The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries - Full Text View

Purpose

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.

Condition	Intervention
Dental Caries	Drug: Sodium Fluoride Drug: vancomycin hydrochloride Drug: chlorhexidine digluconate

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Sodium Fluoride, Chlorhexidine and Vancomycin Effect in the Inhibition of Mutans Streptococci in Children With Dental Caries: a Randomized, Double-Blind Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Tooth Decay

Drug Information available for: Chlorhexidine Vancomycin Vancomycin hydrochloride Sodium fluoride Fluorine Fluoride Chlorhexidine gluconate Hibiclens

U.S. FDA Resources

Further study details as provided by Universidade Federal do Ceara:

Primary Outcome Measures:

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. [ Time Frame: 30-day observational period for each subject ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of new carious lesions within the different study groups 12 months after treatment discontinuation. [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment:	69
Study Start Date:	October 2005
Study Completion Date:	October 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: NaF Sodium fluoride application	Drug: Sodium Fluoride Topical application of 1.23% sodium fluoride to the dentition, every 24 hours, during 6 consecutive days
Experimental: V3 Topical application of 3% vancomycin	Drug: vancomycin hydrochloride Topical application of 3% vancomycin hydrochloride to the dentition, every 24 hours, during 6 consecutive days Other Name: Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil
Experimental: V10 Topical application of 10% vancomycin	Drug: vancomycin hydrochloride Topical application of 10% vancomycin hydrochloride to the primary dentition, every 24 hours, during 6 consecutive days Other Name: Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil
Active Comparator: CHX Topical application of 1% chlorhexidine	Drug: chlorhexidine digluconate Topical application of 1% chlorhexidine digluconate to the dentition, every 24 hours, during 6 consecutive days

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	4 Years to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Generally healthy children
Children with at least one carious cavitated or non-cavitated lesion
Must be able to spit
Must be able to collaborate during clinical intervention

Exclusion Criteria:

Children with history of allergies or allergic diseases, e.g. asthma, urticaria, rhinitis, sinusitis, or intra-oral soft tissue lesions
Children who underwent antibiotic treatment during the course of this clinical trial
Children with developmental disabilities
Children with no clinical signs dental caries

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612469

Locations

Brazil
School of Dentistry, Department of Clinical Dentistry, Federal University of Ceara
Fortaleza, Ceara, Brazil, 60441-750

Sponsors and Collaborators

Universidade Federal do Ceara

Investigators

Principal Investigator:

Cristiane SR Fonteles, DDS, MS, PhD

Federal University of Ceará

More Information

No publications provided

Responsible Party:	Cristiane Sá Roriz Fonteles, Department of Clinical Dentistry, Federal University of Ceará
ClinicalTrials.gov Identifier:	NCT00612469 History of Changes
Other Study ID Numbers:	270/05
Study First Received:	January 29, 2008
Last Updated:	January 29, 2008
Health Authority:	Brazil: Ministry of Health

Keywords provided by Universidade Federal do Ceara:

dental caries
vancomycin
chlorhexidine
sodium fluoride
mutans streptococci

Additional relevant MeSH terms:

Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine gluconate
Anti-Infective Agents
Chlorhexidine
Vancomycin
Fluorides
Sodium Fluoride

Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Disinfectants
Dermatologic Agents
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013