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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bitewing radiograph, Near-infrared light transillumination.
- Who it may be relevant to
- Registry conditions: Dental Caries (Diagnosis), Diagnostic Imaging, Optical Imaging, Radiographic Image Interpretation, Computer-Assisted. Basic parameters: 4 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Detailed 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.
Interventions
- Diagnostic test Bitewing radiograph
Digital radiograph, proximal caries, initial caries - Diagnostic test Near-infrared light transillumination
DIAGNOcam, proximal caries, initial caries
Primary outcome measures
- Diagnosis performance [Time frame: From enrollment to clinical examination on day 7th]
- Age-influenced on diagnostic performance [Time frame: From enrollment to clinical examination at day 7th]
Secondary outcome measures (1)
- Children's acceptance [Time frame: From enrollment to examination at day 0]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Thailand · 2 centers
- Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus) — Bangkok
- Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus) — Bangkok
Identifiers
NCT: NCT07041164 · MU-DT/PY-IRB 2025/025.0304