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

NCT ID: NCT02002728

Last Updated: 2013-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Caries in Children

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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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Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ortek Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universidad Central de Venezuela

Caracas, Venezuela, Venezuela

Site Status

Countries

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Venezuela

Other Identifiers

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ECD0613

Identifier Type: -

Identifier Source: org_study_id