ORIGINAL ARTICLE

Skeletal and dental modifications produced by the

Bionator III appliance
Giovanna Garattini, MD, DDS,a Luca Levrini, MD,b Paolo Crozzoli, MD, DDS,a and
Aurelio Levrini, MD, DDSc
Milan, Italy
The therapeutic results of a functional orthopedic treatment with a Balters Bionator III appliance were
evaluated. The sample group included 39 white growing subjects with a dentoskeletal Class III
malocclusion. A 2-year study compared results with a control group. The results showed that the
Bionator III is effective, especially when the malocclusion is mainly the result of a midfacial deficiency
and when there is a hypodivergent growth pattern. (Am J Orthod Dentofacial Orthop 1998;114:40-4.)

Different therapeutic approaches have

been proposed for the treatment of skeletal Class III

malocclusions; some authors assert the benefits of

early orthopedic therapy, and others believe that
this type of treatment should be delayed or that it
should be treated surgically.1-5 Such different therapeutic strategies demonstrate how difficult it is for
the clinician to choose the correct treatment. Different appliances may be used both in the orthodontic and in the orthopedic treatment of skeletal Class
III malocclusions. These appliances are used in
different ways, according to malocclusion patterns,
skeletal age, patient compliance, and clinicians experience in their use. Successful clinical results
reported by several authors6-13 have led us to verify
the actual skeletal modifications that occur when
using the Balters Bionator III appliance in growing
patients with skeletal Class III malocclusion. The
use of this appliance seems to cause some skeletal
changes1,14-17 through neuromuscular modifications.
In this article the efficacy of Balters Bionator III in
a group of white growing subjects is longitudinally
evaluated. The present study represents the completion of a previous pilot study.18-21 The data of these
subjects were compared considering sex and age
with the longitudinal cephalometric data of the
London Kings College. Unfortunately, it was impossible to compare our findings with other studies
because there was no other analogous research.

From the Department of Dentistry and Stomatology, University of Milan,

School of Medicine, Milan, Italy.
a
Department of Dentistry and Stomatology, University of Milan.
b
Department of Orthodontics, University of Pavia branch of Varese.
c
In private practice.
Reprint requests to: Dott.Luca Levrini, Via Recchi, 7, 22100 Como, Italy.
Copyright 1998 by the American Association of Orthodontists.
0889-5406/98/$5.00 1 0 8/1/84818

40

MATERIAL AND METHODS

Samples examined and selection standards
Bionator III sample group. The sample group included
55 selected patients consecutively treated between 1988
and 1992, their ages ranged from 5 to 11 years (mean age,
8 years). These patients were affected with four or more of
the following anatomic or functional characteristics at the
same time: angle Class III molar relationship; edge-toedge incisor position or anterior cross bite; concave
profile; head hyperextension posture22; static and dynamic
Class III neuromuscular attitude4; hypertonic upper lip;
low and forward tongue rest position.23 The subjects were
radiographically examined (panoramic and lateral cephalometric radiographs taken by the same operator) using
two different instruments (Siemens Nanodor II and Siemens Ortocef 10). The treatment protocol foresaw the
application of a modified Balters Bionator III (Fig. 1) in
each patient selected. The modified Balters Bionator III16
differs from the original24-26 in the following characteristics: deeper and wider lingual wings27; acrylic vestibular
lateral shields extending deeply into the upper fornix28;
upper labial buttons; upper incisor inclined plane.
The construction bite was taken by gently repositioning the mandible distally in centric relation. To do this, the
patient must be in a lying position and relaxation of the
mandible must be obtained for example using the tap-tap
technique. The mandible is thus positioned distally, applying as little force as possible in order to put the condyle
in centric relation, avoiding compression in the retrodiscal
pad. The vertical thickness of the bite, corresponding to
the interocclusal acrylic between upper and lower first
molar should not exceed 3 to 4 mm, according to Balters
indications.17,26 Patients had to wear this appliance for at
least 22 hours a day. In order to check their compliance
parents had to undersign a form on which the daily
wearing time was recorded by the patient. Both body and
oral muscle gymnastics were prescribed as auxillary therapy, according to individual needs.1 At the end of the
2-year treatment period, clinical and radiographic examinations were repeated to evaluate dental and skeletal

American Journal of Orthodontics and Dentofacial Orthopedics

Volume 114, No. 1

Garattini et al. 41

modifications caused by the treatment. From the original

55 patients in the sample group, 4 were excluded as a
result of treatment planning modifications, 4 for poor
compliance, 6 because radiographic examination did not
comply with the expected protocol times at the end of the
observation period (i.e., after 2 years 6 2 months) and 2
because they moved to another town. Finally, the Bionator sample group, reconsidered at the end of the experimental period was composed of 39 patients (average age,
94.9 months): 24 females (average age, 90.4 months) and
15 males (average age, 102.3 months) (Table I).
Control group. Changes in cephalometric values after
Bionator III therapy in the Bionator sample group were
compared with those recorded in a longitudinal study of the
London Kings College matched according to sex and age.29
Analysis method
Cephalometric analysis. We selected cephalometric
measurements that in our opinion detected the changes
produced in the jaws by the orthopedic treatment, more
accurately during the observation period (Fig. 1). All the
lateral headplates were traced by the same operator and
analyzed with a computerized system (Orthocad 8.0,
Databit, Cernusco sul Naviglio, Milan, Italy). Ten cephalograms were selected and traced to evaluate the reliability of the method. The average total difference between
the first and the second measurement was not statistically
significant for any landmark (p , 0.01). Consequently, the
resulting error could be ignored.
Statistical analysis. A computerized system (Statview
4.0, Abacus Concepts Inc, Berkeley, Calif.) was used to
statistically compare the cephalometric data of the patients and the control group. Mean value and standard
deviations were calculated for each measurement, as well
as the differences between the start of treatment and the
end of the observation period. The significance of the
differences between the groups, which were due to both
treatment and growth, was evaluated using the Wilcoxon
signed rank test. Pearsons correlation test was also carried out. Finally, the ANOVA test was carried out to
determine whether the therapeutical effect depended on
the skeletal pattern.
RESULTS

The homogeneity of the initial conditions of

the two examined groups was assessed by comparing the initial cephalometric measurements. No
statistically significant difference was found, except data indicating a skeletal Class III, thus the
two groups were considered equivalent. Analysis
of the therapeutic effects was carried out by
means of the same variables used to check the
initial conditions; these highlighted a significant
increase in all the measurements indicating the
sagittal development of the maxilla. In particular,
the mean interspinal increase of 2.9 mm (Table II)

Fig. 1. A and B, The modified Bionator III appliance.

was accompanied by a significant advancement of

point A (Ba-A 1 4.2 mm, ANS 1 1.2, Pns-A 1 3
mm [Table II]). Moreover, a significant increase
in facial heights was recorded (N-Me 1 5.6 mm,
S-Go 1 3.2 mm [Table II]) along with a slight
posterior rotation of the palatal plane (N-Ans 1 3
mm, S-NPns-Ans 1 0.9, Table II). This posterior rotation was associated with a similar change
of the mandibular plane angle (Ans-Me 13.1 mm,
S-NGo-Gn 1 0.9, Table II).
Such changes contributed to a statistically significant change in the anteroposterior relationships between the upper and the lower jaw (Wits 1 2.7 mm,
ANB 1 2, facial convexity 1 1.7 mm, Table II). In
order to distinguish the modifications produced by the
functional treatment from growth-linked increases,
measurements describing the modifications occurring

42 Garattini et al.

American Journal of Orthodontics and Dentofacial Orthopedics

July 1998

Table I. Initial composition of the Bionator III group and control group
Sex

Observation period
length

Initial age

Wits index

Group

Male

Female

Mean
(months)

SD
(months)

Mean
(months)

SD
(months)

Mean

SD

SE

Bionator
Control

15
15

24
24

94.9
94

20
20

24.3
24

1.2
1

25.3
1.7

1.9
0.9

0.3
0.1

SD, Standard deviation.

SE, Standard error.

(N-Me 1 1.5 mm, Table III). Reduced anteroposterior mandibular growth (Go-Me 21.1 mm, S-N/
Go-Me 1 1.6, PNSog 21, Table III) and the
variation of the anteroposterior relationships between the upper and the lower jaw were noticed
(Wits 1 2.4 mm, Table III).
The ANOVA test was performed to assess the
significance of the therapeutic changes according to
the skeletal pattern, determined by the anterior
facial height/posterior facial height ratio (S-Go/NMe). This test showed that therapeutical changes

in both groups during the observation period were

reciprocally compared.
Analysis of the results confirmed that the Bionator III is effective in producing a statistically significant mean increase in the upper jaw length (PnsAns 1 1.4 mm, Pns-A 1 1.6 mm, Table III) together
with an advancement of point A (Ba-A 1 1.9 mm,
Table III). Besides, palatal and mandibular plane
angles widened (S-NPns-Ans 1 0.7, Table IV,
S-NGo-Gn 1 1.3, Table III). These changes account for the increase of the anterior facial height
Table II. Comparison of Bionator III group and control group
Bionator III group

ANS
SNB
ANB
S-N
Pns-A
WITS
Convessita`
Pns-Ans
Go-Me
PNSog
Ba-A
Ar-Pog
S-N/Go-Me
Ar-Go anat
N-Me
N-Ans
Ans-Me
S-Go
S-Go/N-Me
ArGoMe geo
Som. Jarabak
S-NGo-Gn
Pns-AnsGo-Gn
S-NPns-Ans
IS-N
IGo-Gn
EL-Ls Rik
EL-Li Rik
CmSnLs

Control group

Initial

Final

Difference

SD

SE

Significance

Initial

Final

Difference

SD

SE

79.9
78.5
1.4
66.3
41.6
25.3
1.2
45.9
66.3
78.6
85.4
96.7
99.8
40.2
107.8
46.5
62.6
67.1
60.8
130.5
395.2
35.9
28.9
7
102.3
87.8
23.4
21.3
115.3

81.1
77.7
3.5
67.9
44.6
22.5
2.9
48.8
68.6
78.4
89.6
100.5
98.2
41.5
113.4
49.6
65.7
70.3
60.7
129.5
396
36.8
28.9
7.8
97.9
84.2
23.2
22.2
116

1.2
20.8
2
1.6
3
2.7
1.7
2.9
2.3
20.3
4.2
3.8
21.6
1.4
5.6
3
3.1
3.2
20.1
21
0.8
0.9
e
0.9
24.3
23.6
0.2
1
0.7

2.4
1.7
2
1
1.8
1.9
1.5
1.2
1.9
1.6
1.8
2.1
4
2
2.6
2.3
1.6
1.4
1.7
2.6
2.4
2.4
2.1
2.5
15.2
7.9
2
1.6
9

0.4
0.3
0.3
0.2
0.3
0.3
0.2
0.2
0.3
0.3
0.3
0.3
0.6
0.3
0.4
0.4
0.3
0.2
0.3
0.4
0.4
0.4
0.3
0.4
2.9
1.5
0.3
0.2
1.4

S**
S**
S***
S***
S***
S***
S***
S***
S***
NS
S***
S***
S*
S***
S***
S***
S***
S***
NS
S*
NS
S*
NS
S*
NS
S*
NS
S*
NS

79.6
76.7
3.6
62.6
41.2
1.7
2.7
44.9
58.9
76.7
81.2
87.6
106.3
36.3
98.7
44
56.1
60.9
61.7
132.4
396.7
36.7
29.7
7
101.2
89.1
22.2
21.9
109.7

79.6
76.6
3.2
64.1
42.6
2
2.2
46.4
62.3
77.4
83.5
91.7
103
37.7
102.7
46.3
57.7
63.8
62.1
131.4
396.1
36.2
29
7.1
102.2
90.6
22.6
22
110.5

20.1
20.1
20.4
1.6
1.4
0.3
20.5
1.5
3.4
0.8
2.3
4
23.3
1.4
4
2.3
1.6
2.9
0.4
21
20.5
20.5
20.6
0.1
1.1
1.5
20.4
20.1
0.8

0.2
2.2
0.3
0.3
0.6
0.9
0.2
0.1
0.8
0.2
0.2
0.3
1.3
0.5
0.5
0.4
0.3
0.3
0.4
0.2
0.4
0.4
0.3
0.2
1.2
1
0.2
0.2
1.4

e
0.4
e
e
0.1
0.1
e
e
0.1
e
e
0.9
0.2
0.1
0.1
0.1
e
e
1
e
0.1
0.1
0.1
e
0.2
0.2
e
e
0.2

SD, Standard deviation.

SE, Standard error.
*p , 0.05; **p , 0.01; ***p , 0.001.

Garattini et al. 43

American Journal of Orthodontics and Dentofacial Orthopedics

Volume 114, No. 1

Table III. Comparison of Bionator III group and control group

Variables
Cranial and Craniofacial
Linear (mm)
SN
N-Ans
Ans-Me
N-Me
S-Go
Percentage (%)
S-Go/N-Me
Angular ()
Jarabak summation
Upper jaw
Linear (mm)
Pns-A
Pns-Ans
Ba-A
Angular ()
ANS
SNPns-Ans
EL-Ls
CmSnLs
Mandibular
Linear (mm)
Ar-Pog
Go-Me
Ar-Go
Angular ()
SNB
PNSog
ArGoMe
S-NGoGn
Percentage (%)
SN/GoMe
Anteroposterior jaws
Linear (mm)
Wits
Angular ()
ANB
Convexity
Pns-AnsGo-Gn

Mean
difference

SD

SE

Significance of
difference

20.1
0.7
1.5
1.5
0.3

1
2.2
1.6
2.5
1.4

0.2
0.4
0.2
0.4
0.2

N.S.
N.S.
S.***
S.**
N.S.

20.5

1.7

0.3

N.S.

1.3

2.3

0.4

S.**

1.6
1.4
1.9

1.7
1.3
1.8

0.3
0.2
0.3

S.*
S.**
S.*

1.3
20.7
0.6
20.1

2.4
2.5
2
2

0.4
0.4
0.3
0.3

S.**
N.S.
N.S.
N.S.

20.3
21.1
0.0

2.1
1.9
2.0

0.3
0.3
0.3

N.S.
S.**
N.S.

20.7
21.0
0.0
1.3

2.6
1.5
2.6
2.2

0.4
0.2
0.4
0.4

S*
S.***
N.S.
S.***

1.6

3.9

0.6

S.**

2.4

2.1

0.3

S.***

2.5
2.2
0.7

2.0
1.5
2.1

0.3
0.2
0.3

S.***
S.***
N.S.

SD, Standard deviation.

SE, Standard error.
*p , 0.05; **p , 0.01; ***p , 0.001.

were more significant in hypodivergent rather than

in normodivergent patients (Pns-Ans 1 0.8 mm,
Pns-A 1 1.6 mm, Ar-Go 1 1.8 mm, Wits 1 1.8 mm,
Table IV).

DISCUSSION

The age of the Bionator III patients ranged from

5 to 11 years (mean age, 8 years); during this time
the annual growth rate is reduced in comparison
with prepubertal growth spurt. As a consequence,
although the Bionator III influences the craniofacial
skeleton, its efficacy is higher when used during the
pubertal growth spurt. Different reasons led to the
choice of patients who were far from the pubertal
growth spurt. First of all, the choice of an early
treatment is consistent with studies that show the
growth potential of the incisive-canine suture decreases after the age of 7 years.2,30-34 Besides, the
prognosis of Class III malocclusions has been
judged extremely poor by some authors,1,2 who
consequently assert that early therapy is necessary to
growth. Although in our study the Bionator III
appeared to be more effective in older patients, the
control of the malocclusion is not always predictable. For this reason, we did not consider the
inclusion of older patients in the Bionator III group
ethically correct. To assess the effect of the Bionator
III on the craniofacial skeleton, the modifications in
the Bionator III group were compared with those in
the control group. In particular, the increase in the
maxillary anteroposterior length and the advancing
of point A, explain the significantly greater growth
in the Bionator III group (mean value, 10.8 mm/
year). At the same time, a decrease in mandibular
growth ( 0.5 mm/year) was noticed. The maxillary
length increase and the decrease of the mandibular
growth explain the significant change in the anteroposterior relationships between the jaws (11.2 mm/
year). These favorable changes make the Class III
malocclusion treatment easier. This anteroposterior
jaw relationship improvement is mostly due to structural changes and to anterior movements of the
upper jaw. The anterior facial height increases while
the posterior rotation of both jaws takes place. Such

Table IV. Analysis of the variance (Anova test) according to skeletal pattern in the Bionator III group
Difference between the groups
Number of
cases
F-test
Hypodivergent
19
Normodivergent
14
Hyperdivergent
6
Fischers test PLSD
Hypodivergent vs Normodivergent
*95% significance.

Pns-Ans
(mean of the
differences)

Pns-A
(mean of the
differences)

Ar-Go
(mean of the
differences)

Wits
(mean of the
differences)

2.3
p 5 0.0492
13.2
12.4
13.1
0.8*

4.3
p 5 0.0209
13.7
12.1
13.0
1.2*

3.2
p 5 0.0483
12.2
10.2
11.4
1.4*

4.3
p 5 0.0208
23.5
21.7
22.8
1.3*

44 Garattini et al.

a modification may mean that the Bionator III does

not effectively control the vertical growth, especially
at mandibular level (1 0.7 mm/year), whereas the
maxilla rotates posteriorly in a compensatory way.
Some interesting variations were observed when
comparing the hypodivergent group with the normodivergent group. In particular the anteroposterior maxillary growth in the first group was greater
(0.7 mm/year) and the Wits Index improvement (1
1 mm/year) was bigger.
CONCLUSIONS
Some authors are skeptical about orthopedic treatment with functional appliances.4 Unfortunately we
cannot compare our results with those reported in the
literature, because previous studies only considered
clinical aspects. The results of our study suggest that the
effects of Balters appliance are mainly the result of
dentoalveolar changes in the growing craniofacial skeleton. Although such changes are statistically significant,
they are less evident from a clinical point of view. It was
also proved in the study that the Balters Bionator III is
an effective appliance in the treatment of Class III
malocclusions in growing patients with midfacial deficiency. The Bionator III control of the anteroposterior
mandibular growth is unpredictable and insignificant.
Changes in the anterior facial height should be evaluated in a more exhaustive way with a larger study group.
This may then explain how the improvement of the
anteroposterior jaw relationship is produced. Better
relationships might follow an increased development of
the upper jaw as well as a mandible growth limitation.
A larger study group could also show how important the
role of the posterior rotation of the mandible is in
modifying these cephalometric measures. The Bionator
III failed to show an effective control on vertical
growth. We feel that the use of this appliance should be
preceded by a careful evaluation of patient skeletal and
growing patterns as it is not indicated for use in patients
with increased facial height. Therefore, the Bionator III
is helpful in Class III malocclusion treatment in growing patients with midfacial deficiency, hypodivergent
growth pattern, and reduced facial height. Finally, the
Bionator III may also be considered a valid appliance in
patients with favorable skeletal features. In other
words, a correct diagnosis is necessary to stress facial
and skeletal variables and the extent of the malocclusion in order to rationally use this appliance. Noncompliance with these indications could explain clinical
failures. We believe this therapy is cheap and quite
comfortable, and it may prove helpful when the diagnosis is correct and patient compliance is good.

American Journal of Orthodontics and Dentofacial Orthopedics

July 1998
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