Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-22 @ 7:22 PM
Study NCT ID:
NCT02521467
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2015-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive Role of PRF After Free Gingival Graft Harvesting - Case Series
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'lastUpdateSubmitDate': '2015-08-10', 'studyFirstSubmitDate': '2015-07-28', 'studyFirstSubmitQcDate': '2015-08-10', 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Assessment by Visual Analog Scale (VAS)', 'timeFrame': '1 week postoperative', 'description': 'VAS ranged from 0 (no pain ) to 10 (severe pain)'}, {'measure': 'Clinical healing of the palate', 'timeFrame': '2 weeks postoperative', 'description': 'color match, consistency and thickness of palate (Composite measure)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Platelets Rich Fibrin, Palatal Donor Tissue']}, 'descriptionModule': {'briefSummary': 'Free gingival grafts are important to increase zone of attached gingiva and root coverage. This case series reveals role of platelet-rich fibrin (PRF) as adjunctive therapy in palatal wound healing. The superior healing observed at the PRF membrane sites supports its use in accelerating soft-tissue healing. PRF membrane as a palatal bandage is an efficacious approach to protect the raw wound area of a palatal donor site to reduce healing time and patient discomfort.', 'detailedDescription': 'Introduction:\n\nFree gingival grafts are one of the common treatment modalities used to increase the zone of keratinized tissue (KT) around implants or prior to ridge augmentation and root coverage. The palatal donor sites had many complications as pain, discomfort and healing by secondary intention. Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors fasten the healing and decrease the pain.\n\nMaterials and methods:\n\nTen patients requiring augmentation of KT participated in this case series. The palatal donor sites of 7 of these patients were covered with PRF membranes with a new suturing technique without palatal stent, the other 3 had palatal stent. Palatal tissue will examined clinically after 3, 7, 10 and 14 days. Considerably very fast healing with 0 pain score was observed during one week in the group with PRF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemic free, Good oral hygiene and insufficient attached gingiva prior to ridge augmentation\n\nExclusion Criteria:\n\n* High arched palate, medically compromised'}, 'identificationModule': {'nctId': 'NCT02521467', 'briefTitle': 'Adjunctive Role of PRF After Free Gingival Graft Harvesting - Case Series', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Adjunctive Role of Platelets Rich Fibrin in Palatal Wound Healing After Free Gingival Graft Harvesting - Case Series', 'orgStudyIdInfo': {'id': 'Doaa Adel'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PRF', 'description': 'Platelets Rich Fibrin', 'interventionNames': ['Biological: Platelets Rich Fibrin in healing of palatal donor tissue']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'palatal stent', 'description': 'Palatal stent', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Platelets Rich Fibrin in healing of palatal donor tissue', 'type': 'BIOLOGICAL', 'description': 'Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors as PDGF, IGF, TGF which had a role in hemostasis fasten the healing and decrease the pain.', 'armGroupLabels': ['PRF']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Palatal stent'], 'description': 'the other group is a control group, had no biologic in the palatal wound, only palatal stent', 'armGroupLabels': ['palatal stent']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer Oral Periodontology Department', 'investigatorFullName': 'Doaa Adel Salah Khattab', 'investigatorAffiliation': 'Ain Shams University'}}}}