Effects of Cleft Palate Repair in Infancy

The management of individuals with unilateral cleft lip and palate (UCLP) presents specific clinical challenges for the maxillofacial surgeon, the orthodontist, and the restorative dental team. Orthognathic surgery is a procedure that should be considered as part of the treatment algorithm for patients with UCLP. Ross completed a multicenter, long-term facial growth study to assess the need for orthognathic surgery among individuals born with complete UCLP who had undergone primary lip and palate repair during childhood. He concluded that, even by the most conservative standards and in conjunction with maximum compensating orthodontic camouflage maneuvers, at least 25% of adolescents with UCLP required orthognathic surgery to achieve even the limited objective of a neutralized occlusion.¹⁴⁸ His research indicated that only 25% of adolescents with UCLP had near-normal maxillary growth and that another 50% were in a borderline category with some degree of maxillary hypoplasia. Ross stated that individuals who were born with a cleft lip and palate have an intrinsic deficiency in the midfacial skeleton that is made worse by operations. More recently, Mulliken and colleagues reviewed the prevalence of Le Fort I osteotomies among patients with cleft lip and palate who were treated at Boston Children’s Hospital.⁵⁵ They found that 48% of UCLP patients who underwent repair in infancy later required orthognathic surgery. The study also showed that the need for orthognathic surgery is dependent on the severity of the cleft type as well as the number and extent of previous operative procedures. Similarly, The Hospital for Sick Children in Toronto, Ontario, Canada, found that 48.3% of their patients (i.e. treated since infancy) with complete UCLP required orthognathic surgery. When they looked at all patients with UCLP who were referred to their center, they found that 59.4% needed jaw surgery.²⁷ A retrospective cohort study of five prominent cleft palate centers in North America compared the maxillomandibular relationships of individuals with non-syndromal complete UCLP (n = 169).⁶³ The one center that incorporated primary alveolar bone grafting showed especially poor maxillary growth, with 66% of its patients requiring orthognathic surgery. Interestingly, at the one center in which a single surgeon performed all of the surgeries with the use of a more delayed approach to cleft palate repair and whose patients underwent no revisions until they were 14 years old showed the lowest need for orthognathic surgery at less than 25%.

Saperstein and colleagues described the facial growth of children with complete clefting of the primary palate (i.e., the lip through the incisal foramen) but with an intact secondary palate (i.e., the incisal foramen through the uvula).¹⁵¹ This was a retrospective, cross-sectional analysis of non-syndromal patients with unilateral complete clefting of the primary palate as compared with those with unilateral complete clefting of both the primary and secondary palates. Angular and linear measurements of the midfacial region were made on lateral cephalograms. The study groups included those with unilateral complete clefting of the primary palate (n = 25) and those with unilateral complete clefting of the primary and secondary palate (n = 18). The study documented that individuals with a cleft of only the primary palate who underwent lip repair during infancy typically had a normal or even slightly forward maxillary position as compared with age-matched controls. This was in contrast with children with a cleft of both the primary and secondary palates who underwent lip repair followed by palate repair before they were 1 year old; this group showed a high incidence of maxillary deficiency. The study clarified that the cleft palate repair carried out before 1 year of age—and not the cleft lip repair itself—was responsible for the high incidence of midface hypoplasia.

Effects of Achieving Bone Fusion Across the Cleft Alveolus during Infancy

Reconstruction of the alveolar process in patients with UCLP is an essential part of cleft care. Accomplishing this goal provides support for the alar base of the nose; the teeth in the cleft region; and the periodontium that surrounds those teeth (Figs. 32-1 and 32-2). There are three basic methods that have been described for the closure of the cleft alveolus: 1) primary bone grafting; 2) secondary bone grafting; and 3) gingival periosteoplasty (GPP).⁵⁶ The method of primary bone grafting is now generally recognized to result in severe midface growth disturbance and has therefore been universally abandoned throughout the world.^63,148 The use of secondary (mixed dentition) bone grafting is generally recognized as an effective method to avoid the problem of additional midface growth disturbance and to successfully achieve support for the alar base; to provide bone for the eruption of the canine through the grafted cleft site; and to establish effective periodontal support (Figs. 32-3 through 32-6).¹

The technique of GPP was first described by Skoog in 1965 as a method to achieve fusion across the cleft alveolus at the time of lip repair. The goal was to “remove” the cleft during infancy with the hope that no harm would result.¹⁵⁶ Millard included the use of the Latham device to position the alveolar ridges close to one another before going forward with the GPP procedure at the time of lip repair.^105,106 Grayson and Cutting later proposed the use of a nasoalveolar molding device before the GPP and primary lip repair to accomplish the same alveolar ridge fusion. Several studies confirm that the GPP procedure has a high osteogenic potential that results in the deposition of bone to achieve successful fusion of the alveolar ridge. Unfortunately, clinical studies do not confirm sufficient bone fill to consistently allow for the eruption of the canine through the ridge and to provide ideal periodontal support. Since the late 1970s, clinical studies have been carried out to assess the long-term effects of GPP on midfacial growth in cleft patients.

In 1999, Millard and colleagues used serial dental casts to evaluate the effects of GPP on maxillomandibular relationships.¹⁰⁶ They found a greater frequency of anterior crossbite in the GPP group than in the non-GPP group. They also confirmed that the GPP group had a shorter anteroposterior length of the maxilla as compared with the non-GPP group at 6 years of age. Similar findings of poor midface growth have been documented by Berkowitz and colleagues,⁹ Matic and Powers,⁹⁹ and others.^70,169 In 2005, Renkielska and colleagues evaluated the impact of GPP on occlusal relationships with the use of the Goslon Yardstick occlusal grading system.¹⁴³ They found that patients treated with GPP had a poor occlusal relationship and a Goslon Yardstick score of 4 and 5, thus indicating need for orthognathic surgery. They reaffirmed that the inclusion of the alveolar process in the primary lip repair increased severe occlusal maldevelopment.

More recently, Hsieh and colleagues completed a retrospective clinical study to evaluate the effects of GPP on facial growth in patients with UCLP.⁷⁴ Sixty-two consecutive patients with non-syndromal complete UCLP with records from when they were 5 years old were included in the study. All of the patients had received nasoalveolar molding treatment before primary lip repair. Those individuals who underwent GPP at the time of lip repair (n = 26) were placed in one group. Those that did not undergo GPP at the time of lip repair (n = 36) were placed in another group. Cephalometry was used to evaluate facial growth at 5 years of age in the two treatment groups. GPP was found to have significant negative effects on the maxillary position (i.e., diminished horizontal projection), the intermaxillary position (i.e., negative overjet), the maxillary length, and the maxillary alveolar length at the age of 5 years. The authors concluded that, in patients with UCLP, the sagittal growth of the maxilla was significantly adversely affected by the GPP procedure. As a result of their study, the Chang Gung Cleft Center no longer uses the GPP technique.

1. Maxillary hypoplasia. The maxilla is often vertically short and canted (upward on the cleft side), and the maxillary dental midline is usually shifted off of the facial midline toward the clefted side. Arch-width deficiency that results in a dental crossbite is usually present. The hypoplastic maxilla is retruded in the horizontal plane, thereby resulting in a concave midface profile. There will be an Angle Class III malocclusion and negative overjet. In general, the greater and lesser maxillary segments vary with regard to the degree of dysplasia, thereby making it difficult to achieve a satisfactory occlusion and facial appearance by repositioning the maxilla in one unit. Separation in two segments (through the cleft) with differential repositioning is often required for the management of the arch shape, even if successful mixed-dentition grafting was accomplished.

2. Residual oronasal fistula. Despite a preference for oronasal fistula closure during the mixed dentition, the UCLP candidate for orthognathic surgery will often have residual labial and palatal fistulas. Previous attempts at closure may have failed. Furthermore, buccal (non-keratinized) mucosa may have been placed over the cleft site, thereby resulting in a lack of attached gingiva (keratinized mucosa) in the tooth-bearing region and a loss of vestibular depth.

3. Residual bony defects. In the patient with UCLP who has not been successfully or adequately grafted during the mixed dentition, a bony defect not just at the alveolus but throughout the hard palate and the floor of the nose may exist. This results in an inferiorly displaced or deficient floor of the nose and nasal sill with rotation of the anterior nasal spine and the septum toward the cleft. There may also be inadequate alveolar bony, gingival, and periodontal support for the teeth adjacent to the cleft.

4. Cleft–dental gap. Studies confirm that, approximately 93% of the time in patients with UCLP, the lateral incisor is either congenitally absent or inadequate at the cleft site.163,164 A hypoplastic lateral incisor or a supernumerary tooth may be present adjacent to the cleft, but it will have inadequate root development. Orthodontic closure of this dental gap by bodily moving the canine tooth into the bone-grafted lateral incisor location is generally considered the preferred approach. For a variety of reasons, this may not have occurred at the time of referral for orthognathic surgery. At times, there is mesial angulation of the canine (i.e., crown tipped) into a marginally grafted or non-grafted cleft site, while the apex of the root remains distal. The result may be a full or partial dental crown gap at the cleft site between the central incisor and the canine but with an even greater separation of the roots.

5. Chin dysplasia. The patient with UCLP will frequently suffer with a lifelong history of obstructed nasal breathing and an open-mouth posture. This is often the result of anatomic deformities, including septal deviations, inferior turbinate hypertrophy, an irregular nasal floor, and nasal vestibular stenosis. The presence of a pharyngeal flap since childhood may further increase an open-mouth breathing tendency. The resulting chin deformities that occur during growth are often characterized by excess vertical length and horizontal retrusion.

6. Mandibular dysplasia. True mandibular prognathism or retrognathism is uncommon in the patient with UCLP. However, the need for mandibular osteotomies is frequent. This should be limited to the correction of secondary deformities that result in facial asymmetries and skeletal distortions and the occasional true anteroposterior discrepancy.88,89,171

7. Nasal obstruction and sinus blockage. Obstructed breathing through the nose and frequent bouts of sinusitis are typical among patients with UCLP. This results from a combination of septal deviation; enlarged inferior turbinates; deformities of the nasal aperture, the floor of the nose, and the anterior nasal spine region; and stenosis of the nasal vestibule.

8. VP dysfunction. It has been shown that approximately 20% of patients with a repaired cleft palate will have VP insufficiency by the time they are 5 years old. The adolescent with UCLP who arrives for the evaluation of a cleft jaw deformity may have already undergone a pharyngoplasty with a pharyngeal flap. The planned Le Fort I osteotomy with advancement will alter the upper airway and may also negatively affect VP function, as described later in this chapter.

Evolution of Surgical Technique

Historically, the literature warned of possible complications with maxillary osteotomy among patients with UCLP but provided only limited and often confusing descriptions of techniques to guide the orthognathic surgeon in the performance of safe, reliable osteotomies to solve these complex problems.¹⁵⁸

As with other aspects of orthognathic surgery, Hugo Obwegeser’s milestone contributions to cleft skeletal reconstruction are important (see Chapter 2). By the late 1960s, Obwegeser succeeded in advancing a cleft maxilla to the preferred location without the need for a compromised mandibular setback approach. He eventually felt comfortable with cleft maxillary advancements of up to 20 mm. He also realized that the adequate mobilization of the Le Fort I down-fracture was the key step in advancing the maxilla, whether the patient had clefting or not. With experience, the value of simultaneously closing the cleft–dental gap by moving the lesser segment further forward to position the canine in the lateral incisor location was appreciated. This differential segmental repositioning would essentially replace an anterior dental gap for an edentulous space in the posterior maxilla.

Early on, other surgeons without Obwegeser’s level of expertise reported complications after advancing the maxilla in patients with UCLP.113–117,119,120 In 1974, Willmar described the problems that occurred in 17 patients with UCLP who underwent Le Fort I osteotomy. One patient had aseptic necrosis and a partial loss of the lesser segment of the maxilla.¹⁷⁸ In 1974, Georgiade suggested that a camouflage approach with mandibular osteotomies and set-back was preferred to maxillary advancement to avoid complications.⁵¹ Kiehn and others and Des Prez and Kiehn warned of blood-supply problems that might occur with maxillary osteotomies in patients with cleft lip and palate.^30,83 In 1975, Henderson and Jackson reported combining lip-scar revision, anterior fistula closure, and maxillary osteotomy in a one-stage procedure.⁶⁹ Their concept was innovative, but they did not specify details of their technique. In 1978, Jackson described the technique of Le Fort I osteotomy in patients with cleft lip and palate and noted that, if a large fistula was present, extensive flap mobilization for closure was required, and the blood supply might be compromised.⁷⁷

Historically, surgeons were leery of completing a Le Fort I down-fracture and full mobilization in patients with UCLP because they feared flap necrosis with a subsequent loss of bone and teeth.6,7,31–33,52,53,87 In 1980, Tideman and colleagues proposed the segmental palatal osteotomy for patients with cleft lips and palates.¹⁶⁸ This procedure required significant subperiosteal degloving with the potential for compromised flap circulation but without providing the needed direct exposure for full disimpaction. In 1980, Sinn also reported on the simultaneous Le Fort I advancement, oronasal fistula repair, and bone grafting of the alveolar cleft.¹⁵⁵ He stressed the importance of preserving a vertical soft-tissue pedicle, which was similar to that described by Tideman and colleagues. He completed osteotomies through tunnels rather than under direct vision and used a cheek rotation flap for oral-side closure of the labial and palatal oronasal fistulas. With this technique, non-keratinized buccal mucosa (rather than attached gingiva) was brought into the cleft tooth-bearing region. In 1984, Ward-Booth and colleagues described the results of Le Fort II osteotomy in 13 patients with clefts for the management of midface hypoplasia in an attempt to improve blood supply to the alveolar segments.¹⁷⁵ The residual fistulas were not simultaneously closed, and fixation occurred with direct wires, intermaxillary fixation, and external appliances. In 1985, James and Brook described another variation for the correction of maxillary hypoplasia in patients with cleft lips and palates via the transection of the hard palate.⁷⁸ They raised an extensive palatal flap and used three vertical stab incisions for exposure on the labial aspects of the maxilla. Access was then achieved through subperiosteal tunneling and without direct exposure. Fixation was with intermaxillary fixation and a halo head frame, which was maintained for 10 weeks. A second procedure was required for bone grafting and palatal fistula closure. The authors expressed concern that a more direct down-fracture of the maxilla would result in vascular compromise to the segments. In 1985, Poole and others proposed an additional modification of the Le Fort I osteotomy to be used in patients with cleft palates.¹²⁸ With their technique, a partial-thickness palatal flap was elevated, which left the greater palatine vessels in situ and allowed the maxilla to be repositioned anteriorly, without displacement of the soft palate. Poole and colleagues believed that this approach would limit interference with VP function; they also used small vertical incisions on the labial aspect that required tunneling and lacked direct exposure for osteotomies, disimpaction, fistula closure, bone-graft placement, and plate and screw fixation. Fixation in this series was with intermaxillary fixation, direct wires, and a halo craniomaxillofacial head frame.¹²⁸

During the 1980s and the 1990s, Posnick used and refined Obwegeser’s original techniques involving Le Fort I osteotomy for the treatment of UCLP deformities.129–142 A key aspect was the circumvestibular incision, which allowed for direct exposure for dissection, osteotomies, disimpaction, fistula closure, septoplasty, inferior turbinate reduction, pyriform aperture recontouring, bone grafting, and the application of plate and screw fixation (see Fig. 32-5). This was found to be a reliable approach that did not involve the risk of circulation injury to the greater and lesser dento–osseous–musculo–mucosal segments. The visibility provided by the circumvestibular incision made possible the incorporation of routine closure of the cleft–dental gap through differential maxillary segmental repositioning without necrosis of the bone or any loss of teeth. This method also closes the cleft dead space and brings together the labial and palatal flaps without the need for subperiosteal undermining, which allows for the closure of recalcitrant oronasal fistulas without tension and the establishment of the periodontal health of the cleft adjacent teeth. The down-fracture provides ideal exposure for septoplasty; for the reduction of the hypertrophic inferior turbinates; and for the recontouring of the pyriform rims, the floor of the nose, and the anterior nasal spine. The success of this approach, as initially carried out by Obwegeser,^{114–117,119,120} was confirmed by Bell’s demonstration of the blood supply to these maxillary segments in animal studies.^6–7 The clinical advantages were then further documented by Posnick and colleagues in a consecutive series of UCLP patients.^129–142

Since the mid 1990s, the literature concerning cleft orthognathic surgery has mostly focused on use of DO techniques to avoid the need for complete intraoperative mobilization of the maxilla in the hopes of improved long-term stability.¹⁶⁶ Although the issue of skeletal stability and dental relapse for precise long-term occlusion is important, it should not overshadow the value of achieving the other planned improvements of the airway and enhanced facial aesthetics.^129–142 Unfortunately, the use of DO techniques has not altered the challenges of cleft jaw surgery, which include the following: 1) a lack of postoperative growth when maxillary advancement is carried out in children; 2) a worsening of VP function in some patients; 3) injury to the teeth and bones if circulation to the segments is not maintained; 4) facial and intraoral sensory loss; 5) suboptimal facial aesthetics when basic principles are not followed; and 6) concern for postoperative skeletal or dental relapse (i.e., residual malocclusion). In addition, DO techniques require a prolonged and labor-intensive postoperative convalescence for the patient and family as compared with the standard approach. Despite these disadvantages, DO does offer hope to the occasional patient with UCLP who also has severe maxillary hypoplasia and anodontia (see Fig. 32-21 and the section about controversies later in this chapter).

Standard Le Fort I Osteotomy

The adolescent or adult CLP patient with a jaw deformity but without a residual fistula and with an intact alveolar ridge of adequate height and volume in the area of the cleft may have been born without alveolar clefting or had a successful graft.³⁴ For those with adequate alveolar ridge height and volume, a closed palate, and sufficient periodontal support, a standard Le Fort I osteotomy can be performed (see Figs. 32-8, 32-9, and 32-10). A segmental maxillary osteotomy to adjust the arch width, to correct the vertical dimension, or to close the cleft dental gap to avoid the need for a prosthetic lateral incisor may also be necessary in some of these patients (see Chapter 15). Unfortunately, even in the 21st century, a number of adults and adolescents with UCLP with maxillary hypoplasia also present with alveolar defects and oronasal fistulae. For these patients, a modified (two-segment) Le Fort I osteotomy should be considered, as discussed in the next section of this chapter (see Figs. 32-11 through 32-21).^129–142

Modified Le Fort I Osteotomy (Two Segments)

A maxillary circumvestibular incision is made from one zygomatic buttress to the other without the need to maintain a labial pedicle. Parallel vertical incisions are then made labially in the region of the residual oronasal fistula to separate the oral and nasal mucosa on each side of the cleft. These incisions are perpendicular to the horizontal vestibular incision and follow the line angles of the teeth adjacent to the cleft (i.e., the canine and the central incisor). The nasal and oral mucosa are carefully incised along the palatal aspect of the residual oronasal fistula. Further separation of the tissue layers is accomplished when dissecting the nasal mucosa free of the bony floor during down-fracture. The complete separation of the oral and nasal layers is necessary for the initial down-fracture and then later for the fistula closure. This is accomplished without degloving the palatal mucosa from the underlying hard palate, because this would compromise the circulation to the maxillary segments.

Before osteotomy, subperiosteal dissection on the anterior surface of the maxilla is completed up to the infraorbital foramina. The anterior nasal spine, the pyriform apertures, and the floor of the nose are also exposed. Dissection continues posteriorly past the maxillary tuberosities to the pterygoid–maxillary suture on each side. After retractors have been put in place, horizontal osteotomies are carried out above the roots of the teeth and into the maxillary sinus through the lateral, anterior, and medial maxillary walls with a reciprocating saw and a long straight blade. The nasal septum is separated from the base of the maxilla with the use of a protected chisel. The pterygoid–maxillary sutures are separated with a curved chisel, and the maxilla is down-fractured. Direct trauma of the palatal mucosa via compressive forces during mobilization should be minimized, because such forces could compromise the vascular supply.

Subperichondrial and subperiosteal dissection of the deviated vomer, the perpendicular plate of the ethmoid, and the quadrangular cartilage is accomplished after the maxilla has been down-fractured. Resection of the deviated and buckled aspects of the septum (i.e., the bone and cartilage) is done with a rongeurs while preserving the structural components of the cartilaginous septum (i.e., the dorsal strut and the caudal strut) that are necessary to prevent a late saddle-nose deformity (see Chapter 15). If the inferior turbinates are enlarged, they are also reduced to improve the airway. The nasal mucosa flaps are sutured for a watertight nasal-side closure. If indicated, the impacted maxillary third molars are removed from above through the maxillary sinus (see Chapter 15).

The down-fractured maxilla may already be in two segments if the bony cleft was unrepaired. If the maxilla is intact but needs correction of the arch form, then it is separated using a reciprocating saw with short straight blade. The approximation of the segments to close the cleft–dental gap can occur after bony spurs are shaved from the alveolus along the distal aspect of the central incisor and the mesial aspect of the canine using a rotary drill with a watermelon bur. Care is taken to avoid penetrating the lamina dura, which would expose the dental root and may result in external root resorption. The maxillary segments are then ligated into a prefabricated acrylic occlusal splint. The segmental repositioning closes the cleft–dental gap, brings the alveolar ridges together, and approximates the labial and palatal mucosal soft tissues for oral-side fistula closure. The differential segmental repositioning approximates the mucosal edges along the palate, so they do not need to be sutured. In fact, to limit invaginations of the oral mucosa, the excision of redundant palatal mucosa is generally required just before the segments are placed in the splint. The placement of the splinted maxilla onto the mandibular dentition should be passive. The extent of maxillary advancement is based on the preferred occlusion and the facial aesthetics determined preoperatively. The ideal vertical dimension is achieved intraoperatively on the basis of the preoperative plan (see Chapter 12). The maxillary osteotomy sites are fixed in place with titanium miniplates and screws at each zygomatic buttress and pyriform rim in accordance with the principles originally described by Luhr.⁹² An additional microplate is frequently applied horizontally across the cleft site to stabilize the closure of the cleft–dental gap. The intermaxillary fixation is released, and the occlusion is checked.

The lateral nasal rims, the floor of the nose, and the anterior nasal spine region are recontoured using a rotary drill with a watermelon bur to improve the nasal airway and to enhance nasal aesthetics (see Chapter 15). The dead space associated with the alveolar cleft has already been closed by the differential segmental repositioning. Autogenous iliac cancellous bone graft may be packed along the floor of the nose to raise the ipsilateral sill and across the cleft palate to stabilize the segments. Generally, a crafted iliac corticocancellous bloc graft is placed in between the zygomatic and pyriform fixation plates on each side. Each graft is tightly wedged into the space created by the horizontal advancement and the vertical lengthening (see Chapters 15 and 18). An additional microplate is contoured and secured across the osteotomy, and it also incorporates the graft. With the cleft–dental gap surgically closed, the redundant labial mucosa is excised. Attached gingiva and mucosal edges are approximated without tension and then directly sutured without the need for rotation flaps.

Mandibular and chin osteotomies to correct secondary deformities and facial asymmetries are frequently planned. If so, the osteotomies are completed and secured with plate and screw fixation in standard sequence (see Chapter 15). After the completion of all of the osteotomies and the placement of fixation and grafts, the wounds are closed. The upper and lower teeth are approximated with orthodontic elastics. When maxillary segmental osteotomies are completed, the splint remains wired to the upper teeth postoperatively (see the orthodontic considerations section earlier in this chapter).

Mobilization of the Down-Fractured Cleft Maxilla

Full mobilization of the Le Fort I down-fracture is a critical step in the achievement of accurate intraoperative maxillary repositioning and then with long-term maintenance. Both pterygoid and nasomaxillary disimpaction forceps are used as needed to achieve full mobilization. Taking the necessary time to slowly complete the disimpaction (i.e., 10 to 15 minutes) is often crucial to achieving the desired results. Gaining confidence—first through observing and assisting an experienced cleft jaw surgeon and then by using one’s own hands—is essential to achieving success with the mobilization process.

Horizontal Advancement and Vertical Lengthening of the Cleft Maxilla

The surgeon must often carry out significant horizontal advancement, vertical lengthening, and midline, cant, and occlusal plane correction to enhance facial aesthetics, achieve dental health, and open the airway in a patient with UCLP. The scarring of the palatal soft tissues from previous repairs may be of concern when planning an extensive advancement. A scarred and hypotonic repaired unilateral cleft lip may also caution the surgeon against the vertical lengthening that the midface demands.

In general, to achieve full skeletal correction, all or most of the negative overjet should be managed in the maxilla. The sagitally deficient maxilla in a patient with UCLP will also typically need vertical lengthening. When the maxilla is fully mobilized and repositioned as described previously, stabilization with titanium plates and screws (i.e., a plate at each zygomatic buttress and each pyriform aperture) is performed. The placement of a bloc corticocancellous graft wedged into the dead space between the zygomatic buttress and the pyriform aperture plate on each side is generally necessary (see Chapter 15). Further stabilization across each graft with a titanium plate and screws is also required (see Chapter 15).

Closure of Residual Oronasal Fistula and Alveolar Ridge Management

Ideally, full closure of a residual oronasal fistula and adequate alveolar bone grafting will have been carried out during the mixed dentition. If not, the modified Le Fort I osteotomy in two segments (as described previously) provides the opportunity for complete oronasal fistula closure of the palatal and labial aspects and for the management of skeletal deficiencies without the need for direct alveolar grafting. Many times, grafting and fistula closure will have been carried out during the mixed dentition but without complete correction. A residual fistula may remain on the palatal side; if the dental gap was not closed with the use of orthodontic mechanics (cuspid advancement) after grafting, the volume of bone at the cleft site is likely inadequate for dental implant placement. Unfortunately, when completing a Le Fort I down-fracture without segmental repositioning, any residual palatal fistula cannot be reliably closed, because this would require elevating the palatal flaps and a risk of aseptic necrosis. Direct augmentation of an intact but hypoplastic alveolar ridge at the time of down-fracture is also not practical, because excessive soft-tissue flap elevation around the ridge would be required.

Managing the Nasal Cavity and the Nose

In the patient with UCLP, the inferior turbinates will often be enlarged, asymmetric, and partially blocking the nasal cavity. The reduction of enlarged inferior turbinates will be beneficial for breathing and sinus drainage. The procedure is accomplished through the Le Fort down-fracture (see Chapter 15 and Fig. 32-10).

In the patient with UCLP, the septal bone and cartilage generally show significant deviation and thickening, thus further obstructing the airway. The completion of a submucous resection of the deviated portions of the septum will be helpful to open the airway. The preservation of caudal and dorsal cartilaginous struts will prevent a saddle deformity; this is accomplished through the Le Fort down-fracture (see Chapter 15 and Fig. 32-10).

In the patient with UCLP, the pyriform rims are generally constricted and asymmetric. The nasal floor is uneven, and the anterior nasal spine is deviated. After Le Fort down-fracture, the recontouring of the pyriform rims and the nasal floor and spine using a rotary drill with a watermelon bur is helpful to open the airway and improve nasal aesthetics (see Chapter 15 and Fig. 32-10).

Attempts to “control” the nasal soft-tissue envelope with suturing techniques (e.g., the alar cinch stitch) after Le Fort I osteotomy are often suggested. In my experience, manipulating the nasal soft tissues with suturing techniques after Le Fort I may be counterproductive to both the airway and the facial aesthetics. We anticipate that the nasal soft tissues will be redraped over the repositioned maxilla and the recontoured pyriform rims, nasal floor, and nasal spine for an overall improvement in aesthetics. A definitive rhinoplasty to fully correct the UCL nasal deformities is often beneficial; this is best postponed until 6 to 12 months after jaw reconstruction (see Chapter 38).

Immediately after surgery, the nasal cavity is not packed, and the septum is not stented. Coagulated blood will partially block nasal breathing. The clots and scab are expected to dislodge and be self-eliminating after the underlying mucosa is initially healed (i.e., 5 to 7 days after surgery). The use of saline nasal sprays and the institution of sinus precautions are helpful during this time (see Chapter 11).

Management of the Mandibular Deformity

In the individual with UCLP, the mandible is often secondarily deformed. In a previously published study, 70% of the patients with UCLP had secondarily deformed mandibles to the extent that sagittal split ramus osteotomies were beneficial to improve facial symmetry and proportions.¹⁴¹ The mandibular repositioning is not carried out in an attempt to avoid maxillary advancement but rather to improve overall facial morphology (see Chapter 15).

Management of the Chin Deformity

In the patient with UCLP with maxillary hypoplasia, the chin is often secondarily deformed, with increased vertical length and a flat pogonion. An intraoral oblique inferior border osteotomy is carried out with repositioning and reshaping of the distal chin to accomplish the preferred morphology (see Chapters 15 and 37).

Patients and Methods

Posnick and Tompson prospectively assessed the cleft deformity and clinical results of 66 consecutive adolescents and young adults (age range, 15 to 25 years; mean, 18 years) with UCLP who underwent orthognathic surgery by one surgeon (Posnick) with the use of a single surgical protocol during a 6-year time period.¹⁴¹ All patients underwent perioperative orthodontic treatment and were judged to be skeletally mature at the time of jaw surgery. The clinical follow-up period after maxillary advancement ranged from 1 to 7 years (mean, 40 months). The countries of origin of the patients varied (e.g., Canada, United States, Eastern Europe, Southeast Asia), as did their races (e.g., Caucasian, Asian, African). These patients had their cleft lips and palates repaired by many different surgeons who were using a variety of protocols. The number and extent of previous revisions of the lip, nose, and palate varied greatly (range, 1 to 9 procedures). Many patients had undergone multiple attempts at closure of the residual oronasal fistula and at the reconstruction of the alveolar clefts with bone graft. Seven of the 66 patients with UCLP had previously undergone orthognathic surgery by another surgeon; all seven had residual maxillary hypoplasia, a recalcitrant oronasal fistula, and a cleft–dental gap.

The basic orthognathic procedure carried out by Posnick included a modified Le Fort I osteotomy in two segments (n = 66). Twenty-three of these patients also require simultaneous sagittal split ramus osteotomies to correct facial asymmetry and disproportion. Thirty-five of the 66 patients (53%) underwent osseous genioplasty (vertical reduction and horizontal advancement) to improve their profile aesthetics and lip position.

The 66 adolescents with UCLP had multiple residual deformities, and all but one had residual oronasal fistulas of varying sizes. Sixty-four of the 66 patients (97%) presented with negative overjet at the central incisors. Sixty of the 66 patients (91%) had a lateral (posterior) crossbite of the lesser segment and a maxillary dental midline that was not coincident with the facial midline. An Angle Class III malocclusion was present on the cleft side in 64 of 66 patients. In 60 of the 66 patients (91%), a congenitally absent or structurally inadequate lateral incisor was present at the cleft site. Simultaneous differential repositioning of the maxillary segments was planned for all 66 patients. In 57 of the 60 patients who presented with a cleft–dental gap, surgical closure through segmental repositioning also was planned. Despite the successful preoperative orthodontic cleft–dental gap closure in six patients, surgical arch width and coordination problems remained and required segmental repositioning.

Results

Sixty-one of the 66 patients (92%) underwent successful simultaneous oronasal fistula closure. In the five patients with residual fistulas, definitive closure with standard mucogingival and palatal flaps as a secondary procedure was possible and did not require bone grafting. Surgical cleft–dental gap closure was achieved and maintained in all but 3 of the 57 patients in whom it was attempted. In these patients, the dental gap closure was achieved initially; however, over the subsequent 12 months, the teeth in the lesser segment shifted position. The dental gap opened even though the fistula remained closed, and skeletal continuity across the cleft remained intact.

Nine patients required fixed (prosthetic) bridgework, either to complete the closure of the cleft–dental gap or to achieve other aspects of dental rehabilitation. A bridge was required in three patients in whom a dental gap was intentionally left open and in three others when the space reopened. The techniques of porcelain-veneer finish, composite resin buildups, and tooth sculpting were used to resurface incisor teeth in three other patients as a result of chronic tooth decay and enamel dysplasia.

In all patients, keratinized mucosa was successfully maintained along the labial surface of the cleft-adjacent teeth (n = 132 teeth). Preoperative gingival recession along the distal aspect of the central incisor as a result of longstanding limited alveolar support could not be improved at the time of the orthognathic surgery. Five of the 132 cleft-adjacent teeth required root canal therapy, and five teeth were noted to have further gingival recession after the completion of orthodontic treatment.

The long-term maintenance of overjet was measured directly from the late (>1 year) postoperative lateral cephalometric radiograph; all but two patients (i.e., 64 out of 66) maintained a positive overjet. The long-term maintenance of overbite was also measured directly from the late postoperative lateral cephalometric radiograph; 60 of 66 patients (91%) maintained a positive overbite; 4 patient shifted to a neutral overbite; and 2 patients relapsed into a negative overbite.

Complications were few and generally not serious. One patient who had also undergone septoplasty and inferior turbinate reduction was returned to the operating room for nasal packing to manage epistaxis on postoperative day 10. In another patient, the maxilla was repositioned a second time to reduce the vertical height (gingival show) for improved facial aesthetics on postoperative day 3. No loss of segmental bone or teeth occurred as a result of aseptic necrosis, infection, or for any other reason.

Patients and Methods

Posnick and colleagues reviewed medical records and cephalometric radiographs and completed current surgical and orthodontic clinical examination of all patients (n = 45) with UCLP who had undergone Le Fort I osteotomy by a single surgeon (Posnick) during a 3-year period.¹³⁹ The following information was noted: all previous maxillofacial procedures, details of the orthognathic procedures, osteotomy stabilization techniques used, the presence of a pharyngoplasty, the extent of bone grafting, the segmentalization of the Le Fort I osteotomy, perioperative orthodontics, the age at surgery, the age at final follow up, the amount of overjet and overbite at the 1 year or more postoperative visit, and perioperative morbidity.

For all patients, the prospective protocol required a lateral cephalogram preoperatively, immediately (i.e., 3 to 7 days after surgery), at 6 to 8 weeks, and at 1 year after surgery. At the time of the clinical review, patients were excluded from the study if one or more interval cephalograms were not available (n = 7) or if less than 3 mm of horizontal advancement was required to correct their skeletal deficiency (n = 3).

The serial radiographs for each patient were analyzed with a modified version of the method described by Bachmayer and colleagues.5,6 On each preoperative tracing, the horizontal and vertical coordinates that represented the patient’s natural head position were constructed so that they passed through the sella. These reference lines were transferred and became the x-y grid template onto which all of the postoperative maxillary positional changes could be traced and measured. The end result was a Cartesian coordinate system that illustrated the horizontal and vertical directional changes of the maxilla at intervals after surgery. The measurements of the differences in the position of the maxilla at different postoperative points were taken from the grids and were calculated to within 0.5 mm. In addition, the incisor overjet and overbite measurements from the 1-year (or more) postoperative cephalogram were documented and compared with the measurements taken at the final (1 year or more postoperative) clinical assessment. Differences between groups (e.g., pharyngeal flap in place) were assessed via Student’s t-test. Any association between the magnitude of surgical change and the degree of relapse was examined with the Pearson correlation coefficient (r) and the least-squares linear regression analysis. Correlations were considered significant when the P value was less than .05.

Results

During this study period, 45 skeletally mature patients with UCLP patients underwent Le Fort I maxillary advancement. None were lost to follow up and the final clinical follow-up examination ranged from 1.5 to 4.5 years (mean, 2.5 years) from the time of the surgical procedure and the close of the study. Seven patients missed one of their longitudinal cephalometric records, and three required less than 3 mm of horizontal advancement to correct their maxillary deformity. The 10 excluded patients were reviewed and were not clinically different from the other 35, varying only for the reasons outlined. All patients in the study were judged to be skeletally mature at the time of operation on the basis of the assessment of either a carpal (wrist) radiograph or at least two static serial cephalometric radiographs taken at 6-month intervals. For the 35 patients who were included in the study, the age at operation ranged from 14 to 25 years (mean, 18 years).

All 35 study patients underwent modified Le Fort I osteotomies (two segments) with varying degrees of horizontal advancement, transverse arch widening, and vertical change. Eleven of the 35 patients also underwent sagittal split ramus osteotomies of the mandible to correct asymmetries and secondary deformities; 22 had vertical reduction genioplasty with or without chin advancement to improve their profile aesthetics. In 13 of 35 patients, a pharyngoplasty was in place at the time of the maxillary osteotomy. None required takedown or modification of the flap to achieve passive intraoperative maxillary placement. All 35 patients underwent perioperative orthodontic treatment that was coordinated with their surgical procedure.

No statistically significant differences were seen in the initial vertical or horizontal surgical changes and the postoperative maintenance (relapse) between patients who had maxillary surgery alone or those who had surgery in both jaws and those who had a pharyngoplasty in place at the time of their Le Fort I osteotomy (P < .05). Therefore, these patients were considered a homogeneous group for further analysis. The mean horizontal advancement at the incisors achieved for the group was 6.9 mm, with 5.3 mm maintained 1 year later. In 11 of the 35 patients, the relapse was less than 1.0 mm. The amount of horizontal relapse did not correlate significantly with the amount of maxillary advancement (r = .31).

In the 13 patients with a pharyngoplasty in place at the time of the Le Fort I osteotomy, the mean effective horizontal advancement was 8.2 mm immediately after the operation and 6.5 mm 1 year later. Interestingly, the 22 patients without a pharyngoplasty in place required less horizontal advancement, with a range of 6.4 mm and 4.9 mm maintained at 1 year. The mean vertical change of the maxilla was 2.1 mm initially after the operation and 1.7 mm 1 year later. In 12 of the 35 patients, no vertical change was necessary; in the remaining patients, vertical directional change was necessary and achieved. Analysis indicated that vertical relapse did not correlate significantly with the magnitude of change that occurred at the time of surgery (r = .41). The authors also measured the overjet and overbite directly from the cephalometric radiographs at the 1-year postoperative interval in each patient. A positive overjet was maintained in all patients, whereas a positive overbite was maintained in 86% (30 of 35 patients). This data confirms that, with the combination of orthodontics and orthognathic surgery, a functional long-term occlusion was achieved in most of the patients with UCLP.

Staging of Maxillary Reconstruction

The described modified Le Fort I segmental osteotomies as a method of managing end-stage oronasal fistulas, alveolar defects, and cleft–dental gaps in patients with UCLP who have maxillary hypoplasia is not intended to replace standard techniques and the accepted sequencing of treatment. We always prefer secondary bone grafting during the mixed dentition typically with orthodontic closure of the cleft dental gap. However, the method described does offer an alternative approach when the opportunity for grafting during the mixed dentition (i.e., before the eruption of the permanent canine) is lost and a jaw deformity also exists. Published studies from major cleft centers in the United Kingdom, Scotland, and Canada confirm that, despite best efforts, a number of patients in the mixed dentition will not arrive for treatment, and a percentage of those who do will undergo unsuccessful grafting.39,103,108,177 A two-stage approach to the adolescent or adult with maxillary hypoplasia, residual alveolar clefts, oronasal fistulas, a cleft–dental gap, and nasal obstruction is not cost- or time-effective and, in my experience, the potential overall morbidity is increased. It is in these patients with UCLP that the modified Le Fort I osteotomy offers a reasonable opportunity for the resolution of residual end-stage problems (e.g., maxillary hypoplasia, alveolar defect, residual fistulas, cleft–dental gap, nasal obstruction) in a safe and effective way.

In the patient with UCLP, there are several options for the management of a cleft–dental gap.* From both facial aesthetic and dental health perspectives, the long-term use of a removable partial denture is always a second choice. Fixed bridgework is a viable alternative, but this requires the partial destruction of adjacent normal teeth, it may look artificial, it requires replacement at intervals throughout the patient’s life, and it demands ongoing meticulous oral hygiene (i.e., high-maintenance dentition). Placement of a single-tooth osseous integrated implant is an attractive alternative, but the implant’s aesthetic success is dependent on adequate bone height, width, and volume and sufficient attached gingiva.^{62,93,122,124,146,165,166,172,174,185} This is not routinely established at the cleft site, even after bone and gingival grafting. In addition, it requires staged surgical procedures, and it also produces a high-maintenance dentition. Coordinated comprehensive periodontal and prosthetic rehabilitation is required, and even then failure to provide a natural-looking smile may occur. In a published study conducted at The Hospital for Sick Children in Toronto, only 10% of complete UCLP lateral incisor dental gaps were managed with a dental implant and crown.¹⁷ Other dental refinements for a patient’s dysmorphic and often hypoplastic and decayed anterior maxillary teeth include porcelain-veneer buildups, composite bonding, sculpting of the teeth, and bleaching techniques. Each of these refinements may improve the patient’s function, smile aesthetics, and self-esteem.

A major advantage of the described modified Le Fort I (segmental) osteotomies in the patient with UCLP is its ability to simultaneously close the cleft dead space, the residual oronasal fistulas, and the alveolar defect and to stabilize the dentoalveolar segments. The study by Posnick and colleagues documents the improved long-term periodontal health achieved in the cleft dentoalveolar regions when this technique is used.¹⁴¹ The long-term benefits to the patient of the resulting low-maintenance dentition cannot be over stated. Another advantage of this approach occurs when the lesser segment is advanced to attain this goal. By doing so, a relative arch-width expansion is gained at the mandibular molar and the premolar region without the actual need for a lateral shift of the whole segment. This limits any arch-width relapse tendencies.

Velopharyngeal Function after Le Fort I Advancement

Uncertainties about VP function and the management of an in-place pharyngeal flap should no longer be limiting factors when orthognathic surgery is necessary in a patient with a cleft. A nasoendoscopic guided examination by a speech pathologist and a surgeon who are familiar with cleft anatomy can reasonably predict current and expected VP function in a patient who is scheduled for a Le Fort I osteotomy (see Chapter 8). When postoperative VP deterioration is anticipated, the patient and family are counseled about the sequencing of treatment. Clinical studies have now documented that VP function will deteriorate in a similar fashion when either DO or standard Le Fort I osteotomy techniques are used.^{19,20,57,60,79,86} Despite the frequent need for significant maxillary advancement to normalize the skeleton and the facial aesthetics in patients with UCLP, I have not had to transect an in-place pharyngeal flap to achieve maxillary mobilization. Our research and that of others confirms that a pharyngeal flap in place at the time of Le Fort I osteotomy does not increase complications nor does it result in a higher incidence of relapse.¹⁴¹ The definitive reassessment of VP function after cleft Le Fort I advancement can be carried out 3 months after surgery. A primary or revision pharyngeal flap can be safely carried out within 6 months after surgery in conjunction with cleft rhinoplasty or labial revision, if indicated.

Mixed Dentition Le Fort I Osteotomy

By the mid 1980s, research clarified that, if jaw surgery is undertaken in the growing patient with a cleft palate, another procedure to advance the maxilla will likely be required when skeletal maturity is reached.181–184 More recently, several investigators again tested this theory by proceeding with mixed-dentition Le Fort I procedures using DO techniques. All research to date indicates that the Le Fort I advancement carried out during the mixed dentition in the patient with clefting—whether with standard or DO techniques—results in no significant further horizontal growth.^{21,26,40,41,59,61,75,126} As the mandible continues to grow, an Angle Class III malocclusion will occur with the need for either additional Le Fort I advancement or mandibular set-back.

Skeletal Relapse after Le Fort I Osteotomy in Patients with Clefting

There are more than 100 published articles reviewing skeletal stability and relapse in patients with clefting who have undergone Le Fort I advancement with the use of either standard osteotomy or DO techniques.* Proponents of DO techniques frequently state that, when more than 10 mm of horizontal maxillary advancement are required, the use of standard osteotomies with plate and screw fixation and bone grafting may lead to a greater degree of relapse. However, these studies do not report convincing data that demonstrate significant differences in relapse patterns between the two techniques. To give this situation some perspective, it should be noted that only 5% of patients with clefting who are undergoing Le Fort I advancement will require more than 10 mm of horizontal advancement at the incisors. All clinicians agree that this subgroup of patients is the most challenging to treat, but the reasons for this go beyond the degree of horizontal maxillary deficiency. These patients are also likely to present with multiple residual end-stage deformities (see the section about residual skeletal deformities earlier in this chapter), multiple missing teeth, and previously failed surgical procedures.

Aksu and colleagues documented a horizontal maxillary (skeletal) relapse of 22% in patients with cleft lips and palates after Le Fort I osteotomy with the use of DO techniques.⁴ He and colleagues reported their results for adolescent patients with repaired cleft lips and palates and maxillary hypoplasia who then underwent Le Fort I advancement with the use of an external DO device.⁶⁵ The patients (n = 17) were treated at one center between 2000 and 2006, and they had at least 1 year of follow up and a full set of records. DO treatment was started on day 5 (1 mm per day) and continued until a Class II occlusion (i.e., overcorrection) was achieved. Consolidation time ranged from 4 to 12 weeks, and this was followed by several more months of face mask therapy. The first four patients (two UCLP and two BCLP) who were treated developed fibrous non-union, and all four required reoperation and rigid (i.e., titanium plate and screw) fixation to achieve union. The authors then extended the consolidation period to a minimum of 12 weeks for the remaining patients (n = 13); all of these patients achieved bony union. In the group that achieved satisfactory bony union (13 out of 17 patients; 76%), the mean horizontal relapse was 11.9%, with 5 of 13 patients (38%) developing no better than end-to-end occlusion. Another orthognathic procedure was necessary in 5 of the 13 patients (38%) who initially achieved bony union to obtain a satisfactory occlusion. Overall, 9 out of 17 patients (53%) required two orthognathic procedures. In 2011, Chen and colleagues reported a 30.7% incidence of horizontal skeletal relapse 1 year after Le Fort I osteotomy in patients with clefts who were treated with DO techniques (i.e., the RED device). This was in a consecutive series of patients who presented with Class III malocclusion as a result of cleft maxillary hypoplasia and who agreed to a combined orthodontic and surgical approach.²¹ Posnick and colleagues documented the degree of horizontal relapse and overall occlusal success when using the modified Le Fort I technique as described in this chapter for patients with clefts. They measured horizontal change, stability, and information concerning the maintenance of overjet and overbite from 1-year or more postoperative cephalometric radiographs and clinical examinations.¹⁴¹ The results were reported in accordance with cleft type: patients with UCLP had 6.9 mm mean advancement with 5.3 mm maintained; 94% of patients with BCLP maintained positive overjet for the long term; and patients with isolate cleft palate had 6.1 mm mean advancement with 5.1 mm maintained. Interestingly, the degree of relapse that was documented was less than that generally reported by clinicians who use DO approaches (see earlier).

Standard Approach versus Distraction Osteogenesis Approach to Le Fort I Advancement

As Obwegeser stated in the 1960s and as was confirmed by Precious and colleagues, “relapse in cleft patients [after Le Fort I advancement] may well be more related to failure to adequately mobilize the maxilla and free it of abnormal soft tissue attachments than anything inherent in the osteotomy or the specific [cleft] diagnosis.”113–117,119,120

I agree with Obwegeser when he stated the following: “Today, many surgeons will resort to the use of distraction devices to gradually advance the cleft maxilla. Although in some circumstances this may be appropriate, it should be remembered that most cleft patients can be treated efficiently, even when requiring significant advancement with the classic Le Fort I type procedure.”¹¹⁹

Standard thinking is for the surgeon to commit to an approach (DO versus standard technique) for Le Fort I advancement before he or she arrives in the operating room. The surgeon then sticks to the plan, no matter what happens intraoperatively. On the basis of a review of the literature and almost three decades of personal experience as a cleft jaw surgeon, I make the following observations and recommendations in this area.

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