Skip to content

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

Clinical Effectiveness of Fluorescent Starch Nanoparticles Caries Detection Rinse Versus International Caries Detection and Assessment System for Detection of Early Dental Caries in Children: a Diagnostic Accuracy Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06761248
Acronym
FSNCDR-ICDAS
Enrollment
78
Registered
2025-01-07
Start date
2025-03-10
Completion date
2026-08-15
Last updated
2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Detection, Diagnostic Accuracy, Fluorescence

Keywords

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

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.

Detailed description

Dental caries is a prevalent chronic disease affecting people of all ages globally. It results from the demineralization of tooth enamel and dentin caused by acids produced by bacterial fermentation of dietary sugars in dental plaque. Left untreated, dental caries can progress, leading to pain, infection, and tooth loss. In children, severe caries can interfere with eating, speaking, and learning, while adults may suffer from decreased work performance and lower self-esteem due to poor oral health Early and accurate diagnosis of dental caries is critical for effective management and prevention of disease progression. Detecting caries at an initial stage allows for minimally invasive treatments, such as remineralization therapies, which can arrest or reverse the carious process and prevent the need for extensive restorative procedures. Accurate diagnosis is essential for preserving tooth structure, reducing treatment costs, and improving overall oral health outcomes. Consequently, reliable diagnostic methods are a fundamental aspect of clinical practice, ensuring timely identification and management of caries Traditional caries detection methods, such as visual-tactile examination and radiography, have significant limitations. Visual-tactile examination relies on the clinician's experience and subjective judgment, leading to variability and often missing early caries lesions. Radiographic techniques, useful for detecting interproximal and advanced caries, expose patients to ionizing radiation and may not effectively identify early or non-cavitated lesions. These methods also struggle to detect subsurface demineralization and distinguish between active and inactive lesions, which are critical for effective treatment planning. These limitations highlight the need for more advanced and precise diagnostic tools Fluorescent starch nanoparticles caries detection rinse is an innovative diagnostic tool designed to enhance the detection of active dental caries. It utilizes proprietary fluorescent starch nanoparticles that infiltrate the porous enamel of active lesions. When illuminated with a dental curing light, these nanoparticles fluoresce, allowing clinicians to distinguish active caries from inactive lesions and other conditions like hypomineralization. This rinse provides high sensitivity, specificity, and diagnostic accuracy, addressing limitations in conventional visual-tactile and radiographic methods. LumiCare is an approach to improving early caries diagnosis, aligning with minimally invasive dentistry principles

Interventions

DEVICEFluorescent 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

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracythrough study completion, an average of 1 yearMeasured using sensitivity, specificity, positive predictive value, and negative predictive value.

Countries

Egypt

Contacts

Primary ContactOmar Kamel Salem Eshbair, Bachelor of Dental Science
omarksse@gmail.com+201148899948

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026