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.
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.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo, Giza Governorate, 12613
Omar Kamel salem Eshbair, B.D.Sc., +201148899948, omarksse@gmail.com
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
- Conditions
- Dental Caries, Detection, Fluorescence, Diagnostic Accuracy
- 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 group | Role | What they receive |
|---|---|---|
| Fluorescent Starch Nanoparticles Rinse for Caries Detection | Experimental | 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. 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.
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.
- First posted7 Jan 2025
- Study start10 Mar 2025 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar kamel salem Eshbair, Cairo University
- Investigators
- Associate Prof. Dr. Mariam Mohsen aly, Ph.D., Study director, Cairo UniversityDr. Reem Mohamed Fouad Wahby, Ph.D., Study chair, Cairo University
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 15258077Amaechi 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06761248
- Acronym / sponsor ID
- FSNCDR-ICDAS / FSN-CDR Vs ICDAS
- Conditions
- Dental Caries, Detection, Fluorescence, Diagnostic Accuracy
- Keywords
- Fluorescence-Based Caries Detection, Caries Detection Rinse, Early Caries Detection, ICDAS, FSN
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorescent Starch Nanoparticles Rinse for Caries Detection | Experimental | Device: Fluorescent Starch Nanoparticles Caries Detection RinseParticipants 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with active initial caries.
- At least two teeth with active caries (ICDAS 1 or 2) and two teeth with inactive caries.
Key exclusion criteria (3 listed)
- Teeth with hypoplasia, fractures, or conditions like dentinogenesis imperfecta.
- Children with fixed orthodontic appliances.
- Participants whose guardians refuse consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorescent Starch Nanoparticles Caries Detection RinseAlso: LumiKids™ Rinse GreenMark BiomedicalThe 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. | Device | Fluorescent Starch Nanoparticles Rinse for Caries Detection |
Primary outcome
Diagnostic accuracy
Time frame: through study completion, an average of 1 year
Measured using sensitivity, specificity, positive predictive value, and negative predictive value.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Background: PubMed 15258077Deeks 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.
- Background: PubMed 36941251Amaechi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Associate Prof. Dr. Mariam Mohsen aly, Ph.D. study director
Cairo University
Dr. Reem Mohamed Fouad Wahby, Ph.D. study chair
Cairo University
1 site in 1 country: see every site and its status.
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.