CONTINUING EDUCATION

Benefit of early Class II treatment: Progress report of a

two-phase randomized clinical trial
J.F. Camilla Tulloch, BDS, FDS, DOrth,a Ceib Phillips, PhD, MPH,b and
William R. Proffit, DDS, PhDc
Chapel Hill, N.C.
Preadolescent children with overjet greater than 7 mm were randomly assigned to observation only,
headgear (combination), or functional appliance (modified bionator) and were monitored for 15
months. Of the 166 patients who completed this first phase of the trial, 147 continued to a second
phase of treatment. The data from the first 107 patients to complete phase 2 are available and form
the basis of this progress report. During phase 1, on average there was no change in the jaw
relationship of untreated children, but 5% showed considerable improvement and 15%
demonstrated worsening. Both early-treatment groups had a significant average reduction in ANB
angle, more by change in maxillary dimensions in the headgear group and mandibular growth in the
functional appliance group. There were wide variations in response, however, with only 75% of the
treated children showing favorable skeletal response. Failure to respond favorably could not be
explained by lack of cooperation alone. The preliminary results from phase 2 show that, on
average, time in fixed appliances was shorter for children who underwent early treatment, but the
total treatment time was considerably longer if the early phase of treatment was included. Only
small differences were noted in anteroposterior jaw position between the groups at the completion
of treatment, and the changes in dental occlusion, judged on the basis of Peer Assessment Rating
scores, were similar between groups. Neither the severity of the initial problem nor the duration of
treatment was correlated with the occlusal result. The number of patients who required extraction
of permanent teeth was greater in the early functional appliance group than in the headgear or
control group. The option of orthognathic surgery was presented more often in the cases of
children who did not undergo early treatment, but surgery was accepted or was still being
considered almost as frequently in the previous headgear group as in the controls, less often in the
patients previously treated with functional appliances. (Am J Orthod Dentofacial Orthop 1998;113:
62-72.)

or preadolescent children with Class II

malocclusion, the optimal timing for treatment remains controversial, despite long experience and
many published findings. Because most patients with
Class II malocclusion have some type of skeletal
imbalance, early (preadolescent) treatment often is
aimed mainly at modifying the growth of the jaws.
This early phase of treatment is usually followed by
a second, and presumably simpler, later stage of
tooth movement during adolescence. Thus patients
with Class II malocclusion would benefit from twostage treatment if skeletal growth could be modified,
From the Department of Orthodontics, School of Dentistry, University of
North Carolina.
a
Professor.
b
Research Professor.
c
Professor.
Reprint requests to: J. F. Camilla Tulloch, BDS, FDS, DOrth, Department
of Orthodontics, School of Dentistry, University of North Carolina, Chapel
Hill, NC 27599-7450.
Copyright 1998 by the American Association of Orthodontists.
0889-5406/98/$5.00 1 0 8/5/85971

62

and if this made a difference in terms of the

subsequent treatment duration, treatment complexity, or treatment outcome compared with one-stage
treatment during adolescence.
In this article we present a progress report on a
randomized clinical trial being undertaken at the
University of North Carolina (UNC) to address
some of the issues related to the timing of treatment
for Class II malocclusion. The UNC trial was designed in two parts (Fig. 1). The first phase of the
trial addressed the issue of whether the growth
pattern of Class II patients can be modified; the
second phase approached the more difficult question of whether even if differential growth effects
can be induced during early treatmentthese effects in the end make any difference.
MATERIAL AND METHODS
To review briefly, in the first phase of the trial
preadolescent children with increased overjet (.7mm)
were randomly assigned (in blocks of six, stratified by

Tulloch, Phillips, and Proffit 63

American Journal of Orthodontics and Dentofacial Orthopedics

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Table I. Progress of patients through the two phases of the

UNC trial as of January 1997

Started phase 1
Completed phase 1
Dropped after phase 1
Moved
Parent decision
No reason
Investigator decision
Started phase 2*
Completed phase 2
1 Year recall
2 Year recall
3 Year recall

Control

Functional

Headgear

61
61
9
4
1
2
2
52
38
20
9
1

53
53
8
2
2
2
2
41
37
17
11
0

52
52
2
0
0
1
1
50
36
21
12
0

*Excludes four patients in functional appliance group who desired no

fixed-appliance treatment in phase 2.

gender) to undergo early growth modification (headgear

or a functional appliance) or no treatment during an
observation period. To reduce the influence of differences
in clinical proficiency on the outcomes of early growth
modification, all phase 1 treatment was provided by one
clinician in accordance with a strict treatment protocol.
All patients (treated and controls) were evaluated at 15
months, which was felt to be a reasonable time frame in
which to demonstrate possible differential growth effects.
The comparison being made during phase 1 of the trial
was the skeletal change seen in the two early-treatment
groups compared with that seen in the control group.
Procedures in phase 1 of the UNC clinical trial are
presented in detail elsewhere.1
The second phase of the trial was designed to address
the question, Does early growth modification make a
difference in the subsequent treatment? After phase 1,
patients were maintained in their assigned groups until
their primary teeth were lost. The patients were then
rerandomized, this time in blocks of eight, stratified on the
basis of their phase 1 group assignment, to one of four
doctors for completion of treatment. Thus in phase 2 each
doctor was assigned approximately equal numbers of
observation only or early growth modification (headgear
or functional appliance) patients. This rerandomization
was undertaken to maximize the chance that each doctor
would receive approximately equal distributions of boys
and girls, good and poor early-treatment responders,
compliant and noncompliant children, and children with
other variables that might influence treatment outcome.
The treatment protocol during phase 2 was not specified. Rather, each doctor was permitted to determine
what treatment the patient should receive. In this way the
impact of early growth modification on subsequent treatment and treatment outcome could be reviewed in light of
the widely recognized differences between patients and
differences in clinicians proficiency. In phase 2 of the
UNC trial the comparisons being made involve benefits
accruing to the patients who underwent early treatment,

Fig. 1. Design of the two-phase randomized clinical

trial used to evaluate benefit of early orthodontic treatment for Class II malocclusion.

compared with those who did not. The benefits considered

in this report are the treatment outcome measured as the
amount of skeletal change during late treatment, the
change in Peer Assessment Rate (PAR) score (a summary
of the alignment and occlusion of the teeth,2 the duration
of comprehensive treatment, and the complexity of treatment as indicated by extraction rate and the orthognathic
surgery rate.
Phase 2 of the trial is ongoing at this writing. This
report is based on the 107 patients (of 147) who had
completed comprehensive treatment as of January 1997.
At this point, median values are generally reported for
phase 2 results because these data are less likely than
mean values to be skewed by the addition of later data;
only descriptive statistics are reported as interim results.
The progress of patients through the trial is shown in
Table I.
RESULTS

At the start of the trial the three groups formed

by the first randomization were equivalent with
regard to age, sex, maturity, and morphologic measures from the cephalograms and study models. The
patients, 58% male, were in mixed dentition, with a
mean age of 9.9 years (range 7.712.4 years). The
children had moderate to severe Class II problems,
with a mean ANB angle of 6.2 (range 0.412.2)
and a mean overjet of 8.33 mm (range 715 mm). A
bilateral Class II molar relationship was found in
90.8%.

64 Tulloch, Phillips, and Proffit

American Journal of Orthodontics and Dentofacial Orthopedics

January 1998

Table II. Annualized mean change in the skeletal measures

during phase 1
Control
(n 5 61)

Functional
(n 5 53)

Headgear
(n 5 52)

ANB

0.17

0.93

1.07

SNA

0.26

0.11

0.92

SNB

0.43

1.07

0.15

Mandibular
length

2.36

3.69

2.97

Skeletal measures

The connecting underlines indicate where statistically significant differences exist (p , 0.01) between groups (two-way analysis of variance).

The maxillary and mandibular skeletal changes

during phase 1 are detailed elsewhere1 and summarized here in Table II. The changes are reported as
annualized change in an effort to adjust for minor
differences in the time each patient was observed
and to facilitate comparison with other studies. The
results of an analysis of variance (ANOVA) indicated that, between boys and girls, that there was no
difference in their cephalometric measures and no
difference in the pattern of change of boys and girls
in any of the three groups. The comparison between
the three phase 1 groups showed that early treatment with headgear or functional appliance did, on
average, reduce the severity of the skeletal discrepancy. ANB changes were quite similar in the headgear and functional appliance groups, but the mechanism by which these changes occurred was
different. Headgear patients had a greater tendency
to restricted maxillary forward movement, and the
functional appliance subjects were more likely to
have increased mandibular length and improved
chin position.
Despite the small but statistically significant differences seen between the three groups, there was
wide variation within all three groups. By no means
did all patients respond as one might have expected
from the pattern of average changes. In the control
group, 4% showed highly favorable growth and 15%
unfavorable growth. When the magnitude of skeletal change was categorized from highly favorable to
unfavorable, about 75% of the treated children
showed favorable response; 25% did not (Fig. 2).
Even though we noted a statistically significant
difference in the distribution of these changes between groups, the magnitude of the skeletal change
could not be explained in terms of the patients

initial skeletal severity, age/maturity at the outset of

treatment, pattern of growth, or general compliance
with treatment.3
Fig. 3 shows the amount of skeletal change
(measured as the ANB angle) in the three groups at
the different stages of treatment. We detected no
difference in ANB angle among the three groups at
the outset of the trial. After phase 1, the two
early-treatment groups had statistically significant
reductions in ANB angle. The preliminary data from
phase 2(107 of 147 patients) show a larger average
reduction in ANB in the patients who had no
previous early treatment, so there is only a small
difference between the groups at the end of phase 2.
The outcome of treatment in terms of the alignment and occlusion of the teeth is given in Fig. 4.
The PAR scoring system ranges from 0 (describing a
perfect occlusion with ideal alignment and tooth
relationships) to 50-plus (which categorizes a very
severe malocclusion). PAR scores below 5 generally
describe near-ideal occlusions, whereas scores between 5 and 10 usually denote acceptable occlusions
and scores of greater than 10 reflect less satisfactory
alignment or occlusion.2 Although the average improvement in occlusion in the early-treatment
groups was rather modest during phase 1, some
patients benefited greatly and others actually got
worse. In general, the PAR score for control patients increased over this period, most likely reflecting the increase in crowding that occurs as permanent canines erupt. During phase 2 the treatment
changes were such that the average PAR score at
the end of phase 2 was approximately the same for
patients who did not have early treatment as for
those who did. The distribution of near-ideal, acceptable and less satisfactory final results was also
quite similar in the three groups (Table III). We
found no systematic relationship between the severity of the occlusal problem at the start of treatment,
as measured by the PAR score, and the occlusion
and alignment of the teeth at the end of phase 2
treatment (Fig. 5).
Both the previous controls and the early-treatment patients were treated in phase 2 in accordance
with their assigned doctors preferences. At the start
of phase 2 all children had lost their primary teeth
and were therefore at a stage at which full fixed
appliances could be placed. However, in some cases
the doctor elected to start phase 2 with preliminary
appliances such as an expansion device, lip bumper,
headgear, or partial banding with a 2 3 4 setup. The
treatment time described here is the total treatment
time for phase 2that is, the time in full fixed

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American Journal of Orthodontics and Dentofacial Orthopedics

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Fig. 2. Percentage of children in each group demonstrating different amounts of change

in ANB angle during phase 1 of the UNC trial. Note the variation in the control and the
treatment groups.

appliances plus any time in preliminary appliances.

The time between the end of phase 1 and the start of
phase 2 is not included because we considered this
to be specified more by the research design rather
than by any clinical imperative. Fig. 6 shows the total
phase 2 treatment time for the three groups (headgear, functional appliance, and control) for each
doctor. This graph should be interpreted with some
caution because the number of patients in any one
category may be rather small. In general the phase 2
treatment for patients who had undergone early
treatmentwhether with headgear or a functional
appliancewas, on average, shorter than the treatment time for patients who had no early treatment.
However, the figure also shows the wide variation in
treatment time from patient to patient and between
doctors.
Because it is possible that treatment duration is
related more to the severity of the initial condition
or to the outcome achieved rather than to any effect
from early treatment, the duration of each patients
phase 2 treatment was plotted against both the
patients initial and final PAR score (Fig. 7). These
plots show no systematic relationship between the
phase 2 treatment time and the severity of the initial
occlusal problem or between the treatment time and
the treatment outcome. Very short and very long
treatment periods could result in both good and

poor occlusal results, and very short and very long

treatment periods seemed to occur for patients who
initially had severe or mild occlusal problems.
Table IV shows the complexity of phase 2 treatment in terms of the number of extraction decisions or
surgical plans. Data are given here for all 147 patients
who started phase 2 treatment because, even though
treatment is still ongoing for approximately 28% of the
sample, extraction or surgery decisions have already
been made for all, or nearly all, of the patients. The
data show that the extraction rate was only slightly
different for patients who did not have early treatment
and those who did. The highest extraction rate is
reported for the functional appliance patients and the
lowest for the headgear group. Surgical options were
discussed most frequently with those patients who had
no early treatment, least frequently in the functional
appliance group.
DISCUSSION

The UNC trial was designed to address some

specific questions relating to the issue of the optimal
timing for treatment for preadolescent patients with
Class II malocclusion. The trial poses two separate
questions: Can you change growth? and Does
early growth modification make a long-term difference? Although we hope the clinical procedures
followed in this trial are sufficiently analogous to

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American Journal of Orthodontics and Dentofacial Orthopedics

January 1998

Fig. 3. Distribution of subjects by ANB angle at the three different stages of the UNC
trial.

routine practice for clinicians to make useful generalizations about their own treatment decisions and
practices, the choice of early or later treatment for
Class II malocclusion must inevitably be based on
individual experience and imperfect data. We hope
that the evidence from this and similar trials will
help clinicians reevaluate their beliefs about their
current practices.
The question of whether early treatment can
produce statistically significant and clinically relevant changes in growth was approached in phase 1
with the use of a carefully controlled prospective
study. In the past, comparisons of early treatment
effect have most frequently been made against existing cephalometric standards, alternative treatment groups, or untreated normals.4-6 We question
the validity of such comparisons, particularly in the
evaluation of the effect of treatment on growth. Not
surprisingly, few investigators have monitored untreated Class II children longitudinally. The few
reports of untreated patients that do exist suggest
that growth is highly variable,7-9 difficult to predict,10
and different from that in normal subjects.11,12
Much of the success or failure of treatment that
clinicians deal with on a day-to-day basis may in fact
be more attributable to differences in growth and

clinician proficiency than to the efficacy of a particular treatment approach. It may be salutary for
clinicians to keep in mind the variability in growth
shown in this and other untreated Class II groups
when treatment results are evaluated.
In this trial one clinician was responsible for
phase 1 treatment, using as simple an approach to
treatment possible. The appliances were designed to
avoid, or at least minimize, any movement of the
anterior teeth and the concomitant alveolar bone
remodeling that might affect some of the landmarks
used to measure skeletal change. Our findings of
small but statistically significant skeletal changes
during a short period of treatment may reinforce
widely held beliefs about the effectiveness of both
headgear and functional appliances in reducing the
severity of Class II malocclusion. However, even
though the two early-treatment groups showed an
increase in the proportion of patients experiencing
favorable growth, the magnitude of the differential
effects was small, there was much variability, and so
far we have been unable to identify any patient
characteristics that could serve as useful predictors
of treatment response.3 Although it can be argued
that different appliances or different clinicians
would have produced superior or different results,

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Fig. 4. Distribution of PAR scores for each group at different time points in the UNC
trial.

this carefully controlled trial was designed to explore the differential effects of two common methods of Class II correction, controlling for variation
resulting from growth, clinician proficiency, or both.
Questions such as the effect of change in magnitude
or direction of the headgear force, the amount of
bite opening from a functional appliance, or the
impact of continuous compared with intermittent
wearalthough important clinical issueswere not
considered in this trial. The ability to carry out such
subgroup analyses would greatly increase the number of children who would have to be enrolled and
monitored. If these or other variables are believed
to be critical issues in determining treatment response or treatment benefit, separate well-controlled trials addressing such specific issues could be
planned.
Phase 2 of the trial addresses the question of
whether it makes a difference if treatment for Class
II malocclusion is started sooner or later, provided
effective treatment occurs at some point. Will small
skeletal changes produced by early treatment be
sustained over time, making the subsequent management of and treatment outcomes for these patients different from those of children whose treat-

Table III. Number of patients at the end of phase 2 of the

UNC trial with near-ideal, acceptable, and less satisfactory
PAR scores
PAR category

Control

Functional

Headgear

#5 (ideal)
610 (good)
.10 (less satisfactory)

18
7
11

16
11
8

20
7
8

ment was delayed? Alternatively, will the effects of

early treatment gradually diminish so the early- and
late-treatment groups become once more indistinguishable?
The preliminary data from this trial suggest
that the skeletal effects of early treatment, on
average, are not maintained. Instead, the ANB
differences between the early-treatment and observation groups diminish, so that little if any
difference remains after comprehensive treatment
is completed. It has been suggested that the
skeletal changes in early treatment, particularly
the increase in mandibular growth seen with
functional appliances, may simply represent an
acceleration in growth rather than a net gain.13
The data lend some support to this contention.

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American Journal of Orthodontics and Dentofacial Orthopedics

January 1998

Fig. 5. Initial severity of each patients malocclusion, plotted against treatment outcome,
both measured by PAR score.

Fig. 6. Total time for phase 2 treatment (time in full fixed appliances plus preliminary
appliances such as expansion devices or partial banding) for each group, by each doctor.

American Journal of Orthodontics and Dentofacial Orthopedics

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Tulloch, Phillips, and Proffit 69

Fig. 7. A, Total phase 2 treatment time for each patient, plotted against initial severity of
patients malocclusion. B, Total phase 2 treatment time for each patient, plotted against
outcome of treatment.

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American Journal of Orthodontics and Dentofacial Orthopedics

January 1998

Table IV. Complexity of phase 2 treatment presented for all

147 patients starting phase 2 treatment
Parameters
Number of extraction cases
Surgical options
Discussed
Accepted*
Undecided

Control
(n 5 52)

Functional
(n 5 45)

Headgear
(n 5 50)

14

20
3
4

5
0
1

9
3
2

*As of January 1997, only two patients (both in the control group) have
had surgery, with BSSO and rigid fixation.

The growth effects of early treatment (or no

treatment), however, were far from uniform, and
this variability must be kept in mind when longterm skeletal effects are evaluated. It is possible
that children who sustained large changes in
skeletal jaw relationship during phase 1 showed
a different response during phase 2 than those
that did notthat is, the children who responded
most favorably to phase 1 treatment (about 25%
of those who underwent phase 1 treatment)
achieved a benefit that those with less favorable or
no response did not. It will not be possible to fully
evaluate these findings until the total data set for
the trial is available.
Treatment response is judged in two ways: to
some extent as the improvement in skeletal relationship, but to a much larger extent as the improvement
in dental alignment and occlusion. Many of the few
previous studies whose authors attempted to quantify the success (or failure) of orthodontic treatment
involved different indexes and operational definitions, making it difficult to compare success
rates.14-18
The PAR index was specifically developed to
assess not only the severity of malocclusion but the
outcome of treatment.2 This index, tested and validated in both European19 and American20 settings,
reflects clinicians beliefs about the importance of
the various components of occlusion. The use of an
objective measure of the changes in alignment and
occlusion of teeth that result from treatment should
remove much of the subjectivity in comparison of
responses to alternative treatment approaches.
However, the PAR index can only be regarded as a
measure of the proximate outcomes of care21that
is, the extent to which the clinician has succeeded in
the immediate goal of improving the patients dental
alignment. Little evidence relates reduction in PAR
scores with the ultimate outcomes of treatment that
patients are presumed to care about, such as improved appearance, sociopsychologic well-being, or

oral health. It is also possible for two patients to

have the same PAR score with different relationships of tooth to basal bone. Although this possibility poses a special problem in the comparison of the
outcome of treatment across groups of children who
have sustained more-or-less successful growth modification during early treatment, the distribution of
PAR scores (both percentiles and categories) do not
seem different for the children who had early treatment than for those who did not. This finding,
together with the observed changes in ANB, suggests that, with regard to the issue of whether early
treatment makes a difference in treatment outcome,
there is little difference in the effectiveness of early
and delayed treatment for correction of Class II
malocclusion. The lack of any systematic relationship between the initial severity of the malocclusion
and treatment outcome shown in Fig. 5 suggests that
excellent treatment outcomes occur almost as often
for patients who initially had severe malocclusion as
for those with more moderate problems. Similarly,
less satisfactory results can occur across a wide
range of initial occlusal severity.
Clearly many of the children with high final PAR
scores (.10) were those for whom treatment was
discontinued early, frequently at the request of the
parent or patient. Several of these patients and
parents discussed but declined surgical correction.
Although the distribution of boys and girls with high
final PAR scores was approximately equal in the two
early-treatment groups, 8 of the 11 control failures were male. It may well be that delay in the
start of treatment for boys compromises their ability
to cope with complex extended treatments as they
approach adolescence. Growth modification itself
may not be so important as the childs ability to
cooperate with the treatment regimens given all the
other changes occurring in their lives.
The findings of previous studies have suggested
that two-phase treatments generally take longer
than treatment provided as a single phase;13,22 our
data support this. Comparing the duration of phase
2 treatment for children who started treatment in
mixed dentition with that in patients for whom
treatment was delayed until the permanent teeth
erupted, we see that in these initially equivalent
groups, the average phase 2 treatment time was
almost always shorter for the headgear and functional appliance groups than for the control patients. However, when the time in early treatment
(approximately 15 months) is also included, on
average the two-phase treatments are longer than
the single phase undertaken by the controls. This

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result must be viewed with some caution; the protocol of the trial mandated a separation of phase 1
and phase 2. It is possible that phase 1 could have
been shorter for several of these patients or that
comprehensive treatment could have been phased in
earlier. The question is one of patient preference
and practice efficiency: Even if some treatment time
is spent wearing simpler appliances and perhaps
making less frequent office visits, is an increase in
overall treatment time justified?
A second consideration is the variation in treatment time seen from patient to patient (some
patients being treated in as little as 11 months and
others taking as long as 60 months) and between
doctors (one doctor consistently taking a shorter
time to treat all groups of patients). It has been
suggested that the initial severity of the malocclusion is one of the most important factors in the
determination of treatment duration.22 Our preliminary findings do not support this. The plots in Fig.
6 show no simple systematic relationship between
duration of treatment and initial severity. Less surprisingly, the final treatment outcome also seems to
bear no systematic relation to treatment time. Perhaps clinicians have an ideal occlusion as a goal for
treatment and fight to achieve this goal; for some
patients their persistence works, whereas for others
potential finally expires. It may well be that the
between-doctor differences prove in the end to have
more of an effect on treatment time than does the
effect of early growth modification. These conclusions are tentative at best; approximately 25% of the
patients are still in treatment.
One of the goals of mixed-dentition treatment is
that later treatment should be simpler, perhaps
requiring fewer extractions and less surgery.23,24 If
early treatment does significantly alter growth and
improve jaw relationships, the rates of extraction to
camouflage a Class II skeletal pattern or orthognathic surgery to correct jaw relationships should be
reduced. The extraction rates for the general orthodontic population have always been hard to estimate, with temporal trends reflecting different current clinical beliefs and practices. In the 1990s the
extraction rate for patients attending the UNC
orthodontic clinic (all types of patients, any extraction pattern) is about 30%.25 In the UNC Class II
trial the extraction rate was somewhat lower than
that in all three groups, with the highest rate found
in the functional appliance group. This group had,
on average, approximately 3 more proclination of
the lower incisors than the control or headgear
groups during phase 1 and showed the greatest

variability in change in lower-incisor angulation.

The high extraction rate, then, may have been a
response to dental changes that clinicians believed
could compromise esthetics, stability, or gingival
health.
Surgical options were discussed frequently at the
start of phase 2, most frequently with the control
patients who had had no early treatment and who
were considerably older than the two early-treatment groups at the start of appliance therapy. This
finding most likely reflects not only the clinicians
desire to fully inform the patients of all treatment
options but the prevalent belief that age and malocclusion severity interact to reduce the chances of
successful correction with orthodontic treatment
alone. Whether such a belief is entirely justified in
the early-adolescent group is not clear.26 The functional appliance groupwho, on average, had the
smallest ANB angle at the end of phase 2also had
the lowest rate of surgery. The preliminary data
from this trial suggest that early treatment may
influence both the rate of extraction and the need
for orthognathic surgery, but not in the pattern that
might have been expected. It is not yet clear whether
these differences will prove statistically significant
when all the data are available, or how they might be
explained if they do prove significant. Further analysis of the data set will permit more detailed evaluation of these important clinical questions.
CONCLUSION
We conclude that, for children with moderate to
severe Class II problems, early treatment followed by later
comprehensive treatment on average does not produce
major differences in jaw relationship or dental occlusion,
compared with later one-stage treatment. The severity of
the initial problem and the treatment time, surprisingly,
are not important influences on the final outcome. Variability in skeletal growth pattern appears to be a major
contributor to variability in treatment response. Differences in patient compliance, clinician proficiency, and,
probably, other (yet-unidentified) clinical factors also
must affect treatment outcomes. It is likely that the
indications for early treatment can be refined in the future
to permit better selection of those patients most likely to
benefit from this type of intervention.
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