Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-31 @ 10:04 PM
Study NCT ID:
NCT04181892
Status:
COMPLETED
Last Update Posted:
2019-12-02
First Post:
2019-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Connective Tissue Graft Position
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-26', 'studyFirstSubmitDate': '2019-11-13', 'studyFirstSubmitQcDate': '2019-11-26', 'lastUpdatePostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival Recession depth in millimeters', 'timeFrame': '6 months', 'description': 'measured from the cemento-enamel junction to the gingival margin'}, {'measure': 'keratinized tissue height in millimeters', 'timeFrame': '6 months', 'description': 'measured from the mucogingival junction to the gingival margin'}, {'measure': 'aesthetic evaluation assesed by visual analog scale', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['connective tissue graft'], 'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': 'Aim: The aim of this study was to compare the root coverage and aesthetic results of CAF+ CTG positioned apical to the CEJ (CAF+CTG-ACEJ) with CAF+CTG positioned on the CEJ (CAF+CTG-CEJ) for treating isolated gingival recession defects.\n\nMethods: Thirthy-eight patients with Miller class I and II gingival recessions were enrolled. 19 patients were randomly assigned to the CAF+CTG-ACEJ group or CAF+CTG-CEJ group. Clinical and aesthetical evaluations were made at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 years of age,\n\n * Periodontally and systemically healthy,\n * FMPS and FMBS \\<15%,\n * Presence of Miller Class I/II GR defect (≥3 mm in depth) at the buccal aspect of incisors and canines,\n * Presence of identifiable CEJ (step ≤1 mm at CEJ level and/or presence of a root irregularity/abrasion with identifiable CEJ, was accepted),\n * No previous periodontal surgery.\n\nExclusion Criteria:\n\n* Smoking,\n* Contraindications for surgery,\n* Presence of recession defects associated with caries, deep abrasion, restoration or pulpal pathology.'}, 'identificationModule': {'nctId': 'NCT04181892', 'briefTitle': 'Effect of Connective Tissue Graft Position', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'The Effects of Connective Tissue Graft Position on Clinical and Aesthetical Outcomes of Gingival Recession Treatment. A Controlled Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CukurovaU-PER-I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAF+ CTG positioned apical to the CEJ', 'description': 'Connective tissue graft covered by a coronally advanced flap which CTG apical of the CEJ level', 'interventionNames': ['Procedure: Coronally advanced flap + connective tissue graft']}, {'type': 'OTHER', 'label': 'CAF+CTG positioned on the CEJ', 'description': 'Connective tissue graft covered by a coronally advanced flap which CTG on the CEJ level', 'interventionNames': ['Procedure: Coronally advanced flap + connective tissue graft']}], 'interventions': [{'name': 'Coronally advanced flap + connective tissue graft', 'type': 'PROCEDURE', 'description': 'connective tissue graft covered by a coronally advanced flap with connective tissue graft apical of the cementoenamel junction level', 'armGroupLabels': ['CAF+ CTG positioned apical to the CEJ', 'CAF+CTG positioned on the CEJ']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Cukurova University Faculty of Dentistry', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'overallOfficials': [{'name': 'Onur Ucak Turer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mustafa Ozcan', 'investigatorAffiliation': 'Cukurova University'}}}}