Comparing near-infrared light transillumination and bitewing X-rays to find cavities between baby molars in children aged 4–10.
Official title: 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
Run by Mahidol University · NCT07041164 · Data updated 2026-11-12
This project tests whether near-infrared light transillumination, bitewing X-rays, or both together best detect cavities between primary molars in children aged 4 to 10 and which method children prefer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 4 Years to 10 Years |
| Sex | All |
| Enrollment | 174 (estimated) |
| Sponsor | Mahidol University Academic / other |
| Locations | 2 sites (Bangkok and 1 other locations) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | March 30, 2026 |
| Study ends | April 30, 2026 |
| Registry record updated | September 29, 2025 |
| Trial ID | NCT07041164 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy children aged 4–10 with at least one fully erupted, well-aligned adjacent primary molar showing a radiolucent proximal lesion classified as RA2 or RA3 and who are low risk for periodontal disease are ideal candidates.
✕Probably not a fit
Children with extensive root resorption (> two-thirds), frank cavitated lesions, heavy restorations on target teeth, or who are highly uncooperative (Frankl scale 1) are unlikely to benefit from the procedures in this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will compare three diagnostic approaches—bitewing radiography, near-infrared light transillumination, and their combination—on approximal carious lesions in primary molars of children grouped by age (4–6, 6–8, 8–10 years). About 58 lesions classified as RA2 or RA3 by ICDAS II will be examined after 7 days of tooth separation with orthodontic elastic separators. Diagnostic performance will be measured by sensitivity, specificity, accuracy, and area under the curve (AUC), while patient acceptance will be recorded using the Simplified Facial Pain Scale. Repeated measures ANOVA will be used to compare diagnostic efficacy and Chi-square testing will analyze acceptance, with significance at p < 0.05 and 95% confidence.
Why it matters
Potential benefit: If successful, this work could identify a less invasive or more acceptable method to detect early proximal cavities in children's primary molars, potentially reducing unnecessary X-rays and enabling earlier, simpler treatments.
How similar studies have gone: Previous research on near-infrared transillumination devices has shown promising diagnostic accuracy compared with bitewing radiography, but results vary and it has not fully replaced radiographs in clinical practice.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus)
Bangkok, Thailand Recruiting -
Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus)
Bangkok, Thailand Not yet recruiting
Study contacts
- Study coordinator: Sawanya Prutthithaworn, Ph.D. (Dental biomaterials)
- Email: sawanya.pru@mahidol.ac.th
- Phone: +6622007821
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.