The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Sodium Fluoride
vancomycin hydrochloride
vancomycin hydrochloride
chlorhexidine digluconate
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring dental caries, vancomycin, chlorhexidine, sodium fluoride, mutans streptococci
Eligibility 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
Sites / Locations
- School of Dentistry, Department of Clinical Dentistry, Federal University of Ceara
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Active Comparator
Arm Label
NaF
V3
V10
CHX
Arm Description
Sodium fluoride application
Topical application of 3% vancomycin
Topical application of 10% vancomycin
Topical application of 1% chlorhexidine
Outcomes
Primary Outcome Measures
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 Measures
Number of new carious lesions within the different study groups 12 months after treatment discontinuation.
Full Information
NCT ID
NCT00612469
First Posted
January 29, 2008
Last Updated
January 29, 2008
Sponsor
Universidade Federal do Ceara
1. Study Identification
Unique Protocol Identification Number
NCT00612469
Brief Title
The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries
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 Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidade Federal do Ceara
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
dental caries, vancomycin, chlorhexidine, sodium fluoride, mutans streptococci
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NaF
Arm Type
Placebo Comparator
Arm Description
Sodium fluoride application
Arm Title
V3
Arm Type
Experimental
Arm Description
Topical application of 3% vancomycin
Arm Title
V10
Arm Type
Experimental
Arm Description
Topical application of 10% vancomycin
Arm Title
CHX
Arm Type
Active Comparator
Arm Description
Topical application of 1% chlorhexidine
Intervention Type
Drug
Intervention Name(s)
Sodium Fluoride
Intervention Description
Topical application of 1.23% sodium fluoride to the dentition, every 24 hours, during 6 consecutive days
Intervention Type
Drug
Intervention Name(s)
vancomycin hydrochloride
Other Intervention Name(s)
Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil
Intervention Description
Topical application of 3% vancomycin hydrochloride to the dentition, every 24 hours, during 6 consecutive days
Intervention Type
Drug
Intervention Name(s)
vancomycin hydrochloride
Other Intervention Name(s)
Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil
Intervention Description
Topical application of 10% vancomycin hydrochloride to the primary dentition, every 24 hours, during 6 consecutive days
Intervention Type
Drug
Intervention Name(s)
chlorhexidine digluconate
Intervention Description
Topical application of 1% chlorhexidine digluconate to the dentition, every 24 hours, during 6 consecutive days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Number of new carious lesions within the different study groups 12 months after treatment discontinuation.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristiane SR Fonteles, DDS, MS, PhD
Organizational Affiliation
Federal University of Ceará
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry, Department of Clinical Dentistry, Federal University of Ceara
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60441-750
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries
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