The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries

Sodium Fluoride, Chlorhexidine and Vancomycin Effect in the Inhibition of Mutans Streptococci in Children With Dental Caries: a Randomized, Double-Blind Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Drug: Sodium Fluoride; Drug: vancomycin hydrochloride; Drug: vancomycin hydrochloride; Drug: chlorhexidine digluconate

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil; Drug: vancomycin hydrochloride; Topical application of 10% vancomycin hydrochloride to the primary dentition, every 24 hours, during 6 consecutive days; Other Names: Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil
Experimental: V10; Topical application of 10% vancomycin	Drug: vancomycin hydrochloride; Topical application of 3% vancomycin hydrochloride to the dentition, every 24 hours, during 6 consecutive days; Other Names: Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil; Drug: vancomycin hydrochloride; Topical application of 10% vancomycin hydrochloride to the primary dentition, every 24 hours, during 6 consecutive days; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	30-day observational period for each subject

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of new carious lesions within the different study groups 12 months after treatment discontinuation.	one year

Collaborators and Investigators

• Sponsor: Universidade Federal do Ceará
• Investigators: Principal Investigator: Cristiane SR Fonteles, DDS, MS, PhD, Federal University Of Ceara

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: January 29, 2008
• First Submitted That Met QC Criteria: January 29, 2008
• First Posted (Estimate): February 11, 2008

Study Record Updates

• Last Update Posted (Estimate): February 11, 2008
• Last Update Submitted That Met QC Criteria: January 29, 2008
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: vancomycin; chlorhexidine; dental caries; sodium fluoride; mutans streptococci
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Dermatologic Agents; Anti-Bacterial Agents; Cariostatic Agents; Disinfectants; Vancomycin; Listerine; Fluorides; Sodium Fluoride; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 270/05