Class II treatment with functional appliances:

A meta-analysis of short-term treatment effects

Nikhilesh R. Vaid, MDS, Viraj M. Doshi, MDS, and Meghna J. Vandekar, MDS

The efficacy of functional appliances and changes produced by their

application are still the subject of controversy. Functional appliances
encompass a range of removable and fixed devices that are designed to
create three-dimensional changes in the dentition and development of the
jaws. This meta-analysis aims to analyze current literature up to January
2013 to provide evidence regarding the effects of functional appliances
(removable FA and fixed FA). A literature survey of articles was initiated with
meta-analysis using the random effect model (REM) along with hetero-
genesis and sensitivity analyses. Articles that met the inclusion criteria
included 24 for RFA and 7 for FFA. The total number of subjects evaluated
were 1469 (780 treated and 689 controls) for RFA and 353 (219 treated and 134
controls) for FFA. The results from the REM showed significant effects on
mandibular skeletal (Co–Gn: 2.29 mm, p o 0.0005; SNB—1.431, p o 0.0005;
and N Perp Pg—2.08 mm, p o 0.006) and dental changes (L incisor horizontal
—1.34 mm, p o 0.0005). Significant maxillary dental changes (U molar
horizontal—2.84 mm, p o 0.0005) were only observed for FFAs. Sensitivity
and chi-square tests also confirmed these findings. The analysis of the effect
of treatment by FFAs and RFAs versus untreated controls showed statisti-
cally significant short-term effects. (Semin Orthod 2014; 20:324–338.) & 2014
Elsevier Inc. All rights reserved.

Introduction treatment protocols, sample sizes, and research

designs that have led to some continued con-
lass II malocclusions form the majority of
C skeletal imbalances addressed in clinical
orthodontics, and the most consistent finding for
fusion. There have been more than a 100 dif-
ferent appliance designs that have been descri-
bed in publications for Class II correction over
this malocclusion has been reported to be
more than 100 years. Despite their frequent use
mandibular retrusion.1 Consensus on treatment
in treatment protocols throughout the world, it
protocols and effects of treatment of Class II
appears to many within our specialty that we do
malocclusion is still in a state of evolution;
not have evidence to develop a consensus on
consequently, controversies still exist.2
their effects.
Functional appliances encompass a range of
Systematic reviews in the past have analyzed
devices (removable and fixed) that are designed
relevant literature (1995–2011). The results were
with the intent to induce supplementary
inconclusive at large with limited clinical sig-
lengthening of mandible (both sagitally and
nificance with respect to removable and fixed
vertically) and also alter mandibular position by
functional appliances.3 The difficulties with these
stimulating growth at the condylar cartilage. This
studies, where RCTs were analyzed, related to
postulation has been subjected to different
inconsistencies in measuring treatment outcome
variables due to non-standardized inclusion cri-
Department of Orthodontics, YMT Dental College & Hospital, teria and various cephalometric variables
Navi Mumbai, India. assessed by different authors. In addition, treat-
Address correspondence to Nikhilesh R Vaid, MDS, Ground Floor, ment durations varied, and treatment groups
New Blue Gardenia Hsg Society, Peddar Rd, Opp Jindal Mansion,
Mumbai 400026, India. E-mail: orthonik@gmail.com
were subjected to comparisons with non-uniform
& 2014 Elsevier Inc. All rights reserved.
control groups. Following a systematic review,
1073-8746/12/1801-$30.00/0 data from individual studies may be pooled
http://dx.doi.org/10.1053/j.sodo.2014.09.008 quantitatively and re-analyzed using the

Seminars in Orthodontics, Vol 20, No 4 (December), 2014: pp 324–338 324

 Class II treatment with functional appliances
established statistical methods of a meta-analysis.
The rationale for a meta-analysis is that, by
combining the samples of individual studies, the
overall sample size is increased; thereby, impro-
ving the statistical power of the analysis as well as
the precision of the estimate values.4,5
Controversy specifically exists regarding man-
dibular changes resulting from functional appli-
ances used for Class IIs. Some authors have
reported increased mandibular length6–10 and
changes in amount of condylar growth11–14 while
others believe the altering mandibular growth
cannot be achieved.15–17 It has also been stated
that most corrections are due to dentoalveolar
changes with small, but statistically significant
amount of skeletal effects.18,19 Controversies
concerning the effects on the maxilla also exist.
Studies indicate inhibition of forward maxillary
growth (the so-called headgear effect)17,20 while
other authors disagree with this claim.21–23 These
conflicting conclusions can be attributed to con-
founding study designs and lack of long-term data.
The aim of this study was to use the highest
level of evidence and research methodology to
assess the skeletal and dental changes associated
with removable and fixed functional appliances.
Materials and methods
Meta-analysis
Meta-analysis is a two-stage process. The first
stage involves the calculation of a measure of
treatment effect for individual studies with 95%
confidence intervals (CI). The summary statistics
from the meta-analysis are usually used to
measure treatment effects, including odds ratio
(OR), relative risks (RR), and risk differences.
In the second stage of meta-analysis, an overall
treatment effect is calculated as a weighted
average of the individual summary statistics.
Readers should note that data from the indi-
vidual studies are not simply combined as if they
were from a single study. Greater weightage is
given to the results from studies that provide
more information, because they are likely to be
closer to the “true effect” we are trying to esti-
mate. The weights are often the inverse of the
variance (the square of the standard error) of the
treatment effect, relating closely to sample size.
The typical graph for displaying the results of a
meta-analysis is called a “forest-plot.”
325
Search strategies
A survey of articles published up to January 2013,
describing the effects of functional appliances on
mandibular growth, was performed by using
several electronic databases: Google Scholar,
PubMed, Embase, and Cochrane Central register
of controlled trials. The keywords used to identify
the corresponding studies in the databases were
Class II malocclusion and orthodontic functional
appliances and randomized clinical trial. The ref-
erence lists included in the retrieved articles were
also hand-searched to identify additional articles
that might have been missed in the electronic
bibliographic databases. No language restriction
was applied during the identification process of
published studies.
Selection criteria
The inclusion and exclusion criteria of our study
are given in Table 1.
Articles were not selected if they did not meet
the inclusion criteria, if they did not relate to this
topic, or if they related but had a different aim.
Abstracts, laboratory studies, descriptive studies,
individual case reports, series of cases, reviews,
studies of adult patients, controlled clinical trials,
retrospective longitudinal studies, and previous
meta-analysis (none present) were excluded.
RCTs that included patients who had received
previous or concomitant treatment for their Class
II malocclusion were also excluded.
Data collection and quality analysis
Data was collected based on the following items
for the retrieved studies: year of publication,
study design, materials (i.e., study sample, con-
trol sample, and type of functional appliance),
age of patients at the start of treatment, methods
of measurement, appliance wear, treatment/
observation duration, post-treatment observa-
tion, and authors' conclusions. A quality evalua-
tion of the methodological soundness of each
article was performed for RCTs, according to the
methods described by Jadad et al.,5 with an
extension of the quality appraisal to the CCTs.
The following characteristics were used: study
design, sample size and prior estimate of sample
size, withdrawals (dropouts), method error
analysis, blinding of measurements, and
adequate statistics. The quality of the retrieved
326
Table 1. Selection Criteria
Inclusion Criteria
(1) Related human clinical trial
(2) Randomized selection of samples
(3) Concerned with functional appliances (removable of fixed) in therapy of
Class II malocclusion
(4) Had comparable untreated control group
(5) Treatment effects not confounded by additional and concomitant
treatment (headgears and fixed appliances)
(6) Used cephalometric analysis at start and just after removal of functional
appliance
(7) Concerned with hard tissue changes
(8) Concerned with soft tissue changes
(9) Concerned with maxillary changes
(10) Concerned with mandibular changes
(11) Concerned with duration of treatment
studies was categorized as low, medium, or high.
Two independent reviewers (V.M.D. and N.R.V.)
assessed the articles, separately. The data were
extracted from each article without any blinding
to the authors, and intra-examiner conflicts were
resolved by discussion of each article to reach a
consensus.
Study characteristics
Removable functional appliances
Data was collected from publications featuring 1469
patients (780 treated versus 689 controls) with Class
II malocclusion treated with removable functional
appliances. The samples were heterogeneous for
the number and ages of the participants.
The number of treated subjects and controls
ranged from 17 to 76 and from 17 to 74,
respectively, and it was not possible to assess
clinical sex heterogeneity. Every selected RCT
analyzed a different type of removable functional
appliance (e.g., Activator, Bionator, Twin block,
Frankel 2, and Harvold Activator), but these
devices appear to have similar mechanisms of
action in protracting the mandible. Treatment or
“observation” times ranged from 15 to 18
months.24,25 No article reported long-term results.
Fixed functional appliances
Data was collected from publications featuring
353 patients (219 treated versus 134 controls)
with Class II malocclusion treated with fixed
functional appliances. These samples were
Vaid et al
Exclusion Criteria
(1) Laboratory studies
(2) Studies of adults
(3) Studies performed using magnetic
resonance imaging
(4) Measurements of total mandibular
length using point articulare
(5) Treatment combined with extractions
(6) Surgical treatment
heterogeneous for the number and ages of the
participants.
The number of treated subjects and controls
ranged from 22 to 55 and from 20 to 30,
respectively, and again it was not possible to
assess clinical sex heterogeneity. Every selected
RCT analyzed a different type of fixed func-
tional appliance (e.g., Herbst and MARA), but
these devices also have seemingly similar mech-
anisms of action in protracting the mandible.
Treatment or observation times ranged from 6 to
12 months. Like the removable functional group,
no article reported long-term results for fixed
functionals.
In our analysis, a distinction was made
between statistically significant differences and
clinically significant differences between treated
and untreated groups for both removable and
functional appliances.
Results
Electronic searches for the effects of functional
appliances for Class II patients identified the
following items: 146 articles from PubMed, 45
from Cochrane Central Register of Controlled
Trials, 29 from Ovid, and 1000 from Google
Scholar. Articles that did not relate to our topic,
related with a different aim, and those that were
not RCTs, were excluded. Of the remaining
potentially appropriate articles, 38 were dupli-
cates, so 32 articles were identified as eligible
articles to be included in the study.
However, 29 of the 32 articles were withdrawn
from consideration due to the following
 Class II treatment with functional appliances 327

Table 2. List of Articles Selected for Removable Table 4. List of Original Articles Statistically Evaluated
Functional Appliances in the Meta-Analysis for Treatment Effects With
Removable Functional Appliances (RFAs)
Author Journal
Author Journal
Chen et al.26 AJODO 2002
Cozza et al.27 AJODO 2006 Jakobsson and Paulin28 EJO 1990
Marsico et al.3 AJODO 2011 McNamara et al.22 AJODO 1985
McNamara et al.22 AJODO 1985
McNamara et al.29 AJODO 1990
exclusions: (1) lack of an untreated control Nelson et al.30 AJODO 1993
Nelson et al.30 AJODO 1993
group, (2) lack of random allocation of the Tulloch et al.24 AJODO 1997
untreated control group, (3) lack of cephalo- Tümer et al.31 AJODO 1999
metric analysis, (4) cephalometric analysis that Tümer et al.31 AJODO 1999
Toth et al.10 AJODO 1999
did not use anatomic condylion, (5) simulta- Toth et al.10 AJODO 1999
neous use of additional treatments, (6) progress Baccetti et al.20 AJODO 2000
reports, (7) summary trials, or (8) related to this Mills et al.32 AJODO 2000
Chadwick et al.33 EJO 2001
topic but with a different aim. Almeida et al.9 AJODO 2002
Consequently, only three articles for remov- Almeida et al.9 AJODO 2002
able functional appliances and two articles for Basciftci et al.21 EJO 2003
Faltin et al.34 ANGLE 2003
fixed functional appliances met all eligibility Janson et al.19 EJO 2003
criteria and were selected for the final analysis. O’Brien et al.25 AJODO 2003
In examining the three systematic reviews, each Cozza et al.35 EJO 2004
Webster et al.36 AJODO 1996
of the original articles evaluated in those reviews O’Brien et al.25 AJODO 2003
(i.e., original prospective studies) were then Banks et al.37 AJODO 2004
subjected to data analysis to get statistically
comparable inferences. Hence, there were 24
original articles for RFAs and seven original for subjects and types of appliances evaluated is
FFAs that were evaluated. These 31 articles were provided in Table 6. The results of the analysis of
those included in the three systematic reviews changes exhibited by the early use of functional
and that also met our inclusion criteria; perhaps, appliances are presented in Table 7.
making this one of the most exhaustive analyses
on the topic.
The analysis for the three articles that were Discussion
selected for removable functional appliances The quest for the highest level of evidence for
(RFAs) are shown in Table 2 and those for fixed solutions to Class II malocclusions in growing
functional appliances (FFAs) are listed in patients has seen increasing volumes of data and
Table 3. The selected articles were considered resulting interpretations published over the past
separately for removable and fixed functional four decades. To derive data from an RCT in
appliances as they could not be compared orthodontics is extremely difficult because
directly as data had been analyzed with of the sensitive ethical issue of leaving a control
different statistics. Consequently, all 24 group of patients untreated. Furthermore,
removable functional appliance articles and
seven fixed functional articles that fulfilled the Table 5. List of Original Articles Statistically Evaluated
inclusion criteria are listed in Tables 4 and 5, in the Meta-Analysis for Treatment Effects With Fixed
respectively. The distribution of experimental Functional Appliances
Author Journal

Table 3. List of Articles Selected for Fixed Functional McNamara et al.29 AJODO 1990
Appliances Pancherz38 AJODO 1982
Windmiller39 AJODO 1993
Author Journal Franchi et al.40 AJODO 1999
Pangrazio-Kulbersh et al.41 AJODO 2003
Chen et al.26 AJODO 2002 Pangrazio-Kulbersh et al.41 AJODO 2003
Cozza et al.27 AJODO 2006 O’Brien et al.25 AJODO 2003
328 Vaid et al

Table 6. Subject Distribution and Appliances Evaluated

Removable Functional Appliances (Activator, Fixed Functional Appliances (Herbst and
Bionator, Twin Block, Frankel 2, and MARA)
Harvold Activator)
Subjects Control Subjects Control

Sample size 780 (range: 17–76) 689 (range: 17–74) 219 (range: 22–55) 134 (range: 20–30)
Average treatment time (months) 17.52 17.31 10.6 10.51
Average treatment initiation age (months) 10.53 10.33 12.01 11.42

several items required in quality reviews with
respect to blinding, clearly do not apply to
orthodontics.5,42
Another issue that complicates our under-
standing of clinical realities is that long-term
effects of growth and aging are difficult to eval-
uate. Obviously, functional appliances have been
used by clinicians worldwide for treatment of
the so-called underdeveloped mandible for a
century. This has led clinicians to discuss them
solely on ability to “grow mandibles.” Few
developers of functional appliance or propo-
nents of this theory have ever claimed that
functional appliances are fertilizers for the
mandibular crop. As for the other “optimists,”
they have subjected the results of their efforts to
peer-reviewed scrutiny.6–17 So the belief in
“growing mandibles” warrants serious skepti-
cism. Are there any studies (animal or human)
that have claimed and proved that the effects
of functional appliances are solely due to a change
in the size of the mandible? Absolutely not.43
The correction of Class II malocclusion is the
result of a combination of various effects
including condylar growth, maxillary growth
restriction, glenoid fossa remodeling, gonial
angle changes, and dentoalveolar changes
(noted both in the upper and lower dentition),
both in the sagittal and the vertical planes.
Johnston44 has stated that functional appliances

Table 7. Subject Distribution and Details Evaluated

Removable Functional Appliances Fixed Functional Appliances
(Activator, Bionator, Twin Block, Frankel 2, and Harvold Activator) (Herbst and MARA)
Parameters Number Sample Advantage Statistical Number Sample Advantage Statistical
of Studies Size Over Significance/Clinical of Size Over Significance/Clinical
Control Significance Studies Control Significance

Maxillary skeletal changes

Co–ANS (mm) 8 467 – N/N 4 226 0.52 N/N
SNA (deg) 16 967 0.36 N/N 5 268 0.45 N/N
N Perp A (mm) 9 722 0.65 Y/N 4 226 0.95 Y/N
Maxillary dental changes
U6 Horizontal 13 853 1.07 Y/Y 6 354 2.84 Y/Y
(mm)
U6 Vertical (mm) 11 597 N/N 4 225 0.84 N/N
U1 Horizontal 12 811 2.47 Y/Y 4 236 1.47 Y/N
(mm)
Mandibular skeletal changes
Co–Gn (mm) 21 1297 1.61 Y/N 6 353 2.29 Y/Y
SNB (deg) 18 1089 0.85 Y/N 5 268 1.34 Y/N
N Perp Pg (mm) 9 722 0.32 N/N 4 226 2.08 Y/Y
Go–Po (mm) 9 479 0.52 Y/N 5 311 1.33 N/N
Mandibular dental changes
L6 Horizontal (mm) 14 856 – N/N 6 353 0.52 N/N
L 6 Vertical (mm) 13 656 1.5 Y/N 4 225 0.66 Y/N
L1 Horizontal (mm) 11 755 0.56 N/N 6 353 1.34 Y/Y
 Class II treatment with functional appliances
produce an instant forward shift of the mandible
and, hopefully, a subsequent interdigitation of
the occlusion will lock the position of the
occlusion in Class I as mandibular growth
occurs in the background to make permanent
that “shift.” Hence, during the post-functional
phase, it is postulated that growth of maxilla
modulates mandibular displacement unless the
dental compensative mechanism is again inter-
rupted. Pancherz and Hansen45 and Franchi and
Baccetti46 attempted to predict individual
mandibular changes induced by functional jaw
orthopedics in order to select parameters that
would indicate that a particular type of patient
may respond better to functional jaw
orthopedics.46 They concluded that a Class II
patient, at the peak of skeletal maturation, with a
pretreatment Co–Go–Gn angle less than 125.51
may be expected to respond more favorably to
functional jaw orthopedics.
In the present study, we chose cephalometric
values that have been analyzed in clinical trials
and quantified across most of the studies
selected. The effects of fixed and removable
functional appliances, derived from these
values, were subjected to statistical analysis. We
elected to eliminate studies based on their lack of
methodological soundness in a manner similar to
Cozza et al.27 Therefore, we only included studies
that reported anatomical condylion. All selected
cephalometric values were standardized to a
uniform scale that could be reliably compared
and then subjected them to statistical analysis.
The results obtained were categorized into four
parameters: (a) maxillary skeletal changes, (b)
maxillary dental changes, (c) mandibular
skeletal changes, and (d) mandibular dental
changes (Table 7).
The clinical significance and statistical sig-
nificance of the data in this meta-analysis was dif-
ferentiated on the basis of the threshold
value for a “clinically significant” change as
reported by Cozza et al.27 A statistically significant
linear change reported in a study had to be greater
than 2 mm to be regarded as clinically significant.
Maxillary skeletal changes
Maxillary skeletal changes are noted in Table 7
for three specific measurements: Co–ANS, SNA,
and N perpendicular A. All selected studies
concluded that functional treatment had either
329
little or no effect on maxillary skeletal structures.
In addition, there were also no statistically or
clinically significant changes in maxillary length
with the exception of reports by Tümer and
Gültan31 on RFAs and McNamara et al.,29
describing FFAs (i.e., slight increases in Co–ANS).
Maxillary dental changes
Maxillary dental changes are reported in Table 7
for three measurements: U6 Horizontal, U6
Vertical, and U1 Horizontal. All selected
studies described functional jaw orthopedics as
having a “headgear effect” on the upper
posterior teeth. Distalization of the upper first
molars was reported to be clinical significant, but
statistically insignificant (average 1.07 mm for
RFAs and 2.84 mm for FFAs).
These studies also pointed out clinically and
statistically significant lingual tipping of upper
incisors (except for a report by Mills and McCul-
loch32). Upper incisor horizontal changes were
both clinically and statistically for RFAs (2.47 mm)
and statistically significant for FFAs (1.47 mm).
Mandibular skeletal changes
Mandibular skeletal changes were reported for
four measurements: Co–Gn (Man. length), SNB,
N perpendicular Pg, and Go–Po (Table 7). An
average increase of 1.61 mm in mandibular
length was derived from among the selected
samples. This change was statistically significant,
but not a clinically significant change for RFAs.
On the other hand, a change of 2.29 mm was
both clinically and statistically significant for
FFAs. All studies on FFAs also observed a
change in corpus length and an increase in N
perpendicular to Pg of 2.08 mm, both statistically
and clinically significant. The exceptions to the
general findings in the RFAs group were seen in a
study by Janson et al.19 The mandibular values
are influenced by skeletal maturity at the time of
initiating treatment.
It has previously been demonstrated that the
effectiveness of functional treatment of man-
dibular growth deficiencies strongly depends on
the biological responsiveness of the condylar
cartilage, which in turn depends on the growth
rate of the mandible (expressed as prepeak,
peak, and postpeak growth rates with regard to
the pubertal growth spurt).
330 Vaid et al

Figure 1. Maxillary skeletal and dental parameters evaluated.

Figure 2. Mandibular skeletal and dental parameters evaluated.

 Class II treatment with functional appliances 331

Figure 3. Maxillary skeletal changes. (A) Co–ANS changes with removable functional appliances. (B) SNA
changes with removable functional appliances. (C) N perpendicular A changes with removable functional
appliances. (D) Co–ANS changes with fixed functional appliances. (E) SNB changes with fixed functional
appliances. (F) N perpendicular A changes with fixed functional appliances.

Rabie et al.47 examined the association of
SOX9 (a regulator of chondrocyte differen-
tiation on type II collagen gene) related to
forward positioning of the condyle in an animal
model. The mandible was postured forward
constantly (like that seen with fixed functional
appliances), and the number of replicating
mesenchymal cells was seen to greatly influence
the growth potential of the condyle and glenoid
fossa. However, there were great variations noted,
and the results of animal experiments cannot be
directly applied to humans.
332 Vaid et al

Figure 4. Maxillary dental changes: (A) upper molar horizontal changes with removable functional appliances,
(B) upper molar vertical changes with removable functional appliances, (C) upper incisor horizontal changes with
removable functional appliances, (D) upper molar horizontal changes with fixed functional appliances, (E) upper
molar vertical changes with fixed functional appliances, and (F) upper incisor horizontal changes with fixed
functional appliances

Mandibular dental changes Vertical, and L1 Horizontal. The only

statistically significant mandibular dental
Mandibular dental changes for three measure- changes noted were labial displacement of the
ments are noted in Table 7: L6 Horizontal, L6 lower incisors, specifically for FFAs (1.34 mm).
 Class II treatment with functional appliances 333

Figure 5. Mandibular skeletal changes: (A) Co–Gn changes with removable functional appliances, (B) SNB
changes with removable functional appliances, (C) N perpendicular Pg changes with removable functional
appliances, (D). Go–Po/Pg changes with removable functional appliances, (E) Co–Gn changes with fixed
functional appliances, (F) SNB changes with fixed functional appliances, (G) N perpendicular Pg changes with
fixed functional appliances, and (H) Go–Po/Pg changes with fixed functional appliances.

Lower incisor proclination with FFAs is a Implications for clinicians

commonly observed clinical phenomenon,
and the results of the meta-analysis corrobo- This meta-analysis demonstrated that there were
rate that finding. primarily dental changes associated with
334 Vaid et al
Figure 5. (continued)
functional appliances. In fact, the only significant
skeletal finding was an increase in Co–Gn, but
curiously only with fixed functional appliances,
not removables. Additionally, FFAs also created
flaring of lower incisors, so there appears to be a
price to be paid (lost lower anchorage) for that
minimal mandibular length increase. In contrast,
a significant amount of upper molar distalization
was noted with both RFAs and FFAs. The results
from the present study also augment current
evidence of the effects of one-phase versus two-
phase approaches.48–50
Implications for researchers
The RCTs, suggested by O'Brien51 and
Darendeliler,43 only showcase the average
effect of an intervention on an average patient
with an average condition. This might be useful
information for a clinician treating an “average
patient” and, averages are certainly useful to help
practitioners from wandering too far off the path;
however, caution is warranted in treating
individual patients. Statistical and clinical
readings are different, and dramatic changes
that occur within some treated samples cannot be
ignored. Most of the RCTs had inclusion criteria
that had many variables between subjects. For
example, in some studies, samples were chosen
with a particular amount of overjet without
considering the skeletal biotypes and growth
patterns. For instance, a vertical grower will not
respond in the same manner as a horizontal
grower when wearing a standard functional
appliance; thereby, confounding the statistics
in the larger picture.
On further evaluation of these samples, the
most successfully treated patients (25% top
change category) demonstrated 41–51 of ANB
change while the least 25% of successfully treated
patients demonstrated only a 0.81–0.91 change.43
For 50% of the subjects, a 21 change in ANB
holds minimal significance. To conclude,
evidence and averages are a very important
part of the picture, but not the total picture.
In trying to describe the efficacy of an appli-
ance, it should be noted that the nature of Class
II malocclusions can be attributed to various
three-dimensional permutations and combina-
tions. A blending of such factors does tend to
over-simplify the values derived from research
publications. Studies that differentiate different
divergence and rotation patterns perhaps
will provide more useful information for the
clinician. Another factor that may result in more
homogenous results is a consensus on a
composite cephalometric analysis to be used in
trials to improve interpretations across studies.52
Simplistically speaking, we all know today
that with the advent of 3D imaging, volumetric
changes in all dimensions also need critical
evaluation, data that 2D cephalometrics cannot
provide. Finally, the CONSORT guidelines, if
used uniformly to report all trials, will improve
the database, potentially improving our clinical
decisions.
Conclusions
This meta-analysis evaluated the cephalometric
values that signified the short-term effects of
functional appliance therapy. Unfortunately, no
 Class II treatment with functional appliances 335

Figure 6. Mandibular dental changes: (A) lower molar horizontal changes with removable functional appliances,
(B). lower molar vertical changes with removable functional appliances, (C) lower incisor horizontal changes with
removable functional appliances, (D) lower incisor vertical changes with removable functional appliances, (E)
lower molar horizontal changes with fixed functional appliances, (F) lower molar vertical changes with fixed
functional appliances, (G) lower incisor horizontal changes with fixed functional appliances, and (H) lower incisor
vertical changes with fixed functional appliances.

published long-term results fit our selection cri-
teria. Removable functional appliances (RFAs)
did not demonstrate any clinically significant
skeletal changes; however, clinically significant
dental changes included distal movement of
upper molars and upper incisors, along with
vertical movement of lower molars.
In contrast, fixed functional appliances (FFAs)
showed no significant maxillary skeletal effects,
but in contrast, an increase in Co–Gn
336 Vaid et al
Figure 6. (continued)
(mandibular length) and N perpendicular to Pog
was observed. The dental changes noted were
distal movement of maxillary molars and incisors,
accompanied by lower incisor proclination. In
other words, only FFAs seemed to have any effect
on mandibular length but at the cost of lost
anterior anchorage. The primary effects of both
types of functionals are on the midface and by
interrupting dentoalveolar compensation
(Figs. 1–6).
This investigation validates information that
can be readily gleaned from the literature
regarding the effects of functional appliances.
Despite the significant amount of data, there still
seems to be an ongoing debate about the efficacy
of functional appliances as they are still widely
accepted and used by clinicians. If the vast number
of patients across the world who benefitted from
the effects of these appliances were to have been
subjected to findings of just the RCTs, we would
probably be writing new chapters in the annals of
orthodontic bureaucracy. The method used to
study growth modification in Class II malocclusion
can have concurrent impact on the conclusive
treatment changes.53 Probably yes, or if we assumed
that the averages can bring about X amount of
change. For instance, without quantifying
diagnostic parameters, we may well have been
treating the wrong patients with the right appliance
and when things turned out poorly, we blamed the
appliance (or vice versa). This might be a cynical
perspective, but it is true that statisticians do not
treat patients, only interpret data, often with many
confounding variables involved. The refined RCT
designs for future should at least differentiate the
Class II patient on the basis of their individual
vertical or horizontal growth pattern, maxillary
excess, or mandibular retrusion, so that the gold
standard or preferred treatment modality for each
type of problem is selected. Without differentiating
the diagnostic variables and by simply studying
appliance effects or therapeutic efficacy, then we
 Class II treatment with functional appliances
are contributing to a cookbook culture with little
hope for improvement.
The discerning clinician of the 21st century has
to be astute in knowing that significant variation
exists between individual patients and that this
needs to be considered, deliberated in detail with
patients and their parents, before a treatment plan
incorporating the best evidence is finalized. Finally,
future research in growth and genetics along with
evaluation of three-dimensional treatment effects
of perhaps bone-anchored functional appliance
designs may be useful in developing more effective
and efficient functional appliance therapy.
Acknowledgment
We would like to thank Dr Vidya Wadadekar, our
Biostatistician, and the Faculty and Residents, Depart-
ment of Orthodontics and Dentofacial Orthopedics, YMT
Dental College and Hospital, India for their assistance in
this project.
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