Comparing Fluorescent Starch Nanoparticles Rinse with ICDAS for Early Caries Detection in Children

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-11
SponsorCairo University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Fluorescent Starch Nanoparticles Caries Detection Rinse

    Device

    The 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

78 Participants
are divided into 1 treatment group
Group A: Fluorescent Starch Nanoparticles Rinse for Caries DetectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic accuracy

Measured using sensitivity, specificity, positive predictive value, and negative predictive value.

Time frame
through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Faculty of Dentistry, Cairo University Status unavailable 12613, Cairo, Giza GovernorateEgyptEgypt

Sponsors and contacts

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