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

Universidade Federal do Ceara

Status: Completed

Conditions: Dental Caries

Treatments: Drug: Sodium Fluoride; Drug: vancomycin hydrochloride; Drug: chlorhexidine digluconate

Study type: Interventional

Funder types: Other

Identifiers

NCT00612469

270/05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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69 participants in 4 patient groups, including a placebo group

NaF

Placebo Comparator group

Description:

Sodium fluoride application

Treatment:

Drug: Sodium Fluoride

V3

Experimental group

Description:

Topical application of 3% vancomycin

Treatment:

Drug: vancomycin hydrochloride

Drug: vancomycin hydrochloride

V10

Experimental group

Description:

Topical application of 10% vancomycin

Treatment:

Drug: vancomycin hydrochloride

Drug: vancomycin hydrochloride

CHX

Active Comparator group

Description:

Topical application of 1% chlorhexidine

Treatment:

Drug: chlorhexidine digluconate