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62
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
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).
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,
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-
Control
Functional
Headgear
#5 (ideal)
610 (good)
.10 (less satisfactory)
18
7
11
16
11
8
20
7
8
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.
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.
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.
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
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
(Continued)
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