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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

NCT07041164 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 174

Last updated 2025-09-29

No results posted yet for this study

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)

Conditions

  • Dental Caries (Diagnosis)
  • Diagnostic Imaging
  • Optical Imaging
  • Radiographic Image Interpretation, Computer-Assisted
  • Proximal Dental Caries
  • Tooth, Deciduous

Interventions

DIAGNOSTIC_TEST

Bitewing radiograph

Digital radiograph, proximal caries, initial caries

DIAGNOSTIC_TEST

Near-infrared light transillumination

DIAGNOcam, proximal caries, initial caries

Sponsors & Collaborators

  • Mahidol University

    collaborator OTHER

  • Sawanya Prutthithaworn

    lead OTHER

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-03-30
Completion
2026-04-30
FDA Device
Yes

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07041164 on ClinicalTrials.gov