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NCT06761248 | NOT YET RECRUITING | Dental Caries


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

Cairo University

Information provided by (Responsible Party):

Omar kamel salem Eshbair

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.

Condition or disease

Dental Caries

Detection

Fluorescence

Diagnostic Accuracy

Intervention/treatment

Fluorescent Starch Nanoparticles Caries Detection Rinse

Phase

NA

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 78 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : 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
Actual Study Start Date : 2025-03-10
Estimated Primary Completion Date : 2026-04-15
Estimated Study Completion Date : 2026-08-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 6 Years to 11 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.

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

Location Details

NCT06761248


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Locations


Not yet recruiting

Egypt, Giza

Faculty of Dentistry, Cairo University

Cairo, Giza, Egypt, 12613

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