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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases
Chlorhexidine
Chlorhexidine gluconate
Fluorides
Listerine
Sodium Fluoride
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Cariostatic Agents
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014