Alveolar cleft reconstruction using bone marrow aspirate concentrate and iliac cancellous bone: A 12-month randomized clinical study

OBJECTIVE: This study aimed to compare the bone density and volume in patients with alveolar cleft reconstructions utilizing bone marrow aspirate concentrate with iliac graft versus iliac graft alone. MATERIAL AND METHODS: Thirty-six patients with unilateral alveolar cleft were randomly allocated into either an intervention group receiving an iliac bone graft mixed with bone marrow concentrate or a control group receiving an iliac bone graft. Cone beam CT was obtained preoperative, 6 and 12 months postoperatively to assess the bone density of the graft and bone volume of the alveolar defect, and then, the bone loss ratio was calculated. RESULTS: Bone volume and bone density demonstrated a statistically significant increase in the intervention group at 6 and 12 months. In contrast, the bone loss ratio decreased significantly in the intervention group throughout the follow-up period. CONCLUSION: A combination of bone marrow concentrate and iliac cancellous bone in alveolar cleft reconstruction may improve bone densities and volume in addition to decreasing graft loss rate. CLINICAL SIGNIFICANCE: Using of bone marrow aspirate concentrate will decrease the amount of the graft needed and decrease the ratio of bone loss at the grafted site by the time. Trial registration ClinicalTrials.org (NCT04414423) 4/6/2020