Detection of Non-cavitated Occlusal Caries Lesions by Visual Inspection, LF, QLF and NILT (NCT07532291) | Clinical Trial Compass
CompletedNot Applicable
Detection of Non-cavitated Occlusal Caries Lesions by Visual Inspection, LF, QLF and NILT
Turkey (Türkiye)51 participantsStarted 2024-05-01
Plain-language 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 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.
Who can participate
Age range
6 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.