Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-01-26 @ 12:22 AM
Study NCT ID:
NCT03675334
Status:
UNKNOWN
Last Update Posted:
2018-09-18
First Post:
2018-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mucoderm or Connective Tissue Graft for Treatment of 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': 'The clinical parameters were screened by one single examiner that was not aware of the procedures'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Split-mouth clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-14', 'studyFirstSubmitDate': '2018-09-10', 'studyFirstSubmitQcDate': '2018-09-14', 'lastUpdatePostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Root coverage after 6 months', 'timeFrame': '6 months', 'description': 'Root coverage is measured by the difference between the gingival recession height at 6 months and baseline'}], 'secondaryOutcomes': [{'measure': 'Keratinized tissue gain after 6 months', 'timeFrame': '6months', 'description': 'The difference between keratinized tissue width and depth at 6 months and at baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['clinical trial', 'root coverage', 'biomaterials', 'collagen matrix', 'coronally advanced flap'], 'conditions': ['Gingival Recession']}, 'referencesModule': {'references': [{'pmid': '32382931', 'type': 'DERIVED', 'citation': 'Suzuki KT, de Jesus Hernandez Martinez C, Suemi MI, Palioto DB, Messora MR, de Souza SLS, Novaes AB Jr, Chaves Furlaneto FA, Taba M Jr. Root coverage using coronally advanced flap with porcine-derived acellular dermal matrix or subepithelial connective tissue graft: a randomized controlled clinical trial. Clin Oral Investig. 2020 Nov;24(11):4077-4087. doi: 10.1007/s00784-020-03280-x. Epub 2020 May 7.'}]}, 'descriptionModule': {'briefSummary': 'Coronally advanced flap plus connective tissue graft (CTG) is the gold standard therapy for root coverage. The bioabsorbable porcine collagen matrix (CM) has been widely used in periodontal and mucogingival surgery as a substitute for CTG and has achieved similar results. The CM has the advantage of no need of a second surgical area and availability overcoming the limitations of donor site in autograft.\n\nThe aim of this study is to investigate the use of Mucoderm® in root coverage procedures combined with extended coronally positioned flap (ECAF), test group (TG), in comparison to the connective tissue graft associated with the ECAF, control group (CG).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CEJ without significant damage;\n* localized bilateral RT1 gingival recession ≥3 mm in the same arch\n\nExclusion Criteria:\n\n* previous periodontal surgical treatment on the involved sites;\n* smokers\n* pregnants or lactating\n* compromised systemic health and contraindications for periodontal surgery'}, 'identificationModule': {'nctId': 'NCT03675334', 'briefTitle': 'Mucoderm or Connective Tissue Graft for Treatment of Gingival Recessions', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Clinical Comparison Between the Use of a Connective Tissue Graft or a Porcine Collagen Matrix (Mucoderm) for Treatment of Gingival Recessions Type 1: a Randomized Controlled Clinical Study.', 'orgStudyIdInfo': {'id': 'CAAE 58534216.5.0000.5419'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Test Group', 'description': 'Active comparator: gingival recession\n\nthe aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions', 'interventionNames': ['Procedure: Root coverage with collagen matrix graft', 'Other: Basic periodontal treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions. The control group was treated with the same technique as the collagen matrix graft.', 'interventionNames': ['Procedure: Root coverage with subepithelial connective tissue graft', 'Other: Basic periodontal treatment']}], 'interventions': [{'name': 'Root coverage with collagen matrix graft', 'type': 'PROCEDURE', 'description': 'at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.', 'armGroupLabels': ['Test Group']}, {'name': 'Root coverage with subepithelial connective tissue graft', 'type': 'PROCEDURE', 'description': 'at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.', 'armGroupLabels': ['Control Group']}, {'name': 'Basic periodontal treatment', 'type': 'OTHER', 'description': 'profilaxis, coronary polishing and scaling and root planning', 'armGroupLabels': ['Control Group', 'Test Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'School of Dentistry of Ribeirao Preto - University of Sao Paulo', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd, Ms, DDs. Chairman of Periodontolgy', 'investigatorFullName': 'Arthur Belem Novaes Jr', 'investigatorAffiliation': 'University of Sao Paulo'}}}}