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Comparing Fluorescent Starch Nanoparticles Rinse with ICDAS for Early Caries Detection in Children (FSNCDR-ICDAS)

Cairo University (CU) logo

Cairo University (CU)

Status

Begins enrollment in 1 month

Conditions

Diagnostic Accuracy
Fluorescence
Dental Caries
Detection

Treatments

Device: Fluorescent Starch Nanoparticles Caries Detection Rinse

Study type

Interventional

Funder types

Other

Identifiers

NCT06761248
FSN-CDR Vs ICDAS

Details and patient eligibility

About

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.

Full 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

Enrollment

78 estimated patients

Sex

All

Ages

6 to 11 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

78 participants in 1 patient group

Fluorescent Starch Nanoparticles Rinse for Caries Detection
Experimental group
Description:
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.
Treatment:
Device: Fluorescent Starch Nanoparticles Caries Detection Rinse

Trial contacts and locations

1

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Central trial contact

Omar Kamel Salem Eshbair, Bachelor of Dental Science

Data sourced from clinicaltrials.gov

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