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Note: This record shows only 22 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: 19 February 2015
Main ID:  NCT02002728
Date of registration: 01/12/2013
Prospective Registration: No
Primary sponsor: Ortek Therapeutics, Inc.
Public title: Comparison of Early Caries Detection in Children Utilizing an Electrical Conductance Device and the Gold Standard of Visual-tactile Technique.
Scientific title:
Date of first enrolment: November 2006
Target sample size: 200
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT02002728
Study type:  Observational [Patient Registry]
Study design:  Observational Model: Case-Only, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Venezuela
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

Children whose parents authorize participation by signing a consent form. Children who
attend public school only. Children in good health. Children between 6 and 9 years of age.
Children with all first permanent molars erupted. All permanent first molars must not have
any signs of cavitation but only one molar can have some mineral loss(e.g. white spots).

Children must show some caries in the primary molars as a sign of caries susceptibility.

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Exclusion Criteria:

Children of parents or a guardian who do not agree to participate in the study. Children
registered in private schools. Children not in good health. Children undergoing
antimicrobial or antibiotic treatment. Children outside the range of age selected for the
study. Children with one or more first permanent molars unerupted. Children with any
cavitation in the occlusal surface of any first permanent molar.

Children who do not have a sign of dental caries in the primary molars as a sign of caries
susceptibility.

Children who do not allow themselves to be examined.

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Age minimum: 6 Years
Age maximum: 9 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Dental Caries in Children
Intervention(s)
Primary Outcome(s)
To compare the detection of occlusal caries lesions in the first permanent molars of Venezuelan children by electrical conductance and visual-tactile means. [Time Frame: 14 months from baseline assessment]
Secondary Outcome(s)
Secondary ID(s)
ECD0613
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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