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James A. McNamara, Jr., D.D.S., Ph.D.,* and Scott A. Huge** Dr. McNamara, Jr.
Ann Arbor, Mich., and Atlanta, Gg.
This article describes the construction of the FR-3 appliance classically used in cases of Class Ill malocclusion
characterized by maxillary skeletal retrusion. Included is a description of proper impression technique, construction
bite registration, preparation of the work models, and a complete description of the fabrication of the FR-3
appliance. Specific steps in the clinical management of this appliance are also presented. The cephalometric
records of three patients treated with the FR-3 appliance are then presented. (AM J ORTHOD 88: 409-424,
1985.)
Key words: Functional regulator, Frtinkel, Class III malocclusion, impressions, bite registration
THE FUNCTIONAL REGULATOR (FR-3) OF study that the forward development of the maxilla is
FRiiNKEL stimulated by the FR-3 appliance. However, a definitive
A method of functional jaw orthopedics that has study of the precise mechanism of action of this ap-
gained increased popularity in the United States is pred- pliance or a controlled clinical trial of the efficacy of
icated on the system of functional regulator appli- this type of functional regulator has not been published.
ances. developed by Professor Rolf Frtinkel of the Another use of the FR-3 has been suggested by Petit
German Democratic Republic. One of these appliances, in the treatment of severe Class III cases. Petit advocates
the FR-3,1A is used in the treatment of Class III mal- the use of heavy orthopedic forces generated by the
occlusions. This appliance has been used during the facial mask to achieve the initial correction of the mql-
deciduous, mixed, and early permanent dentition stages occlusion. Further, he suggests that an FR-3 may be
to correct Class III malocclusion characterized by max- used to retrain the maxillary anteroposterior correction
illary skeletal retrusion and not mandibular prognath- and to retrain the associated musculature.
ism.2*3 According to Frinkel,, the vestibular shields Eirew6 has stated that the FR-3 is an excellent re-
and upper labial pads function to counteract the forces training device and aid to muscular reeducation follow-
of the surrounding muscles that restrict forward max- ing surgical correction of mesiocclusion.
illary skeletal development and retrude maxillary tooth The purpose of this article is to describe the
position. FrPnkel* has also stated that the vestibular construction and clinical management of the Frgnkel
shields stand away from the alveolar process of the FR-3 appliance as it is currently used in the United
maxilla but fit closely in the mandible, thus stimulating States. Reports of three treated cases will also be
maxillary alveolar development and restricting mandib- presented.
ular alveolar development.
Fr8nke13reported a study of 74 severe Class III cases PARTS OF THE APPLIANCE
treated with the FR-3, comparing these casesto 58 Class The FR-3 (Fig. 1) is composed of wire and acrylic.
II cases treated with the FR-1 appliance. He noted As with the FR-2 appliance, the base of operation is
greater forward movement of maxillary landmarks in the buccal and labial vestibule. The FR-3 is less com-
the Class III cases than in the Class II cases. He also plicated than the FR-2 appliance in that there is no
stated that the changes in maxillary position in the Class lingual shield, which is necessary in the FR-2 to prompt
II cases were minimal in comparison to what would a forward repositioning of the lower jaw.
normally occur during growth. He concluded from this There are four acrylic parts of the FR-3: two ves-
tibular shields and two upper labial pads (Fig. 1, A and
The preparation of this manuscript was supported in part by United States
B). The vestibular shields extend from the depth of the
Public Health Service Grant DE-03610. mandibular vestibule to the height of the maxillary ves-
*Professor of Dentistry (Orthodontics), Professor of Anatomy and Cell Biology, tibule. These shields act to remove the restrictive forces
and Research Scientist, Center for Human Growth and Development. The
University of Michigan.
created by the buccinator and associated facial muscles
**Clinical Instructor, Department of Orthodontics, Emory University, and Spe- against the lateral surfaces of the alveoli and the as-
cialty Appliance Works. sociated buccal dentition.
409
410 McNamara and Huge
FM. 5. Preparation of work models and oencil outline for future vestibular shields and upper labial
pads. A, Lateral view. 8, Frontal view.
justments in work-model orientation during appliance and compound extension have been used to obtain the
fabrication can lead to an appliance that does not fit impression. This area is carved to allow proper place-
properly. ment of the upper labial pads (Fig. 5).
The bite registration is taken with the patients man- When the preparation of the work models is com-
dible in the mast comfortably retruded position. It is pleted, the wax bite is inserted and the posterior surfaces
necessary to allow 1 to 2 mm of interocclusal space in of the model are checked to ascertain that the backs of
the molar region for the construction of the lower and, the models are flush. This is an important step because
when necessary, upper occlusal rests. A wide open-bite it will allow the laboratory to check the wax bite when
registration should be avoided. In cases with an anterior the work models are received and it will also allow the
open bite, only 1 mm of vertical bite-opening in the clinician to check the bite registration when the appli-
posterior region is necessary. ance is returned from the laboratory.
Fig. 6. Placement of wax relief for the vestibular shields and the upper labial pads. A, Lateral view.
6, Oblique lateral view. C, Frontal view. D, Oblique maxillary view. E, Maxillary occlusal view. F,
Mandibular view. Note the lack of wax relief in the mandibular arch.
the wax bite still in place. After the mounting stone Application of wax relief
has hardened, the wax bite is removed and the amount First, the outlines of the vestibular shields and upper
of interocclusal space is checked for adequate, but not labial pads are drawn on the model with a pencil (Fig.
excessive, separation of the models to allow for con- 5). These outlines are used as a guide in the placement
struction of the appliance. of the wax. The models are then separated and wax
Flg. 7. Completed wax relief and wire work for the FR-3 appliance. A, Lateral view. 6, Frontal view.
C, Maxillary view. D, Maxillary oblique view. E, Mandibular view. This appliance does not include an
upper occlusal rest.
relief is applied in the posterior and upper anterior re- placed on the mandibular cast, although the gingival
gions of the maxillary dental cast as prescribed by the margins are carefully waxed out in the region of the
clinician (Fig. 6). Additional wax is then applied in vestibular shields to prevent the occurrence of gingival
the dental area to establish a smooth contour on the irritation and also to save time in polishing the inside
lingual side of the vestibular shield. No wax relief is of the shields.
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Fig. 8. The relationship of the upper occlusal rest to the lower occlusal rest. A, Maxillary view. B,
Maxillary oblique view.
Fig. 9. Finished functional regulator (F&3). A, Lateral view. 6, Frontal view. C, Maxillary occlusal
view. D, Maxillary oblique view. E, Mandibular view. This appliance does not include an upper occlusal
rest.
The lower occlusal rest wire. The lower occlusal dibular second deciduous molar and first permanent
rest wire (Fig. 7) originates in the lower posterior aspect molar. It then curves posteriorly to traverse the central
of the vestibular shield. It curves medially and then groove of the lower first molar and then recurves lat-
anteriorly at the interproximal surface between the man- erally to insert once again into the vestibular shield.
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Fig. 11. Case I cephalometric tracings. A, Tracing of initial lateral cephalogram. B, Tracing of
ceihalogram taken 15 months later.
tinue treatment. A crosscut fissure burr is used in a low- an idealized mixed-dentition patient, Point A lies on the na-
speed dental handpiece to free the ends of the labial- sion perpendicular).0 The effective midfacial length (mea-
pad support wires. Enough acrylic is removed around sured from condyhon to Point A) was 78 mm. In a balanced
face the corresponding effective mandibular length is 95 to
the end of this wire to allow anterior advancement of
98 mm. I0Since the effective mandibular length in this patient
the wire and maxillary labial pads. The lingual surface was 111 mm, it can be assumedthat the patient had a 13 to
of the upper labial pads are kept 3 mm away from the 16-mm imbalance in the effective lengths of the upper and
underlying alveolus throughout treatment. After the up- lower jaws.
per labial-pad adjustment has been checked for patient The patients lower anterior facial height was greater than
comfort, the holes in the vestibular shields are refilled normal (approximately 5 mm over expectedvalues).The man-
with acrylic to secure the labial-pad support wire. In dibular plane angle was within normal limits (27), as was
cases of severe maxillary skeletal retrusion, more than the facial axis angle (0). The maxillary central incisors were
one advancement of the maxillary labial pads may be in a normal position relative to the maxilla with the facial
necessary. surfaceof the incisors5 mm ahead of a line dropped vertically
through Point A (ideal 4 to 6 mm).OThe mandibular central
CASEREPORTS incisors were 5 mm ahead of the A-pogonion line (ideal 1 to
3 mm).
In the next section of this article, the skeletal and
dental adaptations observed in three patients treated Treatment progress
with the functional regulator appliance will be de- The impressions and construction bite for the FR-3 ap-
scribed. Each patient presented with a different mor- pliance were carried out in accordancewith the methods pre-
phologic configurationat the beginning of treatment. viously outlined in this article. The bite registration was taken
in the most comfortably retruded mandibular position. With
this bite registration, the patient could attain an end-to-end
CASE I incisal relationship. The appliance was worn on a full-time
This patient, an &year-old boy, presented with a Class basis (approximately 20 hours per day) for a period of 12
III malocclusion characterizedby maxillary skeletalretrusion months.
and an anterior crossbite.
The initial lateral head film (Fig. 11, A) was analyzed Analysis of t t=sammt results
according to the cephalometric analysisof the senior author. As can be observed in the cephalometric tracing of the
The maxilla was located posteriorly relative to the cranial lateral head film (Fig. 11, B) taken 1 year 3 months after the
base. Point A was 3 mm behind the nasion perpendicular (in initial head film (Fig. 11, A), both skeletal and dental ad-
Volume 88 Function& regulator (FR-3) of Friinkel 419
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Flg. 11. (Contd). Ctise I cephalometric tracings. C, Sciperimposition of the tracings in A and B along
the basion-nasion line at the ptetygomaxillary fissure. D, Mandibular superimposition on the internal
structures. E, Msuiillary superimposition on internal structures. F, Maxillary displacement. Superim-
position is along the basion-nasion line at nasion.
aptations were observed. During 1 year of treatment, there anterior facial height (approximately 1 mm per year increase
was a 3-mm increase in the length of the midface-about in this dimension is expected). The chin point became more
twice as much as would be normally expected in a patient of retrusive relative to the nasion perpendicular.
this age. The maxilla was displaced 1 mm in an anterior Adaptations in the various regions of the craniofacial
direction relative to Point A. complex were analyzed according to the four-point super-
Mandibular length also increased by 3 mm (2 to 3 mm imposition of Ricketts.I
is usually observed in untreated persons), as did the lower Cranial base superimposition (Fig. 11, C). Superimpo-
Am. J. Orthod.
4%) McNamara and Huge
November 1985
Flg. 12. Case II cephalometric tracings. A, Tracing of initial cephabgram. B, Tracing of cephabgram
taken 2% years later.
sition along the basion-nasionline at its intersection with the and slightly downward direction with even greater movement
pterygomaxillary fissure indicated that the mandible de- observed in the maxillary dentition. The mandible was re-
scendedvertically with no changein anteroposteriorposition. directed vertically in its vector of growth with little evidence
The maxilla moved in a downward and forward direction of anteroposterior repositioning of the chin.
approximately 3 mm. The position of the lower incisor was
CASE II
relatively unchanged, although the upper incisor moved into
a more forward position, eliminating the anterior crossbite. The patient, a girl aged 7 years 6 months, had a Class
A forward and slight downward movement of the upper molar III malocclusion characterizedby a Class 111molar relation-
was also noted. ship and an anterior crossbite. In comparison to the patient
Mandibular superimposition (Fig. 11, D). Superimpo in CaseI, this patient did not have maxillary skeletalretrusion
sition on the internal structuresof the mandible (for example, at the beginning of treatment. The evaluation of the initial
the inferior alveolar canal and the lingual aspect of the sym- head film (Fig. 12, A) indicated the presenceof a normally
physis) indicated that mandibular growth was reoriented in a related maxilla relative to cranial basestructures.Point A was
vertical direction with some areasof resorption at the inferior 2 mm ahead of the nasion perpendicular. A midfacial length
aspect of the gonial angle. The lower molar and the lower of 85 mm should correspondto a mandibular length of 105
incisor erupted vertically with no anteroposteriormovement. to I08 mm, indicating that the mandible of this patient was
Maxillary superimposition (Fig. 11, E). Superimposition normally related to the midface.
on the internal structures of the maxilla showed a forward A patient with an 85mm midfacial length should also
and slight downward movement of the upper incisorsand the have a lower anterior facial height of 60 to 62 mm. This
upper molars. Some changes in the external contour of the patient had a 7-mm deficiency in lower anterior facial height.
maxilla were also evident. The mandibular plane angle was normal (23) and the facial
Maxillary displacement (Fig. 11, F). Superimposition axis angle of 8 indicated a horizontal vector of growth (nor-
along the basion-nasionline at nasion showed that the maxilla mal is 0).
moved slightly forward during treatment, an adaptation that The upper incisor was normally positioned (5 mm ahead
presumably would not have occurred without treatment. Rel- of a vertical line dropped through Point A) and the lower
ative to nasion, the upper incisors moved in a downward and incisors were slightly protrusive (4 mm ahead of the A-po-
forward direction, as did the upper molars. gonion line).
Summary Treatment progress
This patient demonstrated both skeletal and dental ad- The FR-3 appliance was constructed in accordancewith
aptations during treatment. The maxilla moved in a forward the methods outlined in this article. A second appliance was
Volume 88 Functional regulator (FR-3) of Friinkel 421
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made for the patient 14 months after the onset of treatment. in midfacial length, which is greater than normal, as well as
The total treatment time was 2 years3 months with the patient a 7-mm increase in mandibular length, a growth increment
wearing the appliance on an 18 to 20-hour-a-day basisduring within normal limits. Lower anterior facial height, which
that time. usually increases1 mm per year,*Oincreasedby 6 mm. The
position of the upper incisors was relatively unchanged an-
Analysis of traatment results teroposteriorly, whereas the lower incisors became slightly
During the 2Y2years between the first film (Fig. 12, A) more protrusive relative to the A-pogonion line.
and the secondfilm (Fig. 12, B), there was a 7 mm-increase There was no change in the mandibular plane angle which
422 McNamara and Huge
Flg. 13. Case III cephalometric tracings. A, Tracing of initial lateral cephalogram. B, Tracing of the
cephalogram taken 21 months later. -
remained at 23, but there was a decreaseof 2 in the facial be expected during normal growth. In addition, the vector of
axis angle. mandibular growth was redirected more vertically with little
Cranial base superimposition ( Fig. 12, C) . Superimpos- anterior chin movement relative to cranial base structures.
ing along the basion-nasion line at its intersection with the
CASE III
pterygomaxillary fissure indicated that, as observed in Case
I, the direction of mandibular growth was redirected verti- This patient, a boy aged 6 years 8 months, had a Class
cally. There was no change in the mandibular plane angle, III malocclusioncharacterizedby a developing anterior cross-
although there was an opening of the facial axis angle. bite. Analysis of the initial head film (Fig. 13, A) showed a
The maxilla was displaced anteriorly with some vertical maxilia that was4 mm in a posterior position relative to cranial
movement observed as well. The anterior crossbitewas cor- base structures. The midfacial length was 77 mm. An ideal-
rected during the treatment period by a greater forward move- ized midfacial length of 81 mm (adding 4 mm to the actual
ment of the maxillary incisors than the mandibular incisors. midfacial length) indicated that effective mandibular length
Changes in the soft-tissueprofile were also observed. in this patient should be 97 to 100 mm. The patients actual
Mandibular superimposition (Fig. 12, D). Superimpos- mandibular length was 98 mm, indicating no major discrep-
ing on the internal structures of the mandible showed an ancy if the maxilla were in a normal position.
upward and slightly backward direction of condylar growth The patient also presented with a slightly short lower
and some remodeling in the area of the symphysis. Mostly anterior facial height (56 m) that was 1 to 2 mm less than
upward movement of the lower molars and lower incisors ideal values.
was noted.
Treatment progress
Maxillary superimposition ( Fig. 12, E) . Superimposing
on the internal structuresof the maxilla revealedless forward The patient wore the appliance on a full-time basis for
movement of the upper teeth than was observed in the patient approximately 18 months during which time the occlusaldis-
in Case I. However, the maxillary incisors and molars did crepancieswere corrected.
move in a downward and forward direction relative to the
Analysis of treatment results
maxilla.
Maxillary displacement (Fig. 12, F) Superimposition of When the initial head film (Fig. 13, A) was compared
the serial tracings along the basion-nasion line at nasion in- with the posttreatment head film (Fig. 13, B) taken 21 months
dicated that there was no forward maxillary displacement later, significant skeletal and dental adaptations could be ob-
relative to nasion during treatment. The palate descendedin served. Maxillary length increasedby 3 mm-a value within
a downward manner as occurs during normal growth. 0,11 normal limits. Mandibular length increased4 mm and lower
anterior facial height increasedby 2 mm; again values were
Summary within normal limits.
This patient showed an increasein midfacial length and The mandibular plane angle decreasedby 1 as did the
an increase in lower anterior facial height over what would facial axis angle.
Volume 88 Functional regulator (FR-3) of Friinkel 423
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Fig. 13. (Contd). Case III cephalometric tracings. C, Superimposition of the tracings seen in A and
B along the basion-nasion line at the pterygomaxillaty fissure. D, Mandibular superimposition on internal
structures. E, Maxillary superimposition on internal structures. F, Maxillary displacement. Superim-
position is along the basion-nasion line at nasion.
Slight alterations were observed in the position of the Mandibular superimposition (Fig. 13, D). Superimpos-
posterior teeth; the attainment of a Class I molar relationship ing on the internal structuresindicated that there was some
was noted. The potential anterior crossbitewas also averted superior growth at the head of the condyle and slight remod-
primarily due to the downward and forward movement of the eling in the gonial region. The positions of the lower incisors
upper incisors. and lower molars were relatively unchanged.
Cranial base superimposition (Fig. 13, C). Superimpos- Maxillary superimposition (Fig. 13, E) . Superimposing
ing along the basion-nasion line at nasion indicated that once on the internal structuresof the maxilla indicated that some
again mandibular growth was redirected inferiorly with a remodeling had occurred in this area, particularly along the
slight opening of the facial axis angle. The maxilla moved in labial and lingual surfacesof tire upper incisors. Someforward
a downward and slightly forward direction. and slightly downward movement of the upper molars was
The largest change in tooth position was observed in the also observed.
upper molar region. Little change in the contour of the soft- Maxillary displacement (Fig. 13, F). Superimposing
tissue profile was noted. along the basion-nasionline at nasion showed that the maxilla
424 McNamara and Huge
descended in a downward fashion relative to nasion. Little Illustrations were provided by Mr. William L. Brudon and
change in the anteroposterior position of this bone was noted. Mr. Eugene E. Leppanen.
Summary
REFERENCES
Much less skeletal change was observed in this patient 1. Fr;inkel R: Technik und Handhabung der Funktionsregler VEB
than in the patients in Cases I and II. The maxilla moved Verlag Volk und Gesundheit, Berlin, 1976.
downward and forward; the mandible was redirectedin a more 2. Frankel R: Biomechanical aspects of the form/function relation-
inferior direction. The major dental change appears to have ship in craniofacial morphogenesis: A clinicians approach. In
been caused, at least in part, by a downward and forward McNama.ra JA Jr, Ribbens KA, Howe RP (editors): Clinical
alterations of the growing face, Monograph 14, Craniofacial
movement of the upper dentition.
Growth Series, Ann Arbor, 1983, Center for Human Growth
and Development, The University of Michigan.
SUMMARY AND CONCLUSIONS
3. Frtikel R: Maxillary retrusion in Class III and treatment with
The purpose of this article has been to describe the the function corrector III. Trans Eur Orthod Sot 46: 249-259,
clinical use of the FR-3 appliance of Frtinkel, which 1970.
4. Eirew HL, McDowell F, Phillips JG: The functional regulator
has classically been used in cases of Class III maloc-
of Fr;inkel. Br J Otthod 3: 67-74, 1976.
clusion. The parts of the appliance have been described 5. Petit H: Adaptations following accelerated facial-mask therapy.
as have the method of impression taking, bite registra- In McNamara JA Jr, Ribbens KA, Howe RP (editors): Clinical
tion, construction, and appliance delivery. alterations of the growing face, Monograph 14, Craniofacial
The three case reports, each of which demonstrated Growth Series, Ann Arbor, 1983, Center for Human Growth
and Development, The University of Michigan.
a slightly different morphologic type, indicate that this
6. Eirew HL: Personal communication, 1984.
appliance has a different effect on the growing cranio- 7. McNamara JA Jr, Huge SA: The Frlnkel appliance Fr-2: Model
facial skeleton. The two common findings that were preparation and appliance construction. AM J ORWO~ 80: 478-
observed in all three patients were the forward move- 495, 1981.
ment of the maxillary dentition and the redirection of 8. Harvold EP: The activator in interceptive orthodontics. The
C. V. Mosby Company, St. Louis, 1974.
mandibular growth in a vertical direction. Variable re-
9. McNamara JA Jr: The Frtiel appliance: Clinical management.
sponses in the maxilla were noted. J Clin Orthod 16: 390-407, 1982.
Before any precise statement can be made regarding 10. McNamara JA Jr: A method of cephalometric evaluation. AM J
the mechanism of action of the Frgnkel FR-3 appliance, ORTHOD 86: 449-469, 1984.
appropriate prospective clinical trials must be carried 11. Ricketts RM: The influence of orthodontic treatment on facial
growth and development. Angle Orthod 30: 103-133, 1960.
out in Class III patients presenting with a wide variety
of morphologic types. Reprint requests to:
Dr. James A. McNamara
The authors wish to acknowledge the help provided by Department of Orthodontics
Professor Dr. Rolf Ft%nkel in the preparation of this manu- School of Dentistry
script. We also thank Dr. Raymond P. Howe and Dr. Hans The University of Michigan
L. Eirew for their critical review and helpful suggestions. Ann Arbor, Ml 48109