Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-19 @ 4:55 PM
Study NCT ID:
NCT02656251
Status:
COMPLETED
Last Update Posted:
2016-01-14
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Two Chlorhexidine Solutions to Control the Initial Subgingival Biofilm Formation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-04-29', 'releaseDate': '2016-03-29'}], 'estimatedResultsFirstSubmitDate': '2016-03-29'}}, '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': 'D000431', 'term': 'Ethanol'}, {'id': 'D002710', 'term': 'Chlorhexidine'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-13', 'studyFirstSubmitDate': '2015-11-18', 'studyFirstSubmitQcDate': '2016-01-13', 'lastUpdatePostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index.', 'timeFrame': '24hours', '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': ['biofilms', 'cross over trial', 'chlorhexidine'], 'conditions': ['Dental Plaque']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the effect of a suspension containing chlorhexidine and alcohol and another one containing clorhexidine with no alcohol 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. 35 volunteers will stop mechanical supragingival 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 a minute a Solution containing chlorhexidine and alcohol or a solution with chlorhexidine alcohol-free or placebo. Every 24h the presence of deposits will be registered with special attention 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'], 'maximumAge': '40 Years', '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\n * positive history of allergies at using Triclosan;\n * pregnant or lactating patients;\n * patients in use of fixed orthodontic appliance.'}, 'identificationModule': {'nctId': 'NCT02656251', 'briefTitle': 'Efficacy of Two Chlorhexidine Solutions to Control the Initial Subgingival Biofilm Formation', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Rio Grande do Sul'}, 'officialTitle': 'Efficacy of Two Clorhexidine Formulations to Control the Initial Subgingival Biofilm Formation', 'orgStudyIdInfo': {'id': 'URio Grande'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '0.12% Clorhexidine with alcohol', 'description': '0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days', 'interventionNames': ['Drug: 0.12% Clorhexidine with alcohol', 'Drug: placebo', 'Drug: 0.12% Clorhexidine without alcohol']}, {'type': 'EXPERIMENTAL', 'label': '0.12% Clorhexidine without alcohol', 'description': '0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days', 'interventionNames': ['Drug: 0.12% Clorhexidine with alcohol', 'Drug: placebo', 'Drug: 0.12% Clorhexidine without alcohol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'placebo 15ml every 12 hour for 4 days', 'interventionNames': ['Drug: 0.12% Clorhexidine with alcohol', 'Drug: placebo', 'Drug: 0.12% Clorhexidine without alcohol']}], 'interventions': [{'name': '0.12% Clorhexidine with alcohol', 'type': 'DRUG', 'otherNames': ['Periogard', 'No plak'], 'description': 'Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days', 'armGroupLabels': ['0.12% Clorhexidine with alcohol', '0.12% Clorhexidine without alcohol', 'control']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Use of placebo every 12 hours for 04 days', 'armGroupLabels': ['0.12% Clorhexidine with alcohol', '0.12% Clorhexidine without alcohol', 'control']}, {'name': '0.12% Clorhexidine without alcohol', 'type': 'DRUG', 'otherNames': ['Periogard'], 'description': 'Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days', 'armGroupLabels': ['0.12% Clorhexidine with alcohol', '0.12% Clorhexidine without alcohol', 'control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'University of Rio Grande do Sul', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Patricia Weidlich, PhD', 'role': 'STUDY_DIRECTOR', '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': 'Doctor', 'investigatorFullName': 'Patricia Weidlich', 'investigatorAffiliation': 'Federal University of Rio Grande do Sul'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-03-29', 'type': 'RELEASE'}, {'date': '2016-04-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Patricia Weidlich, Doctor, Federal University of Rio Grande do Sul'}}}}