Tissue Engineered Constructs for Alveolar Cleft Repair

Study Overview
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Brief Summary
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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 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.

Official Title
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Clinical, Volumetric and Densitometric Evaluation of Tissue Engineered (TE) Constructs for Secondary Alveolar Cleft Reconstruction (Short Term Randomized Controlled Clinical Trial)

Conditions
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Cleft Lip and Palate

Intervention / Treatment
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* Other: tissue engineered group
* Procedure: autogenous bone graft group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with maxillary unilateral alveolar clefts requiring reconstruction Children free from any systemic disease that may affect normal healing of bone Children in an age range (8-14) year. Exclusion criteria Bilateral alveolar clefts. Cleft lip or palate not including the alveolus. Immunocompromized patients. Children who undergone previous bone grafting procedure for the alveolar cleft

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tissue engineered group<br>autogenous bone marrow derived and cultured stem cells loaded on collagen matrix was implanted in the alveolar cleft in the study group (1st arm) | Other: tissue engineered group<br>* cultured and bone marrow derived autologous mesenchymal stem cells, loaded on collagen matrix (Osteovit)<br>* Other names: BM-MSCs on collagen matrix (Osteovit);|
| Active Comparator: autogenous bone graft group<br>autogenous cortico-cancellous bone graft harvested from the anterior iliac crest was implanted in the alveolar cleft of the control group (2nd arm) | Procedure: autogenous bone graft group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tissue engineering., stem cells., autogenous grafts.