Randomized controlled trial compares BCP/PRF with autogenous bone graft for alveolar cleft defects, suggesting safety and efficacy for BCP/PRF.
Background: Autogenous iliac bone is considered the gold standard grafting material for reconstruction of alveolar cleft defect. However, its donor side morbidity nictitates searching for an alternative. Biphasic calcium phosphate combined platelets rich fibrin (BCP/PRF) has been actively investigated as a grafting material for reconstruction of other bony defects with promising results. Purpose: the purpose of this study was to investigate whether BCP/PRF can be proper alternative to autogenous bone graft in reconstruction of alveolar cleft defect. Study Design: This study is a parallel randomized controlled clinical trial. The study population was composed of 18 patients with alveolar cleft recruited at outpatient clinic of oral and maxillofacial surgery department, Faculty of Dentistry, Cairo University, Egypt from November 2017 to January 2023. They were randomly allocated to one of two study arms: the intervention (BCP + PRF) group in which the alveolar cleft defect was grafted with BCP/PRF or the control group in which the alveolar cleft defect was grafted with autogenous iliac bone graft. Predictable variable grafting material (BCP/PRF) versus iliac graft. Main outcome Variable(s): The primary outcome was bone height (distance between the alveolar ridge and the most coronal part of grafted region). The secondary outcomes were volume of bone bridge (summation of multiplying area by thickness) and operative duration (time elapsed between using the scalable for incision and the last stitch). Covariates: Covariates included patient demographics, operated side, type of cleft, previous bone grafting, volume of preoperative bone defect and volume of grafting material. Analysis: The used tests were Chi-square test, Fisher’s Exact, Student t-test Pearson coefficient, Paired t-test. Statistical significance was defined as p ≤ 0.05. Results: No statistically significant difference was noted after 6 months in bone height between the two groups (MD -1.88; 95% CI - 4.67 to 0.91; p = 0.172). The iliac bone graft group had significant larger volume of bone bridging compared with the BCP +PRF group (MD -121.64; 95% CI-226.67 to -16.60; p = 0.026). The operative time in BCP +PRF group is significantly lower than that in the iliac bone graft group (MD - 0.99; 95% CI -1.19 to - 0.79; p = 0.001). Conclusion: Autogenous bones graft is still the first choice for alveolar bone grafting. This clinical trial suggested that application of BCP/PRF composite in alveolar cleft reconstruction was safe and effective and could be a bone substitute candidate instead of autologous bone graft.
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Samra et al. (2025) studied this question.