PURPOSE: To present long-term results of a novel distraction regimen, Bidirectional Alveolar Docking and Distraction Osteogenesis (BADDOG), as an integrated protocol for treatment of cleft lip and palate. This protocol permits simultaneous correction of cleft lip, alveolus, and cleft nasal deformity using a combination of distraction and orthopedic techniques.
MATERIALS AND METHODS: A prospective, randomized trial was carried out at the Hospital Infantil de Mexico, comparing twenty infants treated with conventional Millard repair at 3 months and palatoplasty at 1 year to those treated with the experimental protocol. This consisted of: 1) Segmental docking of cleft segments with an orthopedic appliance 2) Lip repair, alveoloperiosteoplasty, aggressive alveolar bone graft, and primary cleft rhinoplasty. 3) One month consolidation to permit integration of the alveolar graft. 4) Alveolar distraction across the grafted cleft at 0.5 mm daily, with overcorrection in sagittal and transverse dimensions. The cohort is now in the early mixed dentition stage and serial CT, cephalometric analysis, occlusal radiographs and photographic documentation of the groups are presented.
RESULTS: Mean patient age is 5.75 years. Bony volumes in the regenerated segments are equal to controls. Current maxillary volumes are not significantly different between groups. Facial convexity, arch projection, A/P and lateral maxillary dimensions, and occlusal relationships are all equivalent to or superior to age-matched controls. Early dental axial rotations did not lead to significant malocclusion in this group. Minor anterior cross bites have been easily managed with orthodontic appliances and are due to lingual tilt, not to bony discrepancy. Premaxillary projection is superior to controls. Lip and nasal aesthetics are indistinguishable from conventionally treated patients.
Discussion: Early palatal closure has many theoretical advantages, including: early speech development, improved maxillary projection and arch form due to the orthopedic effect of the tongue upon an intact palatal arch, and reduced incidence of otitis. It has fallen out of favor due to its impact upon midfacial growth. Published reports on early palatoplasty have previously demonstrated measurable growth disturbances by this stage of dental development. Patients treated in this prospective trial have now reached early mixed dentition, and there has been no detrimental effect of this early palatal distraction on maxillary growth. Indeed, these patients have superior facial convexity when compared to controls.
A major advantage of the BADDOG technique is that it permits nearly tension free closure of both the alveolus and the lip. The mucoperiosteoplasty can be performed without elevating tissue beyond the margins of the cleft. By minimizing the amount of dissection and limiting tension,growth disturbances have been avoided.
Conclusion: The theoretical advantages of early palatal surgery may be attainable without the detrimental effect on facial growth seen with conventional palatoplasty. We have made minor modifications to the distractor appliances and plan to begin phase II testing of the concept in a prospective fashion, integrating all of the staged cleft procedures in a single hybrid distraction protocol.