Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT03615092
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2018-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acellular Dermal Matrix Graft In Root Coverage of Gingival Recessions With Previously Restored Cervical Lesions
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': 'NON_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': 'Controlled Split-mouth clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-04', 'studyFirstSubmitDate': '2018-07-30', 'studyFirstSubmitQcDate': '2018-08-02', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Root coverage', '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', 'timeFrame': '6months', 'description': 'The difference between keratinized tissue width and depth at 6 months and at baseline.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acellular dermal matrix graft', 'Clinical Trial', 'Root coverage', 'Noncarious cervical lesion'], 'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': 'Patients with high standards of oral hygiene frequently search for buccal gingival recession (GR) treatment due to cervical wear, root sensitivity and compromising aesthetics. The cervical lesion (NCCL) is commonly produced by improper toothbrushing techniques, sharing the same etiology of GR. Many different surgical approaches have been described. The association of a graft to the coronally advanced flap had demonstrated the best long-term outcome for root coverage. But, substitutes for the autogenous graft must be studied. Therefore, the aim of this clinical trial was to investigate the effectiveness of the acellular dermal matrix graft (ADMG) in root coverage associated with a previous restored cervical lesion or not.\n\nMaterial and methods: Seventeen individuals with bilateral GR were included in the study. At one side, the GR must present a previously restored cervical lesion, as the test group (TG). The contralateral arch, must present GR with an intact root surface (CG). All patients were treated with the extended flap technique associated with the ADMG. All clinical parameters were assessed at baseline and 6-months postoperative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CEJ without significant damage;\n* localized bilateral RT112 gingival recession ≥3 mm in the same arch, in which one had a non-carious cervical lesion (NCCL) restored with composite and the opposite one was intact\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': 'NCT03615092', 'briefTitle': 'Acellular Dermal Matrix Graft In Root Coverage of Gingival Recessions With Previously Restored Cervical Lesions', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Acellular Dermal Matrix Graft In Root Coverage of Gingival Recessions With Previously Restored Cervical Lesions. A Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'CAAE: 0002.0.138.000.-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Test Group', 'description': 'Active Comparator: gingival recession with a previous restored cervical lesion\n\nthe aim of this study is to compare if the acellular dermal matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions with non carious cervical lesions.', 'interventionNames': ['Procedure: Root coverage with extended flap technique and acelular dermal matrix']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'the aim of this study is to compare if the acellular dermal matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions with non carious cervical lesions. The control group had no cervical lesion, and was treated with the same technique as the acelular dermal matrix graft', 'interventionNames': ['Procedure: Root coverage with extended flap technique and acelular dermal matrix']}], 'interventions': [{'name': 'Root coverage with extended flap technique and acelular dermal matrix', 'type': 'PROCEDURE', 'description': 'At one side, the root coverage have been done with a extended flap technique and acellular dermal matrix and there was no cervical lesion. At the other side, the same technique was performed, but the gingival recession was associated with a noncarious cervical lesion.', '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'}}}}