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 (NILT)

Sawanya Prutthithaworn

Status

Enrolling

Conditions

Radiographic Image Interpretation, Computer-Assisted

Optical Imaging

Proximal Dental Caries

Tooth, Deciduous

Dental Caries (Diagnosis)

Diagnostic Imaging

Treatments

Diagnostic Test: Bitewing radiograph

Diagnostic Test: Near-infrared light transillumination

Study type

Observational

Funder types

Other

Identifiers

NCT07041164

MU-DT/PY-IRB 2025/025.0304

Details and patient eligibility

About

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)

Full 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.

Enrollment

174 estimated patients

Sex

All

Ages

4 to 10 years old

Volunteers

Accepts Healthy Volunteers

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