The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries
Information source: Universidade Federal do Ceara
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dental Caries
Intervention: Sodium Fluoride (Drug); vancomycin hydrochloride (Drug); vancomycin hydrochloride (Drug); chlorhexidine digluconate (Drug)
Phase: N/A
Status: Completed
Sponsored by: Universidade Federal do Ceara Official(s) and/or principal investigator(s): Cristiane SR Fonteles, DDS, MS, PhD, Principal Investigator, Affiliation: Federal University of CearĂ¡
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: 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.
Secondary outcome: Number of new carious lesions within the different study groups 12 months after treatment discontinuation.
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
Minimum age: 4 Years.
Maximum age: 8 Years.
Gender(s): Both.
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
Locations and Contacts
School of Dentistry, Department of Clinical Dentistry, Federal University of Ceara, Fortaleza, Ceara 60441-750, Brazil
Additional Information
Starting date: October 2005
Last updated: January 29, 2008
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