We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00612469
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : February 11, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Dental Caries Drug: Sodium Fluoride Drug: vancomycin hydrochloride Drug: chlorhexidine digluconate

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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 Start Date : October 2005
Primary Completion Date : July 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: NaF
Sodium fluoride application
Drug: Sodium Fluoride
Topical application of 1.23% sodium fluoride to the dentition, every 24 hours, during 6 consecutive days
Experimental: V3
Topical application of 3% vancomycin
Drug: vancomycin hydrochloride
Topical application of 3% vancomycin hydrochloride to the dentition, every 24 hours, during 6 consecutive days
Other Name: Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil
Experimental: V10
Topical application of 10% vancomycin
Drug: vancomycin hydrochloride
Topical application of 10% vancomycin hydrochloride to the primary dentition, every 24 hours, during 6 consecutive days
Other Name: Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil
Active Comparator: CHX
Topical application of 1% chlorhexidine
Drug: chlorhexidine digluconate
Topical application of 1% chlorhexidine digluconate to the dentition, every 24 hours, during 6 consecutive days


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of new carious lesions within the different study groups 12 months after treatment discontinuation. [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612469


Locations
Brazil
School of Dentistry, Department of Clinical Dentistry, Federal University of Ceara
Fortaleza, Ceara, Brazil, 60441-750
Sponsors and Collaborators
Universidade Federal do Ceara
Investigators
Principal Investigator: Cristiane SR Fonteles, DDS, MS, PhD Federal University of Ceará
More Information

Responsible Party: Cristiane Sá Roriz Fonteles, Department of Clinical Dentistry, Federal University of Ceará
ClinicalTrials.gov Identifier: NCT00612469     History of Changes
Other Study ID Numbers: 270/05
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: February 11, 2008
Last Verified: December 2007

Keywords provided by Universidade Federal do Ceara:
dental caries
vancomycin
chlorhexidine
sodium fluoride
mutans streptococci

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Sodium Fluoride
Chlorhexidine
Chlorhexidine gluconate
Listerine
Vancomycin
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents