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Completed

NCT Number: NCT00612469

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry, Department of Clinical Dentistry, Federal University of Ceara

Fortaleza, Ceará, 60441-750, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Fluoride

Drug

Topical application of 1.23% sodium fluoride to the dentition, every 24 hours, during 6 consecutive days

Vancomycin Hydrochloride

Drug

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

Chlorhexidine digluconate

Drug

Topical application of 1% chlorhexidine digluconate to the dentition, every 24 hours, during 6 consecutive days

Primary outcomes

  1. 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.

    Time frame: 30-day observational period for each subject

Secondary outcomes

  1. Number of new carious lesions within the different study groups 12 months after treatment discontinuation.

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Universidade Federal do Ceara

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Feb 11, 2008
Registry last updated
Feb 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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