Trial | NCT00612469  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    69
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.
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 Started
Oct 31
2005
Primary Completion
Jul 31
2006
Study Completion
Oct 31
2006
Last Update
Feb 11
2008
Estimate

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 names: 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 names: 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

NaF Placebo Comparator

Sodium fluoride application

V3 Experimental

Topical application of 3% vancomycin

V10 Experimental

Topical application of 10% vancomycin

CHX Active Comparator

Topical application of 1% chlorhexidine

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
No Results Posted