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

NCT07532291 | Completed

• 1 other identifier: MUPEDDENTNSL-1
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Diagnostic performance of laser fluorescence (LF)

  At baseline

• Diagnostic performance of near-infrared light transillumination (NILT)

  At baseline

• Diagnostic performance of quantitative light-induced fluorescence (QLF)

  At baseline

Study Arms (1)

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

Interventions

Diagnostic assessment of occlusal caries DIAGNOSTIC_TEST

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.

Also known as: ICDAS II, DIAGNOcam, DIAGNOdent pen, QLF

Children with non-cavitated occlusal caries

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neslihan Atmaca: lead

Study Sites (1)

Marmara Universty School of Dentistry

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Neslihan Atmaca, Doctor of Dental Surgery

  Marmara Universty Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Neslihan Atmaca, Doctor of Dental Surgery

  Marmara University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: May 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

TU (1)