Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-01 @ 7:06 PM
Study NCT ID:
NCT03563495
Status:
COMPLETED
Last Update Posted:
2018-06-20
First Post:
2018-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Engineered Constructs for Alveolar Cleft Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}], 'ancestors': [{'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C483614', 'term': 'osteovit'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-19', 'studyFirstSubmitDate': '2018-05-26', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of changes in the bone volume at the grafted alveolar cleft site from the immediate postoperative to 6 months', 'timeFrame': 'Immediate postoperative and after 6 months', 'description': 'Measuring the bone volume on CT scan'}], 'secondaryOutcomes': [{'measure': 'Assessment of changes in the bone density at the grafted alveolar cleft site from the immediate postoperative to 6 months', 'timeFrame': 'Immediate postoperative and after 6 months', 'description': 'Measuring the bone density on CT scan'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tissue engineering.', 'stem cells.', 'autogenous grafts.'], 'conditions': ['Cleft Lip and Palate']}, 'descriptionModule': {'briefSummary': 'Description of the research question\n\nIn 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?\n\nObjective of the study:\n\n• Research hypothesis\n\nThe 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.\n\n* The objectives\n\nThe primary objective:\n\nAssessment of bone volume (quantity) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.\n\nThe secondary objective:\n\nAssessment of bone density (quality) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with maxillary unilateral alveolar clefts requiring reconstruction\n* Children free from any systemic disease that may affect normal healing of bone\n* Children in an age range (8-14) year.\n\nExclusion criteria\n\n* Bilateral alveolar clefts.\n* Cleft lip or palate not including the alveolus.\n* Immunocompromized patients.\n* Children who undergone previous bone grafting procedure for the alveolar cleft'}, 'identificationModule': {'nctId': 'NCT03563495', 'briefTitle': 'Tissue Engineered Constructs for Alveolar Cleft Repair', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical, Volumetric and Densitometric Evaluation of Tissue Engineered (TE) Constructs for Secondary Alveolar Cleft Reconstruction (Short Term Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': 'MSCs in alveolar cleft repair'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tissue engineered group', '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)', 'interventionNames': ['Other: tissue engineered group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'autogenous bone graft group', 'description': 'autogenous cortico-cancellous bone graft harvested from the anterior iliac crest was implanted in the alveolar cleft of the control group (2nd arm)', 'interventionNames': ['Procedure: autogenous bone graft group']}], 'interventions': [{'name': 'tissue engineered group', 'type': 'OTHER', 'otherNames': ['BM-MSCs on collagen matrix (Osteovit)'], 'description': 'cultured and bone marrow derived autologous mesenchymal stem cells, loaded on collagen matrix (Osteovit)', 'armGroupLabels': ['tissue engineered group']}, {'name': 'autogenous bone graft group', 'type': 'PROCEDURE', 'armGroupLabels': ['autogenous bone graft group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator at Oral & Maxillofacial Surgery department, Faculty of Dentistry, Cairo University', 'investigatorFullName': 'Walaa Kadry', 'investigatorAffiliation': 'Cairo University'}}}}