Dental CariesNCT07532291
Detection of Non-cavitated Occlusal Caries Lesions by Visual Inspection, LF, QLF and NILT
An observational study of Dental Caries and Non-cavitated Occlusal Caries, run by Neslihan Atmaca at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate and compare the diagnostic accuracy of visual examination using ICDAS-II and three adjunctive optical methods-laser fluorescence (LF), near-infrared light transillumination (NILT), and quantitative light-induced fluorescence (QLF)-for the detection of non-cavitated occlusal caries lesions… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Dental Caries, Non-cavitated Occlusal Caries
- What is being tested?
- Diagnostic assessment of occlusal caries
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 6-14 years attending the Department of Pediatric Dentistry, Marmara University, were recruited for this study. The study population included participants with at least one posterior tooth exhibiting either sound occlusal surfaces or non-cavitated occlusal caries lesions (ICDAS scores 0-2). All examinations were performed under standardized clinical conditions.
Who may be able to join
- Voluntary agreement to participate in the study after the research procedures have been explained.
- Being between 6 and 14 years of age.
- Presence of at least one posterior tooth that is either sound with an ICDAS score of 0 or exhibits a non-cavitated occlusal carious lesion classified as ICDAS scores 1 or 2.
- Having an occlusal surface suitable for standardized clinical and optical evaluation using Diagnodent Pen, Diagnocam, and QLF devices.
- Absence of excessive plaque accumulation on the tooth surface to allow reliable measurements.
Who cannot join
- Declining participation in the study.
- Being younger than 6 years or older than 14 years.
- Presence of cavitated carious lesions (ICDAS ≥ 3) or teeth with Class II or Class III carious involvement.
- Prior restorative treatment or the presence of fissure sealants on the relevant occlusal surface, which would compromise accurate optical assessment.
- Tooth surfaces with excessive plaque accumulation that would hinder proper evaluation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara Universty School of Dentistry
Istanbul, Maltepe, 34854
About this study
Official title: In Vivo Detection of Non-cavitated Occlusal Caries Lesions by Visual Inspection, LF, QLF and NILT
This study aims to evaluate and compare the diagnostic accuracy of visual examination using ICDAS-II and three adjunctive optical methods-laser fluorescence (LF), near-infrared light transillumination (NILT), and quantitative light-induced fluorescence (QLF)-for the detection of non-cavitated occlusal caries lesions in children. A total of 51 children aged 6-14 years, including 320 posterior teeth, will be examined under standardized clinical conditions. Diagnostic performance will be assessed using sensitivity, specificity, accuracy, and area under the curve (AUC) values. The findings are expected to support the use of adjunctive diagnostic methods for early detection and minimally invasive management of occlusal caries.
Read the detailed description
This in vivo observational study was conducted to evaluate and compare the diagnostic performance of visual examination based on the International Caries Detection and Assessment System II (ICDAS-II) and three adjunctive optical methods-laser fluorescence (LF), near-infrared light transillumination (NILT), and quantitative light-induced fluorescence (QLF)-for the detection of non-cavitated occlusal caries lesions in posterior teeth of children.
The study included 51 children aged between 6 and 14 years, comprising a total of 320 posterior teeth (104 molars and 216 premolars) with sound or non-cavitated occlusal surfaces (ICDAS scores 0-2). All examinations were performed under standardized clinical conditions using calibrated examiners. Visual assessment was conducted according to ICDAS-II criteria, and optical evaluations were performed using DIAGNOdent pen (LF), DIAGNOcam (NILT), and Qraypen C (QLF).
QLF analysis included the calculation of fluorescence loss (ΔF), lesion area, and integrated fluorescence loss (ΔQ) using a predefined threshold. Diagnostic performance of each method was evaluated using sensitivity, specificity, accuracy, and area under the receiver operating characteristic curve (AUC), with ICDAS-II serving as the reference standard. Inter-examiner agreement was assessed using kappa statistics.
The study aims to determine the comparative effectiveness of these diagnostic methods in detecting early occlusal caries and to provide clinically relevant evidence for improving diagnostic accuracy and supporting minimally invasive treatment strategies in pediatric dentistry.
- Conditions
- Dental Caries, Non-cavitated Occlusal Caries
- Being tested
- Diagnostic assessment of occlusal caries
- Keywords
- ICDAS-II, Quantitative Light-Induced Fluorescence, Laser Fluorescence, Near-Infrared Light Transillumination, Caries Detection, Occlusal Caries, Pediatric Dentistry
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic assessment of occlusal cariesDiagnostic test
Also called ICDAS II, DIAGNOcam, DIAGNOdent pen, QLF
Visual and optical diagnostic procedures were performed under standardized clinical conditions. These included visual examination using ICDAS II criteria, laser fluorescence measurement (DIAGNOdent Pen), near-infrared light transillumination (DIAGNOcam), and quantitative light-induced fluorescence (QLF; Qraypen C). All procedures were performed on cleaned and dried tooth surfaces without any therapeutic intervention.
| Study group | Role | What they receive |
|---|---|---|
| Children with non-cavitated occlusal caries | Children aged 6-14 years with sound or non-cavitated occlusal caries lesions (ICDAS scores 0-2) in posterior teeth. All participants underwent visual and optical diagnostic assessments under standardized clinical conditions. Receives: Diagnostic Test: Diagnostic assessment of occlusal caries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of caries detection methods
Assessment of the diagnostic performance of visual examination (ICDAS-II), laser fluorescence (LF), near-infrared light transillumination (NILT), and quantitative light-induced fluorescence (QLF) in detecting non-cavitated occlusal caries lesions. All methods were applied under standardized clinical conditions, and diagnostic outcomes were compared using ICDAS-II as the reference standard. Diagnostic parameters including sensitivity, specificity, accuracy, and area under the receiver operating characteristic curve (AUC) were calculated for each method. Higher values indicate improved diagnostic performance in detecting early carious lesions.
Measured: At baseline
Secondary outcomes (3)
Diagnostic performance of laser fluorescence (LF)
Assessment of the diagnostic performance of laser fluorescence using DIAGNOdent pen for the detection of non-cavitated occlusal caries lesions. Measurements were obtained under standardized clinical conditions and compared with ICDAS-II scores. Diagnostic parameters including sensitivity, specificity, accuracy, and area under the receiver operating characteristic curve (AUC) were calculated. Higher values indicate better diagnostic performance.
Measured: At baseline
Diagnostic performance of near-infrared light transillumination (NILT)
Assessment of the diagnostic performance of near-infrared light transillumination using DIAGNOcam for the detection of non-cavitated occlusal caries lesions. Images were obtained under standardized clinical conditions and evaluated in comparison with ICDAS-II scores. Diagnostic parameters including sensitivity, specificity, accuracy, and area under the receiver operating characteristic curve (AUC) were calculated. Higher values indicate better diagnostic performance.
Measured: At baseline
Diagnostic performance of quantitative light-induced fluorescence (QLF)
Assessment of the diagnostic performance of quantitative light-induced fluorescence using Qraypen C for the detection of non-cavitated occlusal caries lesions. Fluorescence-based measurements were obtained under standardized clinical conditions and compared with ICDAS-II scores. Diagnostic parameters including sensitivity, specificity, accuracy, and area under the receiver operating characteristic curve (AUC) were calculated. Higher values indicate better diagnostic performance.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 May 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Neslihan Atmaca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Neslihan Atmaca, Marmara University
- Investigators
- Neslihan Atmaca, Doctor of Dental Surgery, Principal investigator, Marmara Universty Faculty of DentistryNeslihan Atmaca, Doctor of Dental Surgery, Principal investigator, Marmara University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532291
- Sponsor's protocol ID
- MUPEDDENTNSL-1
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including intraoral photographs and clinical evaluation scores) will be made available upon reasonable request to the corresponding author, for scientific research purposes, following approval by the relevant ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Detection of Non-cavitated Occlusal Caries Lesions by Visual Inspection, LF, QLF and NILT
- ClinicalTrials.gov ID
- NCT07532291
- Acronym / sponsor ID
- MUPEDDENTNSL-1
- Conditions
- Dental Caries, Non-cavitated Occlusal Caries
- Keywords
- ICDAS-II, Quantitative Light-Induced Fluorescence, Laser Fluorescence, Near-Infrared Light Transillumination, Caries Detection, Occlusal Caries, Pediatric Dentistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Neslihan AtmacaUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 15 Apr 2026 (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.
This study aims to evaluate and compare the diagnostic accuracy of visual examination using ICDAS-II and three adjunctive optical methods-laser fluorescence (LF), near-infrared light transillumination (NILT), and quantitative light-induced fluorescence (QLF)-for the detection of non-cavitated occlusal caries lesions in children. A total of 51 children aged 6-14 years, including 320 posterior teeth, will be examined under standardized clinical conditions. Diagnostic performance will be assessed using sensitivity, specificity, accuracy, and area under the curve (AUC) values. The findings are expected to support the use of adjunctive diagnostic methods for early detection and minimally invasive management of occlusal caries.
Detailed description
This in vivo observational study was conducted to evaluate and compare the diagnostic performance of visual examination based on the International Caries Detection and Assessment System II (ICDAS-II) and three adjunctive optical methods-laser fluorescence (LF), near-infrared light transillumination (NILT), and quantitative light-induced fluorescence (QLF)-for the detection of non-cavitated occlusal caries lesions in posterior teeth of children.
The study included 51 children aged between 6 and 14 years, comprising a total of 320 posterior teeth (104 molars and 216 premolars) with sound or non-cavitated occlusal surfaces (ICDAS scores 0-2). All examinations were performed under standardized clinical conditions using calibrated examiners. Visual assessment was conducted according to ICDAS-II criteria, and optical evaluations were performed using DIAGNOdent pen (LF), DIAGNOcam (NILT), and Qraypen C (QLF).
QLF analysis included the calculation of fluorescence loss (ΔF), lesion area, and integrated fluorescence loss (ΔQ) using a predefined threshold. Diagnostic performance of each method was evaluated using sensitivity, specificity, accuracy, and area under the receiver operating characteristic curve (AUC), with ICDAS-II serving as the reference standard. Inter-examiner agreement was assessed using kappa statistics.
The study aims to determine the comparative effectiveness of these diagnostic methods in detecting early occlusal caries and to provide clinically relevant evidence for improving diagnostic accuracy and supporting minimally invasive treatment strategies in pediatric dentistry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with non-cavitated occlusal caries | – | Diagnostic Test: Diagnostic assessment of occlusal cariesChildren aged 6-14 years with sound or non-cavitated occlusal caries lesions (ICDAS scores 0-2) in posterior teeth. All participants underwent visual and optical diagnostic assessments under standardized clinical conditions. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 6-14 years attending the Department of Pediatric Dentistry, Marmara University, were recruited for this study. The study population included participants with at least one posterior tooth exhibiting either sound occlusal surfaces or non-cavitated occlusal caries lesions (ICDAS scores 0-2). All examinations were performed under standardized clinical conditions.
Key inclusion criteria (5 listed)
- Voluntary agreement to participate in the study after the research procedures have been explained.
- Being between 6 and 14 years of age.
- Presence of at least one posterior tooth that is either sound with an ICDAS score of 0 or exhibits a non-cavitated occlusal carious lesion classified as ICDAS scores 1 or 2.
- Having an occlusal surface suitable for standardized clinical and optical evaluation using Diagnodent Pen, Diagnocam, and QLF devices.
- Absence of excessive plaque accumulation on the tooth surface to allow reliable measurements.
Key exclusion criteria (5 listed)
- Declining participation in the study.
- Being younger than 6 years or older than 14 years.
- Presence of cavitated carious lesions (ICDAS ≥ 3) or teeth with Class II or Class III carious involvement.
- Prior restorative treatment or the presence of fissure sealants on the relevant occlusal surface, which would compromise accurate optical assessment.
- Tooth surfaces with excessive plaque accumulation that would hinder proper evaluation.
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 |
|---|---|---|
| Diagnostic assessment of occlusal cariesAlso: ICDAS II, DIAGNOcam, DIAGNOdent pen, QLFVisual and optical diagnostic procedures were performed under standardized clinical conditions. These included visual examination using ICDAS II criteria, laser fluorescence measurement (DIAGNOdent Pen), near-infrared light transillumination (DIAGNOcam), and quantitative light-induced fluorescence (QLF; Qraypen C). All procedures were performed on cleaned and dried tooth surfaces without any therapeutic intervention. | Diagnostic test | Children with non-cavitated occlusal caries |
Primary outcome
Diagnostic accuracy of caries detection methods
Time frame: At baseline
Assessment of the diagnostic performance of visual examination (ICDAS-II), laser fluorescence (LF), near-infrared light transillumination (NILT), and quantitative light-induced fluorescence (QLF) in detecting non-cavitated occlusal caries lesions. All methods were applied under standardized clinical conditions, and diagnostic outcomes were compared using ICDAS-II as the reference standard. Diagnostic parameters including sensitivity, specificity, accuracy, and area under the receiver operating characteristic curve (AUC) were calculated for each method. Higher values indicate improved diagnostic performance in detecting early carious lesions.
3 secondary outcomes
Diagnostic performance of laser fluorescence (LF)
Time frame: At baseline
Diagnostic performance of near-infrared light transillumination (NILT)
Time frame: At baseline
Diagnostic performance of quantitative light-induced fluorescence (QLF)
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including intraoral photographs and clinical evaluation scores) will be made available upon reasonable request to the corresponding author, for scientific research purposes, following approval by the relevant ethics committee.
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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. This study is not recruiting at the moment.
Neslihan Atmaca, Doctor of Dental Surgery principal investigator
Marmara Universty Faculty of Dentistry
Neslihan Atmaca, Doctor of Dental Surgery principal investigator
Marmara University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries and Non-cavitated Occlusal Caries, run by Neslihan Atmaca at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 17 Apr 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of caries detection methods (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2026.