Protocols for Late Maxillary Protraction in Cleft Lip and Palate Patients at Childrens Hospital, Los Angeles

Stephen L.-K. Yen

This paper describes the protocols used at Childrens Hospital Los Angeles (CHLA) to protract the maxilla during early adolescence. It is a modication of techniques introduced by Eric Liou with his Alternate Rapid Maxillary Expansion and Constriction technique. The main differences between the CHLA protocol and previous maxillary protraction protocols are the age at which the protraction is attempted, the sutural loosening by alternating weekly expansion with constriction, and the use of Class III elastics to support and redirect the protraction by nightly facemask wear. The CHLA protocol entirely depends on patient compliance and must be carefully taught and monitored. In a cooperative patient, the technique can correct a Class III malocclusion that previously would have been treated with LeFort 1 maxillary advancement surgery. Thus, it is not appropriate for patients requiring 2 jaw surgeries to correct mandibular prognathism, occlusal cants, or facial asymmetry. The maxillary protraction appears to work by a combination of skeletal advancement, dental compensation, and rotation of the occlusal planes. Microscrew/microimplant/temporary anchorage devices have been used with these maxillary protraction protocols to assist in expanding the maxilla, increasing skeletal anchorage during protraction, limiting dental compensations, and reducing skeletal relapse. (Semin Orthod 2011;17:138-148.) 2011 Elsevier Inc. All rights reserved.

lefts of the lip and/or palate are among the most common birth anomalies. On average, cleft lip and palate occurs 1 in every 700 live births in the United States.1 In cleft lip and palate patients, the mandible is usually unaffected by the cleft and grows normally; however, the maxilla often does not grow as far forward and downward as the noncleft child,2 resulting in a short maxilla and a Class III malocclusion.

Staff Orthodontist, Childrens Hospital Los Angeles, Los Angeles, CA. Associate Professor, Departments of Oral and Maxillofacial Surgery, Orthodontics and Basic Sciences, Research Faculty, Center for Craniofacial Molecular Biology, University of Southern California, Los Angeles, CA. Address correspondence to Stephen L.-K. Yen, DMD, PhD, Childrens Hospital Los Angeles, MS 116, 4650 Sunset Blvd, Los Angeles, CA 90027. E-mail: [email protected] 2011 Elsevier Inc. All rights reserved. 1073-8746/11/1702-0$30.00/0 doi:10.1053/j.sodo.2011.01.001

The scar contracture that occurs from the hard palate repair is thought to distort the growth of the maxilla resulting in maxillary hypoplasia.3-8 Fibrosis results from the stripped periosteum and affects the vertical, transverse, and anteroposterior growth of the maxilla. In addition, the brosis that results from the cleft lip repair is also thought to play a role in the maxillary deciency.9 Approximately 22%-26% of cleft lip and palate patients will need orthognathic surgery at the end of adolescent growth to correct the maxillary deciency.10 For maxillary hypoplasia resulting in a difference between upper and lower jaw lengths, the standard of care is to surgically advance the maxillary bone and dentition in cleft patients with a LeFort I osteotomy after adolescent growth has completed. The advantages to surgical advancement of the upper jaw is that surgery targets bony correction, corrects the bite, and can effect

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a signicant facial change in patients with cleft lip and palate. However, orthognathic surgery requires a 6- to 8-week recovery period, is expensive, and can be associated with patient discomfort, liquid diet, facial swelling, and transient paresthesia, and in some occasions, permanent loss of neurosensation. This surgery is more difcult to perform for cleft patients with Class III malocclusions than in noncleft patients with Class III malocclusions because of the scarring from previous surgeries, which restricts the forward movement of the maxilla. Furthermore, the scarring may also increase the relapse rate associated with maxillary surgical advancement in cleft patients. Rates of relapse in these patients have been reported to occur 5%-80% of the time.11 Therefore, the patient with cleft lip and palate may go through the morbidity associated with orthognathic surgery and still relapse back to the prior Class III malocclusion. Orthodontic treatment consists of extraction of teeth, proclination of the maxillary incisors and retraction of the mandibular incisors12 in patients with a mild underbite. However, orthodontic treatment only camouages the malocclusion and can result in a decient amount of supporting bone for the dentition.12 Another option is to treat the patient by orthopedic correction during the early mixed dentition at ages 7-9. This treatment can only correct Class III malocclusions with a negative overjet of 4-5 mm13 and advances the maxilla an average distance of 2.1 mm. The major drawback to early correction during growth is the recurrence of the underbite with mandibular growth; thereby, allowing the occlusion to revert back to a Class III malocclusion during adolescence. For orthopedic correction of a short maxilla in the cleft lip and palate patient, facemask forces range from 300 to 700 g of force, and the period of treatment can be as early as 6 years of age and as late as 12 years. Initial success at correcting dental crossbites at age 6-714 is tempered with limited success at protracting the maxilla at age 8-10.15 In 1996, So16 reported only an average of 1.3 mm of maxillary protraction in Class III patients with unilateral cleft lip and palate. There appears to be less movement of the maxillary skeleton as the patient ages15 and correction of the crossbite is the result of rotation of the occlusal plane.17 Long-term results of

early protraction appear to be only a temporary correction which needs to be readdressed during late adolescence with retreatment14 Historically, orthopedic protraction was not successful in older patients to advance the maxilla in cleft lip and palate patients aged 9-12 years. A protocol of maxillary protraction developed by Liou and Tsai in 200518 includes 3 components: a 2-hinged rapid maxillary expander, repetitive weekly protocol of Alternate Rapid Maxillary Expansion and Constriction (Alt-RAMEC), and intraoral maxillary protraction springs. The innovative part of this technique is the sutural loosening accomplished by alternating expansion with constriction for 8 weeks. This backand-forth motion can mobilize the maxilla and protract the maxilla for longer distances.18,19 In the Alt-RAMEC protocol the maxilla is expanded for 7 consecutive days and constricted for 7 consecutive days for 9 weeks. After the Alt-RAMEC technique, the maxilla is protracted with protraction springs for 3 months. This technique has been shown to advance the maxilla (dened as A point on a cephalometric tracing) an average of 5.8 mm.18,20 In this article, a variation of the Liou18 technique used at Childrens Hospital Los Angeles (CHLA) is described. The Liou prescription for success depends on several custom fabricated devices, such as a 2-hinged rapid maxillary expander and a tooth-borne, intraoral maxillary protraction spring. During our early attempts, we found that these appliances could break and require frequent replacement at every appointment. Moreover, the springs could produce anterior open bites during protraction. At CHLA, the technique has been modied to use a standard Hyrax rapid maxillary expansion appliance (RME; Orthodontic Store, Gaithersburg, MD) and xed orthodontic appliances in the lower arch, Class III elastics and reverse-pull headgear or facemask. The use of standard techniques makes the Alt-RAMEC technique accessible to most orthodontists and eliminates the open bite side effect by using a downward direction of pull. In fact, the modied technique can be used to close anterior open bites in patients. This technique, however, is completely dependent on patient cooperation as opposed to the original spring that was designed for a noncompliant patient.

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The CHLA Maxillary Protraction Protocol

The patients who received maxillary protraction were given a choice between maxillary protraction and surgery to correct their malocclusion and improve their facial esthetics. In our craniofacial team, the patients in the protraction group were considered surgical candidates for a LeFort I surgery to improve their occlusion and facial appearance. A typical prole of a patient with cleft lip and palate tended to show overclosure of the mandible, negligible maxillary incisor display, nasal deformity, a thin upper lip, a full lower lip, and upright maxillary incisors caused by lip tension from previous lip surgeries. The maxillary incisors could benet from some form of maxillary incisor proclination in contrast to the patient without a facial cleft. In our protocol, maxillary expansion and protraction was performed before dental alignment with an archwire because additional space was created with arch expansion. If maxillary dental crowding was present, extractions were deferred until after expansion and protraction. The exceptions to this rule were the patients who had

molars and premolars tilting in opposite directions which would prevent parallel draw of bands. These patients received limited orthodontics with sectional wires to improve the insertion and draw of a rapid palatal expander (RPE). The orthodontic setups for protraction and orthognathic surgery were similar because both treatments decompensated the anterior teeth to maximize skeletal correction during treatment. Table 1 summarizes the clinical protocol for maxillary protraction in an adolescent patient with cleft lip and palate. The management of the protraction technique was determined by our experience and research with maxillary distraction osteogenesis.21 Maxillary protraction is similar to distraction osteogenesis because the correction is attained gradually over a period, is limited to bony deciencies, and is not a suitable replacement for treatment plans involving 2 jaw or segmental surgeries. In both cases, overcorrection of the deformity was needed to plan for relapse when the expanders were removed. Unlike orthognathic surgery, the protraction process is dynamic and can change direction during the

Table 1. The Clinical Protocol for Maxillary Protraction in a Typical Adolescent Patient With Cleft Lip and Palate

At age 13, the patient chooses surgery or maxillary protraction. Pretreatment records. Check for parallel path of insertion of RPE along anchor teeth. Prior alignment is needed if teeth are tilted in opposite directions. Banding of the lower rst and second molars, bonded orthodontic brackets for the lower arch premolars and anterior teeth. Initiate leveling of mandibular dentition. Stabilize lower dentition in a stainless steel rectangular archwire; Banding maxillary molars and premolar (or canines) for a Hyrax rapid palatal expander placed high in vault of palate. Delivery of Hyrax expander. Demonstration of screw turns needed to expand and constrict the Hyrax expander. Sutural loosening is initiated by activating the appliance 2 turns in the morning and 2 turns in the evening. The expansion rate is 1 mm/d. The screw turns follow the same direction for 1 week. At the end of the week, the patient returns to the clinic to demonstrate ability to insert the swivel key into the screw of the Hyrax expander. The swivel key is suspended in the RPE before activation to ensure that the key is fully inserted. The reverse direction is taught so that patient so that he/she is procient in both directions with the swivel key. Expansion and constriction is alternated each week. Recall after 4 weeks. After 8 weeks of alternating expansion with constriction, the facemask and Class III elastics are given to the patient to start protraction. The patients are instructed to wear the facemask at night to pull the maxilla forward and wear the Class III elastics during the day to hold the results obtained by the facemask. Expansion and constriction are continued during protraction. The facemask bar for protraction elastics is placed at the level of the lower lip to provide a slight downward direction of pull from the premolar bands in the Hyrax expander. The facemask is used with elastics to the premolar bands during the evening. Heavy force Class III elastics are placed from hooks anterior to the mandibular canine to the maxillary rst molar bands of the Hyrax expander 24 hours/day with intermittent changes before and after meals. The elastics are stretched to their elastic limit to maximize force. After 2 weeks, the patient returns to demonstrate ability to use facemask and intraoral elastics. Some correction, such as edge-to-edge occlusion should have occurred by this time. The elastics are changed to heavier and shorter elastics as the distance between RPE and headgear is shorter. Continue the facemask and Class III elastics until the underbite is over corrected into a Class II malocclusion by at least 3 mm. Maintain the correction with 24-hour Class III elastics. After 4 months, remove RPE and replace with maxillary brackets and bands for orthodontic alignment. Class III elastics are used for 18 months during the arch alignment, nishing and retention stages of treatment.

RPE, rapid palatal expander.

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treatment; there can be many adjustments of the maxilla possible as it is pulled forward. For example, doubling the elastic pull on one side could provide asymmetric correction if one side lagged behind and rotated the maxilla to one side. Similarly, intraarch elastics can help correct asymmetric expansions of the maxilla. During the rst 9 weeks, continuous alternation between expansion and constriction was used to loosen and maintain the sutures in a exible state for maxillary protraction. During protraction, the patients were instructed to wear the facemask to pull the maxilla forward at night and to wear Class III elastics during daytime to hold the results obtained by the facemask treatment at night. In cooperation, the patient was told that maxillary protraction required full cooperation from the patient or treatment will fail. Intermittent usage was not effective because any interruption in placing tension on the sutures could cause early bone consolidation in a growing patient. In animal distraction studies, a thin cortical layer rapidly formed to span the distraction site21 and stopped the distraction process. Presumably, whenever the protraction process stopped, a similar process could inhibit maxillary protraction. Clinically, patients need to be informed that failure to cooperate during the treatment process would result in the need to restart the treatment process from the beginning. Another problem is if the patient fails to cooperate in the middle of expansion and constriction, the screws in a half-expanded position could still turn without exerting an outward pressure by spinning in the turnbuckle housing. In these cases, RPE appliances were remade to accommodate the slightly expanded position, and the 8-week expansion and constriction period was recalculated according to the restart date. At the end of orthodontic leveling, a 0.019- 0.022-inch stainless-steel archwire was placed that extended to the second molar. Clamp on hooks with titanium inserts from TP Orthodontics (Laporte, IN) were placed mesial to the mandibular canines to support Class III elastics. Heavy force elastics were used to protract the maxilla with the facemask and to maintain the correction with Class III elastics. Heavy force implies that the elastics were stretched to a point just before breaking.

Patients typically progressed from 3/16-inch medium to 1/8-inch medium to 1/8-inch heavy elastics as the maxilla advanced to maintain heavy force pressure. If shorter elastics were needed, extra clamp-on hooks were placed medial to the lateral incisors to increase elastic pressure by forming an elastic triangle between the maxillary rst molar, the canine and the lateral incisor hooks. To increase facemask force, the facemask elastics could be placed to the molar instead of the canine band or the facemask bar was reinserted away from the patient. If a patient did not wear Class III elastics, then any gain at night with facemask would recoil back during the day: there would be no net gain in anteroposterior correction. In a cooperative patient, a 3- to 4-mm anterior crossbite would correct to an edge-to-edge incisor relationship after 2 weeks. A Class II molar relationship with a 3 mm overjet could be produced 1 month later. When correction of the crossbite was not observed in 2 weeks, the patients were retested for compliance with the facemask and Class III elastics usage. In patients with deep underbites, a posterior bite plate made from glass ionomer cement was used to avoid occlusal interferences during the Class III correction. After correction, a protracted maxilla was maintained in the Class II position for 3 months before the RPE was removed. Class III elastics were used for a minimum 18 months following protraction as the teeth were being aligned and leveled. When orthodontic treatment was 18 months, then the patients were debanded and given clear acrylic retainers (1-mm biocryl; Great Lakes Orthodontics, Tonawanda, NY) with embossed or bonded Class III buttons. These retainers allowed the patients to be debanded early yet provide interarch elastics wear for the 18-month period. One goal in treatment was to overcorrect the Class III malocclusion into a Class II malocclusion. Highly motivated patients not only corrected the Class III malocclusion but could overcorrect to produce an 8-mm overjet. The overjet represented extra correction for dealing with relapse after the RPE was removed. Light Class II elastics placed late in treatment were used to correct the overcorrected occlusion.

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Protraction of Maxilla in Adolescent Patients

Figures 1-3 show pre- and posttreatment records of our rst protraction patient treated by the CHLA maxillary protraction, a 13-year-old female patient who presented with repaired unilateral cleft lip and palate and a decient maxilla. The frontal facial changes with maxillary protraction were similar to the LeFort 1 surgery: there was more nasal projection, more maxillary support for the dentition and nose, increased upper lip width and improved symmetry with the lower width, and more upper incisor display. The face looked natural, as there are no steps created by surgical segments. With downward direction of elastic pull, there were no anterior open bites at the end of treatment with this protocol. The occlusion was not always an ideal Class I occlusion as most patients with cleft lip and palate were either missing a lateral incisor or had a smaller lateral incisor. Tight intercuspation of teeth was not always possible because of discrepancies in tooth size. However, there was a positive overjet and overbite. The upper den-

tal midline was more difcult to control with protraction or distraction osteogenesis than with LeFort I surgery as surgery offered more control over the midline position, especially if the maxilla was segmented. If the midface was shallow with exopthalmus before protraction, then the protraction did not eliminate the facial concavity. Usually, a combination LeFort III/LeFort I surgery or malar implants would be recommended for these patients. In our pilot study of 30 patients, 24 were successfully treated with maxillary protraction. Of these 24 patients, none had additional surgery to correct residual problems. Six patients failed to complete the protraction treatment because of poor cooperation. All 6 patients were boys. One boy achieved overcorrection with the protocol but then discontinued elastics shortly after attaining the desired result and relapsed to an edge-to-edge incisor relationship which was corrected using multiloop edgewise mechanics. During treatment, 3 lateral cephalometric radiographs were taken on our protraction patients: a pretreatment radiograph, a maxi-

Figure 1. Pretreatment of a 13-year-old female patient with repaired unilateral cleft lip and palate planned for maxillary protraction. Fixed appliances were used to align premolars in preparation for maxillary protraction. (A) Extraoral frontal view; (B) extraoral prole view; (C) intraoral right lateral view; (D) intraoral frontal view; and (E) intraoral left lateral view. (Color version of gure is available online.)

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Figure 2. Treatment changes in same patient after rst 3 weeks of protraction. (A) Extaroral frontal view; (B) extraoral three-quarter view; (C) extraoral prole view; (D) intraoral right lateral view; (E) intraoral frontal view; (F) intraoral left lateral view; (G) palatal occlusal view; (H) mandibular occlusal view; and (I) view of downward direction of elastic pull to facemask. (Color version of gure is available online.)

mal protraction radiograph, and a (3-month) postprotraction radiograph. Figure 4 shows both maxillary incisor proclination and skeletal movement during the change between the rst and second radiograph as evidenced by the change in unbanded second molar positions. The change between the second and third radiograph illustrated overcorrection of the Class III malocclusion into an 8- to 9-mm Class II overjet. Light Class II elastics were used to reduce the overjet. The Class II elastics were discontinued once an ideal overjet was obtained. A nal cephalometric radiograph could appear as a dental compensation of a

Class III malocclusion with rotation of the occlusal plane even though skeletal advancement occurred early during the rst month of maxillary protraction. In a pilot study of 30 patients who underwent maxillary protraction, we measured 4 components of Class III correction: maxillary length (CoA pt), maxillary incisor proclination (SN-MIA) and mandibular incisor retroclination (I-MPA), and occlusal plane (SN OP, SN-GoGn). All 4 components played a role in correcting the occlusion, but the relative amount each component contributed to the correction varied greatly among the pa-

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Class I (P 0.05; Fisher exact test). The maxilla lengthened as measured from Condylion (Co) to A pt (P 0.05). Most patients showed dental compensation and rotation of the occlusal plane under continuous Class III elastic wear; however, these observations did not show statistical differences with an older group of control patients who were being prepared for orthognathic surgery. None of the 24 patients with cleft lip and palate who underwent maxillary protraction needed additional orthognathic surgery. In other words, additional mandibular growth did not cause a need for retreatment of the Class III malocclusion. Currently, we are trying to prole the patient who chose protraction treatment and carried the protocol to completion. A consistent characteristic found in patients who failed maxillary protraction treatment was an inability to follow the protocol exactly as it was presented to them. Their treatment was interrupted by periods of poor cooperation when they did not have a daily routine for turning the expansion screw, using the facemask and Class III elastics. We advised our patients who considered maxillary protraction that this treatment required considerable commitment and cooperation from the patient and additional appointments are usually required to check their progress.

A Rationale for the Use of Microimplants for Maxillary Protraction

In our original study, we tried to calculate what percentage of the correction was attributable to maxillary incisor proclination, mandibular incisor retroclination, occlusal plane rotation, and maxillary advancement. The question we tried to address was how to increase the skeletal component percentage of the correction. Microimplants, known also as miniscrews and temporary anchorage devices, have the potential to transmit expansion and protraction forces directly to the bone and were used in a small number of patients to limit excessive dental compensation with Class III elastics and increase maxillary advancement in patients with large anterior crossbites that ranged from 8 to 14 mm. We found that microimplants could produce more skeletal change in our patients with cleft lip and palate while limiting skeletal relapse.

Figure 3. After treatment. (A) Intraoral frontal view patient wearing retainers with articial tooth; (B) preand posttreatment tracing; and (C) vacuum-form retainers with buttons for Class III elastics. (Color version of gure is available online.)

tients as did their level of cooperation. In this small sample, we could not separate out why some patients had more skeletal correction than others. At the occlusal level, the Wits analysis showed a correction from Class III to

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Figure 4. Lateral cephalometric radiographs of a patient treated by maxillary protraction demonstrating the importance of overcorrection and settling after expander removal. (A) Lateral cephalographs taken before protraction; (B) overcorrection with 9 mm of overjet; and (C) settling of occlusion at the end of treatment.

Figure 5 shows the lateral cephalometric radiograph of a patient with a 12-mm Class III malocclusion and anterior open bite who was originally referred for distraction of the maxilla. He was treated with microimplants and maxillary protraction because the patient refused surgery. Microimplants were placed near the palatal midline for the RPE to engage the palatal microimplants, thereby transferring the force of the intraoral elastics to the RPE and mobilized maxillary bone. After protraction, Class III elastics helped to limit the amount of skeletal relapse. A second set of microimplants were placed mesial to the mandibular canine to tie a metal wire loop between the microimplant and rst molar band.22 This indirect wire tie was used to limit molar distalization and incisor retroclination during treatment with Class III elastics. The combination of maxillary and mandibular microimplants allowed very large malocclusions to be corrected without surgery. In our older patients, we found that it was possible to use microimplants to force the sutures open and to expand a maxilla; however, the expansion was not stable. Although RPE combined with microimplants expanded the maxilla without causing pain to an older patient, the screws tended to loosen during repetitive expansion and constriction. For a stable expansion in older patients, palatal distractors, such as the Surgi-Tec distractor (Brussels, Belgium) that are completely bone borne were used with surgical assistance rapid palatal expansion (SARPE). The placement of microimplants required planning to be done early on. If microimplants were to be used with RPEs, then the original design of the hyrax RPE was modied so the screw housing was seated high in the palatal vault near the mucosa to engage the microimplant. For the mandibular microimplants, only the gingiva at the site of microimplant access was anesthetized by local anesthetics before placement. During positioning of the microimplant, a painful response from the patient would warn the orthodontist and surgeon that the microimplant had encroached the mental nerve or dental root and needed to be redirected. Although maxillary protraction may theoretically be possible in older patients, many patients in their late teens are not cooperative enough to wear facemasks and elastics. Or-

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Figure 5. Microimplant-supported maxillary protraction. (A) Extraoral prole view; (B) intraoral frontal view showing lower microimplant position; (C) intraoral frontal view showing treatment changes; (D) palatal occlusal view showing microimplant positions; (E) pretreatment lateral cephalogram; (F) post-treatment cephalogram after 4 months of maxillary protraction; and (G) posttreatment extraoral prole view. (Color version of gure is available online.)

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thognathic surgery which is faster and less dependent on patient compliance should be the rst choice for adult and late teenage patients with a skeletal Class III discrepancy. For the patient with cleft lip and palate and maxillary hypoplasia who is unwilling to undergo orthognathic surgery, a SARPE with a LeFort 1 cut can be used to simultaneously expand and protract the maxilla. The recovery for this surgery is less than a week. In skeletal versus dental movements, the SARPE paradoxically produced a high amount of maxillary incisor proclination and lower incisor retroclination. It is not known whether palatal microimplants can limit this protraction response.

Discussion
Maxillary protraction during early adolescence can be a viable alternative to orthognathic surgery in certain cleft lip and palate patients. This technique worked well when an adolescent patient was highly motivated. Thus far, the maxillary protraction protocol has been more successful in girls than in boys during the middle school years. The reasons for patient compliance varied: some patients wanted earlier correction of the facial deformity; some feared orthognathic surgery. The protraction protocol did not work in patients who intermittently followed the protocol, did not overcorrect into Class II occlusion or discontinued the Class III elastics before bony consolidation occurred. Maxillary protraction is therefore not for all patients. Weekly visits screened for problems with the technique or the compliance as the patient was tested for competency with the expansion/constriction and facemask treatment. The patient should be able to insert the activator key into the turnbuckle hole of the RPE and without hand support. If the activator key did not stay in the turnbuckle hole, then it was not properly inserted. In addition, we checked whether the expander was in an expanded position after 28 turns (4 turns/day for 7 days) were completed. When patients reported pain during expansion, then they may have been too old to be expanded with an RPE because of early fusion of the maxillary sutures. Their treatment was changed to conventional orthognathic surgery or SARPE/LeFort 1 protraction. In one case, late dental eruption of permanent teeth delayed the timing of treatment and caused

problems when the maxillary sutures fused before the permanent dentition had completed their eruption. For the orthodontist, the protocol involves an additional cost for making appliances, remaking appliances that do not t well and additional patient appointments. Some patients will stop the protocol procedures within the rst month and elect to have surgery. It is helpful to let patients considering maxillary protraction meet with other patients undergoing protraction treatment for mutual encouragement and for patients to see the nal outcomes. Our interest in this technique continues because thus far, we have not retreated any of the patients with surgery if they completed the maxillary protraction protocol. Treatment relapse often occurred but in most cases, it was planned for by overcorrection. Our treatment failures occurred early during the expansion/constriction phase of treatment. Either the device failed or patient compliance issues were identied. Thus, the rst 3 to 4 months of treatment was used to determine whether the treatment would be successful and avoid long-term investments of time and resources. Most parents were not sure whether their child would be compliant enough to carry out the protocol but were willing to try out the technique to avoid orthognathic surgery. We have used microimplants in challenging cases per our patients request. Some of these patients were candidates for maxillary distraction osteogenesis and secondary orthognathic surgery; however, at this time, it is an experimental procedure and requires more study. With maxillary protraction, microimplants are likely to play a role in maximizing skeletal change and preventing skeletal relapse. As a closing note, it should be noted that orthodontists tend to adapt other techniques into their practice. The most common mistakes by other orthodontists when trying our protocol were forgetting to use Class III elastics to support the protraction and placing a maxillary archwire during expansion and constriction.

Acknowledgments
The multicenter clinical trial is being planned through a grant from the NIDCR: NIH R21 DE19164-01.

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References
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12. Steinberg B, Padwa BL, Boyne P, et al: State of the art in oral and maxillofacial surgery: Treatment of maxillary hypoplasia and anterior palatal and alveolar clefts. Cleft Palate Craniofac J 37:421-422, 2000 13. Williams MD, Sarver DM, Sadowsky PL, et al: Combined rapid maxillary expansion and protraction facemask in the treatment of Class III malocclusions in growing children: A prospective long-term study. Semin Orthod 3:265-274, 1997 14. Tindlund RS: Orthopaedic protraction of the midface in the deciduous dentition. Results covering 3 years out of treatment. J Craniomaxillofac Surg 17(Suppl 1):17-19, 1989 15. Ranta R: Orthodontic treatment in adults with cleft lip and palate. J Craniomaxillofac Surg 17(Suppl 1):42-44, 1989 16. So LL: Effects of reverse headgear treatment on sagittal correction in girls born with unilateral complete cleft lip and cleft palate-skeletal and dental changes. Am J Orthod Dentofac Orthop 109:140-147, 1996 17. Buschang PH, Porter C, Genecov E, et al: Face mask therapy of preadolescents with unilateral cleft lip and palate. Angle Orthod 64:145-150, 1994 18. Liou EJ, Tsai WC: A new protocol for maxillary protraction in cleft patients: Repetitive weekly protocol of alternate rapid maxillary expansions and constrictions. Cleft Palate Craniofac J 42:121-127, 2005 19. Liou EJ: Effective maxillary orthopedic protraction for growing Class III patients: a clinical application simulates distraction osteogenesis. Prog Orthod 6:154-171, 2005 20. Do-Delatour T, Ngan P, Martin CA, et al: Effect of alternate maxillary expansion and contraction on protraction of the maxilla: A pilot study. Hong Kong Dent J 6:72-82, 2009 21. Shang W, Scadeng M, Yamashita DD, et al: Manipulating the mandibular distraction site at different stages of consolidation. J Oral Maxillofac Surg 65:840-846, 2007 22. Vachiramon A, Urata M, Kyung HM, et al: Clinical applications of orthodontic microimplant anchorage in craniofacial patients. Cleft Palate Craniofac J 46:136-146, 2009