DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Universidade Federal do Ceara
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dental Caries

Intervention: Sodium Fluoride (Drug); vancomycin hydrochloride (Drug); vancomycin hydrochloride (Drug); chlorhexidine digluconate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Universidade Federal do Ceara

Official(s) and/or principal investigator(s):
Cristiane SR Fonteles, DDS, MS, PhD, Principal Investigator, Affiliation: Federal University of CearĂ¡


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: 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.

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

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.


Minimum age: 4 Years. Maximum age: 8 Years. Gender(s): Both.


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

Locations and Contacts

School of Dentistry, Department of Clinical Dentistry, Federal University of Ceara, Fortaleza, Ceara 60441-750, Brazil
Additional Information

Starting date: October 2005
Last updated: January 29, 2008

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017