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he best timing for treatment of Class II malocclusion has been controversial. The question is
whether early treatment, which is initiated during the mixed dentition, is more effective and efficient
than treatment started in the permanent dentition.1 Can
early treatment provide superior skeletal, dental, or
esthetic results?
Reviews of Class II treatment studies before 1989
concluded that, because of their inadequate designs, it
was not yet known whether early treatment provided
a
482 Dolce et al
Fig 1. Flowchart depicts the study participants screening, randomization, and treatment.
Dolce et al 483
Three hundred twenty-five subjects were randomized, and 277 subjects began the study, with 261 having
a baseline visit and at least 1 follow-up DC visit. Of
those who completed phase 1, 84 were treated with a
bionator, 93 were treated with a headgear/biteplane,
and 80 were the observation group. The dropout rates
were 7% for phase 1, 11% during the retention phase,
and 9% for phase 2. There were no significant differences initially in the number of subjects in each
treatment group for stratification and demographic
variables (Table I). The mean ages at the start of
treatment were similar for the 3 groups. Similar numbers of subjects in the bionator (49%) and headgear/
biteplane (51%) groups had some pretreatment orthodontic treatment. This usually involved alignment of
maxillary incisors with fixed 2 4 appliances. Pretreatment orthodontics were done in 12% of the observation group. More boys entered the study than girls,
and more subjects were classified with high molar class
severity, and few patients had a high mandibular plane
angle. Cephalometric values representing horizontal
and vertical skeletal points also were not significantly
different at baseline (Table II).
As shown in Figure 2, SNA angle decreased 0.50
during phase 1 treatment in the headgear/biteplane
group but relapsed to its original value during retention/
observation before the start of phase 2 treatment. In the
bionator and observation groups, SNA angle increased
(0.51 and 0.67, respectively) during phase 1 and until
the start of phase 2. SNA angle in these groups
decreased during phase 2 treatment. The mixed-model
analysis for SNA angle (insert in Fig 2) indicated
significant effects from baseline value (P .0001),
treatment group (P .0001), and DC time (P .0001),
but no interaction between treatment group and time
point was found (P 0.10).
At the end of DC3, the greatest increase in SNB
angle was in the bionator group (1.36) (Fig 3). The
observation group had greater changes in SNB angle
than the headgear/biteplane group (0.84 and 0.19,
respectively). Between the end of phase 1 and the
beginning of phase 2, SNB angle increased significantly in the headgear/biteplane group, so that it became similar to the observation group. During phase 2
484 Dolce et al
Table I.
Variable
Age at baseline (mean, range) (y)
Total subjects (n)
Variables (n, %)
Sex
Male
Female
Race
White
Nonwhite
Initial molar class severity
High
Mild
Low
SN-MP
40
30 x 40
30
Pretreatment
No
Yes
Retention
No
Yes
Bionator
Observation
Headgear
P value
9.6 (6.9-12.9)
86
9.5 (8.1-12.6)
80
9.7 (7.3-11.6)
95
.65
52 (60)
34 (40)
51 (64)
29 (36)
57 (60)
38 (40)
75 (87)
11 (13)
74 (92)
6 (8)
88 (93)
7 (7)
39 (45)
23 (27)
23 (28)
37 (46)
20 (25)
23 (29)
44 (46)
22 (23)
29 (31)
8 (10)
57 (66)
21 (24)
6 (8)
56 (70)
18 (22)
6 (6)
63 (66)
26 (28)
44 (51)
42 (49)
70 (88)
10 (12)
47 (49)
48 (51)
B vs H
.82
45 (52)
41 (48)
80 (100)
0 (0)
49 (52)
46 (48)
B vs H
.92
.86
.37
.99
.90
All differences were determined by chi-square tests, except for age at baseline, when ANOVA was used. B vs H indicates comparison of bionator
with headgear/biteplane subjects only, because observation subjects were treated differently per study design.
Table II.
Variable
Bionator
Observation
Headgear
SNA angle ()
SNB angle ()
ANB angle ()
SN-MP angle ()
79.4 (3.5)
74.6 (3.2)
4.8 (2.0)
35.7 (5.6)
79.5 (3.1)
74.9 (3.1)
4.6 (2.1)
36.0 (4.7)
79.8 (3.9)
75.2 (3.5)
4.6 (1.8)
36.1 (5.1)
.80
.56
.79
.90
Dolce et al 485
Fig 2. Changes in SNA angle (o) throughout the study period. Inset shows the results from the
mixed-models analysis.
Fig 3. Changes in SNB angle (o) throughout the study period. Inset shows the results from the
mixed-models analysis.
486 Dolce et al
Fig 4. Changes in ANB angle (o) throughout the study period. Inset shows the results from the
mixed-models analysis.
Fig 5. Changes in SN-MP angle (o) throughout the study period. Inset shows the results from the
mixed-models analysis.
Dolce et al 487
488 Dolce et al
Table III.
Coefficient estimates of linear models of selected cephalometric values, with end of phase 1 values modeled
as function of listed covariates
Variable
Baseline value
Bionator
Headgear
Male
Severe mild
Severe high
Age at DC1
Model R2
0.94*
0.94*
0.99*
0.90*
0.16
0.52*
0.19
0.67*
1.16*
0.60*
1.57*
0.56*
0.31
0.18
0.29
0.12
0.18
0.26
0.42
0.66
0.14
0.13
0.04
0.22
0.05
0.09
0.22
0.13
0.89
0.87
0.88
0.75
SNA angle ()
SNB angle ()
SN-MP angle ()
ANB angle ()
*P .05.
Table IV. Coefficient estimates of linear models of selected cephalometric values, with end of treatment values
modeled as function of listed covariates
Variable
Baseline value
Bionator
Headgear
Male
Severe mild
Severe high
Age at DC1
Model R2
0.88*
0.96*
1.04*
0.79*
0.33
0.33
0.28
0.03
0.66
0.30
0.73
0.35
0.41
0.50
0.59
0.10
0.11
0.19
0.84
0.28
0.26
0.40
0.38
0.50
0.00
0.14
0.53
0.11
0.74
0.69
0.77
0.54
SNA angle ()
SNB angle ()
SN-MP angle ()
ANB angle ()
*P .05.
Table V.
Age at baseline
(mean SD) (y)
Total subjects (n)
Variables (n, %)
Sex
Male
Female
Race
White
Nonwhite
Initial molar class severity
High
Moderate
Mild
SN-MP
40
30 40
30
Pretreatment
Yes
No
Postphase 1 retention
Yes
No
Treatment group
Bionator
Observation
Headgear/biteplane
No DCF
DCF
P value
9.80 (0.93)
117
9.55 (0.89)
208
.053
69 (59)
48 (41)
124 (60)
84 (40)
93 (79)
24 (21)
194 (93)
14 (7)
54 (46)
29 (25)
34 (29)
100 (48)
48 (23)
30 (29)
11 (9)
75 (64)
31 (27)
12 (6)
145 (70)
51 (25)
46 (39)
71 (61)
81 (39)
127 (61)
38 (32)
79 (68)
69 (33)
139 (67)
42 (36)
34 (29)
41 (35)
67 (32)
69 (33)
72 (35)
.91
.002
.93
.39
.95
.90
.70
1. Phase 1 treatment with either a bionator or headgear/biteplane results in a decrease in ANB angle.
2. Headgear/biteplane results in an increase in SN-MP
at the end of phase 1.
3. Early intervention had no effect on the skeletal
pattern at the end of all treatment compared with
treatment in 1 phase at adolescence.
4. Using linear regression analysis, we demonstrated
that treatment group had no effect on the final
cephalometric values.
REFERENCES
1. Proffit WR, Tulloch JF. Preadolescent Class II problems: treat
now or wait? Am J Orthod Dentofacial Orthop 2002;121:560-2.
2. King GJ, Keeling SD, Hocevar RA, Wheeler TT. The timing of
treatment for Class II malocclusions in children: a literature
review. Angle Orthod 1990;60:87-97.
3. Tulloch JF, Medland W, Tuncay OC. Methods used to evaluate
growth modification in Class II malocclusion. Am J Orthod
Dentofacial Orthop 1990;98:340-7.
Dolce et al 489