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COMPLETED
NCT07786259
NA

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

Sponsor: Tanta University

View on ClinicalTrials.gov

Summary

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.

Official title: Evaluation of Bone Marrow Aspirate Concentrate Combined With Bovine Bone Graft for Unilateral Alveolar Cleft Repair (A Randomized Controlled Clinical Trial)

Key Details

Gender

All

Age Range

7 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2025-03-01

Completion Date

2026-06-16

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

PROCEDURE

BMAC-Enriched Bovine Bone Grafting

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.

PROCEDURE

Bovine Bone Grafting

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

Locations (1)

Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, Egypt