Unilateral Alveolar Cleft of Maxilla
Conditions
Keywords
Alveolar Cleft, Bone Marrow Aspirate Concentrate, BMAC, Bovine Bone Graft, Secondary Alveolar Bone Grafting, Bone Regeneration
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.
Detailed description
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.
Interventions
PROCEDUREBMAC-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.
PROCEDUREBovine Bone Grafting
The unilateral alveolar cleft defect was reconstructed using bovine-derived particulate bone graft without the addition of BMAC.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
An oral and maxillofacial radiologist was blinded to group allocation during radiographic assessment using the Chelsea scale.
Intervention model description
Participants were randomized in a 1:1 ratio to receive either bovine-derived bone graft combined with BMAC or bovine-derived bone graft alone.
Eligibility
Sex/Gender
ALL
Age
7 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft Take at 6 Months | 6 months after surgery | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Soft-Tissue Healing | 6 months after surgery |
| Nasal Regurgitation/Oronasal Fistula Recurrence | 6 months after surgery |
| Tooth Eruption | 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 |
| Chelsea Scale Bone Level Assessment at 6 Months | 6 months after surgery |
| CT-Derived Graft Radiodensity at 6 Months | 6 months after surgery |
Countries
Egypt
Outcome results
None listed