Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT05592158
Status:
COMPLETED
Last Update Posted:
2025-03-25
First Post:
2022-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of an Amnion-chorion Membrane 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': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2022-10-07', 'studyFirstSubmitQcDate': '2022-10-21', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical alveolar ridge dimension changes', 'timeFrame': '4 months', 'description': 'Clinically measured alveolar ridge dimension changes in mm using calibers'}, {'measure': 'Digital alveolar ridge dimension changes', 'timeFrame': '4 months', 'description': 'Digitally measured alveolar ridge dimension changes in mm2 using CBCT'}], 'secondaryOutcomes': [{'measure': 'Histological bone density.', 'timeFrame': '4 months', 'description': 'Histomorphometry.'}, {'measure': 'Presence of bone turnover proteins.', 'timeFrame': '4 months', 'description': 'Immunohistochemistry.'}, {'measure': 'Implant survival-Clinical', 'timeFrame': '6 months', 'description': 'Clinically assessed by torque test using a torque wrench, measured in N/cm.'}, {'measure': 'Implant survival-Radiographic', 'timeFrame': '6 months', 'description': 'Radiographically assessed through any signs of radiolucency around the implant.'}, {'measure': 'Esthetic restorative outcomes.', 'timeFrame': '6 months', 'description': 'Clinical changes in hard tissue based on the PES score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healing Wound']}, 'descriptionModule': {'briefSummary': 'This study will examine whether adding an amnion-chorion membrane on top of the traditionally used collagen plug will lead to more bone formation compared to the collagen plug only.', 'detailedDescription': 'Bone grafts and membranes are commonly placed to increase the amount of bone right after tooth extraction and before placing a dental implant. The primary objective of this study is to study the effect of a human amnion-chorion membrane (ACM) in an exposed-barrier ridge preservation technique to a control group without utilizing a ACM.\n\n30 patients requiring a front tooth extraction will be recruited and randomized to receive bone grafting with or without an ACM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age range: 20 to 80 years.\n2. Patients must require tooth extraction (for incisors, canines and premolars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable.\n3. Socket should be free of infection, less than 5mm of dehiscence\n4. Patients interested in implant placement following tooth extraction.\n\nExclusion Criteria:\n\n1. Allergies or hypersensitivities to study related medications such as chlorhexidine.\n2. Hematologic disorders/blood dyscrasias.\n3. Active infectious diseases of any kind.\n4. Liver or kidney dysfunction/failure.\n5. Uncontrolled diabetes (HbA1c \\> 8).\n6. Active cancer treatment - such as active chemotherapy or radiation therapy.\n7. Taking medications that will affect their bone healing (for example, bisphosphonates).\n8. Metabolic bone diseases that affect bone healing such as osteoporosis.\n9. Pregnant or lactating women (self-reported).\n10. Smoke 10 or more cigarettes per day (self-reported).\n11. Poor oral hygiene.'}, 'identificationModule': {'nctId': 'NCT05592158', 'briefTitle': 'Evaluation of the Effectiveness of an Amnion-chorion Membrane for Alveolar Ridge Preservation', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Evaluation of the Effectiveness of an Amnion-chorion Membrane for Alveolar Ridge Preservation', 'orgStudyIdInfo': {'id': 'HUM00208140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': 'Amnion-chorion membrane with collagen plug', 'interventionNames': ['Procedure: Socket preservation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Collagen plug', 'interventionNames': ['Procedure: Socket preservation']}], 'interventions': [{'name': 'Socket preservation', 'type': 'PROCEDURE', 'description': 'After tooth extraction, the socket will be filled with a collagen plug and covered with an amnion-chorion membrane.', 'armGroupLabels': ['Control', 'Test']}]}, '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': 'Muhammad Saleh, BDS, MSD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor, Periodontics and Oral Medicine', 'investigatorFullName': 'Muhammad Saleh', 'investigatorAffiliation': 'University of Michigan'}}}}