Publication date: Available online 5 September 2018
Source: Journal of Oral and Maxillofacial Surgery
Author(s): A. Ayoub, T. Gillgrass
Abstract
Purpose
To report on a 10-year assessment following the application of rhBMP-7 for reconstruction of alveolar clefts.
Method
This study was conducted as prospective phase II clinical trial on 9 unilateral and two bilateral alveolar clefts which received rhBMP-7 (Osigraft). The mean age of patients at surgery was 10.4 years. Six months postoperatively, occlusal radiographs were taken to evaluate bone formation at the cleft site. Patients were followed with routine cleft care pathway for up to 10 years to monitor the impact of BMP-7 on orthodontic treatments and maxillary growth. Radiographs were taken according to the standard cleft care protocol.
Results
The radiographic assessment of the UCLP cases suggested good bone formation with a Kindelan score at 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 similar to that of cases grafted with autogenous bone. No long-term complications or 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.
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