Alveolar Cleft Grafting
Conditions
Keywords
BMAC, alveolar cleft
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.
Interventions
PROCEDUREBMAC MIXED WITH ALLOGRAFT
Study group
PROCEDURECancellous bone from anterior iliac crest
Control group
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
parallel assignment
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* alveolar cleft patients at the mixed dentition phase
Exclusion criteria
* patients with previous alveolar grafting intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bone density | 6 months | Assessment of bone density at the grafting site from a CT scan using Hounsfild Unit (HU) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone gain | 6 months | Assessment of bone gain at the grafting site from a CT scan in millimeters |
| Postoperative donor site morbidity | 1 month | Assessment of donor site morbidity with a questionnaire (VAS Score) |
Countries
Egypt
Contacts
Primary ContactAhmed M Abdelmaksoud
Outcome results
None listed