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REMOVABLE FUNCTIONAL APPLIANCES II FRANKEL FUNCTIONAL REGULATOR

Guide Dr. (Mrs.) Chandralekha B Prof & HOD Dept. Of Orthodontics Vydehi Institute Of Dental Sciences & Research Center
By Dr. Nilofer PG Student Dept. Of Orthodontics VIDS & RC

FRANKEL FUNCTIONAL REGULATOR

FRANKEL FUNCTIONAL REGULATOR

Among all the Other European Orthodontists No one else had a greater impact on the American Orthodontist as Rolf Frankel.

FRANKEL APPLIANCE
Developed by Rolf Frankel of East Germany 1966.
Sometimes also referred to as the Deficiency appliance. Muscle training appliance. The Frankel Device is an Exercise device,stimulating normal function while eliminating the Lip Trap,hyperactive Mentalis and Aberrant Buccinator and Orbicularis Oris action.

The action of Frankel Regulator is intended to change or regulate the muscular environment of the face and teeth to stretch facial musculature to normal dimension, impede abnormal activity of the lips, tongue and cheeks and thus allow development of the jaws and teeth in all three planes. This Functional appliance which is passive in itself plays a mediating role between the orofacial muscles and skeletal-dentoalveolar structures of the maxillae and mandible.

Indications
Patients with Anteriorly Rotating Growth Patterns. Functional Retrusion. Deep Overbite. Excessive inter- occlusal clearance Normally positioned maxillas Are GOOD Candidates PROGNOSIS BETTER IF END TO END CUSPAL RELATIONSHIP PRESENT.

Frankel believes that the active muscle and tissue (buccinator mechanism and orbicularis oris complex) has a potential restraining effect on the outward development of the dental arches, that prevents full accomplishment of the optimal growth and developmental pattern.
The Buccal Shields and Lip Pads hold the buccal and labial musculature away from the teeth and investing tissues, eliminating any possible restrictive influences from this functional matrix.

Frankel conceives his vestibular constructions as an artificial ought-to-be matrix that allows the muscles to exercise and adapt unlike the other appliance which lay stress on the push out from within action. Therefore they say The Frankel appliance is an exercise device, stimulating normal function, while eliminating the lip trap, hyperactive mentalis, and aberrant buccinator and orbicularis oris action.

If the buccinator mechanism pressures are

screened from the dentition, significant expansion in the critical inter canine dimension. Then due to the safety valve mechanism there is considerable transverse growth of the mandible as well relieving crowding. The beauty of this is that the appliance does not even touch the affected teeth.

Frankel never ignored the tongue but felt that

undue stress had been given to the tongue at the expense of the Buccal musculature. According to Frankel much of the tongue function may be compensatory or adaptive dentoalveolar morphology & not necessarily the primary cause of Malocclusion.

The FR buccal shield prevents the pressure

from the buccinator mechanism from being exerted on the dentoalveolar area both during deglutition and at rest. Hence the 24 hr wear time given.

Frankel (& like wise Bjork ) criticised the bulk

of the Activator appliance and found the inadvertent tipping of lower incisors unnecessary. The loose fitting Activator appliance during sleep would contact the lower incisors hence pushing them forward so Frankel avoided this completely by impeding all tooth contacts in the lower arch. The design and construction of the vestibular acrylic and wire configuration augment the proprioceptive trigger by the lingual pads to maintain forward positioning.

Appliance design
The 4 basic variations of the appliance by Rolf and Christine Frankel (1989) : FR I a- Class I deep bite cases b- Class II div 1 cases- overjet <7mm c- Class II div 1 cases- overjet >7mm FR II- Class II division 1,Class II division 2 FR III- Class III cases FR IV- Open bite cases

BASIC PARTS OF A FRANKEL APPLIANCE


Lingual wire loops/ Lingual pads. Buccal Shields. Maxillary Labial Wire. Maxillary Canine Clasp. Palatal Wire. Maxillary Molar Occlusal Rest.

MODE OF ACTION OF THE MAIN PARTS

1.

BUCCAL SHIELDS
During Deglutition

Anterior lip seal + Posterior oral seal Negative atmospheric pressure within oral cavity Cheeks sucked into interocclusal space as mandible returns into postural rest position Constricting influence on the dentoalveolar process and prevention of eruption of buccal segments

Thus Shields Prevent The Pressure Of The Buccinator On The Dentoalveolar Area During Deglutition And At Rest, Inducing Downward And Outward Movement Of Teeth And Tissues.

Buccal Shields Also Cause Periosteal Pull


Shields and pads can be extended into the depth of the vestibule Tension without creating irritation Pull on the contiguous periosteal tissue of the maxillary bone Increased bone activity in contiguous osseous structure Maxillary basal bone is widened Alveolar shell over the erupting teeth proliferates laterally.

A research project on primates at the

American Dental Association Research Institute by Graber et al (1988) confirm these findings.

2. Lingual shields:
Lingual shields that contact only the lingual & gingival mucosa pressure sensation as the mandible falls back activates proprioceptors in the gingiva, which are signaled to maintain the forward posture, to eliminate the painful input. Thus trains protractor muscles.

Lingual shields train protractor muscles:


Training of protractor muscles : induces an alteration of the postural position of the mandible. This is accomplished through a construction bite, which permits the protractor muscles to physiologically position the mandible forward. The appliance acts as an exercise device inducing changes in the postural performance of the protractors of the mandible.

MODE OF ACTION

Condylar growth stimulation:

There are two views here :


Optimal prechondroblastic activity in the condyle due to anterior repositioning of mandible.

[Thus at the right age, condylar growth can be successfully stimulated (Frankel AJO 1969, EJO 1969)].
Others state that the changes seen may be no more than might be expected with normal growth or conventional edgewise treatment. (Robertson; AJO 1983) ,Gianelly; Angle O. 1983) ,Gianelly; AJO 1984)

Condylar growth stimulation:

Hamilton & Sinclair (AJO 1987) in a cephalometric, tomographic and dental cast evaluation of 25 patients treated with Frankel therapy reported that treatment results were primarily dental, with little skeletal or condylar alteration.

The dentoalveolar changes are explained by Frankel (AJO 1989) who states that during sleeping hours, the suspending muscles relax. The mandible drops inferiorly and slides backwards. Thus the maxillary incisor could come into active contact with the maxillary labial bow, and the mandibular incisors were likely to contact the lingual shield or wires attached to it. Thus leading to undesirable maxillary incisor retraction and lower incisor proclination. For this reason, he proposes that during a break-in period of approximately 2-3 months, the appliance should be worn during the daytime only.

LPM
Bilateral Fore Shortening Of The Lateral

Pterygoid Muscle: The Mandible is held forward by the protracting muscles and not holding the appliance itself.

Restraining effect on maxillary teeth and arch:


The FR is anchored to the maxillary dental arch in a positive manner. This is achieved in the mixed dentition

through wires between the contacts at the mesial of the permanent maxillary first molars and the distal of the deciduous maxillary canines.

Maxillary molars are prevented from downward and forward movement by the appliance.
Freeing the lower posterior teeth from acrylic or wire restraints while holding the bite open allows the unrestricted upward and forward movement of these teeth, contributing to both vertical and horizontal correction of the malocclusion.

Graber (1993) has shown that in selected cases, the FR actually has a headgear effect, holding back the maxillas downward and forward progression. The Headgear effect has been explained by Owen (AJO 1981) as follows : 1. As the patient sleeps, muscles attempt to return to their resting length. 2. The protractors (lateral pterygoid) allow the retractors (posterior temporalis) to retract the mandible to its normal resting position. 3. This retracting pressure is transmitted to the maxilla through the appliance and result is similar to headgear traction.

FR-1:
It was developed by Frankel in 1967. Its method of action is based on orthopaedic principles that consider muscle exercise as an important factor in bone development( Bishara, Ziaja 1989). It differs from other functional appliances by protruding the mandible, ideally without contacting any mandibular teeth, and by causing an increase in both apical bases and maxillary and mandibular arch widths.

FR Ia- Frankel recommends its use for Class I deep bite cases with protruded maxillary and retruded mandibular incisors. The maxillary canine loops project from the lingual part of the shield into the caninedeciduous first molar embrasure, wrapping around the lingual of the canines and terminating on their labial surface.

These Lingual Loops 1. Assist in anchoring the appliance on the maxilla. 2. Guiding the eruption of the canines into place. 3. They also exert mild distal pressure on the deciduous first molars to prevent these teeth from coming forward FR 1a Also has a lingual bow with U loops that extend to the floor of the mouth to fit against the lingual tissue below the incisors. These are generally passive in rare cases where proclination is desired it can be Activated.

The buccal shields, the lip pads work by

eliminating abnormal perioral muscle activity, particularly of the hyperactive and potentially deforming mentalis muscle.
To stabilise the entire appliance there are

cross palatal coffin spring, cross- occlusal wires assisted further by a Passive Labial Bow in the maxilla.

FR 1b: The FR Ib has largely


replaced the FR Ia .The lingual acrylic pad replaces the lingual bow with U loop as seen in FR1a . Instead of a single wire crossing the lingual surfaces of the lower incisors, two passive recurved springs rest gently above the cingula made with 0.8-mm (0.028inch) wire.

Lower labial wires: These 0.9.mm wires serve as the skeleton for the lower lip pads. Frankel prefers three wires for this unit: 2 Lateral wires 1 middle wire Lateral wires emerge from the buccal shields in a slightly inferior direction about 7mm from the gingival margin and follows the contour of the mucosa about 1mm away and around to the lateral incisor embrasure. Middle wire is bent in the shape of an inverted V to prevent impingement on the labial muscle attachment.

Palatal Bow: The1mm thick palatal bow has a slightly posterior curve which provides an extra length of wire to facilitate adjustment for slight lateral expansion.
This is necessary if the alveolodental area develops transversely and begins to contact the buccal shield. The wire makes a loop in the buccal shield and emerges to lie between the maxillary first molar buccal cusps, ending in the fossa as occlusal rests.

Maxillary Labial Bow: The O.9mm maxillary labial bow lies in the middle of the labial surfaces of the incisors and then curves gently toward the sulcus between the canine and lateral incisors crossing the middle third of the canine root 2mm from the mucosal surface. This configuration allows eruption and expansion. It does not cause lingual tipping of the maxillary incisors as the appliance will unseat and the appliance will loose its maximum effectiveness.

Canine Loops: the loops wrap


around the lingual surfaces of the canines and emerge labially at the embrasures, curving distally over the canine-lateral incisor embrasures, curving distally over the canine cusps.

The lingual lip pads wire extends into the buccal shields with care being taken not to touch the

occlusal surfaces when the appliance is fully seated.


Frankel Suggests the use of this appliance in Class II, division I malocclusions with deep bite and an overjet that does not exceed 7 mm.
Construction is simpler than it is for the 1a, and patients generally become accustomed to the lingual acrylic pad more easily than they do to

the U-loops

Separation
Heavy elastic separators are placed. These are placed 5-7 days in advance of the

impression. In mixed dentition slicing of the upper deciduous second molars distal surface and the mesial marginal ridge of the deciduous upper first molars to ensure proper locking of the appliance on the maxilla in the critical period of initial adjustment.

Impression
Impressions for any functional appliance critical.

Full depth impressions have to be made. Should

reproduce the whole alveolar process to the depths of the sulcus including the maxillary tuberosities.

The consistency of.the impression material should allow for a good but thin peripheral roll, displacing the tissue gently and reproducing the muscle attachments.

Rimming the tray suggested.

Construction Bite:
The balance between protractor and

retractor muscles must not be disturbed. The principle guideline is the VTO test conducted during clinical evaluation. The mandible may be moved to an edge to edge incisal relationship if the overjet is less than 5mm.

If an end to end relationship or not more than

6mm advancement used, the incisal contact determines the vertical opening. A clearance of at least 2.5-3.5 mm in the buccal segments is necessary. However this is not done and 6mm advancement would be done in 2 stages.

For minor sagittal problems (2-4 mm)

construction bite in an end-to-end incisal relationship. For larger sagittal movement Step-bystep activation produces a better and more continuous tissue reaction and better patient acceptance. Frankel recommends that the construction bite not move the mandible farther forward than 2.5 3 mm. Vertical opening : should be only large enough to allow the crossover wires through the interocclusal space without contacting the teeth

Care should be taken not to strain the

muscles. The correct procedure would be to ask the patient to hold out the mandible in the corrected position with the midlines coinciding for 3-5 min and repeating the manouvre.

The fact that the Frankel Appliance has to

have minimum vertical opening under any circumstances is considered as a limitation by many as compared to other appliances where bite opening can be done to best utilize the other directions of growth as well.

Once bite confirmed the separators placed

again and sent home.

Trimming Of The Cast


Trimming has to be done for the lip pads and buccal shields.

The sulcus width should be 5 mm.


For Lip Pads 5mm carved out

Pear shaped carbide burs used. Alveolar surface flat post carving. The lower relief should be 12 cm from gingival margin.

Buccal Shields :

The sulcular depth must be 10-12 mm The areas of muscular attachments must be well defined.
Trimming of the lower buccal vestibular sulcus not required.

Seating Grooves

Should be deep. 1.5 mm wide. Final Trimming Wax construction bites placed back and trimmed at the back so that the plains are flush with wax. Easier for technician to re-orient.

Wax relief
Outline. Buccal surface covered with layers of wax. Thickness decided by amount of relief

needed. Wax relief most important in the region of deciduous maxillary first molars. Lower arch requires thin layer.

Wire Forming
Palatal Bow : o.040inch (1mm) Occlusal Rests : 0.51 inch Tooth moving wire ( rare ) o.o28 inch Lower Labial Wires o.036inch (0.9mm ) Lower lingual Support wire : 0.051 inch

Maxillary Labial Bow : o.9 mm Canine Loops : 0.036 inch (O.9 mm) Lower Lingual Springs : o.028 inch (0.8mm ) To prevent bulkiness Wire bends should not

be embedded in the wax neither should they be more than 1mm away.

Acrylisation
Cold Cure Various Procedures. Sealing Generally Salt And Pepper Technique. Imprinting Polishing

FR 1c:
Used for more severe Class II, division 1 malocclusion in patients with overjets more than 7 mm and sagittal dysplasia that exceeds an end to end cuspal relationship The buccal shields are split horizontally and vertically into two parts. The anteroinferior portion contains the wire for the lingual acrylic pressure pad and lower lip pads. It eliminates the need for a new appliance when advancement is done step by step.

Vertical split is pried open with an office knife to the desired position by a 2-3mm advancement and filled with cold cure acrylic and polished.
Also because of the farther mandibular advancement, the posteroinferior buccal shield may irritate the sulcus and requires trimming. This is seldom used now as the FR1b and FRII can be modified the same way with horizontal and vertical cuts

FRII: Pre Frankel Appliance Fixed Or Removable Mechanotherapy.


Frankel has used the FR II mostly for Class II division 2 malocclusions. More and more of his disciples are using it for Class II division 1 patients .
Routine alignment of maxillary anterior teeth in Class II division 2 malocclusion is suggested before FRII placement. Also mild expansion prior to Frankels has found to be of great use.

One third to one half of all Class II patients

require such fixed mechanotherapy for the maxillary anterior segment.


80 to 90% of all Frankel appliances now being made in the United States are the FR II type. This is because some clinicians report that the

FRI canine loop can interfere with the eruption of permanent canines.

Class II malocclusion with FR II therapy have variously demonstrated greater mandibular growth development, an absence of maxillary growth changes, an increase in lower facial height, palatal tipping of the maxillary incisors, labial tipping of the mandibular incisors and a greater vertical development of the mandibular molars compared with the control samples ( Frankel 1989, McNamara 1985, Falck 1990) Additionally, statistically significant increase in mandibular intercanine and mandibular and maxillary intermolar distances have been reported. (Hamilton et al 1987)

Modified wire elements: Lingual Bow: Originally called the Protraction Bow It is made of a 0.8mm gauge which lies behind the maxillary incisors. This serves to maintain the prefunctional alignment and stabilizes the appliance as it helps to lock the maxillary arch. It relatively depresses the maxillary anterior segment. The major reason for failure of FR therapy is the lack of a positive maxillary stabilization of the appliance.

The wire forms loops that approximate the palatal mucosa and recurve vertically to contact the incisors at the caninelateral incisor embrasure and then follows the lingual contours of the maxillary incisors. Also additional support to the cross over wire.

It has a mild retrusive effect on the maxilla

along with this the lingual stabilizing wire

has the desirable effect of preventing lingual tipping of the maxillary incisors.
The Lingual Stabilizing wire passes through

the previously notched canine deciduous first molar embrasure.


It forms loops which recurve and incisors at canine lateral incisor embrasure and then rests above the cingulum area..

Canine loops:
They originate from the buccal shield and contact the canine on the buccal surface only as a recurved loop. These 0.8mm loops actually serve as extensions of the buccal shields in the canine area, which is narrowed most by the abnormal perioral muscle function associated with malocclusion so it is placed 2 3 mm away from the deciduous canines eliminating the restrictive muscle function and permiting the needed width development.

Buccal shields: need not stand away from the alveolar mucosa in the vestibule due to broad dental arch in classIIdiv2.
Lip pads are well rounded and polished to prevent mucosal irritation due to strong mentalis activity. Since the need for Bite opening is greater in Div II cases FR II can and must be used for selective eruption of lower buccal segments.

Deep Class I cases Or Class II Div 2 with deep

overbite and infra-occlusion of lower posterior segments , with adequate lip length the vertical dimension can be opened to a greater degree without endangering lip seal.
Especially in anteriorly rotating growth

pattern this tends to open the bite and direct mandibular growth pattern in a more vertical direction.

Experienced clinicians have tried to incorporate extra oral force at night. Buccal tubes can be placed in the buccal shields at the deciduous 2nd molar area. Before going to bed the patient can place a face bow with light force to enhance maxillary retraction potential where needed. (Headgear effect).

Rushforth, Gordon, Arid BJO 1999 did a retrospective study on 63 class II division 1 patients treated with FRII and 39 controls and found out that majority of the correction came from dental movements
The most significant being retroclination of the upper incisor teeth(4.1mm) and proclination of the lowers(2.2mm). The skeletal effects were restraint of normal maxillary growth (-0.2mm) with forward mandibular growth that was not significant.

Janson, Toruno,martins EJO 2003


Class II treatment effect of the frankel appliance evaluated the effects of FRII on dentoskeletal components during a treatment period of 28months on 18 patients, 9years 3months age with Class II div 1 malocclusion.
The results demonstrated that the FRII produced an Increase in body length.

Statistically significant increase in the mandibular body compared to the maxilla.


Increase in lower face height which induced greater vertical development of the mandibular molars, reduced the overjet and overbite and produced an improvement in the molar relation.

Retrusion and palatal tipping of the maxillary incisors were also observed. However the appliance did not produce any changes in maxillary development, in the growth pattern or any improvement in the basal relationship.
Showing primarily dentoalveolar changes with a small participation of skeletal changes.

FR III:
Because successful treatment of early correctional Class III malocclusion is more likely with combination protraction retraction extraoral force, the FR III, or any functional appliance is not usually the appliance of choice. The lip pads are situated in the labial vestibular sulcus of the upper incisor segment, instead of the lower . The pads stand away from the mucosa and underlying alveolar bone in the same manner as with the FR II.

The purposes of the lip pads are threefold:


(1) to eliminate the restrictive pressure of the upper lip on the underdeveloped maxilla. (2) to exert tension on the tissue and periosteal attachments in the depth of the maxillary sulcus for stimulation of bone growth. (3) to transmit upper-lip force to the mandible via the lower labial arch for a retrusive stimulus.

Supporting framework 0.040 inch Gives minimal forces and works more on

the basis of a negative feedback signalto false anterior positioning.

The labial bow rests against the mandibular teeth and not the maxillary incisors. Makes a positive contact with the tissues. It should cross the lower incisors at the lowest possible level, without impinging on the interproximal soft tissue, to keep lingual tipping of the lower incisors to a minimum. .

The Protrusion Bow: It is similar to that of the FR II, passing behind the upper incisors to stimulate slight to moderate forward movement of these teeth by contacting just above the cingula of the maxillary incisors.
Contacting the distal surfaces of the terminal molars on the tuberosities.

The Palatal Bow

Similar to FR II except that the ends of the bow pass distal to the Permanent first molar instead of mesial . This gives an added anterior stimulus for the maxillary growth.

The FR III is not locked on the maxilla by the crosswires from the protrusion bow and palatal bow. However, the close adherence of the buccal shields and lower Iabial wire to the mandibular basal bone and lower incisors give a firm grip on the mandibular dentoalveolar structures.
The occlusal rests are on the mandibular first molar instead of the maxillary molar.

The mandibular molars are prevented from erupting upward and forward.
Where as the maxillary buccal segment is free to erupt down and forward, reducing the Class III relationship. The rests thus enhance the mandibular anchorage of the FR III.

Any constricting or deforming effect of the buccinator mechanism and orbicularis is screened from the maxillary arch and supporting bone to correct the anterior and buccal crossbite by the buccal shields. The approximation of the buccal shields to the mandibular arch has a constricting effect on the mandibular dentition.
The adapted labial wire increases this effect. The shields and lip pads theoretically exert outward pull or tension on the maxillary periosteum at the height of the vestibule.

Construction Bite:
The construction bite procedure involves clinically retruding the mandible as much as possible, with the condyle occupying the most posterior position in the fossa. The vertical dimension is opened only enough to allow the maxillary incisors to move labially past the mandibular incisors for crossbite correction. The bite opening is kept to a minimum to allow lip closure with minimal strain. Bite opening kept to a minimum to allow lip closure with minimum strain.

To Obtain Maximum condylar posterior

position, the patients mandible is gently tapped with fleed knuckles of the dominant hand while the patient opens the bite approximately 1 cm.
The clinician continues tapping gently and

then asks to close his mouth gently.


And then final pressure is applied by pressing

the thumb gently against the chin with the fore finger beneath it.

Before the final registration the mandible

must be held in that position for 1-2min So that the proprioceptive learning process and feedback will strong enough to overcome the natural tendency to protrude the mandible when biting into the wax.

Since it is the registration of a terminal

position it is easier to take this for a patient rather than the Class II construction bite.

Deep bite problems require a wider opening of the vertical dimension for the construction bite

and is done so the appliance can be fabricated to stimulate posterior eruption of the maxillary teeth. If the need for vertical development is minimal, the occlusal rests are sufficient to keep the mandibular teeth from erupting whereas the maxillary teeth are free to move downward and forward correcting the sagittal discrepancy.

When the maxillary incisors are well over their mandibular counterparts, the protrusion bow can be removed to prevent any possible interference with maxillary incisor eruption.
The occlusal rests on the mandibular molars should be left intact, however so the posterior openbite that is usually produced by the sagittal correction closes by virtue of the downward and forward eruption of unimpeded maxillary teeth.

Separating elastics and notching is not

necessary for the Fr III because the appliance is stabilised on the Mandible by : The Buccal shields The Labial Wire. Occlusal Rests. Acrylic Cover (+/-)

Fabrication Procedure
Working Model Pour Up & Trimming. Wax Relief 3mm Wire Forming :

Mandibular labial bow and Palatal Bow 1mm ,0.40 inch SS Wire Maxillary Protrusion Bow 0.06 or 0.07 mm wire Others in o.9 mm

Lower labial bow : Shallow groove carved out

for better fit.


Acrylisation. Frankel considers the maxillary extension

most important believing that it pulls the septomaxillary ligament(Latham Johnston Delaire)..causing bone depostion, relief.

FR IV:
It is truly a functional appliance with evidence of significant basal bone change developed after specific case selections . Aberrant muscle activity can create open-bite problems and redirect growth in a more vertical direction. Because the FR IV reverses the unaffected growth guidance, it must be used during an active growth period. Again the mixed dentition is ideal for its influence, with a longer period of wear usually needed, into the permanent dentition.

LIP SEAL EXCERCISES FORM THE CRUX OF THE FR IV

Configuration: similar to the FR I and II, but it

has no canine loops or protrusion bow. Four occlusal rest on the maxillary permanent first molars and deciduous first molars prevent tipping of the appliance. The rests discourage eruption of posterior teeth which is a vital requisite for anterior open bite conditions.

Palatal bow resembles that of the FR III and is placed always behind the last molar.

The occlusal rests should not prevent movement of the appliance in a posterior direction so In effect the Fr IV is not locked anywhere. Occasionally a thin acrylic wafer is interposed between the upper and lower buccal segments to enhance depressing force on the buccal segment, but the wafer cannot be too thick, otherwise lip closure becomes more difficult.

Without the exercises the appliance is

doomed to failure. A number of operators use the FR IV with vertical extraoral force-chincap therapy, which also helps close down the bite by virtue of a positive depressing action on the buccal segments.

Kraus suggested a modification of this appliance by incorporating tongue crib spurs to discourage anterior tongue posture and compensatory tongue function.

Clinical management of the Frankel appliance: High amount of Clinical Precision. Tissue impingement is the most frequently encountered problem with initial appliance placement,and the areas of greatest concern are the buccal frenula and inferior margins of the lip pads. The anterosuperior periphery of the buccal shields over the maxillary canines is the next most likely area of irritation. Peripheral margins can be reduced and polished the same way as for overextension of the lip pads and shields. Tissue redness around the periphery of shields and pads that are properly extended is a normal consequence of proper fit and good patient cooperation. The clinician, must he careful not to cut away too much acrylic during the first visit.

First appointment :

Check Separators. At delivery Check for fit and seating. Stabilizing on the maxilla absolutely essential Margins checked for smoothness. No Blanching of tissues. Sufficient relief at lip and buccal pad areas

Peripheral portion should contact sulcular tissue. Buccal frenula and inferior margins of the lip pads are specifically checked. Lip pads must be vertical so as to not touch any tissue during insertion or removal. Lip seal regimen explained Asked to put a thin piece of paper between lips Initially part time wear once accustomed full time.

Tissue redness around the periphery of shields and pads that are properly extended is a normal consequence of proper fit and good patient cooperation. The clinician, must be careful not to cut away too much acrylic during the first visit. During the first couple of weeks( 2weeks), the FR I and II are worn during the day only for 2 to 4 hours to allow the soft tissues and muscles to adjust to the" foreign body." An astringent mouthwash, warm saline rinses, benzocaine, or Orabase can help control the abrasion and inflammation. Patient warned of possible tissue irritation within the first 2 weeks.

Second visit: daytime wear extends to 4-6 hours and speaking exercise should begin. During the third appointment. After it has been determined that stabilization is good and tissues are not irritated, exercises may be prescribed in addition to the lip-seal regimen. Grasping the appliance inside the mouth The average patient needs about 2 months before the FR I or II is worn all night. Patients adjust more easily to the FR III, however, the appliance can usually be worn all the time after the first 2 weeks.

Finally once settled appointments at 4 weeks interval given.

Results
Can be seen in 3 months of full time wear. Lateral open bite may develop. 6 months to correct a cusp to cusp

relationship. Full distal relationship 9-12 months

Treatment Time:
The choice of the optimal time for Class II treatment varies but a good indication of readiness is eruption of the four upper and lower incisors, which can happen as early as7 years but is more likely at 8 to 9 years of age Treatment for ClassIII and open-bite cases should usually start sooner than for Class II problems. This means immediaely after eruption of the permanent first molars. Frankel believes that if treatment is started during the permanent dentition, a retention phase of 2 to 3 years is needed. A long retention period is indicated especially in Class II, division 2, ClassIII and open-bite problems.

Summary of Frankel Appliance Effects :

1. Arch expansion 2. Condylar growth 3. Guidance of eruption 4. Headgear effect

Ghafari, Shofer,Hunt, Markowitz, laster Ajo 1998 Head gear versus function regulator in the early treatment of Class II division1 Malocclusion

conducted a prospective randomized clinical trial to evaluate the early treatment of Class II division 1malocclusion in prepubertal children. Facial and occlusal changes after treatment either with a headgear or a frankel functional regulator were reported. Molar and canine relation, overjet, intermolar and intercanine distances were measured from casts taken every 2months. Results indicated that both the Headgear and functional regulator were effective in correcting malocclusion but the treatment effects as well as skeletal and occlusal responses differ. This finding suggests that timing of treatment in developing malocclusions may be optimal in the late mixed dentition thus avoiding a retention phase before a later stage of orthodontic treatment with fixed appliances.

Kerr, Tenhave and McNamara,Ajo 1998 Compared the skeletal and dental changes produced by function Regulators ( FR-2 and FR -3) and took lateral cephalograms of 99 subjects treated with FR2 and 30 with FR3 and reported that the FR 2 group showed a significantly greater annual increase in total length and ramus height, compared to the FR3 group which showed a significant change in position downward and backward facilitated by an opening of the cranial base angle. The greater annual increase in lower facial height compared with a control group in both FR groups was accompanied by a reduction in overbite which was greater in the FR2 group. The favourable changes in overjet seen in both FR groups was contributed to by alteration in Upper and lower incisor angulation.

Colin Nelson, Michael Harkness, Peter Herbison AJODO1993 Tried to determine the changes in position and size of the mandible in children treated with or without the frankel functional regulator on 42 ,10- 13 year old children with classIIdiv1 malocclusions. They reported vertical development of the mandibular molars and increase in the height of the face.
But there was no evidence to support the view that the appliance was capable of altering the size of the mandible.

Neilsen AJO 1984, reported that the maxilla generally becomes more retrognathic during treatment and showed backward rotation and posterior displacement in some patients. Marked individual variations were seen in the mandible. No indications were found that the FRII promoted forward growth of the mandible. The improvement in dental occlusion was primarily due to changes in the vertical relationship between the jaws

Creekmore , Radney AJO 1983,evaluated 9 classI, and 11 classII patients treated with Frankel appliance therapy and were compared to 30 females and 32 males who were in the Control group.

Results: (1)increase in mandibular length of 1.1 mm. as a result of an increased backward direction of condylar growth; (2) increase in lower face height; (3) decrease in forward growth of the maxilla; (4) retraction and elongation of maxillary incisors; (5) retraction of maxillary molars; (6) protraction of mandibular incisors; and (7) increased vertical height of mandibular molars.

The same FR treated group was then treated with 32 females and 18males(25class1 and 25class) treated with edgewiswe therapy for 2years and 5months
(1) edgewise therapy had a greater retractive influence on the maxilla; (2) edgewise therapy also produced a similar backward direction of condylar growth but 1.2 mm. Iess than the Class ll Frnkel group; (3) maxillary incisors were retracted more with no elongation; (4) mandibular incisors were retracted rather than protracted; (5) pogonion came forward 1 mm Iess than in the Frnkel group.

Owen AJO 1983: Fifty patients treated with the Frnkel appliance.The ages ranged from 5.9 to 13.8 years, with the average age 9.6 years (1.54). Twenty-nine patients were girls and twenty-one were boys for 5 years The Angle molar relationships were distributed as follows: Class I-21 patients; Class II-27 patients; and Class III-2 patients. All patients were selected for treatment on the basis of the presence of crowding, excessive overjet or overbite, or excessive open-bite. Frontal cephalograms of the patients were taken before treatment and after treatment. The following measurements were taken and superimposed 1)nasal cavity width,2) maxillary width, 3)mandibular width, 4)intercanine width, and 5) intermolar width.

Results: Increases in the nasal cavity(0.5mm/year), maxillary width(0.8mm/Year), and mandibular width(1.25mm/year), Dental width: intercanine width(2.4mm) and intermolar width(1.8mm) increased. The increase in nasal cavity width may be the result of a conscientious attempt to gain a consistent oral seal and possibly to breathe more through the nose than prior to treatment. The maxillary width increase may be the result of the tension produced by the vestibular shields, as suggested by Frnkel. The mandibular width increase could be due to relaxation of the buccinator and circumoral muscles ,supported by Freeland 1979. Conclusion:The incidence of extraction could be reduced if expansion with frankel appliance is significant and stable, though extraction is necessary for some patients.

Hime, Owen, AJO 1990 studied 11 cases that were treated with frankel appliance therapy which were then observed for 4years and 4months. Results: Intercanine width, width of first premolar, width of second premolar and intermolar width all demonstrated maintenance of treatment increases, which supports the statement of Frankel concerning the stability of arch expansion. In this study, the arch expansion was more stable than after fixed appliance treatment.

Franco, Yamashita, lederman, Proffit, Vigorito AJODO 2002(MRI study) assessed the effect of FRII treatment on the position and shape of the articular disc of the temporomandibular joint at T1 and after 18+/-1month(T2) on 56 Brazilian children with class IIdiv1 malocclusion who were begining their pubertal growth spurt. They were then grouped into the treatment and control groups.
Results: showed that at T2 the articular disc morphology of the control group was unchanged but that of the treated group was significantly more normal progressing from nonbiconcave at T1 (10.7%) to biconcave at T2(100%).So it was concluded that disc displacement is not a complication of functional appliance therapy;infact, such treatment might help some children with incipient temporomandibular

Miethke RR, Lindenau S, Dietrich K Ejo2003:

Aim:To demonstrate the changes in the dental arch and the apical base of both jaws following therapy with Frankel's function regulator type III (FR III). Material and Methods:42 Class III patients (28 females, 14 males, mean age 7.5 years) were selected. The control group consisted of 16 patients (eight females, eight males, mean age 8.3 years) with minor malocclusion symptoms. Study models of all patients at the beginning and end of treatment were evaluated

apical bases of the maxilla and mandible were recorded to facilitate a comprehensive evaluation of treatment effects. Results: 1.The FR III stimulated the development of the maxilla, thus resulting in a more physiological growth pattern. 2.Mandibular prognathism, however, was still discernible after therapy in the Class III patients, even though mandibular growth did not differ significantly between the two groups.

Baik HS, Jee SH, Lee KJ, Oh TK.Ajo 2004

Aim:To evaluate the skeletal and dental effects produced by the Frankel functional regulator III appliance in growing children with Class III malocclusions. Subjects and method:30 preadolescents (mean age, 8.0 +/- 1.2 years; mean treatment duration, 1.3 +/- 0.6 years) treated with the Frankel functional regulator III appliance were compared with 20 matched untreated Class III controls ( mean age 8.2 +/- 1.1 yrs; mean observation period, 1.5 +/- 0.6 yrs). The treatment effects were mainly backward and downward rotation of the mandible and linguoversion of the mandibular incisors

REFERENCES: 1.Miethke RR, Lindenau S, Dietrich k: The effect of Frankel's function regulator type III on the apical base. EJO 2003 June page 311-318 . 2. Baik HS, Jee SH, Lee KJ: Treatment effects of Frankel functional regulator III in children with class III malocclusions. Am J Orthod Dentofacial Orthop. 2004 Mar;125(3):294-301.

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6. Webster T, Harkness M, Herbison P.: Associations between changes in selected facial dimensions and the outcome of orthodontic treatment.Am J Orthod Dentofacial Orthop. 1996 Jul;110(1):46-53
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9.Lestrel PE, Kerr WJ: Quantification of function regulator therapy using elliptical Fourier functions. Eur J Orthod. 1993 Dec;15(6):481-91.
10. Nelson C, Harkness M, Herbison P: Mandibular changes during functional appliance treatment. Am J Orthod Dentofacial Orthop. 1993 Aug;104(2):153-61 11. McNamara JA Jr, Huge SA: The functional regulator (FR-3) of Frankel.Am J Orthod. 1985 Nov;88(5):409-24.

12. McNamara JA Jr, Bookstein FL, Shaughnessy TG: Skeletal and dental changes following functional regulator therapy on class II patients. Am J Orthod. 1985 Aug;88(2):91-110. 13. McNamara JA Jr : Dentofacial adaptations in adult patients following functional regulator therapy.Am J Orthod. 1984 Jan;85(1):57-71 14. Owen AH 3rd: Morphologic changes in the transverse dimension using the Frankel appliance.Am J Orthod. 1983 Mar;83(3):200-17.

15. Franco AA, Yamashita HK, Lederman HM, Cevidanes LH, Proffit WR, Vigorito JW: Frankel appliance therapy and the temporomandibular disc: a prospective magnetic resonance imaging study. Am J Orthod Dentofacial Orthop. 2002 May;121(5):447-57 16. Chadwick SM, Aird JC, Taylor PJ, Bearn DR.: Functional regulator treatment of Class II division 1 malocclusions. Eur J Orthod. 2001 Oct;23(5):495-505. 17. Hime,Albert,Owen:The stability of the arch expansion effects apppliane therapy,AJO 1990 page437-445

18. Moore RN, Igel KA, Boice PA: Vertical and horizontal components of functional appliance therapy. Am J Orthod Dentofacial Orthop. 1989 Nov;96(5):433-43 19. Hime DL, Owen AH 3rd The stability of the arch-expansion effects of Frankel appliance therapy. Am J Orthod Dentofacial Orthop. 1990 Nov;98(5):437-45.

20. Franco AA, Yamashita HK, Lederman HM, Cevidanes LH, Proffit WR, Vigorito JW:Frankel appliance therapy and the temporomandibular disc: a prospective magnetic resonance imaging study. Am J Orthod Dentofacial Orthop. 2002 May;121(5):447-57 .

21.Rushforth CD, Gordon PH, Aird JC Skeletal and dental changes following the use of the Frankel functional regulator.Br J Orthod. 1999 Jun;26(2):127-34. 22.Gianelly, Brosnan, Bernstein: Mandibular growth, condyle position and Frankel appliance therapy, Angle orthodontist 1983 April page131-141

23.Owen:Clinical management of Frankel II appliance, JCO 1983,Vol18 page 605-618.

24.Graber, Vanarsdall: Orthodontic current principles techniques, 4th edition,2005 page645-682


25.Kerr,TenHave,McNamara: A comparison of skeletal and dental changes produced by function regulators(FR-2 and FR-3), Ejo 1989 vol11 page 235-242. 26.Ghafari,Hunt, Markowitz, Laster:Headgear versus function regulator in the early treatment of classII,div 1 malocclusion :A randomized clinical trial, Am J Orthod Dentofacial Orthop, Jan 1998 page51-61.