Clinical trial NCT06761248: Comparing Fluorescent Starch Nanoparticles Rinse with ICDAS for Early Caries Detection in Children
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Caries
Detection
Fluorescence
Diagnostic Accuracy
Keywords: Fluorescence-Based Caries Detection
Caries Detection Rinse
Early Caries Detection
ICDAS
FSN
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 78
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility 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.

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: Giza
Study officials:
affiliation: Cairo University
name: Associate Prof. Dr. Mariam Mohsen aly, Ph.D.
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Dr. Reem Mohamed Fouad Wahby, Ph.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.