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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tissue engineered group | Active Comparator | autogenous bone marrow derived and cultured stem cells loaded on collagen matrix was implanted in the alveolar cleft in the study group (1st arm) |
|
| autogenous bone graft group | Active Comparator | autogenous cortico-cancellous bone graft harvested from the anterior iliac crest was implanted in the alveolar cleft of the control group (2nd arm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tissue engineered group | Other | cultured and bone marrow derived autologous mesenchymal stem cells, loaded on collagen matrix (Osteovit) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediate postoperative and after 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediate postoperative and after 6 months |
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Inclusion Criteria:
Exclusion criteria
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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| ID | Term |
|---|---|
| C483614 | osteovit |
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| autogenous bone graft group | Procedure |
|
| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |