Treatment Timing For Functional Jaw Orthopaedics Followed by Fixed Appliances: A Controlled Long-Term Study
Treatment Timing For Functional Jaw Orthopaedics Followed by Fixed Appliances: A Controlled Long-Term Study
Treatment Timing For Functional Jaw Orthopaedics Followed by Fixed Appliances: A Controlled Long-Term Study
doi:10.1093/ejo/cjx078
Advance Access publication 1 November 2017
Original article
Orthodontics, School of Dentistry, University Paulista, Sao Paulo, Brazil, 3Department of Orthodontics and Pediatric
Dentistry, School of Dentistry and Center for Human Growth and Development, The University of Michigan, Ann
Arbor, MI, USA, 4Department of Orthodontics, University Zoja e Këshillit të Mirë, Tirane, Albania, 5Department of
Surgery and Translational Medicine, University of Florence, Florence, Italy
Correspondence to: Lorenzo Franchi, Department of Surgery and Translational Medicine, The University of Florence, Via del
Ponte di Mezzo, 46-48 50127 Firenze, Italy. E-mail: [email protected]
Summary
Objective: To evaluate the role of treatment timing on long-term dentoskeletal effects of Class II
treatment with removable functional appliances followed by full-fixed appliance therapy.
Materials and methods: A group of 46 patients (23 females and 23 males) with Class II
malocclusion treated consecutively with either Bionator or Activator, followed by fixed appliances
was compared with a matched control group of 31 subjects (16 females and 15 males) with
untreated Class II malocclusion. The treated sample was evaluated at T1, start of treatment (mean
age: 9.9 ± 1.3 years); T2, end of functional treatment and prior to fixed appliances (mean age:
11.9 ± 1.3 years); and T3, long-term observation (mean age: 18.3 ± 2.1 years). The treated and the
control samples were divided into pre-pubertal and pubertal groups according to skeletal maturity
observed at the start of treatment. Statistical comparisons were performed with independent
sample t-tests.
Results: When treatment was initiated before puberty, Class II correction was mostly confined to the
dentoalveolar changes, with significant improvements of both overjet and molar relationships. On
the other hand, treatment with the outset at puberty produced significant long-term improvement
of sagittal skeletal relationships, which were mainly sustained by mandibular changes.
Conclusions: Treatment with removable functional appliances (Bionator or Activator) followed by
full-fixed appliances produced significant skeletal long-term changes when it begins at puberty.
Prepubertal Class II treatment results primarily in dentoalveolar changes.
© The Author(s) 2017. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved.
430
For permissions, please email: [email protected]
C. Pavoni et al. 431
orthopaedics (FJO) in Class II division 1 malocclusion (4). Despite All patients in both the private practice and the University clinic
controversies on the efficacy of functional therapy, recent system- were treated by two expert clinicians. The clinical experience of the
atic reviews and meta analyses have shown that, in the short term, two operators in the management of the two functional appliances
FJO produces greater skeletal mandibular effects when performed was similar. All patients involved in the study were asked to wear
at puberty (7, 10). On the other hand, in Class II patients treated the appliance 16 hours a day until the end of treatment. As occurs in
before the pubertal period, the significant effects are confined to the studies involving any removable device, compliance with the instruc-
dentoalveolar level (11–15). tions of the orthodontist and staff varied among the patients.
Few controlled studies have followed up the long-term effects pro- Each Bionator and Activator was constructed with the same
duced by FJO (9, 16–18). Information on the role of treatment timing amount of mandibular advancement, and the construction bites were
on the long-term effects produced by FJO is even more restricted. obtained in the same way in both groups. In that both the mechan-
Faltin et al. (14) found significantly greater mandibular skeletal ism of action and the efficiency in stimulating mandibular growth of
long-term changes in pubertal versus pre-pubertal Class II patients. these two monobloc appliances are similar, the decision was made
However, these findings were not conclusive due to the small sample to combine patients treated with the two functional appliances (3).
sizes of either pre-pubertal or pubertal treated and control groups. Thirty-one subjects (16 females, 15 males) with untreated
2.5
1.8
2.0
1.6
SD
T1–T3 interval
test), statistical between-group comparisons were performed with
independent sample t-tests. If data were not normally distributed,
(years) statistical between-group comparisons were carried out with the
Mean
8.4
7.6
8.3
7.5
Mann–Whitney test.
As secondary statistical analysis, between-group comparisons
2.4 (ETG versus ECG and LTG versus LCG) for the T1–T2 and T2–T3
1.9
1.9
1.7
SD
LTG and between ECG versus LCG also were carried out for the
craniofacial starting forms at T1 and for the T1–T3 changes.
(years)
Mean
6.5
5.7
6.0
5.6
Results
Weighted kappa coefficient for the intraobserver agreement for the
0.6
0.3
0.7
0.4
SD
Mean
while the error for the angular measurements ranged from 0.19° (SN
1.9
1.9
2.3
1.9
11 CS6
15 CS6
12 CS6
8 CS5
3 CS5
at T3
1.8
2.1
1.3
Mean
17.0
18.5
18.3
12 CS3
19 CS4
10 CS4
5 CS1
6 CS2
2 CS1
2 CS2
4 CS5
5 CS5
at T2
0.7
1.2
1.2
SD
11.4
11.3
12.5
12.7
17 CS3
13 CS3
4 CS2
9 CS1
7 CS2
6 CS2
2 CS2
at T1
Discussion
The aim of the present study was to analyze the role of treatment
timing on the skeletal and dentoalveolar effects induced by func-
1.2
0.7
1.3
1.1
SD
Mean
9.4
10.2
10.8
group (n = 16,
group (n = 23,
group (n = 15,
Early control
Early treated
10f 13m)
11f 4m)
Table 2. Descriptive statistics and statistical comparisons (independent samples t-tests) of the starting forms (cephalometric values at T1)
in the early treated group (ETG) versus the early control group (ECG).
95% CI of the
ETG ECG difference
Variables Mean, median SD, 25/75 Mean, median SD, 25/75 Diff. P value Lower Upper
SNA (deg) 81.0 2.6 79.6 2.7 1.4 0.118 −0.4 3.2
SNB (deg) 74.7 2.8 74.0 2.3 0.7 0.417 −1.0 2.4
Pg to N perp (mm) −7.7 4.8 −7.9 5.8 0.2 0.880 −3.2 3.7
Co–Gn (mm) 106.2 6.4 104.2 3.8 2.0 0.262 −1.6 5.7
ANB (deg) 6.3 1.9 5.6 1.5 0.7 0.235 −0.5 1.9
Wits (mm) 1.9 3.1 1.8 2.5 0.1 0.947 −1.8 1.9
SN to Pal. Pl. (deg) 8.7 3.2 8.1 2.4 0.6 0.532 −1.3 2.5
SN to Mand. Pl. (deg) 35.7 5.5 35.0 3.1 0.7 0.648 −2.4 3.8
SD, standard deviations; Diff., differences; 25/75, 25th/75th percentile; CI, confidence interval; perp., perpendicular; deg, degrees; Pal., palatal; Pl., plane; Mand.,
mandibular; Inc., incisor.
Table 3. Descriptive statistics and statistical comparisons (independent samples t-tests) of the starting forms (cephalometric values at T1)
in the late treated group (LTG) versus the late control group (LCG).
95% CI of the
LTG LCG difference
Variables Mean, median SD, 25/75 Mean, median SD, 25/75 Diff. P value Lower Upper
SNA (deg) 81.7 4.1 81.7 2.7 0.0 0.943 −2.3 2.5
SNB (deg) 74.6 3.7 75.5 2.5 −0.9 0.409 −3.1 1.3
Pg to N perp (mm) −9.0 5.3 −5.7 5.7 −3.3 0.079 −7.0 0.4
Co–Gn (mm) 107.3 5.8 106.6 6.2 0.7 0.722 −3.3 4.7
ANB (deg) 7.2 1.8 6.2 1.6 1.0 0.093 −0.2 2.2
Wits (mm) 3.6 3.1 2.5 3.0 1.1 0.328 −1.1 3.1
SN to Pal. Pl. (deg) 9.0 1.7 7.2 3.7 1.8 0.089 −0.3 4.0
SN to Mand. Pl. (deg) 35.0 4.6 32.6 5.1 2.4 0.138 −0.8 5.6
Pal. Pl. to Mand. Pl. (deg) 25.9 4.1 25.4 5.3 0.5 0.712 −2.5 3.6
ANS–Me (mm) 64.9 3.8 62.3 4.1 2.6 0.054 0.0 5.3
Co–Go (mm) 51.5 4.2 51.6 5.6 −0.1 0.903 −3.4 3.0
CoGoMe (deg) 123.5 4.2 121.6 4.5 1.9 0.197 −1.0 4.8
OVJ (mm) 7.4 6.2/8.1 6.3 5.9/7.5 1.1 0.107
OVB (mm) 3.9 1.6 3.1 1.2 0.8 0.116 −0.2 1.7
Molar relationship (mm) −2.3 1.7 −1.4 1.3 −0.9 0.088 −2.0 0.1
Upper Inc. to Pal. Pl. (deg) 112.6 4.8 113.2 5.7 −0.6 0.752 −4.0 2.9
Lower Inc. to Mand. Pl. (deg) 99.0 5.6 96.9 7.3 2.1 0.328 −2.2 6.3
SD, standard deviations; Diff., differences; 25/75, 25th/75th percentile; CI, confidence interval; perp., perpendicular; deg, degrees; Pal., palatal; Pl., plane; Mand.,
mandibular; Inc., incisor.
There were no differences between the treated and control it is performed during the pubertal growth phase. Only one study
groups in race, chronologic age, gender distribution, cervical stage with small sample sizes of either treated or control groups analysed
maturation, or dentoskeletal relationships at T1. the role of treatment timing on the long-term dentoskeletal changes
Mandibular skeletal effects produced by functional therapy of induced by the Bionator (14).
Class II malocclusions in growing subjects remain a controversial The results of the present study confirmed that treatment timing
topic in orthodontics. A recent systematic review and meta-analysis plays a major role also on the long-term mandibular skeletal changes
(7) pointed out that treatment with removable functional appliances produced by treatment with functional appliances (Activator or
can produce clinically relevant skeletal effects in the short term when Bionator) followed by fixed appliances in the permanent dentition.
434 European Journal of Orthodontics, 2018, Vol. 40, No. 4
Table 4. Descriptive statistics and statistical comparisons (independent samples t-tests) of the T1–T3 changes in the early treated group
(ETG) versus the early control group (ECG).
95% CI of the
ETG ECG difference
SNA (deg) −0.2 2.0 0.6 1.6 −0.8 0.177 −2.0 0.4
SNB (deg) 1.4 2.0 2.2 1.6 −0.8 0.209 −2.0 0.4
Pg to N perp (mm) 4.3 3.8 3.4 4.1 0.9 0.479 −1.7 3.5
Co−Gn (mm) 16.8 4.6 17.5 4.7 −0.7 0.632 −3.8 2.3
ANB (deg) −1.6 1.2 −1.6 1.1 0.0 0.859 −0.8 0.7
Wits (mm) −0.5 2.9 1.2 3.5 −1.7 0.098 −3.8 0.3
SN to Pal. Pl. (deg) 0.9 2.2 0.3 1.5 0.6 0.393 −0.7 1.8
SN to Mand. Pl. (deg) −1.6 2.3 −3.5 2.1 1.9 0.012 0.4 3.4
SD, standard deviations; Diff., differences; CI, confidence interval; perp., perpendicular; deg, degrees; Pal., palatal; Pl., plane; Mand., mandibular; Inc., incisor.
Table 5. Descriptive statistics and statistical comparisons (independent samples t-tests) of the T1–T3 changes in the late treated group
(LTG) versus the late control group (LCG).
95% CI of the
LTG LCG difference
Variables Mean, median SD, 25/75 Mean, median SD, 25/75 Diff. P value Lower Upper
SNA (deg) −1.3 2.7 −0.6 2.0 −0.7 0.391 −2.4 1.0
SNB (deg) 2.1 2.1 1.0 1.9 1.1 0.105 −0.2 2.5
Pg to N perp (mm) 6.8 2.3 3.7 3.4 3.1 0.001 1.3 5.0
Co–Gn (mm) 20.5 3.7 15.0 2.5 5.5 0.000 3.3 7.7
ANB (deg) −3.4 1.5 −1.6 1.4 −1.8 0.001 −2.8 −0.8
Wits (mm) −4.0 3.9 1.8 3.7 −5.8 0.000 −8.3 −3.2
SN to Pal. Pl. (deg) −0.1 2.1 0.2 1.4 −0.3 0.630 −1.6 1.0
SN to Mand. Pl. (deg) −2.0 2.8 −2.3 2.3 0.3 0.753 −1.5 2.0
Pal. Pl. to Mand. Pl. (deg) −1.9 3.1 −2.5 1.5 0.6 0.504 −1.2 2.3
ANS–Me (mm) 9.1 3.2 5.3 2.2 3.8 0.000 1.9 5.7
Co–Go (mm) 14.0 3.7 11.6 3.0 2.4 0.036 0.2 4.8
CoGoMe (deg) −1.6 2.6 −1.9 2.4 0.3 0.707 −1.4 2.0
OVJ (mm) −3.8 −5.1/−2.7 −0.8 −1.5/0.2 −3.0 0.000
OVB (mm) −1.1 1.5 0.0 1.5 −1.1 0.042 −2.1 0.0
Molar relationship (mm) 4.9 1.9 0.5 1.0 4.4 0.000 3.3 5.5
Upper Inc. to Pal. Pl. (deg) −1.9 6.2 −0.8 4.7 −1.1 0.571 −4.9 2.8
Lower Inc. to Mand. Pl. (deg) −0.8 6.0 1.7 4.4 −2.5 0.185 −6.1 1.2
SD, standard deviations; Diff., differences; CI, confidence interval; perp., perpendicular; deg, degrees; Pal., palatal; Pl., plane; Mand., mandibular; Inc., incisor.
Bionator and Activator were constructed with the same man- When treatment with functional appliances was performed and
dibular advancement as the construction bites were registered in the completed before puberty, the long-term effects were mostly limited
same way in both treated groups. The mechanism of action of these to the dentoalveolar level, with a significant improvement in both
two monobloc appliances appears to be similar. As a matter of fact, overjet and molar relationships (−3.6 mm and +3.9 mm, respect-
Cozza et al. (3) evaluated the efficiency of functional appliances in ively) (Table 4). The only significant skeletal effect consisted of an
stimulating mandibular supplementary elongation. Efficiency was increase of about 2 degrees in facial divergency (SN to Mand Pl),
appraised by dividing the supplementary elongation of the mandible which does not represent clinical relevance. No other significant
obtained during the overall treatment period with the functional long-term sagittal or vertical skeletal changes could be recorded in
appliance by the number of months of active treatment (coefficient of the comparison of ETG to ECG.
efficiency). Both the Bionator and the Activator presented intermedi- A few statistically significant (though probably not clinically rele-
ate scores of efficiency (0.17 and 0.12 mm per month, respectively). vant) skeletal changes could be observed immediately after functional
C. Pavoni et al. 435
treatment (T1–T2 interval, Supplementary Table 1) in terms of man- play a major role on the efficacy of mandibular growth stimulation
dibular growth stimulation (Co–Gn +2.3 mm) and reduction of ANB produced by functional appliance therapy. It is interesting to note
angle (−1.2 degrees). These changes, however, were not maintained that the current investigation confirmed the results of Franchi et al.
during the T2–T3 interval (Supplementary Table 3). In particular, the (17) for the comparison of the long-term changes (T1–T3) between
ANB angle increased significantly by about 1 degree, probably due ETG and LTG (Supplementary Table 6). Treatment with a functional
to a significant decrease of about the same amount (−1.5 degrees) appliance that includes the peak in mandibular growth appears to
of the SNB angle, while mandibular growth decreased significantly be more effective than treatment performed before the peak, as it
(−3.0 mm) in ETG when compared to ECG. induces more favourable mandibular skeletal modifications. No sig-
These unfavourable changes in the post-treatment period after nificant T1–T3 changes were found when comparing the two control
the application of removable functional appliances were similar samples (Supplementary Table 8). The only exceptions were a sig-
to those reported by De Vincenzo (25) who described an increase nificantly greater increase in the lower anterior facial height (ANS–
in mandibular length during the functional phase. During the Me +3.5 mm) and a significantly greater decrease of the mandibular
post-functional phase, however, the growth never reached the one angle (Co–Go–Me −1.8 degrees) in ECG with respect to LCG.
observed for the control group; in the final analysis, there was no Thus, if the aim of treatment is to produce skeletal mandibular
7. Perinetti, G., Primožič, J., Franchi, L. and Contardo, L. (2015) Treatment functional appliances in Class II malocclusion. The Angle Orthodontist,
effects of removable functional appliances in pre-pubertal and pubertal 83, 334–340.
Class II patients: a systematic review and meta-analysis of controlled stud- 18. Angelieri, F., Franchi, L., Cevidanes, L.H., Scanavini, M.A. and McNa-
ies. PLoS One, 10, e0141198. mara, J.A. Jr. (2014) Long-term treatment effects of the FR-2 appliance:
8. McNamara, J.A. Jr. and Brudon, W.L. (2001) Orthodontics and Dentofa- a prospective evaluation 7 years post-treatment. European Journal of
cial Orthopedics. Needham Press, Ann Arbor, MI, pp. 63–73. Orthodontics, 36, 192–199.
9. Malta, L.A., Baccetti, T., Franchi, L., Faltin, K. Jr and McNamara, J.A. Jr. 19. Martina, R., Cioffi, I., Galeotti, A., Tagliaferri, R., Cimino, R., Michelotti, A.,
(2010) Long-term dentoskeletal effects and facial profile changes induced Valletta, R., Farella, M. and Paduano, S. (2013) Efficacy of the Sander bite-
by bionator therapy. The Angle Orthodontist, 80, 10–17. jumping appliance in growing patients with mandibular retrusion: a rand-
10. Thiruvenkatachari, B., Harrison, J., Worthington, H. and O’Brien, K.
omized controlled trial. Orthodontics & Craniofacial Research, 16, 116–126.
(2015) Early orthodontic treatment for Class II malocclusion reduces the 20. Baccetti, T., Franchi, L. and McNamara, J.A. Jr. (2005) The cervical verte-
chance of incisal trauma: results of a Cochrane systematic review. Ameri- bral maturation (CVM) method for the assessment of optimal treatment
can Journal of Orthodontics and Dentofacial Orthopedics, 148, 47–59. timing in dentofacial orthopedics. Seminars Orthodontics, 11, 119–129.
11. Janson, I. (1977) A cephalometric study of the efficiency of the Bionator. 21. Cozza, P., De Toffol, L. and Iacopini, L. (2004) An analysis of the cor-
Transactions European Orthodontic Society, 53, 283–293. rective contribution in activator treatment. The Angle Orthodontist, 74,