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

NCT06761248 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-01-07

No results posted yet for this study

Summary

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.

Conditions

  • Dental Caries
  • Detection
  • Fluorescence
  • Diagnostic Accuracy

Interventions

DEVICE

Fluorescent Starch Nanoparticles Caries Detection Rinse

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Associate Prof. Dr. Mariam Mohsen aly, Ph.D. · Cairo University

  • Dr. Reem Mohamed Fouad Wahby, Ph.D. · Cairo University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2026-04-15
Completion
2026-08-15
FDA Device
Yes

Countries

  • Egypt

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06761248 on ClinicalTrials.gov