Professional Documents
Culture Documents
studies was categorized as low, medium, or high. heterogeneous for the number and ages of the
Two independent reviewers (V.M.D. and N.R.V.) participants.
assessed the articles, separately. The data were The number of treated subjects and controls
extracted from each article without any blinding ranged from 22 to 55 and from 20 to 30,
to the authors, and intra-examiner conflicts were respectively, and again it was not possible to
resolved by discussion of each article to reach a assess clinical sex heterogeneity. Every selected
consensus. RCT analyzed a different type of fixed func-
tional appliance (e.g., Herbst and MARA), but
these devices also have seemingly similar mech-
Study characteristics anisms of action in protracting the mandible.
Treatment or observation times ranged from 6 to
Removable functional appliances
12 months. Like the removable functional group,
Data was collected from publications featuring 1469 no article reported long-term results for fixed
patients (780 treated versus 689 controls) with Class functionals.
II malocclusion treated with removable functional In our analysis, a distinction was made
appliances. The samples were heterogeneous for between statistically significant differences and
the number and ages of the participants. clinically significant differences between treated
The number of treated subjects and controls and untreated groups for both removable and
ranged from 17 to 76 and from 17 to 74, functional appliances.
respectively, and it was not possible to assess
clinical sex heterogeneity. Every selected RCT
Results
analyzed a different type of removable functional
appliance (e.g., Activator, Bionator, Twin block, Electronic searches for the effects of functional
Frankel 2, and Harvold Activator), but these appliances for Class II patients identified the
devices appear to have similar mechanisms of following items: 146 articles from PubMed, 45
action in protracting the mandible. Treatment or from Cochrane Central Register of Controlled
“observation” times ranged from 15 to 18 Trials, 29 from Ovid, and 1000 from Google
months.24,25 No article reported long-term results. 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
Fixed functional appliances
potentially appropriate articles, 38 were dupli-
Data was collected from publications featuring cates, so 32 articles were identified as eligible
353 patients (219 treated versus 134 controls) articles to be included in the study.
with Class II malocclusion treated with fixed However, 29 of the 32 articles were withdrawn
functional appliances. These samples were 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
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 they have subjected the results of their efforts to
respect to blinding, clearly do not apply to peer-reviewed scrutiny.6–17 So the belief in
orthodontics.5,42 “growing mandibles” warrants serious skepti-
Another issue that complicates our under- cism. Are there any studies (animal or human)
standing of clinical realities is that long-term that have claimed and proved that the effects
effects of growth and aging are difficult to eval- of functional appliances are solely due to a change
uate. Obviously, functional appliances have been in the size of the mandible? Absolutely not.43
used by clinicians worldwide for treatment of The correction of Class II malocclusion is the
the so-called underdeveloped mandible for a result of a combination of various effects
century. This has led clinicians to discuss them including condylar growth, maxillary growth
solely on ability to “grow mandibles.” Few restriction, glenoid fossa remodeling, gonial
developers of functional appliance or propo- angle changes, and dentoalveolar changes
nents of this theory have ever claimed that (noted both in the upper and lower dentition),
functional appliances are fertilizers for the both in the sagittal and the vertical planes.
mandibular crop. As for the other “optimists,” Johnston44 has stated that functional appliances
produce an instant forward shift of the mandible little or no effect on maxillary skeletal structures.
and, hopefully, a subsequent interdigitation of In addition, there were also no statistically or
the occlusion will lock the position of the clinically significant changes in maxillary length
occlusion in Class I as mandibular growth with the exception of reports by Tümer and
occurs in the background to make permanent Gültan31 on RFAs and McNamara et al.,29
that “shift.” Hence, during the post-functional describing FFAs (i.e., slight increases in Co–ANS).
phase, it is postulated that growth of maxilla
modulates mandibular displacement unless the Maxillary dental changes
dental compensative mechanism is again inter-
rupted. Pancherz and Hansen45 and Franchi and Maxillary dental changes are reported in Table 7
Baccetti46 attempted to predict individual for three measurements: U6 Horizontal, U6
mandibular changes induced by functional jaw Vertical, and U1 Horizontal. All selected
orthopedics in order to select parameters that studies described functional jaw orthopedics as
would indicate that a particular type of patient having a “headgear effect” on the upper
may respond better to functional jaw posterior teeth. Distalization of the upper first
orthopedics.46 They concluded that a Class II molars was reported to be clinical significant, but
patient, at the peak of skeletal maturation, with a statistically insignificant (average 1.07 mm for
pretreatment Co–Go–Gn angle less than 125.51 RFAs and 2.84 mm for FFAs).
may be expected to respond more favorably to These studies also pointed out clinically and
functional jaw orthopedics. statistically significant lingual tipping of upper
In the present study, we chose cephalometric incisors (except for a report by Mills and McCul-
values that have been analyzed in clinical trials loch32). Upper incisor horizontal changes were
and quantified across most of the studies both clinically and statistically for RFAs (2.47 mm)
selected. The effects of fixed and removable and statistically significant for FFAs (1.47 mm).
functional appliances, derived from these
values, were subjected to statistical analysis. We Mandibular skeletal changes
elected to eliminate studies based on their lack of
methodological soundness in a manner similar to Mandibular skeletal changes were reported for
Cozza et al.27 Therefore, we only included studies four measurements: Co–Gn (Man. length), SNB,
that reported anatomical condylion. All selected N perpendicular Pg, and Go–Po (Table 7). An
cephalometric values were standardized to a average increase of 1.61 mm in mandibular
uniform scale that could be reliably compared length was derived from among the selected
and then subjected them to statistical analysis. samples. This change was statistically significant,
The results obtained were categorized into four but not a clinically significant change for RFAs.
parameters: (a) maxillary skeletal changes, (b) On the other hand, a change of 2.29 mm was
maxillary dental changes, (c) mandibular both clinically and statistically significant for
skeletal changes, and (d) mandibular dental FFAs. All studies on FFAs also observed a
changes (Table 7). change in corpus length and an increase in N
The clinical significance and statistical sig- perpendicular to Pg of 2.08 mm, both statistically
nificance of the data in this meta-analysis was dif- and clinically significant. The exceptions to the
ferentiated on the basis of the threshold general findings in the RFAs group were seen in a
value for a “clinically significant” change as study by Janson et al.19 The mandibular values
reported by Cozza et al.27 A statistically significant are influenced by skeletal maturity at the time of
linear change reported in a study had to be greater initiating treatment.
than 2 mm to be regarded as clinically significant. It has previously been demonstrated that the
effectiveness of functional treatment of man-
dibular growth deficiencies strongly depends on
Maxillary skeletal changes
the biological responsiveness of the condylar
Maxillary skeletal changes are noted in Table 7 cartilage, which in turn depends on the growth
for three specific measurements: Co–ANS, SNA, rate of the mandible (expressed as prepeak,
and N perpendicular A. All selected studies peak, and postpeak growth rates with regard to
concluded that functional treatment had either the pubertal growth spurt).
330 Vaid et al
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 appliances), and the number of replicating
SOX9 (a regulator of chondrocyte differen- mesenchymal cells was seen to greatly influence
tiation on type II collagen gene) related to the growth potential of the condyle and glenoid
forward positioning of the condyle in an animal fossa. However, there were great variations noted,
model. The mandible was postured forward and the results of animal experiments cannot be
constantly (like that seen with fixed functional 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
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.
Figure 5. (continued)
functional appliances. In fact, the only significant On further evaluation of these samples, the
skeletal finding was an increase in Co–Gn, but most successfully treated patients (25% top
curiously only with fixed functional appliances, change category) demonstrated 41–51 of ANB
not removables. Additionally, FFAs also created change while the least 25% of successfully treated
flaring of lower incisors, so there appears to be a patients demonstrated only a 0.81–0.91 change.43
price to be paid (lost lower anchorage) for that For 50% of the subjects, a 21 change in ANB
minimal mandibular length increase. In contrast, holds minimal significance. To conclude,
a significant amount of upper molar distalization evidence and averages are a very important
was noted with both RFAs and FFAs. The results part of the picture, but not the total picture.
from the present study also augment current In trying to describe the efficacy of an appli-
evidence of the effects of one-phase versus two- ance, it should be noted that the nature of Class
phase approaches.48–50 II malocclusions can be attributed to various
three-dimensional permutations and combina-
tions. A blending of such factors does tend to
Implications for researchers
over-simplify the values derived from research
The RCTs, suggested by O'Brien51 and publications. Studies that differentiate different
Darendeliler,43 only showcase the average divergence and rotation patterns perhaps
effect of an intervention on an average patient will provide more useful information for the
with an average condition. This might be useful clinician. Another factor that may result in more
information for a clinician treating an “average homogenous results is a consensus on a
patient” and, averages are certainly useful to help composite cephalometric analysis to be used in
practitioners from wandering too far off the path; trials to improve interpretations across studies.52
however, caution is warranted in treating Simplistically speaking, we all know today
individual patients. Statistical and clinical that with the advent of 3D imaging, volumetric
readings are different, and dramatic changes changes in all dimensions also need critical
that occur within some treated samples cannot be evaluation, data that 2D cephalometrics cannot
ignored. Most of the RCTs had inclusion criteria provide. Finally, the CONSORT guidelines, if
that had many variables between subjects. For used uniformly to report all trials, will improve
example, in some studies, samples were chosen the database, potentially improving our clinical
with a particular amount of overjet without decisions.
considering the skeletal biotypes and growth
patterns. For instance, a vertical grower will not
Conclusions
respond in the same manner as a horizontal
grower when wearing a standard functional This meta-analysis evaluated the cephalometric
appliance; thereby, confounding the statistics values that signified the short-term effects of
in the larger picture. 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- upper molars and upper incisors, along with
teria. Removable functional appliances (RFAs) vertical movement of lower molars.
did not demonstrate any clinically significant In contrast, fixed functional appliances (FFAs)
skeletal changes; however, clinically significant showed no significant maxillary skeletal effects,
dental changes included distal movement of but in contrast, an increase in Co–Gn
336 Vaid et al
Figure 6. (continued)
(mandibular length) and N perpendicular to Pog orthodontic bureaucracy. The method used to
was observed. The dental changes noted were study growth modification in Class II malocclusion
distal movement of maxillary molars and incisors, can have concurrent impact on the conclusive
accompanied by lower incisor proclination. In treatment changes.53 Probably yes, or if we assumed
other words, only FFAs seemed to have any effect that the averages can bring about X amount of
on mandibular length but at the cost of lost change. For instance, without quantifying
anterior anchorage. The primary effects of both diagnostic parameters, we may well have been
types of functionals are on the midface and by treating the wrong patients with the right appliance
interrupting dentoalveolar compensation and when things turned out poorly, we blamed the
(Figs. 1–6). appliance (or vice versa). This might be a cynical
This investigation validates information that perspective, but it is true that statisticians do not
can be readily gleaned from the literature treat patients, only interpret data, often with many
regarding the effects of functional appliances. confounding variables involved. The refined RCT
Despite the significant amount of data, there still designs for future should at least differentiate the
seems to be an ongoing debate about the efficacy Class II patient on the basis of their individual
of functional appliances as they are still widely vertical or horizontal growth pattern, maxillary
accepted and used by clinicians. If the vast number excess, or mandibular retrusion, so that the gold
of patients across the world who benefitted from standard or preferred treatment modality for each
the effects of these appliances were to have been type of problem is selected. Without differentiating
subjected to findings of just the RCTs, we would the diagnostic variables and by simply studying
probably be writing new chapters in the annals of appliance effects or therapeutic efficacy, then we
Class II treatment with functional appliances 337
are contributing to a cookbook culture with little activator versus Herbst treatment. A cephalometric
hope for improvement. roentgenographic study. Eur J Orthod. 2002;24:627–637.
12. Croft RS, Buschang PH, English JD, Meyer R. A
The discerning clinician of the 21st century has cephalometric and tomographic evaluation of Herbst
to be astute in knowing that significant variation treatment in the mixed dentition. Am J Orthod Dentofacial
exists between individual patients and that this Orthop. 1999;116:435–443.
needs to be considered, deliberated in detail with 13. Pancherz H, Ruf S, Kohlhas P. Effective condylar growth
patients and their parents, before a treatment plan and chin position changes in Herbst treatment: a
cephalometric roentgenographic long-term study. Am J
incorporating the best evidence is finalized. Finally, Orthod Dentofacial Orthop. 1998;114:437–446.
future research in growth and genetics along with 14. Ruf S, Baltromejus S, Pancherz H. Effective condylar
evaluation of three-dimensional treatment effects growth and chin position in activator treatment: a
of perhaps bone-anchored functional appliance cephalometric roentgenographic study. Angle Orthod.
2001;71:4–11.
designs may be useful in developing more effective
15. Creekmore TD, Radney LJ. Frankel appliance therapy:
and efficient functional appliance therapy. orthopedic or orthodontic?Am J Orthod Dentofacial Orthop.
1983;83:89–108.
16. Giannelly A, Bronson P, Martignoni M, Bernstein L.
Acknowledgment Mandibular growth, condylar position and Frankel
appliance therapy. Angle Orthod. 1983;53:131–142.
We would like to thank Dr Vidya Wadadekar, our 17. Vargervik K, Harvold EP. Response to activator treatment
Biostatistician, and the Faculty and Residents, Depart- in Class II malocclusions. Am J Orthod Dentofacial Orthop.
ment of Orthodontics and Dentofacial Orthopedics, YMT 1985;88:242–251.
Dental College and Hospital, India for their assistance in 18. Robertson NRE. An examination of treatment changes in
this project. children treated with the functional regulator of Frankel.
Am J Orthod Dentofacial Orthop. 1983;83:299–310.
19. Janson GR, Toruno JL, Martins DR, Henriques JF, de
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