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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

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

Recruiting
4-10 years
All
Phase N/A

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Overview

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)

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.

Eligibility

Inclusion Criteria:

  • Healthy Children aged 4-10 years
  • Low risk for periodontal disease
  • At least one quadrant contains fully erupted, well-aligned adjacent primary molars that are free of restorations, exhibit no clinically visible cavitated caries, demonstrate tooth mobility of grade 2 or less, show no developmental dental anomalies
  • Bitewing radiographs show at least one radiolucent lesion in the proximal surface of a primary molar classified as RA2 or RA3 according to the ICDAS II radiographic criteria

Exclusion Criteria:

  • Root resorption exceeding two-thirds of the root length
  • Demonstrate Frankl's behavior rating scale of 1 during either near-infrared light transillumination examination or tooth separation

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

NCT07041164

Sawanya Prutthithaworn

15 October 2025

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