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

Sponsored by:	Universidade Federal do Ceara
Information provided by:	Universidade Federal do Ceara
ClinicalTrials.gov Identifier:	NCT00612469

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

Drug Information available for: Chlorhexidine Fluoride Chlorhexidine digluconate Hibiclens Vancomycin Vancomycin hydrochloride Sodium fluoride Stannous fluoride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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

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
NaF: Placebo Comparator Sodium fluoride application	Drug: Sodium Fluoride Topical application of 1.23% sodium fluoride to the dentition, every 24 hours, during 6 consecutive days
V3: Experimental Topical application of 3% vancomycin	Drug: vancomycin hydrochloride Topical application of 3% vancomycin hydrochloride to the dentition, every 24 hours, during 6 consecutive days
V10: Experimental 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
CHX: Active Comparator 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, Ceara
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:	Department of Clinical Dentistry, Federal University of Ceará ( Cristiane Sá Roriz Fonteles )
Study ID Numbers:	270/05
Study First Received:	January 29, 2008
Last Updated:	January 29, 2008
ClinicalTrials.gov Identifier:	NCT00612469 History of Changes
Health Authority:	Brazil: Ministry of Health

Keywords provided by Universidade Federal do Ceara:

dental caries
vancomycin
chlorhexidine
sodium fluoride
mutans streptococci

Study placed in the following topic categories:

Anti-Bacterial Agents
Anti-Infective Agents, Local
Tooth Diseases
Disinfectants
Chlorhexidine

Chlorhexidine gluconate
Vancomycin
Stomatognathic Diseases
Fluorides
Dental Caries

Additional relevant MeSH terms:

Tooth Diseases
Anti-Infective Agents
Chlorhexidine
Physiological Effects of Drugs
Protective Agents
Dental Caries
Tooth Demineralization
Pharmacologic Actions
Anti-Bacterial Agents

Anti-Infective Agents, Local
Disinfectants
Cariostatic Agents
Chlorhexidine gluconate
Therapeutic Uses
Vancomycin
Stomatognathic Diseases
Fluorides
Dermatologic Agents

ClinicalTrials.gov processed this record on May 07, 2009