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 | Recruiting DMC FDA Device

• 1 other identifier: MU-DT/PY-IRB 2025/025.0304
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

proximal caries; primary molars; Pediatric Patients; Bitewing Radiography; Near-Infrared Light Transillumination; DIAGNOcam; clinical cavitation; children acceptance; Diagnostic accuracy

Outcome Measures

Primary Outcomes (2)

• Diagnosis performance

  The diagnostic performance will be described by sensitivity, specificity, accuracy, and the Area Under the Curve (AUC), with values ranging from 0 to 1 for each parameter. * For sensitivity, zero is equivalent to no true positives detected, and 1 indicates all true positives detected * For specificity, zero is equivalent to no true negatives detected, and 1 indicates all true negatives detected * For accuracy, zero is equivalent to all cases misclassified, and 1 indicates all cases correctly classified * For AUC, zero is equivalent to a perfectly incorrect classification, and 1 indicates a perfectly correct classification

  From enrollment to clinical examination on day 7th

• Age-influenced on diagnostic performance

  The diagnostic performance for each age group will be described by sensitivity, specificity, accuracy, and the Area Under the Curve (AUC), with values ranging from 0 to 1 for each parameter. * For sensitivity, zero is equivalent to no true positives detected, and 1 indicates all true positives detected. * For specificity, zero is equivalent to no true negatives detected, and 1 indicates all true negatives detected. * For accuracy, zero is equivalent to all cases misclassified, and 1 indicates all cases correctly classified. * For AUC, zero is equivalent to a perfectly incorrect classification, and 1 indicates a perfectly correct classification.

  From enrollment to clinical examination at day 7th

Secondary Outcomes (1)

• Children's acceptance

  From enrollment to examination at day 0

Study Arms (3)

4-6 years old

Diagnostic Test: Bitewing radiograph; Diagnostic Test: Near-infrared light transillumination

6-8 years old

Diagnostic Test: Bitewing radiograph; Diagnostic Test: Near-infrared light transillumination

8-10 years old

Diagnostic Test: Bitewing radiograph; Diagnostic Test: Near-infrared light transillumination

Interventions

Bitewing radiograph DIAGNOSTIC_TEST

Digital radiograph, proximal caries, initial caries

4-6 years old; 6-8 years old; 8-10 years old

Near-infrared light transillumination DIAGNOSTIC_TEST

DIAGNOcam, proximal caries, initial caries

4-6 years old; 6-8 years old; 8-10 years old

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric dental clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sawanya Prutthithaworn: lead
• Mahidol University: collaborator

Study Sites (2)

Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus)

Bangkok, 10400, Thailand

NOT YET RECRUITING

Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus)

Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Dental Caries; Disease

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sawanya Prutthithaworn, Ph.D. (Dental biomaterials)

CONTACT

+6622007821; sawanya.pru@mahidol.ac.th

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: August 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

TH (2)