Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-27 @ 4:27 AM
Study NCT ID:
NCT06636461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-10
First Post:
2024-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Dimensional Changes Following Grafting With Microfragmented Adipose Tissue Loaded on Allograft on Ridge Preservation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-09', 'studyFirstSubmitDate': '2024-09-02', 'studyFirstSubmitQcDate': '2024-10-09', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alveolar ridge hight (bone quantity )', 'timeFrame': 'Alveolar ridge hight (bone quantity ) by CBCT after 3-6 months', 'description': 'By CBCT'}], 'secondaryOutcomes': [{'measure': 'Alveolar ridge width.', 'timeFrame': 'Alveolar ridge width. by CBCT after 3-6 months', 'description': 'By CBCT'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hopeless tooth lesion or affected periodontium'], 'conditions': ['Hopeless Tooth']}, 'descriptionModule': {'briefSummary': 'Evaluation of maxillary alveolar ridge changes (bone quantity and quality as revealed by radiographic and Histomorphometry ) utilizing microfragmented adipose tissue loaded on allograft versus allograft only for maxillary posterior ridge preservation', 'detailedDescription': 'All patients involved in this study will be divided into two groups; each group will receive a different graft of bone augmentation: Adipose tissue loaded on allograft will be utilized for the study group and allograft only for the control group.\n\nAfter 3-6 months, assessment of dimensional changes ( RG height \\& width) on CBCT is performed and Histomorphometry will be evaluated via core biopsy at the time of implant placement in both groups.\n\nRadiographic assessment that will be achieved by CBCT scan will be used to calculate the changes of bone height and width from base line (1week) to 3-6 months postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring implant treatment after tooth extraction due to either unrestorable caries lesions or affected periodontium.\n\nAge group: above 18 years\n\n• Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.\n\nExclusion Criteria:\n\n* • General contraindications to implant surgery.\n\n * Subjected to irradiation in the head and neck area less than 1 year before implantation.\n * Poor oral hygiene and motivation.\n * Severe bruxism or clenching.\n * Systemic, immunologic or debilitating diseases that could affect normal bone healing \\& local pathosis.\n * Treated or under treatment of intravenous amino-bisphosphonates.\n * Active infection or severe inflammation in the area intended for implant placement.\n * Patients participating in other studies, if the present protocol could not be properly followed.\n * Heavy somkers'}, 'identificationModule': {'nctId': 'NCT06636461', 'briefTitle': 'Assessment of Dimensional Changes Following Grafting With Microfragmented Adipose Tissue Loaded on Allograft on Ridge Preservation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Assessment of Dimensional Changes Following Grafting With Microfragmented Adipose Tissue Loaded on Allograft on Ridge Preservation Versus Allograft Only for Subsequent Implant Placement in the Maxillary Posterior Region, a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Assessment of dimensional chan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'microfragmented adipose tissue', 'description': 'microfragmented adipose tissue loaded on allograft on ridge preservation', 'interventionNames': ['Procedure: microfragmented adipose tissue loaded on allograft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'allograft', 'description': 'allograft only on ridge preservation', 'interventionNames': ['Procedure: microfragmented adipose tissue loaded on allograft']}], 'interventions': [{'name': 'microfragmented adipose tissue loaded on allograft', 'type': 'PROCEDURE', 'description': 'microfragmented adipose tissue loaded on allograft on ridge preservation', 'armGroupLabels': ['allograft', 'microfragmented adipose tissue']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Giza Governorate', 'country': 'Egypt', 'contacts': [{'name': 'hesham Elhawary, prof', 'role': 'CONTACT', 'email': 'hesham.elhawary@dentistry.cu.edu.eg', 'phone': '01144446373'}, {'name': 'Maha Alnahdi, BDS', 'role': 'CONTACT', 'email': 'maha.alnahdi@dentistry.cu.edu.eg', 'phone': '01559975945'}], 'facility': 'Cairo Universty'}], 'centralContacts': [{'name': 'maha alnahdi, BDS', 'role': 'CONTACT', 'email': 'maha.alnahdi@dentistry.cu.edu.eg', 'phone': '01145684357', 'phoneExt': '01559975945'}, {'name': 'hesham elhawary, prof', 'role': 'CONTACT', 'email': 'hesham.elhawary@dentistry.cu.edu.eg', 'phone': '01144446373'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After 6 months, patients will be evaluated histomorphometrically via core biopsy at the time of implant placement and radiographically via assessment of ridge height on CBCT.\n\nRadiographic assessment that will be achieved by CBCT scan will be used to calculate the changes of bone height and width from base line (1week) to 6 months postoperatively.', 'ipdSharing': 'YES', 'description': 'All patients involved in this study will be divided into two groups; each group will receive a different graft of bone augmentation: Adipose tissue loaded on allograft will be utilized for the study group and allograft only for the control group.\n\nFor both groups: All Patients of both groups will be evaluated radiographically immediately and after 3- 6 months post-operative by cone beam CT scan to record Alveolar ridge height and width.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Maha Omar Salem Alnahdi', 'investigatorAffiliation': 'Cairo University'}}}}