NCT07532291

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Neslihan Atmaca · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2026-04-15
• Last updated: 2026-04-17

Locations

1 site across 1 country: Turkey (Türkiye)