NCT07041164 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
| NCT ID | NCT07041164 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sawanya Prutthithaworn |
| Condition | Dental Caries (Diagnosis) |
| Study Type | OBSERVATIONAL |
| Enrollment | 174 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 174 participants in total. It began in 2025-08-01 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07041164 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 10 Years, studying Dental Caries (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07041164 currently recruiting?
Yes, NCT07041164 is actively recruiting participants. Contact the research team at sawanya.pru@mahidol.ac.th for enrollment information.
Where is the NCT07041164 trial being conducted?
This trial is being conducted at Bangkok, Thailand, Bangkok, Thailand.
Who is sponsoring the NCT07041164 clinical trial?
NCT07041164 is sponsored by Sawanya Prutthithaworn. The trial plans to enroll 174 participants.