Alveolar Cleft Reconstruction Using BMAC and Allograft vs Iliac Cancellous Bone: A Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- bone density
Study Overview
Brief Summary
radiographic and clinical assessment of alveolar cleft grafting using Allograft mixed with BMAC compared to the standard protocol of anterior iliac crest cancellous bone grafting
Detailed Description
In the study group BMAC is collected after processing of bone marrow aspirated from anterior iliac crest using a stab incision and a specialized trocar with no surgical intervention at donor site. The BMAC will be mixed with allow graft and used for alveolar cleft grafting
In the control group the standard protocol for alveolar cleft grafting will be used which is surgical exposure of the anterior iliac crest and harvesting of cancellous bone particles.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •alveolar cleft patients at the mixed dentition phase
Exclusion Criteria
- •patients with previous alveolar grafting intervention
Outcomes
Primary Outcomes
bone density
Time Frame: 6 months
Assessment of bone density at the grafting site from a CT scan using Hounsfild Unit (HU)
Secondary Outcomes
- Bone gain(6 months)
- Postoperative donor site morbidity(1 month)
Investigators
Ahmed Moustafa Ismail Abdelmaksoud
Assistant lecturer
Cairo University