Actively Recruiting

Age: 4Years - 10Years
All Genders
Healthy Volunteers
ID07041164

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

Age: 4Years - 10Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

Loading map...

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

Similar Trials

RESTODATA-NUM: Multicenter Observational Study on Using Digi...

Dental Caries (Diagnosis)

Actively Recruiting

22 locations

Cardiac Point-of-care Ultrasound Clinical Training Pathway I...

Cardiovascular Disease Acute

Actively Recruiting

1 location

Team-based Interventional Triage in Acute Coronary Syndrome ...

Ischemic Heart Disease

Actively Recruiting

6 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here