RecruitingNCT07041164

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

Enrollment

174 participants

Start Date

Aug 1, 2025

Study Type

OBSERVATIONAL

Conditions

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)


Eligibility

Min Age: 4 YearsMax Age: 10 Years

Inclusion Criteria4

  • 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 Criteria2

  • 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

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Interventions

DIAGNOSTIC_TESTBitewing radiograph

Digital radiograph, proximal caries, initial caries

DIAGNOSTIC_TESTNear-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

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NCT07041164


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