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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

174 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-04-30

Brief Summary

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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)

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Detailed Description

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* 58 carious lesions classified as RA2 and RA3 according to the ICDAS II criteria from three groups of 4-6 years, 6-8 years, and 8-10 years pediatric patients will be examined by near-infrared light transillumination
* The patient acceptance towards bitewing radiograph and near-infrared light transillumination will be evulated by Simplified Facial Pain Scale (S-FPS)
* Diagnostic performance will be assessed by calculating sensitivity, specificity, accuracy, and the area under the curve (AUC)
* The diagnostic efficacy of the caries detection methods will be analyzed using repeated measures ANOVA, and patient acceptance will be assessed using the Chi-square test, with statistical significance set at p \< 0.05 and a 95% confidence level.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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