Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
Study NCT ID:
NCT06585566
Status:
RECRUITING
Last Update Posted:
2025-01-22
First Post:
2024-09-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alveolar Cleft Reconstruction With Cortical-Shells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-19', 'studyFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2024-09-04', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Horizontal bone width', 'timeFrame': '6 months consolidation period', 'description': 'The amplitude of radiographic horizontal bone width change'}], 'secondaryOutcomes': [{'measure': 'Vertical bone level', 'timeFrame': '6 months consolidation period', 'description': 'The amplitude of radiographic vertical bone change'}, {'measure': 'Bone density', 'timeFrame': '6 months consolidation period', 'description': 'The radiographic bone density of the consolidated graft at the site of the reconstructed cleft'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bone graft', 'Cortical- shells', 'Radiographic Density', 'Horizontal bone gain', 'Vertical bone loss'], 'conditions': ['Alveolar Cleft']}, 'descriptionModule': {'briefSummary': 'The main goal of the secondary alveolar bone grafting (SABG) for alveolar clefts is the rehabilitation of the disorganized maxilla, aiming to stabilize the maxillary foundation as a solid functional mass that would abort growth disturbance, allow for teeth eruption, and enhance their orthodontic movements.\n\nThe study evaluates the outcomes of a ( SABG) technique that utilizes the retromolar cortical shell technique to reconstruct the alveolar clefts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of both sexes with an age range of (eight to fifteen years), with unilateral maxillary alveolar cleft.\n2. good oral hygiene and general good health\n\nExclusion Criteria:\n\n1. The evidence of clinical or radiographic signs of local maxillary pathosis or palatal fistulae.\n2. Those patients with bilateral alveolar clefts, cleft-associated syndromes, and those with a systemic disease that would affect either bone harvest or graft healing.\n3. A history of previous failed alveolar cleft reconstruction.'}, 'identificationModule': {'nctId': 'NCT06585566', 'briefTitle': 'Alveolar Cleft Reconstruction With Cortical-Shells', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Evaluation of Secondary Alveolar Cleft Reconstruction With Labial and Palatal Retromolar Cortical-Shells (A Case Series Study)', 'orgStudyIdInfo': {'id': '15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Secondary alveolar bone grafting (SBAG)', 'description': 'A SABG technique that utilizes retromolar cortical shells and the underlying cancellous particulates to formulate a three-dimensional alveolar cleft reconstruction.', 'interventionNames': ['Procedure: Cortical-shell graft']}], 'interventions': [{'name': 'Cortical-shell graft', 'type': 'PROCEDURE', 'description': 'Retromolar cortical shell graft technique for SABG', 'armGroupLabels': ['Secondary alveolar bone grafting (SBAG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62764', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Amr Gibaly', 'role': 'CONTACT', 'email': 'amrgibaly@dent.bsu.edu.eg', 'phone': '01113336634'}], 'facility': 'Amr Gibaly', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Modern University for Technology & Information.', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Amr Hanafy Gibaly, PHD', 'role': 'CONTACT', 'email': 'amrgibaly@dent.bsu.edu.eg', 'phone': '01113336634'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Oral and Maxillofacial Surgery', 'investigatorFullName': 'Amr Gibaly', 'investigatorAffiliation': 'Beni-Suef University'}}}}