Description of the research question In children undergoing unilateral alveolar cleft reconstruction, would stem cells carried on collagen scaffold provide bone of a good quality and quantity if compared to autogenous bone grafting? Objective of the study: • Research hypothesis The tissue engineered constructs will provide sufficient bone of a good quality and quantity if compared to autogenous bone graft in children undergoing unilateral alveolar cleft reconstruction. * The objectives The primary objective: Assessment of bone volume (quantity) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction. The secondary objective: Assessment of bone density (quality) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
10
cultured and bone marrow derived autologous mesenchymal stem cells, loaded on collagen matrix (Osteovit)
Assessment of changes in the bone volume at the grafted alveolar cleft site from the immediate postoperative to 6 months
Measuring the bone volume on CT scan
Time frame: Immediate postoperative and after 6 months
Assessment of changes in the bone density at the grafted alveolar cleft site from the immediate postoperative to 6 months
Measuring the bone density on CT scan
Time frame: Immediate postoperative and after 6 months
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