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

NCT00612469 | Completed

• 1 other identifier: 270/05
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

dental caries; vancomycin; chlorhexidine; sodium fluoride; mutans streptococci

Outcome Measures

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.

  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.

  one year

Study Arms (4)

NaF

PLACEBO COMPARATOR

Sodium fluoride application

Drug: Sodium Fluoride

V3

EXPERIMENTAL

Topical application of 3% vancomycin

Drug: vancomycin hydrochloride

V10

EXPERIMENTAL

Topical application of 10% vancomycin

Drug: vancomycin hydrochloride

CHX

ACTIVE COMPARATOR

Topical application of 1% chlorhexidine

Drug: chlorhexidine digluconate

Interventions

Sodium Fluoride DRUG

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

NaF

vancomycin hydrochloride DRUG

Topical application of 3% vancomycin hydrochloride to the dentition, every 24 hours, during 6 consecutive days

Also known as: Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil

V3

chlorhexidine digluconate DRUG

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

CHX

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Ceara: lead

Study Sites (1)

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

Fortaleza, Ceará, 60441-750, Brazil

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Sodium Fluoride; Vancomycin; chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Cristiane SR Fonteles, DDS, MS, PhD

  Federal University of Ceará

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: February 11, 2008
• Study Start: October 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: October 1, 2006
• Last Updated: February 11, 2008

Record last verified: 2007-12

Locations

BR (1)