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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries in Children

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Venezuela
  • Caracas, Venezuela, 1050
    • Universidad Central de Venezuela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 9 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children ages 6 - 9 years.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ortek Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: December 1, 2013
• First Submitted That Met QC Criteria: December 1, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Estimate): December 9, 2013
• Last Update Submitted That Met QC Criteria: December 6, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: ECD0613