Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:03 AM
Study NCT ID:
NCT07439068
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A-PRF and CGF in Palatal Donor Site Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epithelialization', 'timeFrame': 'Baseline', 'description': 'Rate of re-epithelialization with re-total, partial, or none by dropping hydrogen peroxide (3%) on the wound surface'}, {'measure': 'Epithelialization', 'timeFrame': '1 week post-surgery', 'description': 'Rate of re-epithelialization with re-total, partial, or none by dropping hydrogen peroxide (3%) on the wound surface'}, {'measure': 'Epithelialization', 'timeFrame': '2 week post-surgery', 'description': 'Rate of re-epithelialization with re-total, partial, or none by dropping hydrogen peroxide (3%) on the wound surface'}, {'measure': 'Epithelialization', 'timeFrame': '3 week post-surgery', 'description': 'Rate of re-epithelialization with re-total, partial, or none by dropping hydrogen peroxide (3%) on the wound surface'}, {'measure': 'Epithelialization', 'timeFrame': '4 week post-surgery', 'description': 'Rate of re-epithelialization with re-total, partial, or none by dropping hydrogen peroxide (3%) on the wound surface'}, {'measure': 'Pain perception', 'timeFrame': 'Baseline', 'description': 'Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)'}, {'measure': 'Pain perception', 'timeFrame': '1st day after surgery', 'description': 'Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)'}, {'measure': 'Pain perception', 'timeFrame': '2nd day after surgery', 'description': 'Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)'}, {'measure': 'Pain perception', 'timeFrame': '3th day after surgery', 'description': 'Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)'}, {'measure': 'Pain perception', 'timeFrame': '4th day after surgery', 'description': 'Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)'}, {'measure': 'Pain perception', 'timeFrame': '5th day after surgery', 'description': 'Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)'}, {'measure': 'Pain perception', 'timeFrame': '6th day after surgery', 'description': 'Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)'}, {'measure': 'Pain perception', 'timeFrame': '7th day after surgery', 'description': 'Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)'}, {'measure': 'Pain perception', 'timeFrame': '14th day after surgery', 'description': 'Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)'}, {'measure': 'Pain perception', 'timeFrame': '21st day after surgery', 'description': 'Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)'}, {'measure': 'Pain perception', 'timeFrame': '28th day after surgery', 'description': 'Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Concentrated Growth Factor', 'Advanced Platelet-Rich Fibrin'], 'conditions': ['Free Gingival Graft']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to compare and evaluate the effects of concentrated growth factor (CGF) and advanced platelet-rich fibrin (A-PRF) clot membranes on palatal epithelial wound healing and postoperative discomfort following free gingival graft (FGG) harvesting.', 'detailedDescription': 'The objective of this study was to compare and evaluate the effects of concentrated growth factor (CGF) and advanced platelet-rich fibrin (A-PRF) clot membranes on palatal epithelial wound healing and postoperative discomfort following free gingival graft (FGG) harvesting.\n\nFourty-five patients who underwent FGG harvesting were randomly assigned to three groups: (1) control group (n=15), receiving only a sterile gelatin sponge; (2) A-PRF group (n=15), receiving A-PRF clot membranes; and (3) CGF group (n=15), receiving CGF clot membranes at the donor site. The epithelization rate, color match, and sensation scores of the palatal wound were assessed at 1, 2, 3, and 4 weeks postoperatively. Pain levels, analgesic consumption, and bleeding time were self-reported by patients for the first 7 days of healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years old,\n* without systemic or periodontal diseases,\n* without medical contraindications to periodontal surgery\n* with full-mouth plaque control scores ≤ 20%\n* Gingival index scores ≤ 1\n\nExclusion Criteria:\n\n* smoking habits,\n* diabetes mellitus,\n* pregnancy or lactation,\n* removable upper denture,\n* regular medication that could interpose the healing process, undergoing bisphosphonate therapy, history of radiation therapy of the jaws, and follow-up consults'}, 'identificationModule': {'nctId': 'NCT07439068', 'acronym': 'FGG', 'briefTitle': 'A-PRF and CGF in Palatal Donor Site Healing', 'organization': {'class': 'OTHER', 'fullName': 'Ordu University'}, 'officialTitle': "Effects on Patients' Postoperative Morbidity and Donor Site Wound Healing of A-PRF and CGF Application After Free Gingival Graft Harvesting: A Comparative Randomized Clinical Trial", 'orgStudyIdInfo': {'id': '2020\\159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Advanced platelet-rich fibrin', 'description': 'Advanced platelet-rich fibrin clot membranes on palatal epithelial wound after harvesting free gingival graft', 'interventionNames': ['Procedure: Advanced platelet-rich fibrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Concentrated growth factor', 'description': 'Concentrated growth factor clot membranes on palatal epithelial wound after harvesting free gingival graft', 'interventionNames': ['Procedure: Concentrated growth factor']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sterile gelatin sponge', 'description': 'Sterile gelatin sponge on palatal epithelial wound after harvesting free gingival graft', 'interventionNames': ['Procedure: Sterile gelatin sponge']}], 'interventions': [{'name': 'Advanced platelet-rich fibrin', 'type': 'PROCEDURE', 'description': 'Advanced platelet-rich fibrin membranes and free gingival graft', 'armGroupLabels': ['Advanced platelet-rich fibrin']}, {'name': 'Concentrated growth factor', 'type': 'PROCEDURE', 'description': 'Concentrated growth factor membranes and free gingival graft', 'armGroupLabels': ['Concentrated growth factor']}, {'name': 'Sterile gelatin sponge', 'type': 'PROCEDURE', 'description': 'Sterile gelatin sponge and free gingival graft', 'armGroupLabels': ['Sterile gelatin sponge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52100', 'city': 'Ordu', 'country': 'Turkey (Türkiye)', 'facility': 'Ordu University', 'geoPoint': {'lat': 40.97782, 'lon': 37.89047}}], 'overallOfficials': [{'name': 'Figen Öngöz Dede, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ordu Universitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ordu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Prof.Dr. Figen ÖNGÖZ DEDE', 'investigatorAffiliation': 'Ordu University'}}}}