Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT04637451
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2020-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2016-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-18', 'studyFirstSubmitDate': '2020-11-10', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Gingival Recession Depth at 6 month', 'timeFrame': 'Baseline and month 6.', 'description': 'The gingival recession depth consists of the distance from the cement-enamel junction to the most apical extension of the gingival margin. The measurement is recorded in millimeters. Change= (6 month score-baseline score)'}, {'measure': 'Change from Baseline Keratinized Gingiva Height at 6 month', 'timeFrame': 'Baseline and month 6.', 'description': 'Keratinized gingiva height, measured as the distance from the gingival margin to the mucogingival line. The measurement is recorded in millimeters. Change= (6 month score-baseline score)'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Root Hypersensitivity at 6 month', 'timeFrame': 'Baseline and month 6.', 'description': 'Root hypersensitivity at baseline and post-operative 6 month utilizing a visual numerical scale (VNS) test are defined. Possible scores range from (0=no sensitive and 10= worst possible sensitive). Change= (6 month score-baseline score)'}, {'measure': 'Change from Baseline Patient Satisfaction at 6 month', 'timeFrame': 'Baseline and month 6.', 'description': 'The patient satisfaction with the gingiva position, structure and color of the gingival recessions sites utilizing a VNS test (0=not satisfied and 10=very satisfied) are defined. Possible scores range from 0 (not satisfied) to 10 (very satisfied). Change= (6 month score-baseline score)'}, {'measure': 'Change from Baseline Pain at 1 week', 'timeFrame': 'Baseline and week 1.', 'description': 'Pain perception of the surgery at intra and post-operative period (week 1) utilizing a VNS test are defined. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change= (1 week score-baseline score)'}, {'measure': 'Change from Baseline Pain at 2 week', 'timeFrame': 'Baseline and week 2.', 'description': 'Pain perception of the surgery at intra and post-operative period (week 2) utilizing a VNS test are defined. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change= (2 week score-baseline score)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession', 'Periodontal Diseases']}, 'referencesModule': {'references': [{'pmid': '25867992', 'type': 'BACKGROUND', 'citation': 'Zucchelli G, Mounssif I. Periodontal plastic surgery. Periodontol 2000. 2015 Jun;68(1):333-68. doi: 10.1111/prd.12059.'}, {'pmid': '27454460', 'type': 'BACKGROUND', 'citation': 'Cairo F, Pagliaro U, Buti J, Baccini M, Graziani F, Tonelli P, Pagavino G, Tonetti MS. Root coverage procedures improve patient aesthetics. A systematic review and Bayesian network meta-analysis. J Clin Periodontol. 2016 Nov;43(11):965-975. doi: 10.1111/jcpe.12603. Epub 2016 Sep 16.'}, {'pmid': '15119887', 'type': 'BACKGROUND', 'citation': 'Allen AL. Use of the gingival unit transfer in soft tissue grafting: report of three cases. Int J Periodontics Restorative Dent. 2004 Apr;24(2):165-75.'}, {'pmid': '22390550', 'type': 'BACKGROUND', 'citation': 'Kuru B, Yildirim S. Treatment of localized gingival recessions using gingival unit grafts: a randomized controlled clinical trial. J Periodontol. 2013 Jan;84(1):41-50. doi: 10.1902/jop.2012.110685. Epub 2012 Mar 5.'}, {'pmid': '25685769', 'type': 'BACKGROUND', 'citation': 'Yildirim S, Kuru B. Gingival unit transfer using in the Miller III recession defect treatment. World J Clin Cases. 2015 Feb 16;3(2):199-203. doi: 10.12998/wjcc.v3.i2.199.'}, {'pmid': '12423299', 'type': 'BACKGROUND', 'citation': 'Del Pizzo M, Modica F, Bethaz N, Priotto P, Romagnoli R. The connective tissue graft: a comparative clinical evaluation of wound healing at the palatal donor site. A preliminary study. J Clin Periodontol. 2002 Sep;29(9):848-54. doi: 10.1034/j.1600-051x.2002.290910.x.'}, {'pmid': '22548583', 'type': 'BACKGROUND', 'citation': 'Douglas de Oliveira DW, Oliveira-Ferreira F, Flecha OD, Goncalves PF. Is surgical root coverage effective for the treatment of cervical dentin hypersensitivity? A systematic review. J Periodontol. 2013 Mar;84(3):295-306. doi: 10.1902/jop.2012.120143. Epub 2012 May 1.'}, {'pmid': '11551301', 'type': 'BACKGROUND', 'citation': 'Camargo PM, Melnick PR, Kenney EB. The use of free gingival grafts for aesthetic purposes. Periodontol 2000. 2001;27:72-96. doi: 10.1034/j.1600-0757.2001.027001072.x. No abstract available.'}, {'pmid': '34787718', 'type': 'DERIVED', 'citation': 'Kayaalti-Yuksek S, Yaprak E. The comparison of the efficacy of gingival unit graft with connective tissue graft in recession defect coverage: a randomized split-mouth clinical trial. Clin Oral Investig. 2022 Mar;26(3):2761-2770. doi: 10.1007/s00784-021-04252-5. Epub 2021 Nov 17.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to compare the clinical effectiveness of gingival unit graft (GUG) and connective tissues graft (CTG) in Miller's class I and II gingival recession.", 'detailedDescription': 'Patients who accept the study have provided information about the study and required a written informed consent form. The clinical effectiveness of two different periodontal surgical techniques (gingival unit graft and connective tissue graft) in gingival recessions will be evaluated. Periodontal measurements (gingival recession, keratinized gingiva height) and patient-reported outcomes (intra and post-operative pain, patient satisfaction and hypersensitivity) are defined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Systemic healthy individuals\n* Presence Miller's class I and II gingival recession in the anterior and premolar teeth\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Pregnancy\n* Lactation\n* Any cardiovascular, renal or hepatic conditions\n* History of periodontal surgery\n* Tooth mobility\n* Presence of probing depth \\>3 mm and caries or restorations in the teeth undergoing treatment"}, 'identificationModule': {'nctId': 'NCT04637451', 'briefTitle': 'The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage', 'organization': {'class': 'OTHER', 'fullName': 'Okan University'}, 'officialTitle': 'The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage: A Randomized Split-Mouth Clinical Trial', 'orgStudyIdInfo': {'id': '2015/174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gingival Unit Graft', 'description': 'For test group, gingival recessions were treated with gingival unit graft.', 'interventionNames': ['Procedure: Root coverage treatment']}, {'type': 'OTHER', 'label': 'Connective Tissue Graft', 'description': 'For Control group, gingival recessions were treated with connective tissue graft.', 'interventionNames': ['Procedure: Root coverage treatment']}], 'interventions': [{'name': 'Root coverage treatment', 'type': 'PROCEDURE', 'description': 'Gingival unit graft Connective tissue graft', 'armGroupLabels': ['Connective Tissue Graft', 'Gingival Unit Graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34852', 'city': 'Istanbul', 'state': 'Tuzla', 'country': 'Turkey (Türkiye)', 'facility': 'Sibel Kayaaltı Yüksek', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Okan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sibel Kayaalti-Yuksek', 'investigatorAffiliation': 'Okan University'}}}}