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

NCT07786259 | Completed

• 2 other identifiers: BMAC-AC-01OS-2312
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Alveolar Cleft; Bone Marrow Aspirate Concentrate; BMAC; Bovine Bone Graft; Secondary Alveolar Bone Grafting; Bone Regeneration

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after surgery

Secondary Outcomes (8)

• Graft Resorption at 6 Months

  6 months after surgery

• Effective Defect Fill at 6 Months

  6 months after surgery

• Integrated Graft Volume at 6 Months

  6 months after surgery

• CT-Derived Graft Radiodensity at 6 Months

  6 months after surgery

• Chelsea Scale Bone Level Assessment at 6 Months

  6 months after surgery

Study Arms (2)

BMAC-Enriched Bovine Bone Graft

EXPERIMENTAL

Participants received a bovine-derived particulate bone graft combined with autologous bone marrow aspirate concentrate (BMAC) for reconstruction of the unilateral alveolar cleft.

Procedure: BMAC-Enriched Bovine Bone Grafting

Bovine Bone Graft Alone

ACTIVE COMPARATOR

Participants received a bovine-derived particulate bone graft alone for reconstruction of the unilateral alveolar cleft.

Procedure: Bovine Bone Grafting

Interventions

BMAC-Enriched Bovine Bone Grafting PROCEDURE

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.

BMAC-Enriched Bovine Bone Graft

Bovine Bone Grafting PROCEDURE

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

Bovine Bone Graft Alone

Eligibility Criteria

• Age: 7 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with bilateral alveolar clefts.
• Patients with local maxillary pathosis that may interfere with surgery.
• Immunocompromised patients.
• Patients with syndromes associated with alveolar cleft.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location

Related Publications (3)

• Kuhl S, Payer M, Kirmeier R, Wildburger A, Wegscheider W, Jakse N. The influence of bone marrow aspirates and concentrates on the early volume stability of maxillary sinus grafts with deproteinized bovine bone mineral - first results of a RCT. Clin Oral Implants Res. 2014 Feb;25(2):221-5. doi: 10.1111/clr.12101. Epub 2013 Jan 7.

  PMID: 23294470 BACKGROUND

• Chahla J, Mannava S, Cinque ME, Geeslin AG, Codina D, LaPrade RF. Bone Marrow Aspirate Concentrate Harvesting and Processing Technique. Arthrosc Tech. 2017 Apr 10;6(2):e441-e445. doi: 10.1016/j.eats.2016.10.024. eCollection 2017 Apr.

  PMID: 28580265 BACKGROUND

• Shabaan AA, Salahuddin A, Aboulmagd I, Ragab R, Salah KA, Rashid A, Ayad HM, El Aty Ahmed WA, Refahee SM. Alveolar cleft reconstruction using bone marrow aspirate concentrate and iliac cancellous bone: A 12-month randomized clinical study. Clin Oral Investig. 2023 Nov;27(11):6667-6675. doi: 10.1007/s00784-023-05276-9. Epub 2023 Oct 5.

  PMID: 37794139 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An oral and maxillofacial radiologist was blinded to group allocation during radiographic assessment using the Chelsea scale.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Researcher, Department of Oral and Maxillofacial Surgery

Model Details: Participants were randomized in a 1:1 ratio to receive either bovine-derived bone graft combined with BMAC or bovine-derived bone graft alone.

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: March 1, 2025
• Primary Completion: June 16, 2026
• Study Completion: June 16, 2026
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after publication of the main study results and for a period of 5 years thereafter.
• Access Criteria: De-identified data may be provided to qualified researchers who submit a scientifically valid research proposal. Requests will be reviewed by the study investigators and will be subject to institutional and ethical approval, where applicable. Data will be shared only for approved research purposes.

Locations

EG (1)