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 (ß-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 ß-TCP in 2010 and 2011. MAIN OUTCOME MEASURES: In all patients, the alveolar cleft was repaired by micro-structured ß-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 ß-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 ß-TCP bone substitute for repair of the alveolar cleft.