Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT06509867
Status:
COMPLETED
Last Update Posted:
2024-08-07
First Post:
2024-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of De-Epithelialized Gingival Graft With or Without Platelet Rich Fibrin in Multiple Gingival Recessions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal 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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All clinical measurements will be measured and recorded by the blinded researcher. Treatment assignment and surgeries will have been unknown to this examiner. For statistically analysis, groups will be anonymized.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of 15 patients were surgically treated with coronally advanced flap (CAF) associated with de-epithelialized gingival graft. Groups were defined as DGG and DGG+PRF:\n\nDGG Group (n=15): de-epithelialized subepithelial connective tissue grafts + coronally advanced flap DGG+PRF Group (n=15): de-epithelialized subepithelial connective tissue grafts+ L-Platelet Rich Fibrin + Coronally advanced flap'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2024-07-15', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of root coverage', 'timeFrame': 'at 6th month', 'description': 'Percentage of Root Coverage (RC%) were performed with the following formulas. RC%: \\[(Preoperative RD-Postoperative RD)/ Preoperative RD\\] x 100.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession, Generalized']}, 'referencesModule': {'references': [{'pmid': '20590963', 'type': 'BACKGROUND', 'citation': 'Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.'}, {'pmid': '19563288', 'type': 'BACKGROUND', 'citation': 'Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Coronally advanced flap with and without vertical releasing incisions for the treatment of multiple gingival recessions: a comparative controlled randomized clinical trial. J Periodontol. 2009 Jul;80(7):1083-94. doi: 10.1902/jop.2009.090041.'}, {'pmid': '29058084', 'type': 'BACKGROUND', 'citation': 'Kuka S, Ipci SD, Cakar G, Yilmaz S. Clinical evaluation of coronally advanced flap with or without platelet-rich fibrin for the treatment of multiple gingival recessions. Clin Oral Investig. 2018 Apr;22(3):1551-1558. doi: 10.1007/s00784-017-2225-9. Epub 2017 Oct 20.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the clinical efficacy and patient reported outcome measures of de-epithelialized gingival graft (DGG) with or without platelet rich fibrin on treatment of multiple adjacent gingival recessions with coronally advanced flap (CAF) technique.', 'detailedDescription': 'Fifteen patients with split-mouth multiple gingival recessions affecting at least 3 adjacent teeth will be treated with either DGG or DGG+PRF. Recession depth(RD) and width(RW), probing depth(PD), clinical attachment level(CAL), keratinized tissue width (KTW), gingival thickness(GT), and percentage of root coverage (RC%) will be evaluated at 1, 3 and 6 months postoperatively. For patient reported outcome measurements, oral health impact factor-14 (OHIP-14) scores, postoperative pain, bleeding, discomfort and painkiller consumption will be recorded.\n\nA total of 15 patients will surgically treated with coronally advanced flap (CAF) associated with de-epithelialized gingival graft. Groups were defined as DGG and DGG+PRF:\n\nDGG Group (n=15): de-epithelialized subepithelial connective tissue grafts + coronally advanced flap DGG+PRF Group (n=15): de-epithelialized subepithelial connective tissue grafts+ L-Platelet Rich Fibrin + Coronally advanced flap'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria of participants were as belows:\n\nAge \\> 18 years Systemically healthy and non-smoker Full-mouth plaque index and full-mouth gingival index score\\< 20% No mucogingival surgery experience at operation area No active periodontal disease Patients who have not received orthodontic treatment\n\nExclusion criteria of participants were as belows:\n\nPregnancy and lactation Bruxism or occlusal trauma Medical contradictions and for periodontal plastic surgery (i.e. mental disorders) Medication intake\n\nInclusion criteria of surgical area were as below; Presence of at least three single-rooted teeth (anterior-premolar) with RT1 Class \\[25\\] buccal gingival recession defects ≥2 mm in depth Keratinized gingival width\\<3 mm Sufficient oral hygiene (bleeding on probing \\<10%, Periodontal Depth\\<3 mm) Patients without restoration and/or filling in the gingival recession area Absence of non-carious cervical lesions and non-detectable cemento-enamel junction (CEJ) at the defect sites'}, 'identificationModule': {'nctId': 'NCT06509867', 'briefTitle': 'Comparison of De-Epithelialized Gingival Graft With or Without Platelet Rich Fibrin in Multiple Gingival Recessions', 'organization': {'class': 'OTHER', 'fullName': 'Kutahya Health Sciences University'}, 'officialTitle': 'The Clinical and Patient Morbidity Comparison of De-Epithelialized Gingival Graft With or Without Platelet Rich Fibrin in Multiple Gingival Recessions: A Split-mouth, Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'E.4712136290600/110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platelet rich fibrin', 'description': 'de-epithelialized subepithelial gingival grafts+ L-Platelet Rich Fibrin + Coronally advanced flap', 'interventionNames': ['Procedure: DGG+PRF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'de-epithelialized gingival grafts', 'description': 'de-epithelialized gingival grafts + coronally advanced flap', 'interventionNames': ['Procedure: DGG']}], 'interventions': [{'name': 'DGG+PRF', 'type': 'PROCEDURE', 'otherNames': ['platelet rich fibrin'], 'description': 'de-epithelialized subepithelial connective tissue grafts+ L-Platelet Rich Fibrin + Coronally advanced flap', 'armGroupLabels': ['Platelet rich fibrin']}, {'name': 'DGG', 'type': 'PROCEDURE', 'otherNames': ['de-epithelialized gingival graft'], 'description': 'de-epithelialized subepithelial connective tissue grafts+ Coronally advanced flap', 'armGroupLabels': ['de-epithelialized gingival grafts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06490', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University Faculty of Dentistry', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kutahya Health Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof', 'investigatorFullName': 'Berceste Guler', 'investigatorAffiliation': 'Kutahya Health Sciences University'}}}}