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)
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
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
Pediatric dental clinic
Cohort
Cross-sectional
Bitewing radiograph
Diagnostic testDigital radiograph, proximal caries, initial caries
Near-infrared light transillumination
Diagnostic testDIAGNOcam, proximal caries, initial caries
Diagnosis performance
The diagnostic performance will be described by sensitivity, specificity, accuracy, and the Area Under the Curve (AUC), with values ranging from 0 to 1 for each parameter. * For sensitivity, zero is equivalent to no true positives detected, and 1 indicates all true positives detected * For specificity, zero is equivalent to no true negatives detected, and 1 indicates all true negatives detected * For accuracy, zero is equivalent to all cases misclassified, and 1 indicates all cases correctly classified * For AUC, zero is equivalent to a perfectly incorrect classification, and 1 indicates a perfectly correct classification
Age-influenced on diagnostic performance
The diagnostic performance for each age group will be described by sensitivity, specificity, accuracy, and the Area Under the Curve (AUC), with values ranging from 0 to 1 for each parameter. * For sensitivity, zero is equivalent to no true positives detected, and 1 indicates all true positives detected. * For specificity, zero is equivalent to no true negatives detected, and 1 indicates all true negatives detected. * For accuracy, zero is equivalent to all cases misclassified, and 1 indicates all cases correctly classified. * For AUC, zero is equivalent to a perfectly incorrect classification, and 1 indicates a perfectly correct classification.
Children's acceptance
Children's acceptance will be evaluated using the Simplified Facial Pain Scale (S-FPS), which ranges from 0 to 10. The minimum value is 0, representing "no pain", and the maximum value is 10, representing "severe pain".
Click on the lead sponsor to view all of their trials.
Sawanya Prutthithaworn
Lead sponsor
Mahidol University
Sponsor institution
Mahidol University
Collaborator
