Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-07 @ 2:28 PM
Study NCT ID:
NCT04109794
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2019-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Techniques in Gingival Recession Treatment. One-year Clinical Follow-up Study
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-27', 'studyFirstSubmitDate': '2019-09-26', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recession depth', 'timeFrame': 'baseline', 'description': 'Distance between CEJ and GM'}, {'measure': 'recession depth', 'timeFrame': '6 weeks', 'description': 'Distance between CEJ and GM'}, {'measure': 'recession depth', 'timeFrame': '6 months', 'description': 'Distance between CEJ and GM'}, {'measure': 'recession depth', 'timeFrame': '12 months', 'description': 'Distance between CEJ and GM'}], 'secondaryOutcomes': [{'measure': 'recession width', 'timeFrame': 'baseline', 'description': 'horizontal distance between two borders of recession at CEJ level'}, {'measure': 'recession width', 'timeFrame': '6 weeks', 'description': 'horizontal distance between two borders of recession at CEJ level'}, {'measure': 'recession width', 'timeFrame': '6 months', 'description': 'horizontal distance between two borders of recession at CEJ level'}, {'measure': 'recession width', 'timeFrame': '12 months', 'description': 'horizontal distance between two borders of recession at CEJ level'}, {'measure': 'probing depth', 'timeFrame': 'baseline', 'description': 'distance between GM and base of gingival sulcus'}, {'measure': 'probing depth', 'timeFrame': '6 weeks', 'description': 'distance between GM and base of gingival sulcus'}, {'measure': 'probing depth', 'timeFrame': '6 months', 'description': 'distance between GM and base of gingival sulcus'}, {'measure': 'probing depth', 'timeFrame': '12 months', 'description': 'distance between GM and base of gingival sulcus'}, {'measure': 'clinical attachment level', 'timeFrame': 'baseline', 'description': 'distance between CEJ and base of gingival sulcus'}, {'measure': 'clinical attachment level', 'timeFrame': '6 weeks', 'description': 'distance between CEJ and base of gingival sulcus'}, {'measure': 'clinical attachment level', 'timeFrame': '6 months', 'description': 'distance between CEJ and base of gingival sulcus'}, {'measure': 'clinical attachment level', 'timeFrame': '12 months', 'description': 'distance between CEJ and base of gingival sulcus'}, {'measure': 'keratinized tissue width', 'timeFrame': 'baseline', 'description': 'distance between GM and MGJ'}, {'measure': 'keratinized tissue width', 'timeFrame': '6 weeks', 'description': 'distance between GM and MGJ'}, {'measure': 'keratinized tissue width', 'timeFrame': '6 months', 'description': 'distance between GM and MGJ'}, {'measure': 'keratinized tissue width', 'timeFrame': '12 months', 'description': 'distance between GM and MGJ'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession']}, 'referencesModule': {'references': [{'pmid': '35394710', 'type': 'DERIVED', 'citation': 'Evginer MS, Olgun E, Parlak HM, Dolgun AB, Keceli HG. Comparison of two techniques in gingival recession treatment: A randomized one-year clinical follow-up study. Dent Med Probl. 2022 Jan-Mar;59(1):121-130. doi: 10.17219/dmp/137621.'}]}, 'descriptionModule': {'briefSummary': '42 patients were treated either with E-CTG (N=20) or SCAF (N=22). The recordings included clinician-based (recession depth, recession width, probing depth, clinical attachment level, keratinized tissue width, tissue thickness, clinical attachment gain (CAG), root coverage (RC), keratinized tissue change (KTC)) and patient-based (wound healing index (WHI), dentine hypersensitivity (DH), tissue appearance, patient expectations and aesthetics) parameters that were taken at baseline, T1 (sixth week), T2 (sixth month) and T3 (first year).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* single Miller I GR defects ≤3mm at upper anterior or premolar teeth\n* systemically healthy\n* identifiable cemento-enamel junction (CEJ)\n* PD ≤3 mm\n\nExclusion Criteria:\n\n* periodontal surgery experience in the past two years\n* excessive contacts\n* mobility\n* caries\n* loss of vitality\n* smoking\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT04109794', 'briefTitle': 'Comparison of Two Techniques in Gingival Recession Treatment. One-year Clinical Follow-up Study', 'organization': {'class': 'OTHER', 'fullName': 'Kırıkkale University'}, 'officialTitle': 'Comparison of Two Techniques in Gingival Recession Treatment. One-year Clinical Follow-up Study', 'orgStudyIdInfo': {'id': 'SerdarEvginer'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'E-CTG', 'description': 'Envelope connective tissue graft', 'interventionNames': ['Procedure: E-CTG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SCAF', 'description': 'Semilunar connective tissue graft', 'interventionNames': ['Procedure: E-CTG']}], 'interventions': [{'name': 'E-CTG', 'type': 'PROCEDURE', 'description': 'Envelope connective tissue graft', 'armGroupLabels': ['E-CTG', 'SCAF']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kırıkkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'H. Gencay Keceli', 'investigatorAffiliation': 'Kırıkkale University'}}}}