Actively Recruiting

Age: 4Years - 10Years
All Genders
Healthy Volunteers
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

Led by Sawanya Prutthithaworn · Updated on 2025-09-29

174

Participants Needed

2

Research Sites

38 weeks

Total Duration

On this page

Sponsors

S

Sawanya Prutthithaworn

Lead Sponsor

M

Mahidol University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

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

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 and visible cavities
  • Tooth mobility of grade 2 or less
  • No developmental dental anomalies
  • Bitewing radiograph shows at least one radiolucent lesion in 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 examination or tooth separation

AI-Screening

AI-Powered Screening

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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

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Research Team

S

Sawanya Prutthithaworn, Ph.D. (Dental biomaterials)

CONTACT

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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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 | DecenTrialz