Orthod Dentofacial Orthop
1998;113:40-50.
33. Tulloch JF, Phillips C, Koch G, Proffit WR. The effect of early
intervention on skeletal pattern in Class II malocclusion: a
March 2018 57
 The Journal of EVIDENCE-BASED DENTAL PRACTICE
randomized clinical trial. Am J Orthod Dentofacial Orthop
1997;111:391-400.
34. Mäntysaari R, Kantomaa T, Pirttiniemi P, Pykäläinen A. The ef-
fects of early headgear treatment on dental arches and
craniofacial morphology: a report of a 2 year randomized study.
Eur J Orthod 2004;26:59-64.
35. Firouz M, Zernik J, Nanda R. Dental and orthopedic effects of
high-pull headgear in treatment of Class II, division 1 maloc-
clusion. Am J Orthod Dentofacial Orthop 1992;102:197-205.
36. Ulger G, Arun T, Sayinsu K, Isik F. The role of cervical headgear
and lower utility arch in the control of the vertical dimension.
Am J Orthod Dentofacial Orthop 2006;130:492-501.
37. Nucera R, Lo Giudice A, Rustico L, Matarese G,
Papadopoulos MA, Cordasco G. Effectiveness of orthodontic
treatment with functional appliances on maxillary growth in the
short term: a systematic review and meta-analysis. Am J Orthod
Dentofacial Orthop 2016;149:600-611.e3.
38. Thiruvenkatachari B, Harrison J, Worthington H, O’Brien K.
Early orthodontic treatment for Class II malocclusion reduces
58 Volume 18, Number 1
the chance of incisal trauma: results of a Cochrane systematic
review. Am J Orthod Dentofacial Orthop 2015;148:47-59.
39. Johnston C, Hunt O, Burden D, Stevenson M, Hepper P. Self-
perception of dentofacial attractiveness among patients
requiring orthognathic surgery. Angle Orthod 2010;80:361-6.
40. Webb MA, Cordray FE, Rossouw PE. Upper-incisor Position as a
Determinant of the ideal soft-tissue profile. J Clin Orthod
2016;50:651-62.
41. Nucera R, Lo Giudice A, Bellocchio M, Spinuzza P, Caprioglio A,
Cordasco G. Diagnostic concordance between skeletal ceph-
alometrics, radiograph-based soft-tissue cephalometrics, and
photograph-based soft-tissue cephalometrics. Eur J Orthod
2017;39:352-7.
42. Mev J. Are random controlled trials appropriate for orthodon-
tics? Evid Based Dent 2002;3:35-6.
43. Johnston LE Jr. Moving forward by looking back: ‘retrospective’
clinical studies. J Orthod 2002;29:221-6.