Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-02 @ 3:42 PM
Study NCT ID:
NCT02192060
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
2013-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014260', 'term': 'Triclosan'}], 'ancestors': [{'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-14', 'studyFirstSubmitDate': '2013-11-13', 'studyFirstSubmitQcDate': '2014-07-14', 'lastUpdatePostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of Plaque Free Zone', 'timeFrame': '24 hours', 'description': 'The presence of scores 0, 1 or 2 of the index "Plaque Free Zone" will be recorded at baseline and at each 24 hours, during a period of 96 hours (4 days).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Biofilm', 'Triclosan', 'Crossover', 'Clinical trial'], 'conditions': ['Dental Plaque']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the effect of a suspension containing Triclosan in dynamic of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).', 'detailedDescription': 'This is a double blind, cross over, randomized clinical trial. 28 volunteers will stop mechanical supragingiva biofilm removal measures for 96h following a complete scaling and polishing of the tooth surfaces. During this period they will be asked to rinse for one minute with a slurry of either a triclosan containing dentifice or a control without triclosan. Every 24h the presence of deposits will be registered with special atention to the presence of a plaque free zone between the apical border of the deposits and the gingival margin. Absence of deposits is scored 0, presence of deposits and plaque free zone =1 and presence of deposits and absence of plaque free zone =2 (MALISKA, A. N. et al. Measuring early plaque formation clinically. Oral health preventive dentistry, v. 4, p. 273-278, 2006). The prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated for significance. Sample size was calculated taking the results from the study o MALISKA, AN (2006) as reference.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age from 18 years;\n* non-smokers;\n* have good general health;\n* present at least 20 natural teeth in the mouth, including the incisors, canines and premolars without restorations, crowns, gingival recession, anatomic defects, gingivitis e/or periodontitis.\n\nExclusion Criteria:\n\n* positive history of using antibiotic e/or anti-inflammatory drugs in the month previous to the initial consultation;\n* positive history of allergies at using Triclosan;\n* pregnant or lactating patients;\n* patients in use of fixed orthodontic appliance.'}, 'identificationModule': {'nctId': 'NCT02192060', 'briefTitle': 'Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Rio Grande do Sul'}, 'officialTitle': 'Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation', 'orgStudyIdInfo': {'id': 'RVOppermann01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': 'Using of a suspension containing Triclosan', 'interventionNames': ['Other: Test - Using of a suspension containing Triclosan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Using of a suspension without Triclosan or other active ingredient', 'interventionNames': ['Other: Control - Using of a suspension without Triclosan']}], 'interventions': [{'name': 'Test - Using of a suspension containing Triclosan', 'type': 'OTHER', 'description': 'The participants should have used only the suspension containing Triclosan during 5 days and have stopped with their biofilm control homemade procedures.', 'armGroupLabels': ['Test']}, {'name': 'Control - Using of a suspension without Triclosan', 'type': 'OTHER', 'description': 'The participants should have used only the Placebo suspension during 5 days and have stopped with their biofilm control homemade procedures.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-003', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Dentistry Faculty, Federal University of Rio Grande do Sul', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Rui V. Oppermann, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Rio Grande do Sul'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Rio Grande do Sul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, PhD', 'investigatorFullName': 'Rui Vicente Oppermann', 'investigatorAffiliation': 'Federal University of Rio Grande do Sul'}}}}