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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-10
SponsorSawanya Prutthithaworn

About this trial

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)

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Bitewing radiograph
  • Near-infrared light transillumination

Treatment groups

174 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Sawanya Prutthithaworn

Lead sponsor

Mahidol University

Sponsor institution

Mahidol University

Collaborator