Evaluation of Bone Marrow Aspirate Concentrate Combined With Bovine Bone Graft for Unilateral Alveolar Cleft Repair (A Randomized Controlled Clinical Trial)
Evaluation of Bone Marrow Aspirate Concentrate Combined With Bovine Bone Graft for Unilateral Alveolar Cleft Repair (A Randomized Controlled Clinical Trial)
This randomized clinical trial evaluated whether adding autologous bone marrow aspirate concentrate (BMAC) to a bovine-derived bone graft improves healing and bone regeneration in patients undergoing reconstruction of a unilateral alveolar cleft. Sixteen participants were randomly assigned in a 1:1 ratio to receive either bovine bone graft combined with BMAC or bovine bone graft alone. Participants were followed for 6 months. Clinical assessments included postoperative pain, soft-tissue healing, fistula recurrence, and tooth eruption. Radiographic assessments included alveolar bone level, CT-derived graft radiodensity, and three-dimensional volumetric measurements of graft integration, resorption, and defect fill.
Inclusion Criteria:
Patients with unilateral alveolar clefts requiring repair.
Patients with good oral hygiene and good general health.
Patients free from any systemic disease that may affect normal bone healing.
Patients aged 7 to 25 years.
Absence of blood disorders that might cause complications following bone marrow aspiration.
Exclusion Criteria:
Patients with bilateral alveolar clefts.
Patients with local maxillary pathosis that may interfere with surgery.
Immunocompromised patients.
Patients with syndromes associated with alveolar cleft.
This prospective randomized controlled clinical trial was conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University. The study investigated the clinical and radiographic effectiveness of bone marrow aspirate concentrate (BMAC) combined with a bovine-derived particulate bone graft for reconstruction of unilateral alveolar cleft defects. Eligible participants were randomly allocated in a 1:1 ratio to either the study group or the control group using a simple lottery method.
Participants in the study group received bovine-derived particulate bone graft combined with autologous BMAC, whereas participants in the control group received bovine-derived bone graft without BMAC. For the study group, BMAC was mixed with the bovine graft at a ratio of 1 mL of BMAC per 1 cc of graft approximately 10 minutes before implantation. The interval was used as a standardized procedural step to allow contact and wetting of the graft particles and was not considered a biologically validated incubation period.
Both groups underwent standardized alveolar cleft reconstruction and were followed for 6 months. Clinical evaluation included postoperative pain, soft-tissue healing, fistula recurrence, and tooth eruption. Radiographic evaluation included assessment of alveolar bone level using the Chelsea scale, CT-derived graft radiodensity, and three-dimensional volumetric analysis to assess graft integration, graft resorption, and effective defect fill.