ORIGINAL ARTICLE

Transverse skeletal base adaptations with

Bionator therapy: A pilot implant study
Adriano Marotta Araujo, DDS, MS,a Peter H. Buschang, PhD,b and Ana Claudia Moreira Melo, DDS, MSa
Araraquara, São Paolo, Brazil, and Dallas, Tex

The purpose of this randomized, controlled trial was to evaluate transverse skeletal base adaptations to
Bionator therapy. The sample included 25 patients (15 male, 10 female) aged 6.9 to 11.2 years with Class II
Division 1 malocclusion. The patients were randomly allocated to either a control (n ⫽ 11) or treatment (n ⫽
14) group and followed longitudinally for approximately 12 months. Treatment consisted of a Bionator only,
constructed to remain approximately 2 mm from the buccal dentition. Transverse maxillary and mandibular
changes were evaluated cephalometrically according to 4 bilateral maxillary and 2 bilateral mandibular
implants. Untreated Class II controls exhibited significant increases between posterior maxillary implants but
no significant changes between the anterior maxillary or mandibular implants. There were no significant width
differences between the control and treated groups before treatment. Posterior maxillary implant widths
increased significantly (P ⬍ .05) in both groups, but the treated group showed significantly greater width
increases than the control group. The treated group also showed greater increases between mandibular
implants, but the differences were not statistically significant. These results suggest that transverse skeletal
base adaptations occur as a result of Bionator therapy. (Am J Orthod Dentofacial Orthop 2004;126:666-71)

B
oth the maxilla and the mandible normally
increase in width during growth. Transverse
increases have been reported at the level of the
dentoalveolar processes and the skeletal bases. Interca-
nine widths increase with the eruption of the permanent
incisors and maxillary canines1,2; intermolar widths
increase throughout the growth period.3-5 Implant stud-
ies have also established age-related increases of max-
illary6,7 and mandibular skeletal base dimensions.8,9
Both skeletal bases rotate in the transverse plane
because of greater posterior increases; the maxillary
skeletal base normally rotates more than mandibular
base.
The literature shows that treatment can increase
both maxillary and mandibular widths. The ability of
palatal expanders to widen the maxillary skeletal base
is well established.10-14 Various orthodontic appliances
have also been shown to increase dentoalveolar width
of the maxilla.15-17 Although transverse treatment
changes of the mandibular skeletal base have not been
a
Department of Orthodontics, Araraquara School of Dentistry, Universidade
Estadual Paulista, Araraquara, São Paolo, Brazil.
b
Department of Orthodontics, Baylor College of Dentistry, Texas A&M
University System Health Science Center, Dallas, Tex.
Supported by Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior
– Brazil.
Reprint requests to: Dr P.H. Buschang, Texas A&M University System Health
Science Center, Baylor College of Dentistry, Department of Orthodontics, 3302
Gaston Ave, Dallas, TX 75246; e-mail, phbuschang@tambcd.edu.
Submitted, May 2003; revised and accepted, October 2003.
0889-5406/$30.00
Copyright © 2004 by the American Association of Orthodontists.
doi:10.1016/j.ajodo.2003.10.037
666
studied, significant dentoalveolar width increases have
been demonstrated with appliances (eg, lip bumpers
and Swartz plates) that actively expand the mandi-
ble.18-20
It has been suggested that functional appliances,
particularly the Fränkel appliance, increase width by
removing cheek pressure and allowing buccal eruption
of the teeth.21,22 It has also been proposed that the
buccal shields stretch the periosteum and increase
appositional remodeling of the buccal surface.23,24
Brieden et al22 reported increases between maxillary
implants after 1 year of Fränkel treatment, but owing to
the lack of untreated controls they were unable to
ascertain whether the increase was due to growth or
treatment. To date, no implant studies have been
conducted to evaluate transverse mandibular skeletal
base changes associated with functional appliance ther-
apy.
The purpose of this prospective clinical trial was to
determine whether Class II Division 1 patients treated
solely with a Bionator appliance show greater trans-
verse growth changes than comparable, untreated con-
trols. We hypothesized that patients treated with the
Bionator appliance would experience greater increases
in interimplant width than untreated controls.
MATERIAL AND METHODS
The sample was composed of 25 patients (15 male,
10 female) aged 6.9 to 11.2 years (Table I) with Class
II Division 1 malocclusions, erupted maxillary and
American Journal of Orthodontics and Dentofacial Orthopedics
Volume 126, Number 6
Table I. Mean pretreatment (T1) and posttreatment (T2) ages (in years) and treatment duration (T2-T1)
Group n Sex
Control 11 6M, 5F
Bionator 14 9M, 5F
Total 25 15M, 10F
Min, minimum; max, maximum; M, male; F, female.
Fig 1. Occlusal and frontal views of Bionator used in experimental group.
mandibular incisors, no crowding (⬍1.5 mm), and no
crossbites. Informed consent to participate in the study
and to have metallic implants placed for research
purposes was obtained from all subjects and their
parents. Subjects were randomly allocated to either a
control (n ⫽ 11) or treatment group (n ⫽ 14) and
followed for approximately 12 months (range, 0.8-1.2
years). Subjects allocated to the control group were
informed that they would be treated after 1 year.
Treatment consisted of a Bionator only (Fig 1), as
described by Asher.25 All Bionators were constructed
to remain approximately 2 mm away from the buccal
dentition. The control subjects were treated at the end
of the 12-month follow-up period.
With the techniques described by Björk and
Skeiller,7 each subject had 7 metallic implants placed in
the maxilla and mandible before treatment. Four max-
illary implants were placed bilaterally in the zygomatic
process (posteriorly) and on either side of the anterior
nasal spine (anteriorly). The zygomatic implants were
placed in close proximity to the key ridge. The 3
mandibular implants included an anterior implant in the
midline of the symphysis and 2 posterior implants
placed as far as possible proximal and inferior to the
first permanent molar. One of the control patients had
only 1 posterior mandibular implant.
Transverse growth changes were assessed with
cephalograms (lateral, posteroanterior [PA]) taken at
Araujo, Buschang, and Melo 667
T1 Min-max T2 Min-max T2-T1 Min-max
8.9 9.9 1.0
6.9–10.6 7.8–11.6 0.8–1.2
9.5 10.5 1.0
7.3–11.2 8.2–12.3 0.9–1.2
9.2 10.2 1.0
6.9–11.2 7.8–12.3 0.8–1.2
the beginning of treatment (T1) and at the follow-up
(T2) appointment. The lateral cephalograms were
taken with the head positioned relative to the Frank-
fort horizontal plane (FH), at standardized source–
subject and subject–film distances. The PA radio-
graphs were also taken with the head positioned
relative to FH at a standard source–subject distance,
but the film was placed to make light contact with the
nose. The distance between the anterior implants and
the tip of the nose could have increased because of
growth, which would produce different magnifica-
tion for the PA films. By measuring the distances
between the anterior maxillary implants and prona-
sale, as seen on the lateral radiographs, the PA
magnification was corrected to control for each
individual’s growth changes (average correction fac-
tor was 0.07%). Given the size of the correction
factor, the short duration of the study, and, most
importantly, the fact that the 2 groups were randomly
allocated and growing similarly, the small amount of
anterior implant displacement associated with
growth was not considered to be problematic.
One anatomic landmark and 7 implants were iden-
tified and digitized (Fig 2). Transverse distances be-
tween implants, as seen on the PA radiograph, were
used to quantify mandibular and maxillary width
changes. The linear distances between the 2 posterior
mandibular implants, the 2 anterior maxillary implants,
668 Araujo, Buschang, and Melo American Journal of Orthodontics and Dentofacial Orthopedics
December 2004

Fig 2. Cephalometric landmarks and implants. 1, pronasale; 2, right posterior maxillary implant; 3,
left posterior maxillary implant; 4, right anterior maxillary implant; 5, left anterior maxillary implant;
6, right mandibular implant; 7, left mandibular implant; 8, symphyseal implant.

Table II. Pretreatment (T1) mandibular and maxillary interimplant widths (in millimeters) of control and Bionator
groups
Controls Bionator

Variables Mean SD SE Mean SD SE Difference P

Maxillary anterior 10.56 2.33 0.70 11.14 2.29 0.61 0.58 .538
Maxillary posterior 60.50 3.68 1.11 60.57 3.33 0.89 0.75 .958
Mandibular 63.22 4.05 1.28 63.76 3.94 1.13 0.54 .756

Table III. Interimplant width changes (in millimeters) in control and Bionator groups
Controls Bionator

Variables Mean SD SE Mean SD SE Difference P

Maxillary anterior ⫺0.14 0.32 0.09 0.10 0.40 0.10 0.24 .055
Maxillary posterior 0.40 0.17 0.05 0.68 0.40 0.10 0.28 .025
Mandibular 0.03 0.25 0.07 0.36 0.70 0.20 0.33 .080

and the 2 posterior maxillary landmarks were evalu- RESULTS

ated. To increase reliability, each radiograph was eval-
uated twice, and the averages were computed for each
of the measures. Error analyses of 15 replicates showed
no systematic error and method errors [公(⌺devia-
tions2)/2n] ranging from 0.08 to 0.10 mm.
The distribution of each variable was normal, on the
basis of its skewness and kurtosis. Means and standard
deviations were used to describe central tendencies and
dispersion; parametric tests were used to evaluate width
changes between implants (paired t test) and group
differences (t test). On the basis of the working hypoth-
esis, 1-tailed tests were used to evaluate group differ-
ences in width changes.
Table II shows that there were no group differ-
ences in maxillary and mandibular widths before
treatment; the treated-group measurements were 0.5
to 0.8 mm wider than the control-group measure-
ments, but the differences were not statistically
significant. There were no statistically significant
differences by sex in pretreatment interimplant
widths and changes in interimplant width.
Width increases occurred over the 12-month
observation period, with greater increases in the
treated than the control group (Table III). The
posterior maxillary implant widths increased signif-
American Journal of Orthodontics and Dentofacial Orthopedics Araujo, Buschang, and Melo 669
Volume 126, Number 6

Fig 3. Width changes (in millimeters per year) between posterior maxillary implants of treated
(Bionator) and untreated (control) patients.

Fig 4. Average increases (in millimeters) in posterior maxillary and mandibular interimplant
distances after 1 year. A, Bionator group; B, control group.

Table IV. Annual changes (millimeters per year) and standard deviations in maxillary and mandibular implant widths
of untreated subjects
Authors (reference) Maxillary anterior width Maxillary posterior width Mandibular width

Björk and Skieller (7) 0.12 (0.06) 0.42 (0.12) NR

Korn and Baumrind (6) 0.15 (0.11) 0.43 (0.18) 0.28 (0.15)
Gandini and Buschang (8) ⫺0.10 (0.18) 0.27 (0.13) 0.19 (0.20)
Iseri and Solow (9) NR NR 0.13 (0.06)
Present study ⫺0.14 (0.53) 0.40 (0.17) 0.03 (0.25)

NR, not reported.

icantly (P ⬍ .05) in both the control and experimen- DISCUSSION

tal groups (Fig 3). Anterior maxillary and mandibu-
lar interimplant width changes were not statistically
significant. Although the group differences were
small, the Bionator group showed greater increases
than the control group for all 3 measures; the
differences were statistically significant for the pos-
terior maxillary width only (Fig 4).
The results confirm previous studies showing in-
creases in the posterior maxillary interimplant distances
for untreated controls. Table IV shows that the in-
creases seen in this study compare favorably with those
observed by Björk and Skieller,7 as well as those
reported by Korn and Baumrind.6 Gandini and Bus-
670 Araujo, Buschang, and Melo
chang8 reported smaller increases between posterior
maxillary implants, but their sample was older and had
less growth potential. Even smaller but statistically
significant increases have been reported between ante-
rior maxillary implants for samples followed longitu-
dinally over extended periods.6,7 Given the small
amount of change expected and the inherent cephalo-
metric errors and other sources of variability, we were
not able to identify anterior maxillary width changes for
our small sample followed for only 1 year. Changes in
interimplant distances for samples followed for 5 years
or more are apparently sufficiently large to be estab-
lished with relatively high levels of confidence.
Relative to mandibular width, our results differ
from previous studies6,8,9 showing significant increases
in interimplants width ranging between 0.13 mm/year
and 0.28 mm/year for untreated subjects (Table IV).
Our controls showed no significant changes in interim-
plant distances, which might again be related to the
amount of change expected, the size of our sample, and
the length of our follow-up. It might also be indicative
of actual transverse mandibular growth deficiencies,
which have been previously reported for individuals
with Class II malocclusion.26,27 Implant studies with
larger samples followed over longer periods are re-
quired to substantiate whether the mandibular skeletal
base dimensions of Class II malocclusions have a more
limited potential to expand.
Most importantly, Class II patients treated exclusively
with a Bionator showed greater maxillary expansion than
untreated Class II patients. Brieden et al22 showed a
0.6-mm increase between maxillary implants after 1 year
of Fränkel treatment. Our results suggest that the increase
that they reported was at least partially related to the
functional appliance therapy. Width increases with func-
tional appliances therapy most likely reflect developmen-
tal adaptations to an altered environment. Buccal shields
have previously been shown to produce significant width
increases in experimental animals.28-30 It seems that the
buccal shields remove the pressure of the perioral muscles
and soft tissues, which increases, relatively, the forces that
normally expand the two halves of the maxilla. In other
words, it is possible that functional appliances disrupt the
equilibrium by removing pressure that normally limits
expansion at the midpalatal suture. Long-term studies of
Class 1 Division 1 patients are required to fully appreciate
the transverse skeletal changes that occur during Bionator
treatments, to understand why they occur and to determine
whether the changes are maintained.
CONCLUSIONS
In conclusion, this short-term, randomized, pro-
spective implant study of children with Class II
American Journal of Orthodontics and Dentofacial Orthopedics
December 2004
malocclusion showed (1) increases in the posterior
maxillary base width but no increases in the anterior
maxillary and mandibular interimplant distances, and
(2) greater-than-expected transverse expansion of the
maxillary skeletal base with Bionator appliance ther-
apy, indicating skeletal base adaptations to Bionator
therapy.
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