An observational study in Dental Caries in Children, sponsored by Ortek Therapeutics, Inc.. Completed at 1 site in Venezuela. Open to participants aged 6 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-09.
Sponsored by Ortek Therapeutics, Inc. · Observational
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.
This is the only study on the registry with Ortek Therapeutics, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Children ages 6 - 9 years.
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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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To compare the detection of occlusal caries lesions in the first permanent molars of Venezuelan children by electrical conductance and visual-tactile means.
Time frame: 14 months from baseline assessment
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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