Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT01175720
Status:
COMPLETED
Last Update Posted:
2011-11-16
First Post:
2010-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Comparison Between Two Surgical Techniques for the 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-11', 'studyFirstSubmitDate': '2010-08-03', 'studyFirstSubmitQcDate': '2010-08-04', 'lastUpdatePostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of root coverage', 'timeFrame': '6 months', 'description': 'Clinical parameters will be assessed after 6 months of surgical procedures.'}], 'secondaryOutcomes': [{'measure': 'Keratinized Tissue', 'timeFrame': '6 months', 'description': 'Clinical parameters will be assessed after 6 months of surgical procedures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gingival recession', 'acellular dermal matrix graft', 'root coverage'], 'conditions': ['Gingival Recession']}, 'referencesModule': {'references': [{'pmid': '22712624', 'type': 'DERIVED', 'citation': 'Ayub LG, Ramos UD, Reino DM, Grisi MF, Taba M Jr, Souza SL, Palioto DB, Novaes AB Jr. A Randomized comparative clinical study of two surgical procedures to improve root coverage with the acellular dermal matrix graft. J Clin Periodontol. 2012 Sep;39(9):871-8. doi: 10.1111/j.1600-051X.2012.01915.x. Epub 2012 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test a surgical technique for the treatment of gingival recessions. The hypothesis of the study is to promote greater root coverage and better healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Recession defects are Miller's class I or II and do not vary more or equal than 3 mm\n* Main complaint aesthetic issues or dentine hypersensitivity\n* The patient must be a candidate for bilateral root coverage procedure\n* Patient shows sufficient plaque control (FMPS \\< 20%)\n* The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures\n* The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent\n\nExclusion Criteria:\n\n* Smokers\n* Systemic diseases\n* Pregnants or lactating\n* Periodontal disease\n* General contraindications for dental and/or surgical treatment are present\n* The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years\n* The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)"}, 'identificationModule': {'nctId': 'NCT01175720', 'briefTitle': 'Clinical Comparison Between Two Surgical Techniques for the Treatment of Gingival Recessions', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Clinical Comparison Between Two Surgical Techniques With Acellular Dermal Matrix Graft in the Treatment of Gingival Recessions', 'orgStudyIdInfo': {'id': 'lga030183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'test and control', 'description': 'The test and control technique will be tested in a split-mouth design.', 'interventionNames': ['Procedure: Periodontal surgery to gingival recessions']}], 'interventions': [{'name': 'Periodontal surgery to gingival recessions', 'type': 'PROCEDURE', 'description': 'Test and control technique to treat gingival recessions.', 'armGroupLabels': ['test and control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14040-904', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Faculty of Dentistry of Ribeirão Preto USP', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Arthur B. Novaes Júnior, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Lauro G. Ayub, MSD student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical comparison between two surgical techniques with acellular dermal matrix graft in the treatment of gingival recessions', 'investigatorFullName': 'Arthur Belem Novaes Jr', 'investigatorAffiliation': 'University of Sao Paulo'}}}}