NCT00612469

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Universidade Federal do Ceara · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
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
DRUG	vancomycin hydrochloride	Topical application of 10% vancomycin hydrochloride to the primary dentition, every 24 hours, during 6 consecutive days
DRUG	chlorhexidine digluconate	Topical application of 1% chlorhexidine digluconate to the dentition, every 24 hours, during 6 consecutive days

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-07-01
• Completion: 2006-10-01
• First posted: 2008-02-11
• Last updated: 2008-02-11

Locations

1 site across 1 country: Brazil