Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT02129504
Status:
COMPLETED
Last Update Posted:
2014-05-02
First Post:
2014-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Techniques for Root Coverage With a Xenogeneic Collagen Matrix
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': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-01', 'studyFirstSubmitDate': '2014-04-29', 'studyFirstSubmitQcDate': '2014-05-01', 'lastUpdatePostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing changes for Root coverage measure (in millimeter) from baseline at 3, 6 and 12 months', 'timeFrame': 'Change from Baseline at 3, 6 and 12 months', 'description': 'At the mid-buccal point of the involved tooth, the gingival recession height was measure by the same operator, who was previously calibrated (intra-examiner calibration) using a digital paquimeter.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['root coverage', 'gingival recession', 'periodontal surgery'], 'conditions': ['Gingival Recession']}, 'referencesModule': {'references': [{'pmid': '20350159', 'type': 'BACKGROUND', 'citation': 'McGuire MK, Scheyer ET. Xenogeneic collagen matrix with coronally advanced flap compared to connective tissue with coronally advanced flap for the treatment of dehiscence-type recession defects. J Periodontol. 2010 Aug;81(8):1108-17. doi: 10.1902/jop.2010.090698.'}]}, 'descriptionModule': {'briefSummary': 'Gingival recessions are often successfully treated by coronally advanced flap technique (CAF) associated with subepithelial connective tissue grafts (SCTG). Currently the xenogeneic collagen matrix (CM) has been used as a substitute for SCTG associated with CAF technique for root coverage. CAF technique was not developed for use with CM and has shown limited results when applied to the CM. The aim of this study was to compare and show the benefits of the extended flap technique (EFT) compared to CAF technique using CM for root coverage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages 25 to 50 years old\n* bilateral gingival recession type Miller class I or II\n* with 3 mm in height and less than 3mm of keratinized tissue\n* non-molar teeth\n\nExclusion Criteria:\n\n* diabetics\n* pregnant women\n* chronic use of medication\n* periodontitis'}, 'identificationModule': {'nctId': 'NCT02129504', 'briefTitle': 'Two Techniques for Root Coverage With a Xenogeneic Collagen Matrix', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Comparison of Two Surgical Techniques to Optimize the Treatment of Gingival Recessions Using a Gingival Graft Substitute.', 'orgStudyIdInfo': {'id': 'PCM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'coronal advanced technique', 'description': 'root coverage with the porcine collagen matrix using the coronal advanced technique (standard technique)', 'interventionNames': ['Device: root coverage comparing two techniques']}, {'type': 'EXPERIMENTAL', 'label': 'extended flap technique', 'description': 'root coverage with the porcine collagen matrix using the extended flap technique (new surgical technique)', 'interventionNames': ['Device: root coverage comparing two techniques']}], 'interventions': [{'name': 'root coverage comparing two techniques', 'type': 'DEVICE', 'otherNames': ['Mucograft', 'porcine collagen matrix', 'extended flap technique', 'coronal advanced flap technique'], 'description': 'The aim of this study was to compare and show the benefits of the extended flap technique (new technique) compared to coronal advanced technique (gold standard technique) both techniques using the porcine collagen matrix for root coverage.', 'armGroupLabels': ['coronal advanced technique', 'extended flap technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14040-904', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'School of dentistry of Ribeirão Preto', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Arthur Belem Novaes Jr', 'investigatorAffiliation': 'University of Sao Paulo'}}}}