Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-17 @ 4:44 PM
Study NCT ID:
NCT00612469
Status:
COMPLETED
Last Update Posted:
2008-02-11
First Post:
2008-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012969', 'term': 'Sodium Fluoride'}, {'id': 'D014640', 'term': 'Vancomycin'}, {'id': 'C010882', 'term': 'chlorhexidine gluconate'}], 'ancestors': [{'id': 'D005459', 'term': 'Fluorides'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D002327', 'term': 'Cariostatic Agents'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-29', 'studyFirstSubmitDate': '2008-01-29', 'studyFirstSubmitQcDate': '2008-01-29', 'lastUpdatePostDateStruct': {'date': '2008-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Salivary mutans streptococci levels prior to treatment, on the last day of treatment (day 6), two weeks after day 1 and 30 days after day 1.', 'timeFrame': '30-day observational period for each subject'}], 'secondaryOutcomes': [{'measure': 'Number of new carious lesions within the different study groups 12 months after treatment discontinuation.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dental caries', 'vancomycin', 'chlorhexidine', 'sodium fluoride', 'mutans streptococci'], 'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to compare salivary MS levels in four different groups of children with caries, that have been submitted to intraoral topical treatment with either 1,23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin, during 6 consecutive days. This clinical trial was designed to test two different hypotheses. First, that topical vancomycin would be more effective than chlorhexidine and sodium fluoride in salivary MS reduction. Secondly, a 6-day antimicrobial treatment with either one of these agents would produce a long lasting MS suppression, dispensing repeated antibacterial treatments.', 'detailedDescription': 'The present study aimed to compare the effect of sodium fluoride, chlorhexidine and vancomycin on salivary mutans streptococci (MS) levels, on a double-blind, randomized clinical trial. Sixty-nine healthy volunteers, aged 4-8 years, with at least one active carious lesion and no previous history of allergies were selected to participate in the study. A gel formulation containing 1.23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin was topically administered to the dentition every 24 hours, during 6 consecutive days. Salivary MS levels were measured at baseline (D1), on the 6th (D6), 15th (D15) and 30th day (D30). For microbiological analysis, MSB agar medium was used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy children\n* Children with at least one carious cavitated or non-cavitated lesion\n* Must be able to spit\n* Must be able to collaborate during clinical intervention\n\nExclusion Criteria:\n\n* Children with history of allergies or allergic diseases, e.g. asthma, urticaria, rhinitis, sinusitis, or intra-oral soft tissue lesions\n* Children who underwent antibiotic treatment during the course of this clinical trial\n* Children with developmental disabilities\n* Children with no clinical signs dental caries'}, 'identificationModule': {'nctId': 'NCT00612469', 'briefTitle': 'The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Ceara'}, 'officialTitle': 'Sodium Fluoride, Chlorhexidine and Vancomycin Effect in the Inhibition of Mutans Streptococci in Children With Dental Caries: a Randomized, Double-Blind Clinical Trial', 'orgStudyIdInfo': {'id': '270/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'NaF', 'description': 'Sodium fluoride application', 'interventionNames': ['Drug: Sodium Fluoride']}, {'type': 'EXPERIMENTAL', 'label': 'V3', 'description': 'Topical application of 3% vancomycin', 'interventionNames': ['Drug: vancomycin hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'V10', 'description': 'Topical application of 10% vancomycin', 'interventionNames': ['Drug: vancomycin hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CHX', 'description': 'Topical application of 1% chlorhexidine', 'interventionNames': ['Drug: chlorhexidine digluconate']}], 'interventions': [{'name': 'Sodium Fluoride', 'type': 'DRUG', 'description': 'Topical application of 1.23% sodium fluoride to the dentition, every 24 hours, during 6 consecutive days', 'armGroupLabels': ['NaF']}, {'name': 'vancomycin hydrochloride', 'type': 'DRUG', 'otherNames': ['Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil'], 'description': 'Topical application of 3% vancomycin hydrochloride to the dentition, every 24 hours, during 6 consecutive days', 'armGroupLabels': ['V3']}, {'name': 'vancomycin hydrochloride', 'type': 'DRUG', 'otherNames': ['Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil'], 'description': 'Topical application of 10% vancomycin hydrochloride to the primary dentition, every 24 hours, during 6 consecutive days', 'armGroupLabels': ['V10']}, {'name': 'chlorhexidine digluconate', 'type': 'DRUG', 'description': 'Topical application of 1% chlorhexidine digluconate to the dentition, every 24 hours, during 6 consecutive days', 'armGroupLabels': ['CHX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60441-750', 'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'School of Dentistry, Department of Clinical Dentistry, Federal University of Ceara', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}], 'overallOfficials': [{'name': 'Cristiane SR Fonteles, DDS, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Ceará'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Ceara', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Cristiane Sá Roriz Fonteles', 'oldOrganization': 'Department of Clinical Dentistry, Federal University of Ceará'}}}}