In Vivo Detection of Non-cavitated Occlusal Caries Lesions by Visual Inspection, LF, QLF and NILT
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Neslihan Atmaca
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of caries detection methods
Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
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.
Intervention: Diagnostic assessment of occlusal caries (Diagnostic Test)
Outcomes
Primary Outcomes
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
- 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)
Investigators
Neslihan Atmaca
Principal Investigator
Marmara University