Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-29 @ 6:52 AM
Study NCT ID:
NCT01237795
Status:
COMPLETED
Last Update Posted:
2014-07-28
First Post:
2010-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Experimental Denture Pastes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}, {'id': 'D013282', 'term': 'Stomatitis, Denture'}, {'id': 'D002180', 'term': 'Candidiasis, Oral'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003802', 'term': 'Dentifrices'}, {'id': 'D014100', 'term': 'Toothpastes'}], 'ancestors': [{'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D003358', 'term': 'Cosmetics'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-24', 'studyFirstSubmitDate': '2010-11-09', 'studyFirstSubmitQcDate': '2010-11-09', 'lastUpdatePostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Denture plaque coverage area (%)', 'timeFrame': '7 days', 'description': 'Relation between stained area and total surface area on the internal surface of maxillary complete dentures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chloramine T', 'Complete Denture', 'Dental Plaque Index', 'Dentifrice', 'Denture Bases', 'Denture Cleansers', 'Edentulous Mouth', 'Fluorosurfactant', 'Oral Health', 'Toothpaste'], 'conditions': ['Dental Plaque', 'Denture Stomatitis', 'Oral Candidiasis', 'Oral Hygiene']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.forp.usp.br', 'label': 'Institutional page of the Ribeirão Preto Dental School (research site)'}, {'url': 'http://lattes.cnpq.br/6275169074451249', 'label': 'Principal Investigator´s CV'}]}, 'descriptionModule': {'briefSummary': 'This trial aims to evaluate the efficacy of three experimental dentifrices to remove denture biofilm. Complete denture wearers will be instructed to brush their dentures with a specific toothbrush and four compositions: (1) A proprietary denture-specific paste (active comparator); (2) 0.2% chloramine T; (3) 1.0% chloramine T; (4) 0.01% fluorosurfactant. Each treatment will be used for periods of 7 days, and participants will be randomized to use them according to one of four sequences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completely edentulous\n* Good general health\n* Patients requesting new complete dentures (volunteers will receive the interventions before new complete dentures)\n* Regular wearing of the same maxillary and mandibular complete dentures for 3 to 10 years\n* Both denture bases and artificial teeth should be composed by acrylic resin\n\nExclusion Criteria:\n\n* Unsatisfactory complete dentures in use (i.e. with poor fitting, relining or fractures)\n* Absence of deposits of biofilm at baseline'}, 'identificationModule': {'nctId': 'NCT01237795', 'briefTitle': 'Experimental Denture Pastes', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'A Randomized Trial of Experimental Dentifrices for Cleaning Dentures', 'orgStudyIdInfo': {'id': 'FORP-PT-003'}, 'secondaryIdInfos': [{'id': '2008.1.33.58.7', 'type': 'OTHER', 'domain': 'Institutional Review Board (FORP-USP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.01% fluorosurfactant', 'description': 'An experimental formula for denture hygiene containing 0.01% fluorosurfactant.', 'interventionNames': ['Other: Dentifrice']}, {'type': 'EXPERIMENTAL', 'label': '1.0% chloramine T', 'description': 'An experimental formula for denture hygiene containing 1.0% chloramine T.', 'interventionNames': ['Other: Dentifrice']}, {'type': 'EXPERIMENTAL', 'label': '0.2% chloramine T', 'description': 'An experimental formula for denture hygiene containing 0.2% chloramine T.', 'interventionNames': ['Other: Dentifrice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Proprietary dentifrice.', 'description': 'A proprietary denture-specific dentifrice.', 'interventionNames': ['Other: Dentifrice']}], 'interventions': [{'name': 'Dentifrice', 'type': 'OTHER', 'otherNames': ['Denture-specific paste', 'Toothpaste'], 'description': 'Dentifrices (4 formulations) used as auxiliary agents for brushing complete dentures.', 'armGroupLabels': ['0.01% fluorosurfactant', '0.2% chloramine T', '1.0% chloramine T', 'Proprietary dentifrice.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14040-904', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Ribeirão Preto Dental School', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Helena FO Paranhos, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Raphael Freitas de Souza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Raphael Freitas de Souza', 'investigatorAffiliation': 'University of Sao Paulo'}}}}