Authors' afliations: Cordasco G., Matarese G., Rustico L., Fastuca S., Caprioglio A.,
G. Cordasco, G. Matarese, L. Rustico, S. Lindauer S. J., Nucera R. Efficacy of orthopedic treatment with
Fastuca, R. Nucera, Department of
Scienze Sperimentali Medico Chirurgiche
protraction facemask on skeletal Class III malocclusion: a systematic
ed Odontostomatologiche, Section of review and meta-analysis
Orthodontics, School of Dentistry, Orthod Craniofac Res 2014; 17: 133143. 2014 John Wiley & Sons A/S.
University of Messina, Messina, Italy
Published by John Wiley & Sons Ltd
A. Caprioglio, Department of Orthodon-
tics, School of Dentistry, University of
Insubria, Varese, Italy Abstract
S. J. Lindauer, Department of The objective of this systematic review was to estimate the efficacy of protrac-
Orthodontics, School of Dentistry, Virginia
tion facemask on the correction of Class III malocclusion in the short term. A
Commonwealth University, Richmond,
VA, USA systematic review of articles was performed using different electronic data-
bases (PubMed, Ovid, Cochrane Central Register of Controlled Trials, Web of
Correspondence to: Science, LILACS, and Google Scholar). Search terms comprised orthopedic
R. Nucera
Department of Scienze Sperimentali Med-
treatment and Class III malocclusion. The selection criteria were set in order
ico Chirurgiche ed Odontostomatologiche to include in this review only randomized clinical trials (RCTs) performed treat-
Section of Orthodontics ing with facemask Class III growing patients. Studies selection, data extrac-
School of Dentistry
tion, and risk of biass assessment were executed independently by two
University of Messina
AOU Policlinico G. Martino authors using pre-defined data forms. All pooled analyses of data were based
UOC di Odontoiatria e Odontostomatologia on random effects models. A pre-specified subgroup analysis was planned
Via Consolare Valeria to evaluate the effect of preliminary rapid palatal expansion on facemask effi-
1 98100 Messina
cacy. Three RCTs met our inclusion criteria. In total, data from 155 patients
Italy
E-mail: riccardo.nucera@gmail.com (92 treated and 63 controls) were collected. The treated group showed the
following significant changes: ANB +3.66 [95%CI (2.58, 4.74)]; SNA +2.10
[95%CI (1.14, 3.06)]; SNB 1.54 [95%CI ( 2.13, 0.95)]; SN-palatal plane
0.82 [95%CI ( 1.62, 0.02)]; and SN-mandibular plane +1.51 [95%CI
(0.61, 2.41)]. Heterogeneity varied from low to moderate (mean I2 value:
41.4 20.8). Facemask is effective correcting Class III malocclusion in the
short term. The skeletal modifications induced by facemask are forward dis-
Date:
placement of maxilla, backward displacement of mandible, clockwise rotation
Accepted 15 March 2014 of the mandibular plane, and counterclockwise rotation of the maxillary plane.
DOI: 10.1111/ocr.12040
Table 1. PubMed search history the groups compared; had results evaluated by
cephalometric analysis performed before and
Keywords Results
immediately after treatment; were studies con-
(1) Randomized controlled trial 417 185 ducted on growing patients without any cranio-
(2) Randomized controlled trias 423 383 facial deformity; had treatment conducted
(3) Random allocation 77 152 without orthognathic surgery; had treatment
(4) Double blind 142 901 conducted using protraction facemask; and had
(5) Double blind method 118 144 analyzed treatment effects which were not con-
(6) Single blind 36 215 founded by additional and concomitant proce-
(7) Single blind method 29 595 dures (extractions, fixed appliances, etc.)
(8) #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 53 052 Duplicate reports were excluded. Articles were
(9) Class III malocclusion 2806 not selected if they did not meet the inclusion
(10) Malocclusion, angle class III/therapy 1742 criteria, if they did not relate to this topic, or if
(11) Orthopedic treatment class III 351 they were related but had a different aim.
(12) #9 OR #10 OR #11 2934 Abstracts, laboratory studies, descriptive studies,
(13) #8 AND #12 52 individual case reports, series of cases, reviews,
(14) #8 AND #12, limit: humans 49 studies of adult patients, controlled clinical tri-
als, retrospective longitudinal studies, and meta-
analyses were also excluded. Articles reporting risk of bias assessment was resolved after con-
interim outcomes or updates were considered sulting the third author (G.C.). The level of
only once. RCTs including patients who had agreement between the two investigators was
received previous or concomitant treatment for assessed with the Cohen kappa statistic. The fol-
their Class III malocclusion were excluded. Two lowing qualitative criteria of each article were
review authors (L.R. and S.F.) screened all titles examined: sequence generation; allocation con-
and abstracts achieved from the database cealment; blinding of participants, personnel,
searches. The same authors reviewed the full and outcome assessors; incomplete outcome
texts of the potentially relevant articles and data; selective outcome reporting; and other
abstracts. The eligibility of the trials was sources of bias. The risk of bias for each domain
assessed independently, and any disagreement was judged as low risk, high risk, or unclear risk.
was resolved after consulting a third author Each randomized controlled trial was assigned
(R.N.). The level of agreement between the two an overall risk of bias in terms of low risk (low
reviewers was assessed with the Cohen kappa for all evaluated domains), high risk (high for
statistic. one or more domains), and unclear risk (unclear
for one or more domains).
Data extraction and management
Quantitative data synthesis
Two authors (L.R. and S.F.) independently
extracted study characteristics (appliances fea- Data were analyzed by means of Review Man-
tures, sample size, age, sex, setting, time of treat- ager computer program (version 5.2). For all the
ment and observation, time of daily appliance evaluated cephalometric parameters, difference
wear, presence of follow-up) and outcomes from in means and standard deviations of the contin-
the selected studies using pre-defined data uous outcomes were used to summarize and
extraction forms. Any disagreements were combine data using the random effect model. A
resolved by discussion with a third author (R.N.). pre-specified subgroup analysis was planned
The Cohen kappa statistic was used to score the with the aim to evaluate the capabilities of RME
agreement between the two review authors. The promoting facemask effectiveness. It was per-
following angular cephalometric parameters formed for particular outcomes (SNA, SNB,
were collected as outcomes: SNA, SNB, ANB, ANB), comparing the data of two subgroups
SN-palatal plane, and SN-mandibular plane. treated with and without preliminary RME. A
sensitivity analysis that excluded the studies
Assessment of risk of bias with the higher risk of bias was performed in
order to examine the influence of the study
A qualitative evaluation for assessment of risk of quality assessment on the overall estimates of
bias of the selected articles was performed using effect.
the Cochrane Collaborations tool for assessing
risk of bias by means of the specific software Assessment of heterogeneity
Review Manager [computer program] (version
5.2, Copenhagen, Denmark: Nordic Cochrane Clinical heterogeneity among studies was evalu-
Centre, Cochrane Collaboration; 2012). A sum- ated by examining the types of participants and
mary assessment of the risk of bias within and the interventions for the outcome in each
across the evaluated RCTs was performed included study. For all the performed analysis,
according to Cochrane Collaboration guidelines heterogeneity was assessed by means of the I2
(16). The qualitative assessment of risk of bias index, which is an indicator of true heterogene-
was undertaken autonomously and in duplicate ity in percentages. A value of 0% indicates no
by using separate printed forms by two review- observed heterogeneity, and larger values show
ers (G.M. and A.C.). Any disagreement on the increasing heterogeneity with 25% indicating
low, 50% moderate, and 75% high heterogeneity characteristics of the selected RCTs. Clinical sex
(17). heterogeneity was good for two RCTs (9, 18) and
poor for one RCT that evaluated only female
subjects (3). Weak heterogeneity was found in
Results time of daily appliance wear that was around
1014 h/day for all evaluated RCTs. Weak heter-
Electronic searches identified the following items: ogeneity was also found for treatment and
49 articles were retrieved from PubMed, 14 from observation time ranging from 12 to 15 months.
Cochrane Central Register of Controlled Trials, 95 No article reported long-term results.
from Ovid, 23 from LILACS, 172 from Web of Sci- Evaluating the selected RCTs relatively to the
ence, and 535 from Google Scholar. Duplicates performed subgroup analysis, it was found that
articles, studies that did not relate to our topic or Kilicoglu and Kirlic (3) evaluated a standalone
related with a different aim, and those that were facemask protocol, Mandall et al. (18) evaluated
not RCTs were excluded (Table 2). the RME + facemask protocol, and Vaughn et al.
Of the remaining potentially appropriate RCTs, (9) assessed and compared both of the protocols
seven were identified as eligible RCTs to be previously mentioned. Vaughn et al. (9) reported
included in this analysis (3, 9, 1822). Four of mean values for each of the groups included in
the seven selected RCTs were withdrawn accord- the RCT (i.e., facemask; RME+facemask, control).
ing to the exclusion criteria reported in Table 3. Because of these characteristics, the RCT of Vau-
Three articles met all eligibility criteria and were ghn et al. (9) was included in the meta-analysis
selected for the final analysis. Figure 1 illustrates as if it were two different substudies (RME+face-
the flow diagram of the selection of the studies mask and standalone facemask). Its control
process according to the PRISMA guidelines group was divided into two control subgroups
(16). (nine and eight subjects) presenting the same
mean outcome. The subgroup of nine patients
Study characteristics was associated with the RME + facemask treat-
ment substudy; the subgroup of eight patients
All of the selected RCTs evaluated orthopedic was associated with the facemask standalone
facemask treatment in growing children in the treatment substudy. Using this method, the con-
mixed dentition with Class III malocclusion. In trol subjects of the study of Vaughn et al. (9)
total, data from 155 patients (92 treated and 63 were not included two times in the meta-analy-
controls) were collected. The samples were het- sis. Moreover, Vaughn et al. (9) reported the
erogeneous for the numbers and the ages of par- mean standard error (SE) of its coupled sub-
ticipants. Table 4 describes the study group; consequently, the SE values for each
Table 3. Studies excluded from the data analysis and reasons of exclusion
Chin cup effects using two different force Abdelnaby & Nassar (19) Different appliance from the facemask
magnitudes in the management of Class III malocclusions
Maxillary rotation following early orthopedic Shargill (20) Identified like a multiple report from the
treatment of Class III malocclusion study of Mandall et al. (34)
nkels function regulator on the
The effects of the Fra Ulgen & Firatli (21) Different appliance from the facemask
Class III malocclusion.
Short-term soft- and hard-tissue changes following Saleh M et al. (22) Different appliance from the facemask
Class III treatment using a removable mandibular
retractor: a randomized controlled trial
Discussion
Mandall Facemask + Treated = 33 8.7 0.9 Female = 38 Eight UK 15 months Minimum of SNA, SNB, ANB, No
et al. (18) RME Controls = 36 9.0 0.8 Male = 32 hospital 14 h/day SN/Maxillary
plane
Vaughn Facemask and Facemask = 22 8.1 1.9 Female = 29 Seattle, 12 months Full time at the SNA, SNB, ANB, No
et al. (9) Facemask + FM + RME = 21 7.3 1.9 Male = 31 Wash, beginning of SN/Palatal plane,
RME Controls = 17 6.6 1.9 Phoenix, treatment, SN/Go-Gn
Ariz, and then 14 h/day
Los Angeles,
Calif
Klc lu &
og Facemask Treated = 16 8.6 1.4 Female = 26 Istanbul 12 months Minimum of SNA, SNB, ANB, No
Kirlic
(3) Controls = 10 9.2 1.4 Male = 0 University, 1012 h/day SN/Go-Me
Turkey
| 139
Cordasco et al. Efficacy of protraction facemask
Table 5. Summary assessment of risk of bias performed according the guidelines provided by the Cochrane Handbook for
Systematic Reviews of Interventions (16)
Type of Bias
Mandall et al. (33) Low risk Low risk Low risk Low risk Low risk Low risk Low risk
Vaughn et al. (26) Low risk Low risk Low risk Low risk Low risk Low risk Low risk
Klc lu & Kirlic
og (14) Unclear Unclear Unclear Unclear Low risk Low risk Unclear
Fig. 2. Forest plot representing the effect of facemask on the ANB angle. A subgroup analysis was performed. Two subsamples
were created and compared according the used protocol: facemask standalone or facemask + patal expansion.
Fig. 3. Forest plot representing the effect of facemask on the SNA angle. A subgroup analysis was performed. Two subsamples
were created and compared according the used protocol: facemask standalone or facemask + patal expansion.
Fig. 4. Forest plot representing the effect of facemask on the SNB angle. A subgroup analysis was performed. Two subsamples
were created and compared according the used protocol: facemask standalone or facemask + patal expansion.
Fig. 5. Forest plot representing the effect of facemask on the SN-mandibular plane angle.
Fig. 6. Forest plot representing the effect of facemask on the SN-palatal plane angle.
variation. From this perspective, the 1.54 of SNB ular change could be partly due to mandibular
reduction could be the result of two different rotation, it appears that facemask treatment
phenomena: anterior mandibular growth inhibi- induces a prevalent orthopedic effect on the
tion and/or clockwise mandibular plane rotation. maxilla rather than on the mandible.
There is some evidence in the literature that The limitations of this review article are
when the mandibular plane rotates upward, in related to the small number of RCT (three) that
non-growing patients, an increase in the SNB was possible to include in the meta-analysis.
angle occurs (26). As this meta-analysis found The small number of included trails affects the
relatively larger effects of facemask treatment on I2 index, underestimating the extent of between-
the maxilla (SNA: +2.10) than the mandible study heterogeneity (17). It is important to con-
(SNB: 1.54), and considering that the mandib- sider this assumption to properly consider the
Fig. 7. Sensitivity analysis: forest plot representing the effect of protraction facemask on the ANB angle. The RCT presenting the
highest risk of bias (3) was excluded.
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