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Completed

NCT Number: NCT07532291

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.

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Key information

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara Universty School of Dentistry

Istanbul, Maltepe, 34854, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: ICDAS II, DIAGNOcam, DIAGNOdent pen, QLF

Primary outcomes

  1. 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.

Secondary outcomes

  1. Diagnostic performance of laser fluorescence (LF)

    Time frame: At baseline

    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.

  2. Diagnostic performance of near-infrared light transillumination (NILT)

    Time frame: At baseline

    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.

  3. Diagnostic performance of quantitative light-induced fluorescence (QLF)

    Time frame: At baseline

    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.

Sponsors and collaborators

Lead sponsor

Neslihan Atmaca

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 15, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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