Evaluation of Bone Marrow Aspirate Concentrate Combined With Bovine Bone Graft for Unilateral Alveolar Cleft Repair (A Randomized Controlled Clinical Trial)
Sponsor study identifier
Secondary identifiers
OTHER · Tanta Univ
interventional
16
1 country
1
Study Start
March 1, 2025
Actual (reported)Primary Completion
June 16, 2026
Actual (reported)Study Completion
June 16, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 16, 2026
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2025
Actual (reported)June 16, 2026
Actual (reported)June 16, 2026
Actual (reported)August 21, 2026
Actual (reported)August 25, 2026
Actual (reported)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
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
Participants received a bovine-derived particulate bone graft combined with autologous bone marrow aspirate concentrate (BMAC) for reconstruction of the unilateral alveolar cleft.
Participants received a bovine-derived particulate bone graft alone for reconstruction of the unilateral alveolar cleft.
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.
The unilateral alveolar cleft defect was reconstructed using bovine-derived particulate bone graft without the addition of BMAC.
Faculty of Dentistry, Tanta University
Tanta, Gharbia Governorate, 31527, Egypt
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.
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.
16 participants (actual enrollment reported by the registry).
First Submitted
August 21, 2026
First Posted
August 25, 2026
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
Study Start
March 1, 2025
Actual (reported)Primary Completion
June 16, 2026
Actual (reported)Study Completion
June 16, 2026
Actual (reported)Last Updated
August 25, 2026
Record last verified: 2026-08
De-identified individual participant data underlying the reported clinical and radiographic results may be shared upon reasonable request, subject to approval by the study investigators and applicable institutional and ethical requirements.
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Source: ClinicalTrials.gov.
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