J. Nihon Univ. Sch. Dent., Vol.

34, 278-287, 1992

Functional Regulator Therapy in Treatment

of Skeletal Open-bite

Balent HAYDAR1 and Ayhan ENACAR2

(Received13 November1991and accepted3 July 1992)

Key words: Frankel appliance, open bite, functional regulator

Abstract
A study was performed on the functional regulator, Frankel appliance (FR4)
in order to test its efficiency in the treatment of patients with skeletal open-bite.
Pretreatment and post-treatment cephalometric evaluation was done on 11 patients
and 10 untreated patients with skeletal open-bite. The results showed that the FR4
appliance was mainly effective on changes in dentoalveolar structures and
produced no significant skeletal changes. The degree of anterior open-bite was
decreased significantly in the treatment group in comparison with the controls
(p<0.01), due to vertical eruption of upper and lower incisors and retraction of
maxillary incisors.
Introduction
Treatment of skeletal anterior open-bite deformity is one of the most difficult
challenges for the orthodontist. The main cephalometric characteristics of this
malocclusion are a decrease in the ratio of posterior to anterior face hight[1-5], an
increase in anterior face height[1-8], due mainly to a rise in lower anterior face
height and the mandibular plane angle as a result of backward rotation of the
mandible, and a rise in the posterior and anterior maxillary and mandibular dental
height[2,6,8,9].Extraorally, affected patients have a narrow alar base and a parted
lips posture which is a characteristic feature of their mouth breathing[10]
The etiology of this malocclusion may be multifactorial including heredity,
sucking habits, mouth breathing with associated head-posture and some develop-
mental anomalies[11]. Various methods of orthodontic treatment have been used
with reference to the etiology of open-bite malocclusion[9,10,12-16]. Depending on
the age of the patient, a functional therapy approach during the mixed dentition
period or fixed appliance therapy after establishment of permanent dentition may
be used.
Moss et al. [17]states that capsular functional matrices may play an important
role in open-bite. Either the form of the oral functional space or its location may
be abnormal relative to the nasal and pharyngeal functional spaces. On the basis
of this concept, FRANKELAND FRANKEL[18] developed a functional approach to
Based on a thesis submitted in partial fulfillment of the requirements for the Master of Science
degree, Faculty of Dentistry, University of Hacettepe
1 Department of Orthodontics, Faculty of Dentistry, Hacettepe University.
2 Department of Orthodontics, Faculty of Dentistry, Hacettepe University.
To whom all correspondence should be addressed: Dr. Balent HA YDAR, Ba4ak Sokak, 45/ 21,
Kacakesat 06660, Ankara, TURKEY.
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orofacial orthopedics, and introduced the FR4 appliance for the treatment of
skeletal open-bite malocclusion. This works by correcting the faulty postural
activity of the orofacial musculature and helps to correct the associated skeletal
deformity. It has also been claimed that this approach reverses the backward
rotational growth pattern of the mandible.
The aim of the present study was to determine the effects of the FR4 appliance
on the developing dentofacial skeletal structures in patients with skeletal open-
bite. Cephalometric comparisons of the treated and control groups were made to
evaluate the effects of the appliance.

Materials and Methods

Eleven patients in the mixed dentition period who had an anterior open-bite
were treated with the FR4 appliance at the postgraduate orthodontic clinic of
Hacettepe University. In addition, 10 children in the mixed dentition period with
the same type of malocclusion were used as a control group. Average ages at the
beginning and end of the observation period are shown in Table I. The patients
were selected according to the following criteria: 1-Presence of anterior open-bite
with a vertical growth pattern. 2-Lack of sucking habits. 3-Patients were in their
mixed dentition period.

Table I
Average ages at the beginning of treatment and duration of treatment

Lateral cephalograms of all patients were taken before and after the observa-
tion or treatment period. The FR4 appliance was constructed according to the
methods described by FRANKELAND FRANKEL[191 and GRABERet a1.[201(Fig. 1, a
and b).

Fig. 1 a The FR 4 appliance on a maxillary model showing the occlusal rests on permanent and
deciduous first molars
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Fig. 1b Finished appliance tested on mounted models before applying to the mouth

The patients were instructed to wear the appliance for 3 h on the first day and

add one hour each day for the first ten days. After this period the patients were

instructed to wear the appliance full-time (at least 20 h per day) except during

eating or sports activity. They were advised not to wear the appliance during

sleeping hours during the first 10 days. The importance of lip seal exercises were

explained to the patients, and they were instructed to keep their lips together as

much as possible. The patients were instructed to perform lip seal exercises such

as holding a coin between the lips, blowing up a balloon or whistling.

Patients with upper airway problems were told to consult an ear-nose-throat

(ENT) specialist, and adequate treatment measures were taken whenever necessary.
The pre- and post-treatment lateral cephalograms were traced, and 21 ana-

tomic landmarks were used; 35 parameters-16 angular and 19 linear- were used

to evaluate the effects of the FR4 appliance. Cephalometric evaluation was carried

out on maxillary and mandibular skeletal and dental structures and also on

vertical changes.

Statistical evaluation was made by Wilcoxon signed-rank test for longitudinal

changes and Mann-Whitney U test for comparison of two groups.

Findings

The data showed that before treatment the FR4 group had more retroclined

maxillary incisors than the controls (Ul-SN•‹ p<0.05, Ul-NA•‹ p<0.05) (Table II ).

In addition the FR4 group displayed higher U1-PP(mm) and U6-FH(mm) values

(p<0.05) (Table II ).
Maxillary skeletal and dental changes (Tables III, IV, V)

The Frdnkel appliance appeared to restrain maxillary growth slightly.

Maxillay length (Harvold) increased 1.227 mm in the treatment group (p<0.05)

and 2.250 mm in the control group (p<0.01).

Maxillary incisors showed a significant amount of angular retraction (U1-SN•‹:

3.864•‹ p<0.05, Ul-NA: -3.091•‹ p<0.05) and bodily retraction (U1-NAmm: -1.136
-

p<0.05). Upon comparison of these changes with the control group, only the
decrease in the Ul-NAmm measurement was found to be significant (p<0.05).
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Table II
Pretreatment comparison of FR4 and control groups

Although significant extrusion of the upper incisors was found (U1-FHmm:

3.227 mm p<0.01, Ul-PP mm: 1.864 mm p<0.01), these changes were not
significant when compared with the control (p>0.05). Similarly, upper 1. molars
showed a noticeable increase in vertical height (p<0.05), but this was not found
to be significant when compared with the control (p>0.05).
Mandibular skeletal and dental changes (Tables III, IV, V)
No measurements in these groups were found to be significantly noteworthy
when the two groups were compared.
Although significant increases in the mandibular length and ramus height
282

Table III
Longitudinal changes in the treatment group

were observed in the FR4 group (3.182 mm p<0.01, 1.545 mm p<0.05), these
changes were considered to be non-significant when compared with the control.
Despite a higher incidence of vertical eruption of the lower incisors, compari-
son of the two groups showed no significant difference (p>0.05).
Vertical Changes (Tables III, IV, V)
The decrease in the amount of open-bite (mm) was found to be crucial when
the groups were compared.
In the treatment and control groups the degree of open-bite was decreased by
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Table IV
Longitudinal changes in the control group

2.636 mm (p<0.01) and 1.100 mm (p<0.05), respectively, and the difference

between the groups was found to be significant (p<0.01).
Anterior face height increased to 2.682 mm (p<0.01), which was significant in
comparison with the control (p<0.05).
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Table V
Comparison of treatment changes between FR4 and control groups

Discussion

Although the treatment period used here of one year and two months was less
than the proposed Frdnkel treatment duration, the changes observed during this
period gave sufficient information about the efficiency of FR4.
There has been only one study on the effects of the FR4 appliance since that
of FRANKEL AND FRANKEL [18]. OWEN[21] reported the results of treatment of some
open-bite patients using the FR4. Accordingly, we shall compare our results with
those of FRANKEL AND FRANKEL[18'191.
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The FR4 appliance was found to affect the changes in dental structures rather

than skeletal configuration.

Although not significant when compared with the control, vertical eruption of

the upper and lower incisors in the FR4 group was found more frequently. This

vertical eruption of incisors in the FR4 group combined with the retraction of the

upper incisors which would have affected the vertical height, were considered to

be the main reasons for the decrease in open-bite. This change may have resulted

from the lip seal exercises and the change from mouth breathing to nasal breathing,

which in turn would have caused the tongue to alter its postural position back-

ward, thus allowing the incisors to erupt freely.

Our findings show that the use of the FR4 appliance caused some backward

rotation of the mandible (FMA: 1.045•‹), which was significant when compared

with the control. However, this contradicts the findings of Frankel's study, where

appliance caused anterior rotation of the mandible, whereas backward rotation of

the mandible continued in his control sample.

In addition, the fact that the increase in the anterior face height in our

experimental group was significantly greater than in the control suggests that the
appliance restricts the natural anterior rotation of the mandible, as seen in the

control sample.
FRANKEL AND FRANKEL[18,19] explained the forward rotation of the mandible

as an increase in posterior face height, which they attributed to compensatory

growth at the condyle and raising of the anterior part of the mandible as a result
of lip seal exercises. No such anterior rotation of the mandible was observed in our

group, although they performed lip seal exercises throughout the treatment, and no
significant increase in ramus height was observed in compaison with the controls.

FRANKEL AND FRANKEL[18,19] stated that in their experimental group, posterior

maxillary and mandibular dentoalveolar growth was not inhibited by use of the

appliance, although they did not believe that maxillary dentoalveolar excess was

a factor causing open-bite. We also found that the use of FR4 did not change the
normal eruption of the upper and lower first molars in compaison with the

control. FRANKEL AND FRANKEL[18'191 set out from Nahoum's finding that the

distance from the maxillary first molar to the palatal plane was not significantly

different from that in normal subjects. More recent research has shown that

posterior maxillary dentoalveolar excess is a significant finding in open-bite cases.

From this viewpoint, this is one area that has to be controlled during the treatment

of skeletal open-bite.

Importance of vertical control in the treatment of malocclusion has been

stressed many times[1,8,15,21]. OWEN[21] stated that the FR4 appliance did not prove

effective in his study, in agreement with our results. He modified the appliance by

adding a posterior bite block and tubes for occipital-pull head-gear for positive

control of the posterior maxilla.

MCNAMARA{221 stated that patients with an excessive vertical dimension were

least likely to benefit from the Frankel treatment, and therefore he combined the

FR4 appliance with a vertical-pull chin cap in patients with skeletal open-bite.

It is not clear why excessive eruption of posterior theeth, causing backward

286

rotation of the mandible, occurs in children with open-bite, although the occlusal
forces are not low during this period in comparison with normal individuals. The
findings of PROFFIT'Sgroup[23,24]suggest that the long face pattern present in
children when occlusal forces are not low, is not a cause of, but rather an effect of
this condition. INGERVALL et al. [25]in their study concluded that the long face
morphology characterisitc of mouth-breathing children, is not due to weak
muscles.
The theory of soft tissue stretching proposed by SoLow et al. [26]states that in
upper airway inadequacy a mouth breather will alter his head posture, and that
this in turn will affect craniofacial morphology. This change in head posture may
increase the interocclusal space, causing excessive eruption of posterior teeth.
Considering the results of these studies, it seems improbable that lip seal
exercises, which are highly recommended by FRANKELANDFRANKEL[18] can alter
growth direction by strengthening the elevator muscles, which in any case are not
weak during this period.
Further research on this subject may result in different conclusions, and by
focusing treatment planning on the cause of the vertical excess, it should be
possible to alter the direction of growth in the early mixed dentition period.
Summary and Conclusions
The effects of the FR4 appliance in cases of skeletal open-bite were evaluated
cephalometrically and the following conclusions reached:
1-The FR4 appliance did not produce any skeletal changes.
2-No significant changes in facial proportions occurred.
3-The lack of any significant increase in ramus height and an unexpected
slight posterior rotation of the mandible contradict the hypothesis on which
this appliance is based.
4-The amount of open-bite decreased significantly in the FR4 group. Vertical
eruption of the upper and lower incisors and retraction of the upper incisors
are considered responsible for the closure of open-bite.
The FR4 appliance was found to affect dental structures rather than skeletal
configuration, thus failing to improve the facial pattern, and merely masking the
existing vertical problem.
References
[1] NAHOUM, H. I.: Vertical proportions and the palatal plane in anterior open-bite,Am. J.
Orthodont.,59, 273-282,1971
[2] LOPEZ-GAVITO, G., WALLEN, T. R., LITTLE, R. M. and JOONDEPH, D. R.: Anteroir open-bite
malocclusion:a longitudinal 10-yearpostretentionevaluation of orthodonticallytreated
patients, Am. J. Orthodont.,87, 175-186,1985
[3] CANGIALOSI, T. J.: Skeletalmorphologicfeaturesof anterior open-bite,Am. J. Orthodont.,
85, 28-36,1984
[4] NAHOUM, H. I.: Anterior open-bite; a cephalometricanalysis and suggested treatment
procedures,Am. J. Orthodont.,67, 513-520,1975
[5] NAHOUM, H. I. and HOROWITZ, S. L.: Varietiesof anterior open-bite,Am. J. Orthodont.,61,
486-492,1972
[6] ELus, E. and MCNAMARA, J. A. Jr.: Componentsof adult class III open-bitemalocclusion,
 287

Am. J. Orthodont., 86, 277-290, 1984

[7] JONES, O.G.: A cephalometric study of 32 North American black patients with anterior
open-bite, Am. J. Orthodont. Dentofac. Orthoped., 95, 289-296, 1989
[8] SCHENDEL, S. A., EISENFELD, J., BELL,W. H., EPKER,B. N. and MISHELEVICH, D. J.: The long
face syndrome; vertical maxillary excess, Am. J. Orthodont., 70, 398-408, 1976
[9] EPKER,B. N. and FIsH, L. C.: Surgical-orthodontic correction of open-bite deformity, Am.
J. Orthodont., 71, 278-299, 1977
[10] PROFFIT,W. R. and BELL,W. H.: Open bite. In Surgical Correction of Dentofacial
Deformities, 1058-1209, BELL,W. H., PROFFIT, W. R., WHITE,R. P., eds., W. B. Saunders,
Philadelphia, U.S.A., 1980
[11] VANDERLINDEN,F.P.M.G. and BOERSMA, H.: Etiology. In Diagnosis and Treatment
Planning in Dentofacial Orthopedics, 17-37, VANDERLINDEN, F.P.M.G., ed., Quintessence
Publishing Co., London, U.K., 1987
[12] GRABER, T. M. and SWAIN, B. F.: Dentofacial Orthopedics. In Current Orthodontic Concepts
and Techniques, Vol II, 365-452, GRABER, T. M., ed., W. B. Saunders, Philadelphia, U.S.A.,
1975
[13] WOODSIDE, D. G. and LINDER-ARANSON, S.: Progressive increase in lower anterior face height
and the use of posterior occlusal bite-block in its management. In: Orthodontics. State of
the Art: Essence of the Science, 200-221, GRABER, L. W., ed., C.V. Mosby, St. Louis,
U.S.A., 1989
[14] DELLINGER, E. L.: Orthodontic correction of the long-face syndrome, Ear Nose Throat J.,
66, 237-241, 1987
[15] KIM,Y. H.: Anterior open-bite and its treatment with multiloop edgewise archwire, Angle
Orthodont., 57, 290-321, 1987
[16] HUANG, G., JUSTUS, R., KENNEDY, D. B. and KOKICH, V. G.: Stability of anterior open-bite
treated with crib therapy, Angle Orthodont., 60, 17-24, 1990
[17] Moss, M. L. and SALENTIJN, L.: Differences between the functional matrices in anterior
open-bite and in deep overbite, Am. J. Orthodont., 60, 264-280, 1971
[18] FRANKEL, R. and FRANKEL, C.: A functional approach to treatment of skeletal open-bite,
Am. J. Orthodont., 84, 54-68, 1983
[19] FRANKEL, R. and FRANKEL, C.: The function regulator in the treatment of skeletal open-bite.
In Orofacial Orthopedics with the Function Regulator, 73-89, Karger, Basel, 1989
[20] GRABER, T. M., RAKOSI, T. and PETROVIC, A. G.: The Frankel Function Regulator. In
Dentofacial Orthopedics with Functional Appliances, 219-274, GRABER, T. M. ed., C.V.
Mosby, St. Louis, U.S.A., 1985
[21] OWEN,A. H.: Modified function regulator for vertical maxillary excess,J. Clin. Orthodont.,
19, 733-749, 1985
[22] MCNAMARA, J. A. Jr.: On the Frankel appliance, part-2, Clinical Management, J. Clin.
Orthodont., 16, 390-407, 1982
[23] PROFFIT, W. R., FIELDS,H. W. and NIXON,W. L.: Occlusal forces in normal and long-face
adults, J. Dent. Res., 62, 566-570, 1983
[24] PROFFIT, W. R. and FIELDS, H. W.: Occlusal forces in normal and long-face children, J. Dent.
Res., 62, 571-574, 1983
[25] INGERVALL, B., THUER, V. and KUSTER, R.: Lack of correlation between mouth-breathing and
bite force, Eur. J. Orthodont., 11, 43-46, 1989
[26] SOLOW, B., SIERSBAEK-NIELSEN, S. and GREVE,E.: Airway adequacy, head posture and
craniofacial morphology, Am. J. Orthodont., 86, 214-223, 1984
[27] FRANKEL, R.: Lip seal training in treatment of open-bite, Eur. J. Orthodont., 62, 113-141,
1972