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Идёт набор 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

— Наблюдательное Dental Caries (Diagnosis) Diagnostic Imaging Optical Imaging Radiographic Image Interpretation, Computer-Assisted

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Bitewing radiograph, Near-infrared light transillumination.
Кому может быть актуально
Состояния в реестре: Dental Caries (Diagnosis), Diagnostic Imaging, Optical Imaging, Radiographic Image Interpretation, Computer-Assisted. Базовые параметры: 4 лет — 10 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Таиланд
Следующий шаг
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Обзор

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)

Подробное описание

* 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.

Вмешательства

  • Диагностический тест Bitewing radiograph
    Digital radiograph, proximal caries, initial caries
  • Диагностический тест Near-infrared light transillumination
    DIAGNOcam, proximal caries, initial caries

Первичные конечные точки

  • Diagnosis performance [Срок оценки: From enrollment to clinical examination on day 7th]
  • Age-influenced on diagnostic performance [Срок оценки: From enrollment to clinical examination at day 7th]
Вторичные конечные точки (1)
  • Children's acceptance [Срок оценки: From enrollment to examination at day 0]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Таиланд · 2 центра
  • Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus) — Bangkok
  • Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus) — Bangkok

Идентификаторы

NCT: NCT07041164 · MU-DT/PY-IRB 2025/025.0304

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗