The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Drug: vancomycin hydrochloride; Drug: chlorhexidine digluconate; Drug: Sodium Fluoride

• Registration Number: NCT00612469
• Lead Sponsor: Universidade Federal do Ceara

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.

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-07
• Study Completion: 2006-10
• Status Verified: 2007-12
• Study First Submitted: 2008-01-29
• Study First Submitted QC: 2008-01-29
• Last Update Submitted: 2008-01-29
• Study First Posted: 2008-02-11
• Last Update Posted: 2008-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V3	vancomycin hydrochloride	Topical application of 3% vancomycin
V10	vancomycin hydrochloride	Topical application of 10% vancomycin
CHX	chlorhexidine digluconate	Topical application of 1% chlorhexidine
NaF	Sodium Fluoride	Sodium fluoride application

Primary Outcome Measures

Name	Time	Method
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.	30-day observational period for each subject

Secondary Outcome Measures

Name	Time	Method
Number of new carious lesions within the different study groups 12 months after treatment discontinuation.	one year

Trial Locations

Locations (1)

School of Dentistry, Department of Clinical Dentistry, Federal University of Ceara; 🇧🇷 Fortaleza, Ceara, Brazil