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

NCT07786259 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-08-25

No results posted yet for this study

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.

Conditions

  • Unilateral Alveolar Cleft of Maxilla

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.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-06-16
Completion
2026-06-16

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07786259 on ClinicalTrials.gov