ajodo 1999_115_1_1_12_Figueroa

Distraction osteogenesis is rapidly becom-ing an alternative technique to treat craniofacial dys-plasias. It was initially used successfully to treat unilat-eral or bilateral mandibular dysplasias.1 The applica-tion to other regions of the craniofacial skeleton arecurrently being explored, and animal and clinical trialshave been conducted.2-8 The purpose of this report is topresent our technique for maxillary distraction osteo-genesis in cleft patients with severe maxillary deficien-cy, with the use of a rigid external distraction (RED)device (Fig 1), to describe the orthodontic appliancerequired to deliver the traction force through the denti-tion to the maxillary bone, and to present the clinicaland cephalometric results in our initial series of 14 con-secutive patients.

MATERIAL AND METHODSPatient Selection and Evaluation

Patients were selected based on cause and severity ofthe maxillary hypoplasia. Presurgical records wereobtained including a comprehensive speech evaluationby the speech and language pathologist. The cephalo-metric radiographs are obtained at the completion of dis-traction and at yearly intervals to monitor outcome.Time was spent with the patient and the patients family,explaining in detail the distraction process with pho-

tographs and video imaging, as well as discussion withother patients and their families who have undergonethe procedure. The patient and parents were thoroughlyfamiliarized with the mechanics of the distraction appa-ratus and distraction protocol before the procedure.

Intraoral SplintIn order to apply traction to the maxilla through the

dentition, a rigid intraoral splint needs to be fabricated.Orthodontic bands with 0.050 inch headgear tubes arefitted either on the second primary molars (childrenunder 6 years) or first permanent molars and an algi-nate or compound impression is taken of the maxillaryarch. The impression is poured with dental stone. Thesplint is made on the working model, with 0.045 or0.050 stainless steel rigid orthodontic wire. If thepatient does not have orthodontic brackets, the labialand palatal wires are bent in close contact with most ofthe maxillary teeth. If the patient has orthodonticbrackets, the labial wire has to be bent outward andgingivally to clear the existing appliances. If needed, atranspalatal bar can be added to increase rigidity. Con-necting wires between the labial and palatal archesthrough the embrasures between the lateral and canineteeth bilaterally or in any other area where the wire canbe passed without interfering with the occlusion mayalso be incorporated (Fig 2).

The basic design of the splint has been successful-ly used in patients undergoing protractive face masktherapy. The rigid splint is then tried in the patient,assuring adequate fit, and two markings are done onthe labial wire just medial to both commissures. Thesplint is removed from the patients mouth and twostraight pieces of 0.050 or 0.060 inch rigid stainless

1

ORIGINAL ARTICLE

Management of severe cleft maxillary deficiency with distractionosteogenesis: Procedure and results

Alvaro A. Figueroa, DDS, MS,a and John W. Polley, MDbChicago, Ill.

Distraction osteogenesis has become an important technique to treat craniofacial skeletal dysplasia. In thisstudy, the technique of maxillary distraction with a rigid external distraction device is presented.Cephalometric results in the first 14 consecutive patients are analyzed. The study sample consisted of 14patients with various cleft types and maxillary hypoplasia treated with the rigid external distractiontechnique. Analysis of the predistraction and postdistraction cephalometric radiographs revealed significantskeletal maxillary advancement. All patients had correction of the maxillary hypoplasia with positive skeletalconvexity and dental overjet after maxillary distraction. The morbidity for the procedure was minimal.Surgical and orthodontic procedures are thoroughly described. (Am J Orthod Dentofacial Orthop1999;115:1-12)

From the Craniofacial Center and Department of Orthodontics,University of Illinois at Chicago.aAssociate Professor, Department of Orthodontics.bDirector, Craniofacial Center; Associate Professor, Department of Surgery.Reprint requests to: Alvaro A. Figueroa, DDS, MS, Craniofacial Center, Uni-versity of Illinois at Chicago, 811 S. Paulina St., Rm. 161 COD M/C 588,Chicago, IL 60612; E-mail, [email protected] 1999 by the American Association of Orthodontists.0889-5406/99/$8.00 + 0 8/1/91527

2 Figueroa and Polley American Journal of Orthodontics and Dentofacial OrthopedicsJanuary 1999

steel orthodontic wire are soldered perpendicular to thelabial wire. These vertical wires have a short end towardsthe vestibule that eventually will be used as intraoralhooks. The long end of the vertical wire is marked whilethe device is in the mouth to bend the external tractionhooks (Fig 2). The wire is bent under, over and anteriorto the lip. The ends of the wire are bent in a circle to

eliminate sharp ends and to have a rigid eyelet fromwhere to apply the traction. This traction eyelet is posi-tioned at the level of the floor of the nose or at any otherdesired level to control rotational movements of themaxilla (Fig 2). The purpose of this external hook is toavoid any irritation to the lip while applying traction andalso to control the direction of the traction forces, rela-tive to the approximate center of resistance of the max-illa.9,10 The completed splint is cemented in the clinicalsetting and at the time of surgery, circumdental wires arepassed through most of the maxillary teeth to increaserigidity and stability (Fig 3).

In certain instances, it becomes necessary to do anintraoral splint to an abnormal arch form, knowing thatafter distraction, the patient will undergo further ortho-dontic treatment or surgical orthodontic expansion ofthe arch. If it is determined that the arch will be expand-ed surgically at the time of the required osteotomy fordistraction, the cast has to be cut, aligned, and the splintmade to the newly desired maxillary arch form.

It is preferable to do arch expansion proceduresbefore or after maxillary distraction to avoid movingthe maxillary bone simultaneously in several directionswhere vector control can become more difficult. If theclinician desires to expand simultaneously with anteri-or distraction, an expansion screw can be incorporatedinto the splint, which has to be split into two segments,but the rigidity of the device may be compromised.

The intraoral splint can also be made with a com-mercially available orthodontic headgear facebow witha long external outer bow and an inner bow withoutloops. The inner bow is bent to the desired arch form,and the loose ends are passed through the headgeartubes for future soldering. The outer bow is bent down-ward and anteriorly, in order to clear the upper lip. Theadvantage of using a face bow is that the wires for thetraction hooks (outer bow) are strong and rigid and thetraction hooks are already soldered (Fig 4). It is diffi-cult to use the face bow in maxillary arches with poorarch form or in young children because it is difficult toadapt the inner bow to the teeth, making circumdentalwiring difficult.

In younger patients in which cooperation might be afactor, the splint can be cemented after the patient isanesthetized and before surgical preparation in the oper-ating room. In cases in which a splint has been made to asurgically created arch form, the splint has to be cement-ed after the maxillary osteotomy is completed and thesegments have been mobilized. This procedure can bedifficult, as the segments are mobile and maintaining adry field can be difficult. Adequate assistance from thesurgeon and assisting personnel are required to hold thesegments in place and maintain a dry field.

Fig 1. A, Disassembled RED device with activating andassembling screwdrivers. B, Patient undergoing RED.Note anterior adjustable outrigger system connectedwith surgical wires to the hooks from the intraoral appli-ance. C, Close-up view of the distraction screws linkedto the intraoral splint through the external traction hookswith surgical wires.

American Journal of Orthodontics and Dentofacial Orthopedics Figueroa and Polley 3Volume 115, Number 1

Surgery and Rigid External Distraction DevicePlacement

The indications, details of surgery, and placementof the cranially fixed rigid external distraction (RED)device have been previously reported.8 A complete LeFort I osteotomy is performed, including pterygomax-

illary and septal dysjunction, with mobilization. Metal-lic markers are placed above and below the osteotomyand in the anterior aspect of the maxilla for follow-up,and the soft tissue incision is closed. In young children,a modified high LeFort I osteotomy, with minimaldownfracturing, is required to avoid disturbing devel-

Fig 2. A, Intraoral appliance in working model. Note transpalatal bar as well as interdental bars to increase rigidity. B,Vertical wires soldered perpendicular to labial aspect of intraoral splint. Upper portion of wire to be used as intraoralhooks and lower extensions to be used for external traction hooks. C, Facial photograph of patient with cheek mark-ings identifying approximate center of rotation of maxilla to be used as guidelines to bend external traction hooks. D,External traction hooks with eyelets for connecting wire to RED device. Note position of eyelets at the level of the floorof the nose and above approximate center of resistance of maxilla. External traction hooks have been bent to com-fortably clear upper lip.


oping tooth buds (Fig 5). Every effort is made at thetime of surgery to make an osteotomy cut that willdirect the maxillary segment with the appropriate hori-zontal and vertical vectors to prevent the creation of ananterior open bite or elongation of the lower face. Inyounger patients, the presence of tooth buds may notallow placement of the osteotomy in the desired direc-tion, making the placement of the traction hooksextremely important to control maxillary vertical andhorizontal movements. Once the maxillary osteotomy

is completed, the halo portion of the RED device isadjusted for the width of the neurocranium and is rigid-ly fixed around the head with two or three scalp screwson each side. The vertical bar of the RED is in the cen-ter, sufficiently anterior and also parallel to the facialplane. Initially the vertical facial bar is removed as thetraction forces are not applied until 3 to 5 days aftersurgery, facilitating postoperative management andfeeding.

Distraction ProtocolA sample of 14 patients with various cleft types

(Table I) underwent distraction with the RED device(Fig 1). The vertical bar was connected to the halo andthe horizontal bar with the distraction screws and wasplaced at the appropriate vertical level based on thevector needed to obtain the desired maxillary move-ment 4 days (with children) or 5 days (with teenagersand adults) after surgery. The force vector is deter-mined by clinical evaluation and through cephalomet-ric prediction tracings (Fig 2). A 25 gauge surgical wirewas used to connect the traction hook to the tractionscrews (Fig 1).

Distraction was performed at home by turning theactivating screw at a rate of 1 mm per day (2 turns).

Fig 3. Intraoral appliance used to deliver distractionforce to the maxilla. Note circumdental wiring.

Fig 4. A, Intraoral splint made with an orthodontic headgear face bow with long external outer bow. B, Complet-ed intraoral appliance made from a head gear face bow.The outer bow has been bent to form the traction hooks.Note small soldered hooks (arrow) to be used during thefacial mask retention phase after distraction.

Fig 5. Intraoperative view of a modified high LeFort Iosteotomy in 6-year-old patient. Note proximity of theosteotomy to the infraorbital nerve (arrow). Three metal-lic bone markers were utilized for postoperative follow-up. Traction hook in the foreground.

Table I. Diagnosis and sex distribution of the sampleDiagnosis N Male Female

UCL/P 7 5 2BCL/P 5 4 1Facial cleft and BCL/P 2 1 1Total 14 10 4


The patients were followed weekly to assess bone con-solidation and to make adjustments in the vertical posi-tion of the horizontal traction bar and screws, to main-tain control over the maxillary position.

Once the appropriate amount of distraction wasachieved, the RED system was left in place for 2 to 3weeks to permit bone consolidation. The RED devicewas removed in the clinic. After the RED device was

Fig 7. Anatomic landmarks: sella (S), center of sella turci-ca; nasion (N), most anterior point of nasal frontal suture;anterior nasal spine (ANS), most anterior point of thespine; A point (A), most anterior limit of the maxillary alve-olar bone at the level of the incisor root apex; posteriornasal spine (PNS), intersection between the nasal floorand the posterior contour of the maxilla; apex of maxillaryincisor root (U1A), uppermost point of the incisor root; tipof maxillary incisor crown (U1T), maxillary incisor edge;tip of mandibular incisor (L1T), mandibular incisor edge;apex of mandibular incisor root (L1A), lowermost point ofthe mandibular incisor root; B point (B), most anterior limitof the mandibular alveolar bone at the level of the incisorroot apex; pogonion (PG), most anterior limit of themandibular symphysis; menton (ME), most anterior pointof the mandibular symphysis; gonion (GO), the point atthe greater convexity of the mandibular gonial region.Reference planes: sella-nasion plane (SN); palatal plane(PPL), line through ANS and PNS; maxillary incisor axis(U1), line passing through U1A and U1T); mandibularplane (Mand Pl), tangent to the lower border of themandible through ME and GO.

Fig 6. Six-year-old female with left unilateral cleft lip andpalate and maxillary hypoplasia treated with maxillarydistraction with RED. Predistraction (A) and postdistrac-tion (B) photographs. Note improvement in facial con-vexity, cheek projection, and balance of face. C, Patientunderwent 6 to 8 weeks of retention with a removableface mask with elastic traction.

A


removed, the labial hooks were cut. Positive tractionwas continued by means of elastic traction through anorthodontic face mask, using the intraoral hooks (Fig6). For this purpose, one or two 6 oz elastics were usedon each side. The retention period after active distrac-tion was between 6 and 8 weeks. Although not done inthis series of patients, if orthodontic appliances are inplace, interarch elastics can be used to further improveocclusal relations.

CEPHALOMETRIC EVALUATIONThe preoperative and postretention lateral cephalo-

metric radiographs were used for analysis. The postre-tention radiographs were obtained 3 to 4 months afterdistraction. The radiographs were traced, and 13anatomic landmarks were recorded (Fig 7). All tracingswere done by a single investigator (AAF). Availabilityof serial radiographs in all patients permitted landmarkverification. All x-rays were corrected to 0% magnifi-cation. We looked at the recorded anatomic landmarksand calculated 14 measurements, 7 angular and 7 linear(4 horizontal and 3 vertical). For the linear measure-ments, an x-y coordinate system with the S-N plane as

the horizontal was used. Linear horizontal changeswere measured relative to a line perpendicular to the S-N plane, passing through sella, and vertical changeswere measured perpendicular to the S-N plane. Thepreoperative and postoperative cephalometric valueswere statistically analyzed by means of a paired t test.

RESULTSAll of the surgery and RED device placement in

this series was performed by a single surgeon (JWP).Perioperative antibiotics were routinely used. Allpatients began routine oral hygiene and an unrestrictedsoft diet 24 hours postoperatively. No intermaxillaryfixation nor bone grafts were used.

There was no surgical morbidity in any of the 14patients in this series. There were no problems withbleeding or infection. None of the patients required ablood transfusion; there were no problems of dentalinjury, avascular necrosis, or gingival injury. Therewere no complications with wearing the externaldevice, including pain, discomfort, or loosening duringthe distraction process. The intraoral splint remainedintact in all patients through the active and retentionphases. None of the families had difficulty followingthe distraction instructions.

The predistraction and postdistraction angular andlinear cephalometric measurements are given in TablesII and III. The average predistraction SNA angle was77.6 and the postdistraction SNA angle was 85.3, foran average increase of 7.7. The average predistractionANB was -1.2 and postdistraction was 7.3, with anincrease of 8.6. The skeletal angle of convexityincreased postdistraction by 17.2. All of these threemeasurements were statistically significant. The hori-zontal ANS change between predistraction and post-

Fig 8. Predistraction (solid line) and postdistraction (bro-ken line) average cephalometric tracings for all patients.Note maxillary advancement with correction of negativeoverjet and improvement of skeletal convexity, upper lipand nose advancement, and minimal changes inmandibular position.

Fig 9. Predistraction (solid line) and postdistraction (bro-ken line) average tracings of the maxilla for all patients.Note minimal changes in incisor position relative to themaxillary palatal plane.


distraction cephalometric radiographs was 7.1 mm, andthe average horizontal advancement of the A point afterdistraction was 8.3 mm. The horizontal advancement atthe upper incisal edge averaged 11.6 mm, and allpatients had a positive correction of their overjet withan average 12.7 mm change. All of the linear horizon-tal changes were significant (P < .001) between predis-traction and postdistraction measurements. The desiredtreatment goals were obtained in all patients. The ver-tical changes in the position of ANS, A point, andupper incisor edge were small and not significant.None of the patients resulted with an open bite. Themandibular plane angle changed 2.2. The averageskeletal changes after RED are shown in Fig 8.

The predistraction and postdistraction dental changesare also given in Tables II and III and Fig 9. The changein the angle of the upper incisor edge to the palatal planeaveraged -1.2 for all patients, and it was not statistical-ly significant. None of the patients in this series resultedwith interdental spaces created posterior to the most dis-tal point of anchorage of the intraoral splint.

DISCUSSIONIt has been estimated that 25% to 60% of all

patients born with complete unilateral cleft lip andpalate will require maxillary advancement to correctthe maxillary hypoplasia and improve aesthetic facialproportions.11,12 Patients with severe cleft maxillarydeficiency are difficult to treat with standard surgi-cal/orthodontic approaches. These patients have maxil-lary hypoplasia (vertical, horizontal, and transversedimensions) and often thin or structurally weak bone.The hypoplasia in cleft patients is also compounded byresidual palatal and alveolar fistulas, absent and aber-rant dentition, pharyngeal flaps, and scarring of thepalatal and pharyngeal soft tissues.

The physical deformities associated with maxillaryhypoplasia contribute to multiple functional deficien-cies. These include severe malocclusions that result in

compromised mastication and speech and nasal pha-ryngeal airway patency. The severe concave facial pro-file has negative psychosocial ramifications. Currentprotocols for the treatment of maxillary hypoplasia incleft patients rely on a surgical/orthodontic approach,including a LeFort I maxillary advancement with con-comitant fistula closure, and maxillary and alveolarbone grafting. This surgery includes rigid internal fix-ation hardware for stabilization of the repositionedmaxilla in the postoperative period.

The long-term results of cleft patients with maxil-lary deficiency treated in such fashion have beenreported and allude to increased relapse tendency(greater than 20%) after maxillary advancement.13-16All of the patients in our series, if they had undergonecorrection of the deformity with a standard orthognath-ic approach, would have also required mandibular set-back surgery because of the severity of the maxillaryhypoplasia. The main disadvantage to this two-jawapproach for cleft patients is that the majority of themhave a mandible that is normal in both size and posi-tion or even small and retrognathic,17-24 Setback of themandible in an effort to reduce the amount of maxillaryadvancement compromises final lower facial form andesthetics. Expansion of the soft tissue facial maskyields the most pleasing long-term aesthetic facial bal-ance and harmony. This concept is extremely importantin cleft patients.25

The concept of gradually advancing the maxillaafter LeFort I corticotomy was originally presented byMolina and Ortiz-Monasterio.26 In their technique, anorthodontic face mask with elastics was used to deliv-er the traction force to the maxilla. This technique hasseveral shortcomings, such as not delivering controlledforces, pressure sores on the chin and forehead, com-pliance, and most importantly the inability to advancethe maxilla sufficiently to correct severe cleft maxillaryhypoplasia. We have used this face mask approachafter complete maxillary osteotomy with disappointing

Table II. Angular changes after RED (n = 14)Measurements Postdistraction

(degrees) Predistraction (4 months) Difference Significance

SNA 77.6 5.6 85.3 5.6 7.7 2.9 **SNB 78.8 4.0 77.9 4.1 0.8 1.8 NSANB 1.2 3.5 7.3 3.0 8.6 3.6 **Convexity 3.5 7.5 13.7 6.0 17.2 7.3 **

(NAPg)Mand Pl/SN 39.2 6.7 41.4 5.9 2.2 2.4 *

angleU1 -PPL 100. 7 15.7 98.8 14.4 1.2 11.3 NS

angle

*P < .01, **P < .001.

Table III. Horizontal (x) and vertical (y) linear changesafter RED (n = 14)

Landmark-axis Change (mm)

ANS-x 7.1 + 3.9**ANS-y 0.4 + 3.0A Point-x 8.3 + 3.3**A Point-y 1.3 + 3.4U1-x 11.6 + 4.6**Ul-y 1.8 + 3.5Overjet 12.7 3.0**

**P < .001.


results.27 The patients were undercorrected with resid-ual anterior crossbites. This limited maxillary skeletalresponse has also been observed by others.28-30 Theseunfavorable experiences prompted us to modify thetechnique and use a RED device.

RED uses a skeletally (cranial) fixed distractiondevice that allows for predictable control over the dis-traction process. The RED device is adjustable, offeringthe ability to change the vertical and horizontal vector ofdistraction, at any time, without discomfort to thepatient during the distraction process. The differencebetween the two systems is evidenced by the greatermaxillary advancement obtained in those patients whounderwent RED, compared with those reported inpatients who underwent face mask distraction.27-30

In the past, it has been virtually impossible usingmaxillary advancement alone to treat patients withsevere maxillary deficiency. With the use of RED, aseverely hypoplastic maxilla can be repositioned andmaintained to the desired horizontal and vertical posi-tion without the use of bone grafting and fixation hard-ware (Fig 10). Contrary to the use of protraction facemask,31,32 with or without osteotomy, maxillaryadvancement with distraction using the RED systemcan be done with minimal alterations on mandibularposition (Fig 8).

Maxillary advancement at the LeFort I level withthe RED device allows for complete versatility in boththe amount and direction of the distraction process.This control on maxillary movement is feasible

Fig 10. Profile photographs and cephalometric radiographs of a 10-year-old patient with bilateral cleft lip and palateand severe maxillary hypoplasia before (A and B) and after (C and D) distraction. Note dramatic improvement in facial,skeletal, and dental relations after a 16 mm total maxillary advancement with correction of anterior crossbite. (Printedwith permission, J Craniofacial Surg 1997;8:181-5.

A

B

C

D


because of the design of the RED device system. Theexternal distraction system allows complete verticaladjustability of the distraction screws mounted on thehorizontal bar. The design of the intraoral splint, withplacement of the external traction hooks located at thelevel or above the palatal plane, assures the clinicianthat the vector of the distraction force can be controlledrelative to the position of the center of mass of the max-illa. It is believed that the center of resistance, of thenot osteotomized maxillary bone, is located approxi-mately at the apex of the maxillary premolars in the lat-eral view.9,10 With the RED system, one can controland change as needed, the force vector that passesthrough (straight advancement) or above (downwardadvancement) the center of resistance of the maxilla(Figs 1 and 2). This is one of the main advantages ofRED over internal devices that inherently have limitedvector control.

Before bending the traction hooks, the clinician can

transfer the approximate center of resistance of themaxilla from the cephalometric radiographs and fromthe clinical examination to the face of the patient. Theskin is marked, corresponding to the center of resis-tance, and the external traction hooks are bent to thedesired position (Fig 2). After connecting the distrac-tion screw with the traction hook, the clinician canevaluate the direction of the distraction force and canadjust it, relative to the center of mass or resistance ofthe maxilla (Fig 1).

Because the intraoral splint is made rigid enough,preventing permanent deformation of the tractionhooks, the use of casted full coverage rigid splints isnot necessary. The slight flexibility present in the trac-tion hooks allows for energy storage that may result incontinuous force to the maxilla between activations.This continuous tension is believed to be conducive toosteogenesis,33,34 a favorable event during the distrac-tion process. Our current experience indicates that the

Fig 11. Preoperative (A and B) facial profile view and intraoral view of a 512 year old boy with right unilateral cleft lipand palate and bilateral crossbites. Facial and intraoral views 3 months after distraction (C and D). Note improvementin facial convexity and lip and nose relations, as well as correction of the crossbites. The intraoral splint is still securedwith circumdental wires and is being used for the retention period after distraction.


use of a commercially available face bow facilitates thefabrication of the intraoral splint. The outer face bowwire has significant diameter to allow for the necessaryrigidity. The amount of necessary soldering is also min-imized as the outer bows are used as the traction hooks.Care must be taken to bend the traction hook while theouter bow arms are long; working with short segmentsof wire of heavy diameters is difficult. The commer-cially available face bow is indicated for those patientswith a dental alveolar arch of sufficient size and formto facilitate contouring the inner bow. If the dental alve-olar arch is irregular or too small, it will be difficult toobtain close adaptation to the teeth, which makesplacement of the required circumdental wires a difficultand unstable process. For small or irregular arches, we

prefer to bend our own splint with appropriate gaugewire. The advantages of the described intraoral splintare various and include the following: It is custom designed, which is imperative, especially in

patients with clefts that present with severe dental malpo-sitions and collapsed cleft arch segments.

The device is inexpensive and easily constructed by theorthodontist.

It is hygienic, comfortable, and nontraumatic. It does not interfere with speech and eating. Simultaneous orthodontic movement, such as correction of

dental rotations, as well as expansion, can be performed. The active and retention intraoral devices are the same. The vectors of distraction can be changed at any time dur-

ing the distraction process without discomfort to thepatient, thus allowing for force vector changes as needed.

Fig 12. Preoperative facial profile view and intraoral view in a 12-year-old female with right cleft lip and palate with max-illary hypoplasia, anterior crossbite, and open bite (A and B). Postoperative views (C and D) after maxillary distractionwith RED demonstrating improvement in facial convexity, fullness of the infraorbital region, and improved lip and noserelations. The intraoral view demonstrates correction of anterior crossbite and open bite. Degree of maxillary advance-ment is shown by the position of the second maxillary premolar in full Class II relation after distraction (arrows).


The use of the cranium as an anchorage base for thestabilization after maxillofacial surgery is not a newconcept.35 Not even the youngest patients had com-plaints or problems with wearing the device throughoutthe distraction process. No special scalp pin care is re-quired and the use of ointments and creams at the scalppin interface is discouraged. The patients simply sham-poo and wash their hair with the device in place. TheRED device is removed in the clinic after the rigid reten-tion phase usually without the use of local anesthesia.

Contemporary surgical/orthodontic approaches forthe treatment of maxillary deficiency in cleft patients isusually dependent on the patient having reached skele-tal maturity before the reconstructive surgery can beperformed. The RED technique for maxillary distrac-tion osteogenesis eliminates the negative technical fac-tors associated with traditional orthognathic surgery inpatients in transitional dental development. An osteoto-my with complete mobilization is required with norepositioning or placement of bone grafts. Rigid inter-nal fixation hardware is not used, eliminating the riskof dental injury during plate stabilization; thus thistechnique can be used throughout childhood. The onlylimitations in the application of this technique forpatients with severe skeletal hypoplasia include ade-quate dentition (primary or permanent) for fixation ofthe intraoral splint and patient tolerance to the externaldistraction device. Because the RED system uses den-tal support, the presence of a healthy dentition isrequired. Skeletal anchorage for maxillary tractionhooks or osseointegrated implants may need to be con-sidered for patients with inadequate dentition. Rigidexternal distraction has allowed us to effectively treatpatients with severe maxillary skeletal hypoplasia fromthe age of 5 years and up (Figs 11 and 12). No longeris it necessary to wait years for the patient to reachmaturity before their severe maxillary facial deformityis corrected with the associated functional, esthetic,and psychosocial benefits.

All patients treated with RED are cautioned that apercentage will require a final finishing LeFort pro-cedure at skeletal maturity. It is anticipated that thisprocedure will not require a major movement, thusenhancing stability. This technique provides an excel-lent modality for correcting severe maxillary deficien-cy in patients with facial clefting and other anomalieswith structurally thin bone in the maxilla (ectodermaldysplasia, Johansson Blizzard syndrome, etc.).

Modifications of this technique are undergoingclinical trials to advance not only the maxilla at theLeFort I level but also advancement at the LeFort II, III,monoblock, and fronto-orbital levels. This articlereports our preliminary experience with this technique.

We will prospectively follow these patients to evaluatethe stability of maxillary distraction, and its effects onfacial, dental, and velopharyngeal development.

CONCLUSIONSMaxillary distraction osteogenesis after complete

osteotomy with the RED technique is a highly effectivetreatment modality to manage cleft-related maxillaryhypoplasia. The technique allows for vector control ofthe osteotomized maxilla throughout the distractionprocess. It has been used, with minimal morbidity, inchildren as young as 5 years of age, adolescents, andadults. In all patients treated with RED the initial neg-ative skeletal convexity and dental overjet were satis-factorily corrected with the associated favorable softtissue changes.

We thank Dr. Eric Jein-Wein Liou for computer andstatistical assistance.

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