Actively Recruiting
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
Led by Sawanya Prutthithaworn · Updated on 2025-09-29
174
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
S
Sawanya Prutthithaworn
Lead Sponsor
M
Mahidol University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the ability of three different methods to detect approximal carious lesions in primary molars of children aged 4 to 10 years. This observational study focuses on comparing bitewing radiography, near-infrared light transillumination, and their combination to see differences in sensitivity, specificity, accuracy, and area under the curve (AUC). The study also investigates how age affects these diagnostic results and which technique children prefer. Participants will undergo bitewing radiographs and near-infrared light transillumination exams. They will have tooth separation for 7 days using orthodontic elastic separators to assist in examination. Clinical examination of the targeted tooth surfaces will be performed, and children will be asked to rate their experience using the Simplified Facial Pain Scale (S-FPS). The study evaluates diagnostic accuracy and patient acceptance across three age groups: 4-6, 6-8, and 8-10 years. During the study, children will be examined at enrollment and again on day 7 for clinical assessment. Researchers will analyze diagnostic performance parameters from enrollment to the day 7 examination and assess patient acceptance at enrollment. Statistical methods will compare the efficacy of the detection methods and children's preferences. The total participation period lasts 7 days, during which clinical and diagnostic evaluations are completed.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy children aged 4 to 10 years
- Low risk for periodontal disease
- At least one quadrant with fully erupted, well-aligned adjacent primary molars free of restorations, visible cavities, and developmental dental anomalies
- Tooth mobility grade 2 or less
- Bitewing radiographs showing at least one radiolucent lesion in the proximal surface of a primary molar classified as RA2 or RA3 according to ICDAS II radiographic criteria
You will not qualify if you...
- Root resorption exceeding two-thirds of the root length
- Frankl's behavior rating scale of 1 during near-infrared light transillumination exam or tooth separation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants undergo diagnostic tests including bitewing radiographs and near-infrared light transillumination to detect proximal cavitation in primary molars.
2 visits (in-person) during the first week
Duration - Up to 7 days after diagnostic evaluation
Participants' diagnostic performance results and acceptance of diagnostic tests are evaluated over time.
Follow-up assessments within 1 week after initial diagnostic tests
Trial Site Locations
Total: 2 locations
1
Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus)
Bangkok, Thailand, 10400
Not Yet Recruiting
2
Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus)
Bangkok, Thailand, 10400
Actively Recruiting
Research Team
S
Sawanya Prutthithaworn, Ph.D. (Dental biomaterials)
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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