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Dental CariesFSNCDR-ICDASNCT06761248

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

A study testing Fluorescent Starch Nanoparticles Caries Detection Rinse in people with Dental Caries and Detection, run by Cairo University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 11 years
Conditions the study is for
Dental Caries, Detection, Fluorescence
What is being tested?
Fluorescent Starch Nanoparticles Caries Detection Rinse
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteEgypt
Study dates
10 Mar 2025to 15 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Omar Kamel Salem Eshbair, Bachelor of Dental Science contact

+201148899948

omarksse@gmail.com

Egypt1 site
  • Faculty of Dentistry, Cairo University

    Cairo, Giza Governorate, 12613

    Omar Kamel salem Eshbair, B.D.Sc., +201148899948, omarksse@gmail.com

Other trials in Egypt

About this study

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

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.

Read the 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

Being tested
Fluorescent Starch Nanoparticles Caries Detection Rinse
Keywords
Fluorescence-Based Caries Detection, Caries Detection Rinse, Early Caries Detection, ICDAS, FSN
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluorescent Starch Nanoparticles Caries Detection RinseDevice

    Also called LumiKids™ Rinse GreenMark Biomedical

    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.

Study groups in NCT06761248
Study groupRoleWhat they receive
Fluorescent Starch Nanoparticles Rinse for Caries DetectionExperimentalParticipants 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.
Receives: Device: Fluorescent Starch Nanoparticles Caries Detection Rinse

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic accuracy

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

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2025
  2. Study start10 Mar 2025 (estimated)
  3. Primary completion15 Apr 2026 (estimated)
  4. Study completion15 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06761248
Sponsor's protocol ID
FSN-CDR Vs ICDAS
Acronym
FSNCDR-ICDAS
Status last verified
Dec 2024
First submitted
27 Dec 2024
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 15258077
  • 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.

    PubMed 36941251

Questions about this trial

What is this clinical trial studying?

A study testing Fluorescent Starch Nanoparticles Caries Detection Rinse in people with Dental Caries and Detection, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Omar Kamel Salem Eshbair, Bachelor of Dental Science (+201148899948, omarksse@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06761248, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

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