Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT06457867
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Microfragmented Adipose Tissue Loaded on Bovine Graft Versus Bovine Graft Only on Ridge Preservation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014086', 'term': 'Tooth Mobility'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, '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': 22}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantity of bone (vertical bone height)', 'timeFrame': 'Quantity of bone (vertical bone height) by CBCT after 6 months', 'description': 'By CBCT'}], 'secondaryOutcomes': [{'measure': 'Quality of bone', 'timeFrame': 'Histological analysis (Core biopsy) Percentage of newly formed bone after 6 months', 'description': 'Histological analysis (Core biopsy) Percentage of newly formed bone'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['unrestorable caries lesions or affected periodontium.'], 'conditions': ['Tooth Mobility']}, 'descriptionModule': {'briefSummary': 'Evaluation of maxillary alveolar ridge changes (bone quantity and quality as revealed by Radiographic and Histomorphometry) utilizing microfragmented adipose tissue loaded on bovine graft versus bovine graft 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 bovine graft will be utilized for the study group and bovine raft only for the control group.\n\nAfter 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 from base line (1week) to 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\n * Age group: above 21 years\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 smokers'}, 'identificationModule': {'nctId': 'NCT06457867', 'briefTitle': 'Assessment of Microfragmented Adipose Tissue Loaded on Bovine Graft Versus Bovine Graft Only on Ridge Preservation.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Radiographic and Histomorphometric Assessment of Microfragmented Adipose Tissue Loaded on Bovine Graft on Ridge Preservation Versus Bovine Graft Only for Subsequent Implant Placement in the Maxillary Posterior Region, a Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'microfragmented adipose tissue'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'microfragmented adipose tissue', 'description': 'microfragmented adipose tissue loaded on bovine graft on ridge preservation', 'interventionNames': ['Procedure: microfragmented adipose tissue loaded on bovine graft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bovine graft', 'description': 'bovine graft only on ridge preservation', 'interventionNames': ['Procedure: microfragmented adipose tissue loaded on bovine graft']}], 'interventions': [{'name': 'microfragmented adipose tissue loaded on bovine graft', 'type': 'PROCEDURE', 'description': 'microfragmented adipose tissue loaded on bovine graft on ridge preservation', 'armGroupLabels': ['bovine graft', 'microfragmented adipose tissue']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bshaer Bayashot, BDS', 'role': 'CONTACT', 'email': 'bshaer.bayashot@dentistry.cu.edu.eg', 'phone': '01064825199'}, {'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 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 bovine graft will be utilized for the study group and bovine raft only for the control group.\n\nFor both groups: All Patients of both groups will be evaluated radiographically immediately and after 6 months post-operative by cone beam CT scan to record Alveolar ridge height.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Bashaer Maruf Jamaan Bayashot', 'investigatorAffiliation': 'Cairo University'}}}}