|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00612469 |
|
Date of registration:
|
29/01/2008 |
|
Primary sponsor: |
|
|
Public title:
|
The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries
|
|
Scientific title:
|
Sodium Fluoride, Chlorhexidine and Vancomycin Effect in the Inhibition of Mutans Streptococci in Children With Dental Caries: a Randomized, Double-Blind Clinical Trial |
|
Date of first enrolment:
|
October 2005 |
|
Target sample size:
|
69 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00612469 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
Brazil
| | | | | | | |
|
Contacts
|
|
Name:
|
Cristiane SR Fonteles, DDS, MS, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Federal University of Ceará |
| | |
|
Key inclusion & exclusion 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
Age minimum:
4 Years
Age maximum:
8 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Dental Caries
|
|
Intervention(s)
|
|
Drug: chlorhexidine digluconate
|
|
Drug: Sodium Fluoride
|
|
Drug: vancomycin hydrochloride
|
|
Primary Outcome(s)
|
|
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(s)
|
|
Number of new carious lesions within the different study groups 12 months after treatment discontinuation.
[Time Frame: one year]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|