Detection of Non-cavitated Occlusal Caries Lesions by Visual Inspection, LF, QLF and NILT

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries; Non-cavitated Occlusal Caries
• Intervention / Treatment: Diagnostic test: Diagnostic assessment 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 Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Maltepe
    • Istanbul, Maltepe, Turkey (Türkiye), 34854
      • Marmara Universty School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: Diagnostic assessment of occlusal caries; 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.; Other Names: ICDAS II; DIAGNOcam; DIAGNOdent pen; QLF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	At baseline

Collaborators and Investigators

• Sponsor: Neslihan Atmaca
• Investigators: Principal Investigator: Neslihan Atmaca, Doctor of Dental Surgery, Marmara Universty Faculty of Dentistry; Principal Investigator: Neslihan Atmaca, Doctor of Dental Surgery, Marmara University Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quantitative Light-Induced Fluorescence; Pediatric Dentistry; Caries Detection; Occlusal Caries; Laser Fluorescence; Near-Infrared Light Transillumination; ICDAS-II
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: MUPEDDENTNSL-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: De-identified individual participant data (IPD), along with supporting documents such as the study protocol and statistical analysis plan, will be available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.
• IPD Sharing Access Criteria: Requests for access to de-identified individual participant data and supporting documents will be considered for academic or scientific research purposes. Interested researchers must submit a written proposal detailing the planned analysis, including objectives and statistical methods. Requests will be reviewed by the principal investigator and institutional review board (IRB) representatives to ensure ethical compliance and scientific merit. A data use agreement must be signed prior to data release. Requests can be submitted via email to the corresponding author listed in the publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No