NCT07041164

Diagnostic Performance and Children's Acceptance of Near-Infrared Light Transillumination and Bitewing Radiographs for Detecting Proximal Cavitation in Primary Molars of Patients Aged 4 to 10 Years

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 174 (estimated)
• Sponsor: Sawanya Prutthithaworn · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Accepted

Summary

The goal of this observational study is to compare the diagnostic performance of three detection methods for approximal carious lesions in primary molars among pediatric patients aged 4-10 years. The study focuses on children in three age groups: 4-6 years, 6-8 years, and 8-10 years. The main questions it aims to answer are: * Are the sensitivity, specificity, accuracy, and area under the curve (AUC) different across the three diagnostic techniques (bitewing radiography, near-infrared light transillumination, and their combination)? * Are these diagnostic parameters influenced by patient age? * Which technique yields the highest level of patient acceptance? Researchers will compare the three diagnostic approaches to determine whether age influences diagnostic performance and patient acceptance. Participants will: * Be examined using bitewing radiography and near-infrared light transillumination * Undergo tooth separation for 7 days using orthodontic elastic separators * Receive clinical examination of the target approximal surface * Be asked to rate their experience using the Simplified Facial Pain Scale (S-FPS)

Detailed description

* 58 carious lesions classified as RA2 and RA3 according to the ICDAS II criteria from three groups of 4-6 years, 6-8 years, and 8-10 years pediatric patients will be examined by near-infrared light transillumination * The patient acceptance towards bitewing radiograph and near-infrared light transillumination will be evulated by Simplified Facial Pain Scale (S-FPS) * Diagnostic performance will be assessed by calculating sensitivity, specificity, accuracy, and the area under the curve (AUC) * The diagnostic efficacy of the caries detection methods will be analyzed using repeated measures ANOVA, and patient acceptance will be assessed using the Chi-square test, with statistical significance set at p \< 0.05 and a 95% confidence level.

Conditions

• Dental Caries (Diagnosis)
• Diagnostic Imaging
• Optical Imaging
• Radiographic Image Interpretation, Computer-Assisted
• Proximal Dental Caries
• Tooth, Deciduous

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Bitewing radiograph	Digital radiograph, proximal caries, initial caries
DIAGNOSTIC_TEST	Near-infrared light transillumination	DIAGNOcam, proximal caries, initial caries

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-03-30
• Completion: 2026-04-30
• First posted: 2025-06-27
• Last updated: 2025-09-29

Locations

2 sites across 1 country: Thailand

Regulatory

• FDA-regulated device study