Early Results on the Efficacy of Demineralized Bone Matrix, Bone Morphogenic Protein, and Freeze-dried Bone Chips in Alveolar Cleft Repair.

Background: Conventional treatment for alveolar cleft repair is done using autologous iliac crest alveolar bone graft (ABG). However, this method may not be ideal in all patients. Analysis of the efficacy of a mixture of demineralized bone matrix (DBX), bone morphogenic protein (rhBMP-2), and freeze-dried bone chips (FDBC) as an alternative for alveolar cleft repair was performed. Methods: Consecutive patients from August 2019 to June 2022 undergoing early alveolar cleft repair, concomitant hard palate and alveolar cleft repair, secondary alveolar cleft repair, and regrafting from a previously failed ABG were analyzed. Computed tomography scans were performed to evaluate graft take at least 6 months postoperatively. Images were reviewed and scored. Alveolar graft height and graft thickness were recorded. A standardized scoring system was developed, with a score of 0 representing no graft take and 3 representing best possible graft take. Results: Fifty-five consecutive alveolar clefts (43 patients) were identified as having undergone ABG and satisfied all the other inclusion criteria. Of these, 29 underwent first time ABG and 26 underwent redo ABG. The mean graft height and graft thickness recorded for all clefts was 2.2 and 2.0, respectively. Conclusions: Early results evaluating the efficacy of ABG using DBX, rhBMP-2, and FDBC show feasibility in regard to both graft height and thickness when using a maxillary computed tomography scan to measure the bone graft take. These results suggest that DBX, rhBMP-2, and FDBC may act as a versatile bone graft material in cleft care, although further studies are needed to determine long-term outcomes.

Novel Custom Maxillary Disimpaction Splint.

LeFort I, II, and III osteotomies are commonly used in complex craniofacial reconstruction. Patients requiring these procedures typically have a craniofacial cleft, other congenital craniofacial deformities, or severe facial trauma. Both the cleft and traumatized palate have poor bony support, which leads to possible complications when the disimpaction forceps are used during the downfracture of the maxilla. Such potential complications include trauma or formation of a fistula of the palatal, oral, or nasal mucosa; trauma to adjacent teeth; and fracture of the palate and alveolar bone. To help prevent these complications, we developed a custom disimpaction splint. The splint is designed to cover the palate and occlusal surfaces to increase retention and minimize splint movement during the maxillary downfracture portion of the surgical procedure. The base of the splint is fabricated from a two-layered biocryl material, and the palatal area is built with soft-cushion rebase material. This allows for a stable grip of the disimpaction forceps blades and provides protective coverage of the cleft, traumatized palate, or alveolar bone graft site during the downfracture. The custom maxillary disimpaction splint has been routinely used in our clinic from September 2019 to the present for LeFort osteotomies in patients with a compromised primary palate. No surgical complications related to the maxillary downfracture have been noted during this period of time. We conclude that the routine use of a custom maxillary disimpaction splint can result in improved outcomes and decreased complications of LeFort osteotomy procedures in patients with cleft and traumatized palate.

Multidisciplinary Presurgical Education: Clinical Impact on Children With Orofacial Clefts Undergoing Maxillary Distraction via Rigid External Distraction.

OBJECTIVE: Treatment of severe maxillary hypoplasia is commonly addressed via distraction osteogenesis with a rigid external device (RED). While effective, this method can be socially stigmatizing in an already vulnerable patient population. To prepare children and their caregivers for life with a RED and decrease peri-operative anxiety, we instituted a multidisciplinary pre-surgical education session (MPES). This educational team involves our cleft care coordinator, child life specialist, orthodontist and plastic surgeon 2 weeks prior to surgery. We reviewed the impact of this intervention by examining clinical outcomes before and after its implementation. DESIGN: From February 2017 to February 2020, a retrospective chart review was performed to include patients with orofacial clefts and maxillary hypoplasia who underwent maxillary distraction osteogenesis with RED at our center before (28 patients) and after (29 patients) the implementation of MPES. RESULTS: MPES was associated with a significantly shorter length of stay compared to controls who did not receive MPES (3.6 vs 3.1 days, p < 0.03) and significantly decreased usage of inpatient narcotic pain medication compared to controls (16.8 morphine equivalents vs 31.8 morphine equivalents, p < 0.02). Our intervention also demonstrated a trend towards decrease in minor complications but did not achieve statistical significance p = 0.32). CONCLUSIONS: Multidisciplinary presurgical education is a beneficial adjunct in the care of patients with orofacial clefts and maxillary hypoplasia undergoing maxillary advancement with a RED.

A Custom Stabilizing Splint for the Management of BLCP with Protruding Premaxilla.

A severely protruding premaxilla in a patient with bilateral cleft lip and palate prevents functional closure of the orbicularis oris muscle and acceptable reconstruction of the nasolabial components during primary cheiloplasty. This is typically corrected with vomerine osteotomy and premaxillary setback, followed by cheiloplasty and rhinoplasty. Due to the risk of vascular compromise to the prolabium and premaxillary segment, the lip and nose repair is often staged after the vomerine osteotomy and premaxillary setback has healed. Stabilizing the premaxillary segment to allow adequate healing has been a topic of interest. Several methods have been described, but each is associated with varying degrees of compromise of the blood supply to the premaxilla. To combat this, the authors created a custom oral splint that effectively maintained the position of the premaxilla with minimal impingement of the blood supply. The authors present two cases in which a two-stage premaxillary setback with a custom-stabilizing oral splint was performed, followed by primary cheiloplasty and rhinoplasty in an age-appropriate and delayed presentation of bilateral cleft lip and palate and protruding premaxilla.

Customizable interdental splinting for repair of pediatric mandibular fractures in children with mixed dentition: A novel technique.

OBJECTIVE: Repair of pediatric mandibular fractures (PMFs) can be challenging due to the lack of permanent dentition for immobilization, and the presence of unerupted teeth and growth plates in the mandible limiting the space for fixation. Interdental splinting (IDS) has been advocated to provide temporary fixation without the need for mandibular plating; however, there is sparse description of the surgical methodology, and data on long term outcomes are even more limited. The aim of this study is to present our technique and outcomes using a novel technique for IDS repair of pediatric mandible fractures. STUDY DESIGN: Observational retrospective chart review. SETTING: Tertiary care pediatric hospital. SUBJECTS AND METHODS: Pediatric patients requiring operative repair for mandibular fracture at our tertiary care institution between 2004 and 2021 were included. Patients over 18 years of age, those who died due to associated injuries, or those who underwent non-IDS repairs were excluded. Subjects with at least 3 months of follow-up were assessed for efficacy of surgical repair and short-term adverse outcomes, and at least 1 year for long-term adverse events. Descriptive statistics were obtained. RESULTS: Twenty-three children were included in the study with an average age of 7.4 years (range 2-17 years). Fifty-two percent (52.2%) were female. The most common fracture site was the condyle, occurring in 16 children (70%). The indication for operative repair in all cases was malocclusion. The average duration of maxillomandibular fixation (MMF) with the novel IDS was 21 days (range 12-42 days). The average length of follow up was 1.6 years (range 3 months-11 years). All children had restored, functional occlusion at follow up with none requiring further orthodontic or dental intervention. Three children of the total cohort (13.0%) had prolonged hospitalization beyond 48 h for poor oral intake. Five children (21.7%) experienced minor long-term complications including persistent temporomandibular joint pain (n = 1, 4.3%), infection (n = 2, 8.7%), hypertrophic scar (n = 1, 4.3%) and exposure of hardware (n = 1, 4.3%). CONCLUSION: PMFs resulting in malocclusion are safely and effectively managed with operative repair utilizing a customizable IDS, with few observed short- and long-term complications.

Simultaneous Closure of the Cleft Alveolus and Hard Palate with Concomitant Bone Grafting.

Cleft repair has been in constant evolution since its inception. Conventional repair of the cleft hard palate involves closure of nasal and oral mucosa without bony reconstitution. In many instances, this approach is adequate, but, particularly in complete clefts, the lack of bony support can lead to collapse of the maxillary arch, dental crowding, and posterior cross-bite. To address these shortcomings, our institution performs a two-staged palatoplasty with concomitant bone grafting of the alveolus and hard palate in the second stage. A retrospective review of children who underwent a two-staged palatoplasty at our institution was performed. These patients' records and images were reviewed for complications and changes in maxillary morphology. Fourteen patients with complete clefts had a two-staged palatoplasty with bone grafting in the second stage. The mean age at surgery was 37.5 months, and the mean follow-up was 16 months. One patient had resorption of the alveolar bone graft requiring additional bone grafting. The remaining patients were without complications and had good consolidation of the bone graft on follow-up imaging. Our early results support that there is a low complication rate (7% regrafting) in those patients who underwent bone grafting at the time of cleft palate repair with early evidence of bony consolidation on imaging and clinical examination. Wide exposure during the repair allows complete grafting of the maxillary bony deficit, which is not possible with traditional alveolar cleft repair and may alleviate the shortcoming of soft-tissue closure only. Future study is necessary to determine long-term outcomes.

Risk of Malocclusion Among Patients Undergoing Single-Stage Versus Two-Stage Cleft Palate Repair.

OBJECTIVE: Evaluate impact of single-stage versus staged palate repair on the risk of developing malocclusion among patients with cleft palate (CP). DESIGN: Retrospective cohort study 2000-2016. SETTING: Academic, tertiary children's hospital. PATIENTS: Patients undergoing CP repair between 1999-2015. INTERVENTIONS: CP repair, categorized as either single-stage or staged. MAIN OUTCOME MEASURE: Time to development of Class III malocclusion. RESULTS: 967 patients were included; 60.1% had a two-stage CP repair, and 39.9% had single-stage. Malocclusion was diagnosed in 28.2% of patients. In the model examining all patients at ≤5 years (n = 659), patients who were not white had a higher risk of malocclusion (HR 2.46, p = 0.004) and staged repair was not protective against malocclusion (HR 0.98, p = 0.91). In all patients >5 years (n = 411), higher Veau classification and more recent year of birth were significantly associated with higher hazard rates (p < 0.05). Two-staged repair was not protective against developing malocclusion (HR 0.86, p = 0.60). In the model examining patients with staged repair ≤5 years old (n = 414), higher age at hard palate closure was associated with reduced malocclusion risk (HR 0.67, p < 0.001) and patients who were not white had increased risk (HR 2.56, p = 0.01). In patients with staged repair >5 years old, more recent birth year may be associated with a higher risk of malocclusion (HR 1.06, p = 0.06) while syndrome may be associated with lower risk of malocclusion diagnosis (HR 0.46, p = 0.07). CONCLUSION: Our data suggests that staged CP repair is not protective against developing Class III malocclusion.

Management of Tessier Type 3 Cleft With a Novel Reverse Palatal Expander.

ABSTRACT: The purpose of this clinical report is to present the novel management of a type Tessier 3 cleft which was treated using a palatal expander in reverse fashion to reapproximate the craniofacial skeleton allowing for closure of the palate and soft tissue of the cleft. Reapproximation of the bony component of the cleft was achieved without osteotomies and allowed for easier and earlier realignment of the bony and soft tissue components of the cleft. To our knowledge, this is the first use of reverse palatal expansion in the treatment of type 3 Tessier cleft. Reverse palatal expansion made management of this cleft more straightforward and should be considered as a useful adjunct in the management of wide facial clefts.

Oronasal Fistula Risk After Palate Repair.

OBJECTIVE: To assess risk factors for oronasal fistula, including 2-stage palate repair. DESIGN: Retrospective analysis. SETTING: Tertiary children's hospital. PATIENTS: Patients with non-submucosal cleft palate whose entire cleft repair was completed at the study hospital between 2005 and 2013 with postsurgical follow-up. INTERVENTIONS: Hierarchical binary logistic regression assessed predictive value of variables for fistula. Variables tested for inclusion were 2 stage repair, Veau classification, sex, age at surgery 1, age at surgery 2, surgeon volume, surgeon, insurance status, socioeconomic status, and syndrome. Variables were added to the model in order of significance and retained if significant at a .05 level. MAIN OUTCOME MEASURE: Postoperative fistula. RESULTS: Of 584 palate repairs, 505 (87%) had follow-up, with an overall fistula rate of 10.1% (n = 51). Among single-stage repairs (n = 211), the fistula rate was 6.7%; it was 12.6% in 2-stage repairs (n = 294, P = .03). In the final model utilizing both single-stage and 2-stage patient data, significant predictors of fistula were 2-stage repair (odds ratio [OR]: 2.5, P = .012), surgeon volume, and surgeon. When examining only single-stage patients, higher surgeon volume was protective against fistula. In the model examining 2-stage patients, surgeon and age at hard palate repair were significant; older age at hard palate closure was protective for fistula, with an OR of 0.82 (P = .046) for each additional 6 months in age at repair. CONCLUSIONS: Two-stage surgery, surgeon, and surgeon volume were significant predictors of fistula occurrence in all children, and older age at hard palate repair was protective in those with 2-stage repair.

Alveolar Bone Graft Stabilization with Custom Maxillary Splints.

For secondary alveolar bone grafting in cleft patients, the success of bone graft take is dependent upon creating an ideal environment for both bony and soft tissue healing. This is particularly challenging in patients with existing fistulas, wide clefts, and bilateral alveolar clefts, where large soft tissue mobilization is required to get a tensionless repair, and micro-motion around the bone graft is significantly higher. Herein we describe our method for manufacture and placement of a custom postoperative maxillary splint following secondary alveolar bone grafting. Our splint encompasses the palate and alveolus to stabilize the maxillary arch and protect the incision lines during healing. We find our splint to be a useful adjunct to facilitate postoperative healing following secondary alveolar bone grafting.

Cost-Effectiveness Analysis of Demineralized Bone Matrix and rhBMP-2 versus Autologous Iliac Crest Bone Grafting in Alveolar Cleft Patients.

BACKGROUND: The standard of care for patients with alveolar cleft deformities is autologous bone grafting using iliac crest bone graft (ICBG). The combination of demineralized bone matrix with recombinant human bone morphogenetic protein-2 (DBX/rhBMP-2), as a substitute for ICGB, has been shown to have similar bony incorporation within the maxilla without donor-site morbidity. It has been argued that one of the drawbacks of using DBX/rhBMP-2 is the higher cost. The aim of this study was to compare the cost, operative time, and hospital length of stay associated with these two treatment modalities. METHODS: A chart review was conducted for 71 patients who underwent secondary alveolar cleft reconstruction. Forty patients received ICBG and 31 patients underwent reconstruction using DBX/rhBMP-2. Operative costs, operative time, and hospital length of stay were compared between the two groups. RESULTS: The average total operative cost was $6892 in the ICBG surgery population versus $4836 in the DBX/rhBMP-2 population (p < 0.01). Statistically significant decreases in anesthesia, pharmacy, and operating room costs were found in patients who underwent the DBX/rhBMP-2 surgery. Operative time decreased from an average of 97.3 minutes to 67.0 minutes (p < 0.01), and length of inpatient stay decreased from an average of 29.8 hours to 9.3 hours (p < 0.01). CONCLUSION: In the treatment of alveolar cleft deformities, operative material costs were greater in the DBX/rhBMP-2 group but-secondary to decreased hospital, anesthesia, pharmacy, and operating room costs-DBX/rhBMP-2 was more cost-effective than ICBG.

Modified Lefort Distraction Osteogenesis for the Treatment of Nager Syndrome-Associated Midface Hypoplasia: Technique and Review.

The surgical management of midface hypoplasia in the setting of Nager syndrome remains a significant challenge for craniofacial surgeons. This study describes a novel technique using distraction osteogenesis and modified osteotomies for the treatment of midface bony defects in an 11-year-old child with Nager syndrome.Presurgical 3-dimensional planning was performed to design the osteotomies and placement of distractors. The surgical approach required upper buccal sulcus and extended transconjunctival incisions only. Osteotomies were performed from the pyriform aperture through the orbit to include the lateral orbital wall, with bilateral osteotomy of the zygomas through the anterior arch via the transconjunctival incision. Distraction of the en bloc midface segment was successfully performed using external distractors. Bone grafting was not required. There were no complications.External distraction was well tolerated and there were no intraoperative or postoperative complications. The distractors were removed uneventfully after consolidation. The midface was successfully advanced without the need for bone grafting or bicoronal incision. The occlusal plane was leveled and the aesthetic appearance of the child was improved.Symmetrical midface hypoplasia in the context of Nager syndrome can be successfully corrected with en bloc distraction osteogenesis of the maxilla and bilateral zygomas through modified osteotomies that exclude the upper nasal pyramid. The approach is simplified and the need for bicoronal incision and bone grafting is mitigated in this technique, which the authors have named Lefort 2.5.

Protection of the Temporomandibular Joint During Syndromic Mandibular Distraction With a Novel Condylar Offloading Device.

Mandibular distraction for severe micrognathia in syndromic patients often leads to temporomandibular joint (TMJ) ankylosis, which requires further interventions to regain joint motion. The increased incidence of postdistraction ankylosis is likely related to increased prevalence of preoperative joint pathology in syndromic micrognathic patients. Previous studies have demonstrated that offloading the pressure on the condyle during the distraction process can prevent such TMJ pathology. In this article, the authors describe a successful new method for offloading the condyle to prevent postdistraction ankylosis using an external TMJ offloading device.

Improving quality of life of children with oral clefts: perspectives of parents.

Quality of life is increasingly recognized as an important health outcome in people with surgically treatable conditions. However, few data are available on children with oral clefts. Focus groups provide a rich exploratory approach to understanding health-related quality of life issues. We report findings from 2 focus groups of parents of children with oral clefts (cleft lip, cleft palate, and cleft lip and palate) in Utah and Idaho. Participants were guided into a discussion of issues and drivers of quality of life, from diagnosis through treatment to school entry. Parents identified crucial factors including the early need for support (including parent support groups), for credible information, and for advice for daily life. Surgery was a major factor affecting satisfaction and quality of life, and satisfaction depended not only on surgical results but importantly on communication, empathy, expectations, postsurgical care, and discharge management. Many parents underscored as critically important the preparation and the postsurgery experience, rather than the surgery itself. Parents also identified crucial milestones, including birth, diagnosis, the first surgery, and school entry. Combining these crucial issues with a life-stage approach provides a framework for intervention that focuses on drivers of quality of life at selected milestones in the life of children with oral clefts.