About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Bitewing radiograph
- Near-infrared light transillumination
Treatment groups
Sponsors and collaborators
Sawanya Prutthithaworn
Lead sponsor
Mahidol University
Sponsor institution
Mahidol University
Collaborator