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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sodium Fluoride, Chlorhexidine and Vancomycin Effect in the Inhibition of Mutans Streptococci in Children With Dental Caries: a Randomized, Double-Blind Clinical Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: Sodium Fluoride
* Drug: vancomycin hydrochloride
* Drug: vancomycin hydrochloride
* Drug: chlorhexidine digluconate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: NaF<br>Sodium fluoride application | Drug: Sodium Fluoride<br>* Topical application of 1.23% sodium fluoride to the dentition, every 24 hours, during 6 consecutive days<br>|
| Experimental: V3<br>Topical application of 3% vancomycin | Drug: vancomycin hydrochloride<br>* Topical application of 3% vancomycin hydrochloride to the dentition, every 24 hours, during 6 consecutive days<br>* Other names: Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil;|
| Experimental: V10<br>Topical application of 10% vancomycin | Drug: vancomycin hydrochloride<br>* Topical application of 10% vancomycin hydrochloride to the primary dentition, every 24 hours, during 6 consecutive days<br>* Other names: Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil;|
| Active Comparator: CHX<br>Topical application of 1% chlorhexidine | Drug: chlorhexidine digluconate<br>* Topical application of 1% chlorhexidine digluconate to the dentition, every 24 hours, during 6 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of new carious lesions within the different study groups 12 months after treatment discontinuation. |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental caries, vancomycin, chlorhexidine, sodium fluoride, mutans streptococci