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

Dental Caries in Children Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002728
• Other study ID #: ECD0613
• Status: Completed
• Phase: N/A
• First received: December 1, 2013
• Last updated: December 6, 2013
• Start date: November 2006
• Est. completion date: April 2009

Study information

• Verified date: December 2013
• Source: Ortek Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela: Central University of Venezuela, School of Dental Medicine
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 9 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Locations

Country	Name	City	State
Venezuela	Universidad Central de Venezuela	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
Ortek Therapeutics, Inc.

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No