Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-02-22 @ 5:09 PM
Study NCT ID:
NCT07023757
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-24
First Post:
2025-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Age on PRF Quality; Assessed by Evaluating Healing Outcomes of ARP
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': 44}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2025-06-13', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alveolar ridge dimension changes', 'timeFrame': '4 months', 'description': 'Digitally measured alveolar ridge dimension changes in mm\\^2 using cone-beam computed tomography'}, {'measure': 'Soft tissue dimension changes', 'timeFrame': '4 months', 'description': 'Digitally measured soft tissue changes in mm\\^2 using intraoral scans'}], 'secondaryOutcomes': [{'measure': 'Histological bone density.', 'timeFrame': '4 months', 'description': 'Histomorphometry.'}, {'measure': 'Presence of bone turnover proteins.', 'timeFrame': '4 months', 'description': 'Immunohistochemistry.'}, {'measure': 'Amount of growth factors', 'timeFrame': 'At baseline surgery', 'description': 'Growth factors (PDGF, VEGF and TGF b1) from PRF obtained from drawn blood'}, {'measure': 'Wound healing index', 'timeFrame': '1 week, 2 weeks, 4 weeks, and 8 weeks', 'description': 'Wound healing index (WHI) according to the following scheme: Score "1" for uneventful wound healing with no gingival edema, erythema, suppuration, discomfort or barrier exposure; Score "2" for uneventful wound healing with slight gingival edema, erythema, or discomfort but no suppuration; Score "3" for poor wound healing with significant gingival edema, erythema, discomfort, loss of barrier or any suppuration.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healing Wound']}, 'descriptionModule': {'briefSummary': 'This study will examine whether using PRF and your age are going to affect the healing and regeneration benefits gained from PRF.', 'detailedDescription': 'Platelet-rich fibrin (PRF) is commonly used to enhance gum tissue healing and reducing pain after tooth extraction and before placing a dental implant. 44 patients requiring a tooth extraction will be recruited and randomized to receive a collagen plug with or without platelet-rich fibrin.'}, '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 (molars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable.\n3. Non-infected sockets with intact buccal bone (≥1.5 mm in thickness measured through calipers)\n4. Patients interested in implant placement following tooth extraction.\n\nExclusion Criteria:\n\n1. Allergies or hypersensitivities to study related medications.\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, Long-term NSAIDs use, Steroid).\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.\n12. Systemic diseases that compromise the immune system\n13. Anti-coagulant therapy'}, 'identificationModule': {'nctId': 'NCT07023757', 'briefTitle': 'Effect of Age on PRF Quality; Assessed by Evaluating Healing Outcomes of ARP', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Effect of Age on PRF Quality; Assessed by Evaluating Healing Outcomes of ARP', 'orgStudyIdInfo': {'id': 'HUM00264197'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Platelet-rich fibrin group.', 'description': 'Following extraction, a Platelet-rich fibrin plug will be placed in the extraction socket and covered with a collagen plug.', 'interventionNames': ['Procedure: Socket preservation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Collagen plug only', 'description': 'Collagen plug only', 'interventionNames': ['Procedure: Socket preservation']}], 'interventions': [{'name': 'Socket preservation', 'type': 'PROCEDURE', 'description': 'After tooth extraction, the extraction socket will be filled with a collagen plug in one group or a platelet-rich fibrin plug in the other.', 'armGroupLabels': ['Collagen plug only', 'Platelet-rich fibrin group.']}]}, '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'}}}}