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

Completed

• Conditions: Dental Caries in Children

• Registration Number: NCT02002728
• Lead Sponsor: Ortek Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2013-12
• Study First Submitted: 2013-12-01
• Study First Submitted QC: 2013-12-01
• Study First Posted: 2013-12-06
• Last Update Submitted: 2013-12-06
• Last Update Posted: 2013-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universidad Central de Venezuela; 🇻🇪 Caracas, Venezuela