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

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ClinicalTrials.gov Identifier: NCT00612469
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : February 11, 2008
Sponsor:
Information provided by:
Universidade Federal do Ceara

Tracking Information
First Submitted Date  ICMJE January 29, 2008
First Posted Date  ICMJE February 11, 2008
Last Update Posted Date February 11, 2008
Study Start Date  ICMJE October 2005
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2008)
Number of new carious lesions within the different study groups 12 months after treatment discontinuation. [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries
Official Title  ICMJE Sodium Fluoride, Chlorhexidine and Vancomycin Effect in the Inhibition of Mutans Streptococci in Children With Dental Caries: a Randomized, Double-Blind Clinical Trial
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2008)
69
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2006
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00612469
Other Study ID Numbers  ICMJE 270/05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cristiane Sá Roriz Fonteles, Department of Clinical Dentistry, Federal University of Ceará
Study Sponsor  ICMJE Universidade Federal do Ceara
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cristiane SR Fonteles, DDS, MS, PhD Federal University of Ceará
PRS Account Universidade Federal do Ceara
Verification Date December 2007

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