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

This study has been completed.
Sponsor:
Information provided by:
Universidade Federal do Ceara
ClinicalTrials.gov Identifier:
NCT00612469
First received: January 29, 2008
Last updated: NA
Last verified: December 2007
History: No changes posted

January 29, 2008
January 29, 2008
October 2005
July 2006   (final data collection date for primary outcome 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. [ Time Frame: 30-day observational period for each subject ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Number of new carious lesions within the different study groups 12 months after treatment discontinuation. [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Dental Caries
  • Drug: Sodium Fluoride
    Topical application of 1.23% sodium fluoride to the dentition, every 24 hours, during 6 consecutive days
  • 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
  • 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
  • Drug: chlorhexidine digluconate
    Topical application of 1% chlorhexidine digluconate to the dentition, every 24 hours, during 6 consecutive days
  • Placebo Comparator: NaF
    Sodium fluoride application
    Intervention: Drug: Sodium Fluoride
  • Experimental: V3
    Topical application of 3% vancomycin
    Intervention: Drug: vancomycin hydrochloride
  • Experimental: V10
    Topical application of 10% vancomycin
    Intervention: Drug: vancomycin hydrochloride
  • Active Comparator: CHX
    Topical application of 1% chlorhexidine
    Intervention: Drug: chlorhexidine digluconate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
October 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
4 Years to 8 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00612469
270/05
No
Cristiane Sá Roriz Fonteles, Department of Clinical Dentistry, Federal University of Ceará
Universidade Federal do Ceara
Not Provided
Principal Investigator: Cristiane SR Fonteles, DDS, MS, PhD Federal University of Ceará
Universidade Federal do Ceara
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP