Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-28 @ 3:47 AM
Study NCT ID:
NCT02018120
Status:
COMPLETED
Last Update Posted:
2013-12-23
First Post:
2013-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet Rich Fibrin in the Treatment of Multiple Gingival Recessions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-20', 'studyFirstSubmitDate': '2013-12-17', 'studyFirstSubmitQcDate': '2013-12-20', 'lastUpdatePostDateStruct': {'date': '2013-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean root coverage percentage', 'timeFrame': '6 months', 'description': 'mean area of root coverage achieved by surgical root coverage therapy.'}, {'measure': 'complete root coverage percentage', 'timeFrame': '6 months', 'description': 'percentage of gingival recession defects completely covered by flaps after 6 months'}], 'secondaryOutcomes': [{'measure': 'keratinized tissue width', 'timeFrame': '6 months', 'description': 'changes in keratinized tissue width at 6 months'}, {'measure': 'gingival tissue thickness', 'timeFrame': '6 months', 'description': 'changes from baseline in gingival tissue thickness at 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['multiple gingival recession', 'platelet rich fibrin', 'connective tissue graft', 'microsurgery', 'periodontal diseases', 'gingival recession'], 'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.', 'detailedDescription': 'The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.\n\nPrimary outcome variables were percentage of complete root coverage and mean root coverage percentages at 6 months follow up. The secondary outcome variables include keratinized tissue and gingival thickness gain.\n\nSample size has been estimated as 13 in each treatment arm. All recessions are treated with modified coronally advanced flap. On test sites PRF membrane and on control sites connective tissue grafts will be placed under modified coronally advanced flaps. Random allocation of the treatment sites to test and control groups were performed using a computer software designed for randomization.\n\nClinical parameters such as gingival index, plaque index, keratinized tissue width, gingival recession depth and width were measured at 1, 3 and 6 months. Probing pocket depth, clinical attachment level, gingival thickness and gingival recession area were measure at baseline and 6 months. All gingival recession-related parameters such as recession height, recession width and recession area and keratinized tissue width along with mean root coverage and complete root coverage were assessed on standardized clinical photographs using an image analysis software.\n\nClinical photographs were obtained at baseline and 1, 3 and 6 months after surgical intervention. 4 mm length wire was placed on gingiva to check reproducibility and to obtain standardized pictures.\n\nGingival tissue thickness were measured with an #15 endodontic reamer attached to rubber stopper inserted perpendicularly into the gingival tissue 2 mm below the gingival margin; thickness of the reamer will be measured with a digital caliper.\n\nMean root coverage percentage was calculated as percentage of covered root surface area at 6 months.\n\nFollow up of subjects was 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Two or more adjacent teeth with at least 2 mm Miller Class I gingival recessions at non-molar teeth\n* Identifiable CEJ on all teeth\n* Age ≥ 18\n* Presence of tooth vitality and absence of restorations and superficial caries in the treatment area\n* No past surgical treatment history of affected area.\n* Gingival thickness ≥ 0,8 mm for recession areas.\n* Sufficient palatal donor tissue for connective tissue harvesting.\n\nExclusion Criteria:\n\n* Smoking\n* Pregnancy or lactation\n* Systematic diseases that may affect outcomes of periodontal therapy\n* Self-reported antibiotic medication within three months\n* Occlusal trauma in treatment site'}, 'identificationModule': {'nctId': 'NCT02018120', 'briefTitle': 'Platelet Rich Fibrin in the Treatment of Multiple Gingival Recessions', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Comparison of Platelet Rich Fibrin and Connective Tissue Graft in Treatment of Multiple Gingival Recessions', 'orgStudyIdInfo': {'id': '2012-Dis-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'connective tissue graft', 'description': 'connective tissue graft harvested from palatum of subjects and placed under modified coronally advanced flap', 'interventionNames': ['Procedure: connective tissue graft']}, {'type': 'EXPERIMENTAL', 'label': 'Platelet rich fibrin', 'description': 'Autogenous platelet rich fibrin was obtained from subjects own blood samples after centrifugation. Platelet rich fibrin membranes were placed under modified coronally advanced flaps.', 'interventionNames': ['Procedure: platelet rich fibrin']}], 'interventions': [{'name': 'connective tissue graft', 'type': 'PROCEDURE', 'armGroupLabels': ['connective tissue graft']}, {'name': 'platelet rich fibrin', 'type': 'PROCEDURE', 'armGroupLabels': ['Platelet rich fibrin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Izmir', 'state': 'Bornova', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University School of Dentistry Department of Periodontology', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Gül Atilla, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ege University School of Dentistry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Asude Merve Polat', 'investigatorAffiliation': 'Ege University'}}}}