Clinical trial NCT00612469: The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: dental caries
vancomycin
chlorhexidine
sodium fluoride
mutans streptococci
Lead sponsor: Universidade Federal do Ceara
Sponsor class: OTHER
First posted: 2008-02-11
Enrollment: 69
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
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.
timeFrame: 30-day observational period for each subject
Secondary outcomes:
measure: Number of new carious lesions within the different study groups 12 months after treatment discontinuation.
timeFrame: one year
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: School of Dentistry, Department of Clinical Dentistry, Federal University of Ceara
state: Ceara
Study officials:
affiliation: Federal University of Ceará
name: Cristiane SR Fonteles, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: