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

NCT06761248 | Not Yet Recruiting FDA Device

• 1 other identifier: FSN-CDR Vs ICDAS
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fluorescence-Based Caries Detection; Caries Detection Rinse; Early Caries Detection; ICDAS; FSN

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

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

  through study completion, an average of 1 year

Study Arms (1)

Fluorescent Starch Nanoparticles Rinse for Caries Detection

EXPERIMENTAL

Participants in this arm will undergo diagnostic evaluation using the fluorescent starch nanoparticles caries detection rinse. The rinse contains fluorescent starch nanoparticles that infiltrate porous enamel in active caries lesions. After application, a dental curing light will be used to activate fluorescence, allowing clinicians to identify and differentiate active caries from inactive lesions and other conditions like hypomineralization. The performance of the rinse will be compared to the International Caries Detection and Assessment System (ICDAS), which serves as the reference standard for evaluating early dental caries. Data on sensitivity, specificity, and diagnostic accuracy will be collected for analysis.

Device: Fluorescent Starch Nanoparticles Caries Detection Rinse

Interventions

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.

Also known as: LumiKids™ Rinse GreenMark Biomedical

Fluorescent Starch Nanoparticles Rinse for Caries Detection

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with active initial caries.
• At least two teeth with active caries (ICDAS 1 or 2) and two teeth with inactive caries.

You may not qualify if:

• Teeth with hypoplasia, fractures, or conditions like dentinogenesis imperfecta.
• Children with fixed orthodontic appliances.
• Participants whose guardians refuse consent.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Giza Governorate, 12613, Egypt

Location

Related Publications (2)

• Deeks JJ, Altman DG. Diagnostic tests 4: likelihood ratios. BMJ. 2004 Jul 17;329(7458):168-9. doi: 10.1136/bmj.329.7458.168. No abstract available.

  PMID: 15258077 BACKGROUND

• Amaechi BT, Phillips TS, Perozo BI, Kataoka Y, Movaghari Pour F, Farah R, Obiefuna AC, Farokhi MR. Evaluation of a novel caries detecting oral rinse. BDJ Open. 2023 Mar 20;9(1):12. doi: 10.1038/s41405-023-00134-y.

  PMID: 36941251 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Associate Prof. Dr. Mariam Mohsen aly, Ph.D.

  Cairo University

  STUDY DIRECTOR

• Dr. Reem Mohamed Fouad Wahby, Ph.D.

  Cairo University

  STUDY CHAIR

Central Study Contacts

Omar Kamel Salem Eshbair, Bachelor of Dental Science

CONTACT

+201148899948; omarksse@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 7, 2025
• Study Start: March 10, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: January 7, 2025

Record last verified: 2024-12

Locations

EG (1)