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Micro-structured Beta-Tricalcium Phosphate for Repair of the Alveolar Cleft in Cleft Lip and Palate Patients: A Pilot Study

Objectives Can a synthetic bone substitute be used to repair the alveolar cleft to bypass donor site morbidity as well as to shorten the operating time? In earlier experimental studies, micro-structured beta-tricalcium phosphate (β-TCP) provided similar bone healing when compared with grafting with iliac crest bone. This justifies the clinical evaluation of this bone substitute in the human alveolar cleft situation. Design Prospective clinical study. Setting University clinic. Participants Seven patients, all with unilateral alveolar cleft, were randomly included for alveolar cleft repair with β-TCP in 2010 and 2011. Main Outcome Measures In all patients, the alveolar cleft was repaired by micro-structured β-TCP grafting. Our assessments were distilled from cone beam computed tomography scans taken preoperatively, 1 week postoperatively, and 6 months postoperatively. A volumetric outcome could be realized. Results Six months after the operative grafting of micro-structured β-TCP into the alveolar cleft, the bone volume thus acquired was satisfactory. We found an average bone volume percentage of 73% ± 6% compared with the original cleft volume. Conclusions Previous experimental and clinical studies and the initial findings of this pilot study now elucidate a path toward the clinical use of micro-structured β-TCP bone substitute for repair of the alveolar cleft.