Bone Marrow Aspirate Concentrate With Bovine Bone Graft for Unilateral Alveolar Cleft Reconstruction

Tanta University16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

BMAC-Enriched Bovine Bone GraftingPROCEDURE

Autologous bone marrow aspirate concentrate (BMAC) was prepared from bone marrow aspirated from the anterior iliac crest and combined with bovine-derived particulate bone graft. BMAC was mixed with the graft at a ratio of 1 mL per 1 cc approximately 10 minutes before implantation into the alveolar cleft defect.

Bovine Bone GraftingPROCEDURE

The unilateral alveolar cleft defect was reconstructed using bovine-derived particulate bone graft without the addition of BMAC.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 25 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Graft Take at 6 Months

Graft take was assessed using three-dimensional CT-derived volumetric analysis. It was calculated as the percentage of the grafted volume that remained integrated within the reconstructed alveolar cleft at the 6-month follow-up.