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.
Keywords: bone grafting; bone regeneration; bone substitute; cleft lip and palate (CLP); β-TCP.