About this trial
The present study aims to evaluate the diagnostic accuracy of fluorescent starch nanoparticles caries detection rinse versus the International Caries Detection and Assessment System (ICDAS) in identifying early dental caries among children from 6 to 11 years old.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children with active initial caries.
At least two teeth with active caries (ICDAS 1 or 2) and two teeth with inactive caries.
Disqualifiers
Teeth with hypoplasia, fractures, or conditions like dentinogenesis imperfecta.
Children with fixed orthodontic appliances.
Participants whose guardians refuse consent.
Trial design
Single group
Treatments tested in this trial
Fluorescent Starch Nanoparticles Caries Detection Rinse
DeviceThe fluorescent starch nanoparticles caries detection rinse is an innovative diagnostic tool designed to enhance the early detection of active dental caries. It contains proprietary fluorescent starch nanoparticles that infiltrate the porous enamel of active caries lesions. Upon illumination with a standard dental curing light, the nanoparticles fluoresce, allowing clinicians to differentiate active caries from inactive lesions and other enamel conditions. This rinse is evaluated as a non-invasive, highly sensitive, and specific diagnostic device.
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic accuracy
Measured using sensitivity, specificity, positive predictive value, and negative predictive value.
Locations
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Sponsors and contacts
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