Clincosm LogoSign in Get a demo

Comparison of Early Caries Detection in Children Utilizing an Electrical Conductance Device and the Gold Standard of Visual-tactile Technique.

Sponsor
Ortek Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02002728
Collaborator
(none)
200
Enrollment
1
Location
29
Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate a methodology for detecting early forming cavities in children that is more accurate and reliable than the gold standard used by dentists around the world. The new method uses an electrical current device to detect early enamel mineral loss before it can develop into a cavity. The manual gold standard is for a dentist to probe the surfaces of the teeth with a fine pick, searching for areas of defect.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Study Start Date :
    Nov 1, 2006
    Actual Primary Completion Date :
    Apr 1, 2009
    Actual Study Completion Date :
    Apr 1, 2009

    Outcome Measures

    Primary Outcome Measures

    1. To compare the detection of occlusal caries lesions in the first permanent molars of Venezuelan children by electrical conductance and visual-tactile means. [14 months from baseline assessment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 9 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    -

    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.

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidad Central de Venezuela Caracas Venezuela 1050

    Sponsors and Collaborators

    • Ortek Therapeutics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ortek Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02002728
    Other Study ID Numbers:
    • ECD0613
    First Posted:
    Dec 6, 2013
    Last Update Posted:
    Dec 9, 2013
    Last Verified:
    Dec 1, 2013
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of Dec 9, 2013