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RECRUITING
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

Sponsor: Sawanya Prutthithaworn

View on ClinicalTrials.gov

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)

Key Details

Gender

All

Age Range

4 Years - 10 Years

Study Type

OBSERVATIONAL

Enrollment

174

Start Date

2025-08-01

Completion Date

2026-04-30

Last Updated

2025-09-29

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Bitewing radiograph

Digital radiograph, proximal caries, initial caries

DIAGNOSTIC_TEST

Near-infrared light transillumination

DIAGNOcam, proximal caries, initial caries

Locations (2)

Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus)

Bangkok, Thailand

Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus)

Bangkok, Thailand