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SYSTEMATIC REVIEW

Fixed functional appliances with multibracket


appliances have no skeletal effect on the
mandible: A systematic review and meta-analysis
Ramy Abdul Rahman Ishaq,a Maged Sultan AlHammadi,b Mona M. S. Fayed,c Amr Abou El-Ezz,d
and Yehya Mostafae
Sanaa and Ibb, Yemen, and Cairo, Egypt

Introduction: Our aim was to assess the skeletal mandibular changes (anteroposterior and vertical) in circumpubertal patients with xed functional appliances installed on multibracket appliances compared with untreated
patients. Methods: An open-ended electronic search of 4 databases (PubMed, Embase, Cochrane Library, and
Web of Science) up to April 2014 was performed. Additional searches of relevant journals, reference lists of the
retrieved articles, systematic reviews, and gray literature were performed. Specic inclusion and exclusion
criteria were applied to identify relevant articles. Quality was evaluated using the Cochrane Collaboration risk
of bias tool and the Newcastle-Ottawa scale for prospective controlled clinical trials. Meta-analyses were
conducted with xed and random effects models as appropriate. Statistical heterogeneity was also examined.
Results: Seven articles were included in the qualitative synthesis and 5 in the meta-analysis. The included
randomized controlled trials were at high risk of bias, and the methodologic quality of the prospective
controlled clinical trials was high. Based on assessment of the xed functional appliance phase in isolation,
no difference in mandibular anteroposterior positional changes (SNB angle) (standard mean difference,
0.11 ; 95% CI, 0.28, 0.50) was found between the treated and control groups. The vertical dimension was
not inuenced by the xed functional appliance treatment. Conclusions: There is little high-quality evidence
concerning the relative inuence of xed functional appliances on skeletal and dentoalveolar changes.
However, based on the limited evidence, it appears that they have little effect on the skeletal mandibular
parameters. (Am J Orthod Dentofacial Orthop 2016;149:612-24)

keletal Class II malocclusion is characterized by a


sagittal discrepancy caused by mandibular retrusion or maxillary excess. The most common source
is mandibular retrusion, which affects about one third of
the population.1 Mandibular retrusion is managed in
growing patients with functional appliances (removable
and xed) designed to alter the anteroposterior and vertical positions of the mandible and to induce
a

Private practice. Sanaa, Yemen.


Assistant professor, Faculty of Dentistry, Ibb University, Ibb, Yemen.
c
Professor, Department of Orthodontics, Faculty of Oral and Dental Medicine,
Cairo University, Cairo, Egypt.
d
Professor, Department of Orthodontics; dean, Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt.
e
Professor, Department of Orthodontics, Faculty of Oral and Dental Medicine,
Cairo University, Cairo, Egypt.
All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conicts of Interest, and none were reported.
Address correspondence to: Ramy Abdul Rahman Ishaq, Hadda Street, facing
Mojamma Post Ofce, P.O. Box 271, Sanaa, Yemen; e-mail, ishaqramy@
gmail.com.
Submitted, January 2015; revised and accepted, November 2015.
0889-5406/$36.00
Copyright 2016 by the American Association of Orthodontists.
http://dx.doi.org/10.1016/j.ajodo.2015.11.023
b

612

supplementary mandibular growth and remodeling of


the condyle.
Fixed functional appliances (FFA) are compliancefree, tooth-borne appliances. They do not require a second phase of treatment when used with multibracket
appliances (MBA). They are classied into 4 groups:
rigid, exible, hybrid, and substitutes for elastics.2
They may be categorized into 2 major groups according
to the timing of the MBA. The Herbst3 and the mandibular advancement repositioning appliance4 can be
applied before the MBA. The Jasper jumper,5 Forsus
Nitinol Flat Spring,6 Forsus FatigueResistant Device,7
Twin Force Bite Corrector,8 Sabbagh Universal Spring,9
and integrated Herbst10 require an alignment and
leveling phase with the MBA in preparation for application on a rigid stainless steel archwire attached to the
teeth through the MBA.
There is considerable debate as to whether FFAs can
stimulate mandibular growth and potentially lead to lasting skeletal changes. Several systematic reviews have
focused on the treatment effects of the removable functional appliance (RFA),11-15 FFA,16-18 or both.19 The

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Table I. The search engines included, keywords, dates of searches, and data retrieved
Search
engine
PubMed

Cochrane
Library

Embase

Web of
Science

Total

Keywords
(functional appliances OR
functional appliance) and
Class II and (TMJ or
mandib* or
temporomandibular joint)
(functional appliances OR
functional appliance) and
Class II and (TMJ or
mandib* or
temporomandibular joint)
(functional appliances OR
functional appliance) and
Class II and (TMJ or
mandib* or
temporomandibular joint)
Class II and (functional
appliance*) and (mandib* or
TMJ or temporomandibular
joint)

Internal
duplicates
2

External
duplicates
0

Exclusion
by title
412

Exclusion
by abstract
77

Exclusion
by full text
57

Final
2

90

79

11

09/03/2014

153

127

21

05/04/2014

570

489

62

1363

695

506

88

60

Date
09/03/2014

Result
550

09/03/2014

The process of exclusion that led to the nal list of included studies is presented.

results were either inconclusive or controversial, mostly


indicating the lack of a signicant skeletal effect. According to Perinetti et al,18 FFAs are effective in Class II treatment with skeletal effects in pubertal patients related to
mandibular elongation with treatment. The authors
acknowledged that this study was potentially confounded
by variations in the duration of functional treatment
(6-18 months). This limitation was caused by the inclusion of different treatment modalities. To evaluate the
effectiveness of a therapy, inconsistencies between the
appliances used should be eliminated, such as the differences in the mode of action of the appliance, the timing
and duration of application, and the force delivered by the
appliance, to allow for a fair comparison. To our knowledge, no previous systematic review has focused on the
treatment of patients with skeletal Class II malocclusion
with FFAs combined with MBAs.
The aim of this systematic review was to evaluate the
skeletal mandibular changes (horizontal and vertical) in
circumpubertal patients with FFA and MBA compared
with untreated patients. The assessed outcomes included
skeletal mandibular anteroposterior and vertical changes
produced by the FFA with the MBA in growing subjects
with Class II malocclusion assessed using cephalometric
measurements. The following inclusion criteria were
applied: (1) population of growing Class II subjects,
(2) intervention of FFA with MBA, (3) comparator of
untreated Class II subjects, and (4) outcomes of mandibular anteroposterior and vertical skeletal changes.

MATERIAL AND METHODS


Protocol and registration

This systematic review was based on the PRISMA


statement. The rst step included the development of
a protocol that was registered on the PROSPERO database, International Prospective Register of Systematic
Reviews (http://www.crd.york.ac.uk/PROSPERO/index.
asp, CRD42014009741).
Information sources and search strategy

An open-ended survey of articles published up to


April 2014 investigating the effects of functional appliances on mandibular changes was performed in the
following electronic databases: PubMed, Cochrane Library, Embase, and Web of Science. The keywords used
to identify the studies and the electronic search results
are given in Table I. The search was complemented by
(1) a manual search in the American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontist, European Journal of Orthodontics, and Journal of
Orofacial Orthopedics; and (2) a manual search of the
reference lists from the retrieved articles and any available systematic reviews. Gray literature was also searched
for relevant articles.
Eligibility criteria

The retrieved articles were processed systematically


and separately by 2 reviewers (R.A.R.I.) and (M.S.A.).

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Table II. Inclusion and exclusion criteria for selecting

articles
Inclusion criteria
1. Related human clinical trials (RCTs and nonrandomized
prospective CCTs)
2. Pertained to the treatment of skeletal Class II malocclusion
3. Using FFA therapy with MBA
4. Availability of a suitable untreated control group
5. Treatment carried out so that FFA was tted after
alignment and leveling with MBA
6. Applied to patients in the permanent dentition
7. Set to evaluate the effect of the FFA immediately before
and after placing it (not comprehensive treatment)
8. Concerned with mandibular AP and vertical changes or TMJ
changes by using lateral cephalometric radiographs or
computed tomography scans or CBCT scans
9. The outcome measure was evaluated by using linear or
angular measurements
Exclusion criteria
1. If it did not meet the inclusion criteria
2. If it did not relate to this topic
3. If it was related but had a different aim
4. Abstracts, laboratory studies, descriptive studies, individual
case reports, series of cases, reviews, studies of adult patients,
retrospective studies, and meta-analyses were excluded
5. Clinical studies including patients who had received previous
treatment for their Class II malocclusion were also excluded
6. Studies with patients who had concomitant treatment other
than MBA
RCTs, Randomized controlled trials; CCTs, controlled clinical trials;
FFA, xed functional appliances; MBA, multibracket appliance; AP,
anteroposterior; TMJ, temporomandibular joint.

following domains were considered: random sequence


generation, allocation sequence concealment, blinding of outcome assessment, incomplete outcome
data, selective outcome reporting, and other sources
of bias. For all included trials, the risk of bias for
each domain was judged as low risk, high risk, or unclear risk. Each RCT was assigned an overall score: low
risk (low for all key domains), high risk (high for $1
key domain), and unclear risk (unclear for $1 key
domain).
The Newcastle-Ottawa scale21 was applied to assess
the quality of the nonrandomized controlled clinical
trials. The Newcastle-Ottawa scale is based on 3 broad
perspectives: selection of the study groups, comparability of the groups, and ascertainment of the outcome
of interest. Further elaboration of the NewcastleOttawa scale and its application in this study are shown
in Table III. The assessment of risk of bias and the
methodologic scoring were performed independently
by 2 investigators (R.A.R.I.) and (M.S.A.). Any disagreement was resolved by discussion with a third reviewer
(M.M.S.F.)
Risk of bias across studies

If more than 10 studies were included in the metaanalysis, standard funnel plots and contoured
enhanced funnel plots would be drawn to identify publication bias.
Summary measures and synthesis of results

Any disagreements were resolved by discussion between


the reviewers and a third reviewer (M.M.S.F.) to reach a
denitive decision. Inclusion and exclusion criteria are
given in Table II.
Data items and collection

Two authors (R.A.R.I. and M.S.A.) independently extracted characteristics and outcomes from the included
studies using predened data extraction forms that
were piloted on several articles and modied as required.
The collected data included the study design and setting,
sample description (size, age, sex distribution, and skeletal age assessment), selection criteria, and treatment
details (appliance type, observation period, activation,
or end of treatment).
Risk of bias and quality assessment in individual
studies

The risk of bias of the included randomized


controlled trials (RCTs) was assessed with the Cochrane Collaboration's risk of bias tool.20 The

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Data were combined using Review Manager software, version 5.3 (http://www.cochrane.org). Statistical heterogeneity was explored using the chi-square
based Q statistic method and the I2 index, with values
of 25%, 50%, and 75% corresponding to low, moderate, and high heterogeneity, respectively.22 According
to the I2 test, the xed-effects model and the
random-effects model were applied to studies with
less than 50% heterogeneity and greater than 50%
heterogeneity, respectively. The Tau2 test was also
calculated for the heterogeneity in the randomeffects model. The combined data were expressed as
mean differences and 95% condence interval (95%
CI). Combined data with pooled measurements or
measuring tools were expressed as standard mean deviations and 95% CI. Measurements for sagittal and
vertical mandibular changes were combined according
to similarity.
Additional analyses

Subgroup analyses were performed when possible to


evaluate the effect of pubertal status. In studies

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Table III. Quality assessment for the nonrandomized prospective controlled clinical trials with the Newcastle-Ottawa

scale
Authors and year
Item
Selection
Representativeness of the FFA group (true representation
of the average in the community or somewhat
representative of the average in the community)
Selection of the untreated control group (drawn from the
same community of the FFA treated group)
Ascertainment of FFA treatment group (secured record by
x-rays)
Demonstration that the outcome of interest was not
present at the day of start (yes)
Comparability
Comparability of the FFA group and control group
(comparison of starting forms: baseline characteristics
of age, sex, skeletal maturity, and skeletal
characteristics)
Outcome
Assessment of the outcome with independent blinding
(independent blind assessment)
Was follow-up adequate enough for outcomes to occur?
(Yes, an adequate follow up for short-term ndings)
Loss to follow-up acceptable (complete follow-up,
subjects lost to follow-up unlikely to introduce bias,
description provided of those lost, small number of loss
to follow up \10%)
Total quality (score)

Nalbantgil
et al,26 2005

kkeles
K
ucu
et al,27 2007

Jena and
Duggal,28 2010

Oztoprak
et al,29 2012

6 (High)

5 (High)

6 (High)

7 (High)

This table presents each item on the Newcastle-Ottawa scale and explains when stars should be given in each step. The assessment consists of 3
sections. The selection included 4 items, with 1 star for each item. Comparability included 1 item with at most 2 stars for this item. Outcome included
3 items with 1 star at each item. The total quality score represents the quality of the study. If the total number of stars was less than 5, the study was
low quality. Otherwise, it was a high-quality study. The quality assessment of each study is also presented. All included studies were of high quality
according to this assessment.

including 2 or more treated groups compared with 1


control group, data from the treated groups were pooled
according to the Cochrane Handbook indications. The
signicance level was set at P \0.05 (2-tailed z tests).
Outcomes that were not included in the meta-analysis
were presented separately.
RESULTS
Study selection
[F1-4/C]

Details of the search and the study selection are


shown in Figure 1. Among the 1366 initially identied
relevant articles, 662 unique citations remained after
removal of duplicates. A total of 594 articles were
excluded on the basis of title and abstract, and 61 articles were excluded on the basis of their full texts. Finally,
7 articles were selected for the qualitative evaluation,
and only 5 were deemed appropriate for inclusion in
the meta-analysis.

Study characteristics and risk of bias in studies

The systematic review included 1 RCT,23 2 quasiRCTs,24,25 and 4 prospective controlled clinical
trials.26-29 The RCTs were all judged to be at high risk
of bias (Table IV). The prospective controlled clinical trials were judged to be of high quality according to the
Newcastle-Ottawa scale (Table III).
All included studies were conducted in a university
setting (Table V). The ages of the study and control subjects ranged from 11.2 to 15.2 years and from 10.9 to
15.1 years, respectively. Two studies clearly described
the ages of the male and female participants separately.23,26 The studies of Jena and Duggal28 and Elkordy et al23 had girls only. Sex distribution in the
study group was mentioned in all studies, whereas in
the control group it was mentioned in 3 studies25-27
and not mentioned in 2 studies.24,29
The criteria for recruitment were clear and adequate
in only 4 studies.23,24,27,29 The remaining articles

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Fig 1. PRISMA owchart for the steps of the systematic review.

lacked important information in terms of selection


criteria. Skeletal age evaluation was included as a
selection criterion in 5 studies.23,25-27,29 Sample size
calculations were performed in 2 studies.23,25
The appliances used were rigid (Mandibular Protraction appliance-IV),28 exible (the Jasper jumper),24 and
semirigid (including the Forsus Fatigue Resistant
Device23,25,29 and the Sabbagh Universal Spring).29
The mean duration of treatment was reported in
months (average, 6 months), although Karacay et al24
did not report the treatment duration. Mandibular
changes were evaluated with cone-beam computed
tomography (CBCT) in only 1 study23 and with lateral
cephalometric radiographs in 6 studies. One study
included 2 treated groups (FFA group and a similar

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group with miniscrews) compared with an untreated


control group.23 The data of the FFA group were
included in this study.
The operators were not blinded regarding the measurements in any study. Reliability was described in all
the studies with 1 exception.28 Dropouts were
mentioned in just 1 study.23
Results of individual studies, meta-analysis, and
additional analysis

Mandibular changes in the treated groups were


compared with the untreated controls. In this review,
the ndings were categorized as horizontal (positional
and dimensional) and vertical.

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Table IV. Assessment of risk of bias (ROB) for the included RCTs

Author and year


Karacay et al,24 2006
Bilgic et al,25 2012
Elkordy et al,23 2015

Random sequence
generation
(selection bias)
Unclear
High
Low

Allocation
concealment
(selection bias)
Unclear
Unclear
Low

Blinding of
outcome assessment
(detection bias)
Unclear
Unclear
High

Incomplete
outcome data
(attrition bias)
Low
Low
Low

Selective reporting
(reporting bias)
Low
Low
Low

Other
bias
High
High
Low

Overall
ROB
High
High
High

This table presents the assessment of ROB in the included studies. It was based on 6 domains. The domain blinding of participants and personnel
was not assessed, since it was judged to be unfeasible. A study was judged as follows: low ROB (if low risk in all domains), high ROB (if high risk in at
least 1 domain), or unclear ROB (if unclear in at least 1 domain). All included studies were judged to be at high ROB.

[F2-4/C]

Measurements indicating positional changes


included SNB angle and pitchfork analysis.30 SNB
angular changes were reported in 5 studies24-27,29
using lateral cephalometric radiographs and in 1
study23 with CBCT (Fig 2). In the meta-analysis, the prepubertal subgroup included 3 studies, with 60 participants in the treated group and 52 participants in the
control group with no signicant differences observed
between the groups (standard mean difference [SMD],
0.07 ; 95% CI, 0.31, 0.44).23,25,27 In the postpubertal
subgroup, 2 studies included 55 participants in the
treated group and 34 participants in the control
group.26,29 No signicant differences were observed
between the groups (SMD, 0.17 ; 95% CI, 0.26,
0.61). No signicant difference was found in the SNB
angle for the total effect estimate (SMD, 0.11 ; 95%
CI, 0.17, 0.40). For this outcome, the xed-effects
model was applied because of the low heterogeneity of
the data.
The pitchfork analysis used to evaluate positional
changes was adopted by Jena and Duggal.28 They
showed the absence of a signicant effect compared
with the controls. This study was not included in the
meta-analysis.
Dimensional changes

[F3-4/C]

[F4-4/C]

Dimensional changes were reported in 6 studies


(Fig 3). Three of those studies23-25 used condyliongnathion, and the others26,27,29 used articularepogonion. The meta-analysis for the pubertal group
included 2 studies, with 36 subjects in the treated group
and 32 in the control group.23,25 A nonsignicant
difference was found between the treated and control
subjects (mean difference, 1.18 mm; 95% CI, 1.38,
3.73). The postpubertal group included 2 studies, with
55 subjects in the treated and 34 in the control group,
with no signicant difference between them (mean
difference, 0.86 mm; 95% CI, 2.49, 0.76).26,29
Five studies reported the mandibular plane angle
(Fig 4).24-27,29 No statistical signicance was found in
the pubertal subgroup (60 participants treated, 52

control yielding SMD of 0.20 ; 95% CI, 0.58,


0.17), the postpubertal subgroup (55 participants
treated, 34 control yielding SMD of 0.29 ; 95% CI,
0.72, 0.15), or the total group (SMD, 0.24 ; 95%
CI, 0.52, 0.05).
The ratio of lower face height to total face height
(Fig 5) was measured in 3 studies.26,27,29 The results
showed no effect on the lower face height ratio in the
pubertal subgroup (mean difference, 0.65%; 95% CI,
1.37, 0.07), the postpubertal subgroup (mean
difference, 0.36%; 95% CI, 1.11, 0. 39), or the
total group ( 0.43%; 95% CI, 1.04, 0.17).
Risk of bias across studies

Tests for publication bias were not undertaken


because only 5 studies were included in the
meta-analysis.
DISCUSSION

This systematic review is the rst to specically


address the treatment effects of FFA with MBA on the
mandible, a therapy different from other xed functional
treatment protocols for 2 reasons. These appliances are
often used in a later stage of maturation (with permanent teeth erupted) and can be used in concert with xed
appliances. The criteria for selection involved specic
treatment approaches, investigating the effects at specic times (just before and after the FFA and not for
the comprehensive treatment) and having a control
group to factor out normal growth changes.
The included RCTs were judged to be at high risk of
bias. The prospective controlled clinical trials, however,
were judged to be of high quality. This indicates the
importance of performing further bias-free studies that
adhere to the CONSORT guidelines.31 Various factors
seem to inuence the response to FFA treatment. The inuence of patient sex could not be assessed because of
the absence of separate outcome reporting for male
and female subjects. Previous reports, however, have reported that mandibular growth is related to sex.32

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[F5-4/C]

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Table V. Characteristics of the included studies


Selection criteria
Sample size (S or C),
sexes (M and F); ages
(y), mean (SD)
S, 15: M, 7; F, 8;
15 6 0.96
C, 15: M, 6 F, 9;
15.1 6 0.81

Study design/setting
pCCT/university (Turkey)

Karacay
et al,24 2006

Quasi-RCT/university
(Turkey)

S (FNFS), 16: M, 9; F, 7;
13.6 6 1.2
S (JJ), 16; M, 10; F, 6;
14 6 1.9
C, 16; 13.8 6 1.5

Not mentioned

kkeles,
K
ucu
et al,27 2007

pCCT/university
(Turkey)

S, 25: M, 12; F, 13;


11.83
C, 20: M, 10; F, 10;
11.3

HWM Grave's criteria

Jena and
Duggal,28
2010

pCCT/university
(India)

S, 15: girls; 11.28 6 0.52


C, 10: girls; 10.9 6 0.46

Not mentioned

Skeletal maturation
method/stage
HWM/postpubertal

Inclusion criteria
(1) Skeletal and dental
Class II (retrognathic
mandible)
(2) Normal or low-angle
growth
(1) Active growth
(2) Normal or mildly
prognathic maxilla;
(3) Retrognathic
mandible;
(4) Horizontal or normal
growth
(5) Class II molar
(6) Overjet #7 mm
(7) Minimum dental
crowding
(8) Permanent dentition
(1) Skeletal and dental
Class II
(2) Normal or reduced
incisor-MPA
(3) Well-aligned
mandibular arch
(4) Patient at peak stage
of growth curve
(5) Normal or low-angle
growth
(1) Class II Division 1
malocclusion normal
maxilla
(2) Retrognathic
mandible
(3) Class II molar
relationship bilaterally
(4) FMA range
20 -25
(5) Minimal or no
crowding or spacing
in either arch
(6) Overjet 6-10 mm

Appliance type/name
Flexible/JJ with MBA
Untreated

Observational
period mean
(mo) (SD)
Not mentioned

Activation/end of
treatment
Every 8 wk/Class I canine
and molar
relationship

Flexible/FNFS with MBA


Flexible/JJ with MBA
Untreated

5.28 (1.18)
5.23 (1.2)

Appliance activated as
required/Class I molar
relationship

Flexible/JJ with MBA


Untreated

After 1 wk, 2 mm,


renewed once in 6 wk/
Class I relationship

Rigid/MPA-IV with MBA


Untreated

6 (0.6)

Not mentioned/
mandible advanced to
an edge-to-edge
incisor position

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Authors and
year
Nalbantgil
et al,26 2005

Treatment

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Table V. Continued
Selection criteria
Authors and
year

Study design/setting

Sample size (S or C),


sexes (M and F); ages
(y), mean (SD)

Skeletal maturation
method/stage

Oztoprak
et al,29 2012

pCCT/university
(Turkey)

S (FFRD), 20: M, 9; F, 7;
15.08 6 1
S (SUS), 20: M, 10; F,
6; 15.25 6 1.16
C, 19; 14.7 5 6 1.1.25

CVMI/CVMI 5 and CVMI


6 postpeak growth
period

Bilgic
et al,25 2014

Quasi-RCT/university
(Turkey)

S, 20: M, 12; F, 8;
12.9 6 1.2
C, 20: M, 11; F, 9;
13.8 6 1.4

CVMI/CVMI stages 4-7

Inclusion criteria

Appliance type/name

Observational
period mean
(mo) (SD)

Activation/end of
treatment

Semirigid/FFRD
with MBA
Semirigid/SUS
with MBA
Untreated

5 (1)
5 (2)

Every 8 wk/Class I or
overcorrected Class I
canine and molar
relationship

Semirigid/FFRD with
MBA

5.6 (1.8)

Activated with a split


crimp as required/
Class I molar
relationship

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(1) Skeletal and dental


Class II malocclusion
(2) due to mandibular
retrognathia
(3) Normal or low-angle
growth pattern SN/
MP angle 25 -35
(4) No extracted or
congenitally missing
permanent teeth
(excluding third
molars)
(5) Minimum crowding
in mandibular arch
(0-5 mm)
(1) Active growth period
(2) Class II relationship
(3) Normal or slightly
forward maxilla and
retrognathic mandible
(4) Horizontal or normal
grower
(5) Permanent or mixed
dentition
(6) Normal or reduced
incisor-MPA
(7) Mild dental crowding
(8) Increased
overjet #8 mm

Treatment

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Table V. Continued
Selection criteria
Authors and
year
Elkordy
et al,23 2015

Study design/setting
RCT/university
(Egypt)

Sample size (S or C),


sexes (M and F); ages
(y), mean (SD)
S, 16: F; 13.25 6 1.12
C, 12: F; 12.71 6 1.44

Skeletal maturation
method/stage
MP3 index/MP3-G
MP3-H

Inclusion criteria

Appliance type/name
Semirigid/FFRD with
MBA
Untreated

Observational
period mean
(mo) (SD)
4.86 (1.32)

Activation/end of
treatment
Follow-up 3-4 wk
Activation as required
by crimpable stops/
Class I canine
edge-to-edge incisor
relationship

F, Female; M, Male; pCCT, prospective controlled clinical trial; RCT, randomized controlled clinical trial; S, study group; C, control group; HWM, hand-wrist maturation; CVMI, cervical vertebral
maturation index; MP3, middle phalanx of the middle nger; FNFS, Forsus Nitinol Flat Spring; JJ, Jasper jumper; FFRD, Forsus Fatigue Resistant Device; MPA-IV, mandibular protraction
appliance-IV; SUS, Sabbagh Universal Spring; MBA, multibracket appliance; MPA, mandibular plane angle.

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(1) Girls, 11-14 y


(2) Skeletal Angle Class II
Division 1
(3) Decient mandible
(SNB #76 )
(4) Horizontal or neutral
growth pattern
(MMP #30 )
(5) Overjet $5 mm
(6) Class II canine
relationship ($1/2
unit)
(7) Permanent teeth
(8) Mandibular arch
crowding \3 mm
(9) MP3 G or MP3 H
stage at insertion of
the FFRD

Treatment

Ishaq et al

621

Fig 2. Meta-analysis of the positional changes of the SNB angle ( ). Subgroup analysis consisted of
the results for the pubertal and postpubertal groups.

Fig 3. Meta-analysis of the dimensional changes: A, condylion-gnathion in the pubertal group and B,
articulare-pogonion in the postpubertal group.
Summary of the evidence

No signicant differences were observed when the


treated subjects were compared with the controls for
any of the evaluated outcomes. The positional changes
(SNB angle) did not signicantly differ when the treated
subjects were compared with the controls for the overall
effect estimate and for the pubertal and postpubertal

subgroups. A previous systematic review by Antonarakis


and Kiliaridis12 evaluating the effect of RFA showed a
signicant inuence on the SNB angle with activator
and Twin-block treatment. This difference may be
attributed to the differences in treatment duration and
timing, rendering FFA less inuential in terms of skeletal
change. However, a more recent review has also

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622

Fig 4. Meta-analysis of vertical changes using the mandibular plane angle ( ). Subgroup analysis
consisted of the results for the pubertal and postpubertal patients.

Fig 5. Meta-analysis of the vertical changes using face height ratio (ANS-Me/Na-Me) (%). Subgroup
analysis consisted of the results from the pubertal and postpubertal patients.

identied no SNB angle difference under the effect of


RFAs; this agrees with our ndings.15
Regarding effective mandibular length, no difference between the treated and control patients was
observed in the pubertal and postpubertal groups.
This nding does not agree with that of Perinetti
et al,18 who stated that FFAs are more effective in pubertal than postpubertal subjects. This discrepancy may
be attributed to the fact that the latter study included
studies with historic controls, which may have skewed
the results toward signicance. Another reason for
the difference is the inconsistency in terms of treatment duration.

May 2016  Vol 149  Issue 5

Regarding the vertical changes, little impact on the


vertical dimensions was observed. It may therefore be
tentatively inferred that FFA can be used in high-angle
cases without concerns relating to excessive increases
in the vertical dimension. However, further research
comparing the response and outcome with different
Class II phenotypes may be required to validate this.
Limitations of the available evidence

The meta-analysis included 5 studies (1 RCT, 1 quasiRCT, and 3 prospective controlled clinical trials). The
RCT evaluated the outcomes with CBCT, and the rest
used lateral cephalometric radiographs. Both imaging

American Journal of Orthodontics and Dentofacial Orthopedics

Ishaq et al

techniques evaluated the same outcomes. However, no


information about the comparability of CBCT with
lateral cephalometric radiographs in terms of the evaluation of growth changes is available. Therefore, the SMD
was computed in the meta-analysis rather than the mean
difference of the change.
This systematic review is based on evidence from
RCTs at high risk of bias and prospective controlled clinical trials with high methodologic soundness; nevertheless, the absence of randomization may predispose to a
risk of selection bias and possible confounding effects.33
Language restrictions were applied, with English publications more likely to be associated with positive ndings, thus risking skewing of the results toward
statistical signicance. Data from the study by Oztoprak
et al29 were combined according to the Cochrane Handbook, which also stated that this procedure can result in
underestimation of the computed standard deviations.
Data in some of the included meta-analyses also had
considerable statistical heterogeneity; the resultant effect estimates should therefore be interpreted with
caution.
CONCLUSIONS

Based on relatively weak evidence, FFAs with MBAs


appear to have no signicant positional or dimensional
skeletal effects on the mandible. A slightly greater skeletal dimensional effect was observed in the pubertal
subgroup than in the postpubertal subgroup, although
this difference was not statistically signicant. The vertical dimension was not affected by FFA therapy. Overall,
however, methodologically sound clinical trials controlling for potential confounders including age and duration of treatment are required to provide higher levels
of evidence regarding the effect of FFA on mandibular
growth.
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