Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-01-02 @ 11:41 AM
Study NCT ID:
NCT07020650
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-23
First Post:
2025-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Carbonate Apatite Bone Graft for Alveolar 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2025-06-05', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical alveolar ridge dimension changes', 'timeFrame': '4 months', 'description': 'Clinically measured alveolar ridge dimension changes in mm'}], 'secondaryOutcomes': [{'measure': 'Histological bone density', 'timeFrame': '4 months', 'description': 'Histomorphometry'}, {'measure': 'Presence of bone turnover proteins', 'timeFrame': '4 months', 'description': 'Immunohistochemistry'}, {'measure': 'Alveolar volumetric changes following tooth extraction', 'timeFrame': '4 months', 'description': 'Digitally measured alveolar ridge changes in mm\\^3 using CBCT'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healing Wound']}, 'descriptionModule': {'briefSummary': 'This study will examine whether the use of synthetic carbon apatite bone graft material will lead to more bone formation compared to human derived allograft and bovine derived xenograft material.', 'detailedDescription': 'Bone grafts are commonly placed to increase the amount of bone right after tooth extraction and prepare the site for future dental implant placement.\n\n45 patients requiring a tooth extraction will be recruited and randomized to receive either allograft, xenograft, or synthetic bone grafting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age between 20 and 80 years old\n* Patients requiring tooth extraction (incisors, canines, and premolars) due to caries, periodontal disease, tooth fracture, or unrestorable condition.\n* Extraction sockets must be infection-free with dehiscence less than 5mm.\n* Patients interested in implant placement after tooth extraction.\n\nExclusion criteria:\n\n* Known allergies or hypersensitivities to medications related to the study (e.g., chlorhexidine)\n* Hematologic disorders or blood dyscrasias.\n* Active infectious diseases.\n* Liver or kidney dysfunction/failure.\n* Uncontrolled diabetes (i.e., HbA1c \\> 8).\n* Undergoing active cancer treatment, including chemotherapy or radiotherapy within the last 12 months from the procedure.\n* Use of medications affecting bone healing (e.g., bisphosphonates, long-term anti-inflammatory medications).\n* Metabolic bone diseases affecting bone healing, such as osteoporosis (self-reported).\n* Pregnant or lactating women (self-reported).\n* Current smokers of 10 or more cigarettes per day and former smokers who quit less than 10 years ago (self-reported).\n* Poor oral hygiene.\n* Presence of fenestration defects equal to or greater than 5mm.'}, 'identificationModule': {'nctId': 'NCT07020650', 'briefTitle': 'The Effectiveness of Carbonate Apatite Bone Graft for Alveolar Ridge Preservation', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'The Effectiveness of Carbonate Apatite Bone Graft for Alveolar Ridge Preservation: A Clinical, Radiographic, and Histomorphometric Study', 'orgStudyIdInfo': {'id': 'HUM00267966'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Synthetic bone', 'description': 'Bone graft with carbonate apatite (Cytrans Granules)', 'interventionNames': ['Procedure: Socket preservation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Allograft', 'description': 'Bone graft with allograft (Puros)', 'interventionNames': ['Procedure: Socket preservation']}, {'type': 'EXPERIMENTAL', 'label': 'Xenograft', 'description': 'Bone graft with xenogeneic plug (BioOss)', 'interventionNames': ['Procedure: Socket preservation']}], 'interventions': [{'name': 'Socket preservation', 'type': 'PROCEDURE', 'description': 'After tooth extraction, the socket will be filled with a collagen plug and bone graft.', 'armGroupLabels': ['Allograft', 'Synthetic bone', 'Xenograft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan School of Dentistry', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Hom-Lay Wang, DDS,MSD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Collegiate Professor of Periodontics and Professor of Dentistry, Department of Periodontics and Oral Medicine, School of Dentistry', 'investigatorFullName': 'Hom-Lay Wang, DDS, MSD, Ph D', 'investigatorAffiliation': 'University of Michigan'}}}}