The Clinical Application of Recombinant Human Bone Morphogenetic Protein 7 for Reconstruction of Alveolar Cleft: 10 Years' Follow-Up.

PURPOSE: The purpose of this study was to report on a 10-year assessment after the application of recombinant human bone morphogenetic protein 7 (rhBMP-7) for the reconstruction of alveolar clefts.

PATIENTS AND

METHODS

This study was conducted as a prospective phase II clinical trial on 9 unilateral and 2 bilateral alveolar clefts that received rhBMP-7 (Osigraft; Stryker Biotech, UK). The mean age of the patients at surgery was 10.4 years. At 6 months postoperatively, occlusal radiographs were taken to evaluate bone formation at the cleft site. Patients were followed within the routine cleft care pathway for 10 years to monitor the impact of bone morphogenetic protein 7 on orthodontic treatments and maxillary growth. Radiographs were taken according to the standard cleft care protocol.

RESULTS

The radiographic assessment of the unilateral cleft lip and palate cases suggested good bone formation with a Kindelan score of grade 1 or 2. The bilateral alveolar cleft cases had a score of grade 3 or 4, indicating failure or partial failure. The children with successful grafts underwent a routine orthodontic follow-up without incident. The maxillary growth appeared to be similar to that in cases grafted with autogenous bone. No long-term complications and no abnormal pattern of bone formation were detected.

CONCLUSIONS

The study provides unique evidence on the long-term safety of rhBMP-7 when applied at the area of skeletal immaturity for the reconstruction of alveolar clefts in children.