Clinical Trial

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

Study acronym: NILT
Recruiting
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Record status
This record was last updated September 29, 2025 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.
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)
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-06-19; most recent amendment 2025-09-23.
Status change: Not Yet Recruiting → Recruiting 2025-09-23
Trial Details
NCT Number NCT07041164
Lead Sponsor Sawanya Prutthithaworn
Collaborators: Mahidol University
Conditions Dental Caries (Diagnosis), Diagnostic Imaging, Optical Imaging, Radiographic Image Interpretation, Computer-Assisted, Proximal Dental Caries, Tooth, Deciduous
Enrollment 174 participants
Start Date 2025-08-01
Primary Completion 2026-03-30 (estimated)
Study Completion 2026-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-29