Back to resultsTissue Engineered Constructs for Alveolar Cleft Repair
Primary Purpose
Cleft Lip and Palate
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tissue engineered group
autogenous bone graft group
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Lip and Palate focused on measuring tissue engineering., stem cells., autogenous grafts.
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
tissue engineered group
autogenous bone graft group
Arm Description
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 cortico-cancellous bone graft harvested from the anterior iliac crest was implanted in the alveolar cleft of the control group (2nd arm)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03563495
Brief Title
Tissue Engineered Constructs for Alveolar Cleft Repair
Official Title
Clinical, Volumetric and Densitometric Evaluation of Tissue Engineered (TE) Constructs for Secondary Alveolar Cleft Reconstruction (Short Term Randomized Controlled Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate
Keywords
tissue engineering., stem cells., autogenous grafts.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tissue engineered group
Arm Type
Active Comparator
Arm Description
autogenous bone marrow derived and cultured stem cells loaded on collagen matrix was implanted in the alveolar cleft in the study group (1st arm)
Arm Title
autogenous bone graft group
Arm Type
Active Comparator
Arm Description
autogenous cortico-cancellous bone graft harvested from the anterior iliac crest was implanted in the alveolar cleft of the control group (2nd arm)
Intervention Type
Other
Intervention Name(s)
tissue engineered group
Other Intervention Name(s)
BM-MSCs on collagen matrix (Osteovit)
Intervention Description
cultured and bone marrow derived autologous mesenchymal stem cells, loaded on collagen matrix (Osteovit)
Intervention Type
Procedure
Intervention Name(s)
autogenous bone graft group
Primary Outcome Measure Information:
Title
Assessment of changes in the bone volume at the grafted alveolar cleft site from the immediate postoperative to 6 months
Description
Measuring the bone volume on CT scan
Time Frame
Immediate postoperative and after 6 months
Secondary Outcome Measure Information:
Title
Assessment of changes in the bone density at the grafted alveolar cleft site from the immediate postoperative to 6 months
Description
Measuring the bone density on CT scan
Time Frame
Immediate postoperative and after 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Tissue Engineered Constructs for Alveolar Cleft Repair
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