Evaluation of Radiation-Free Caries Detection Integrated Into Intraoral Scanners Compared With Conventional Diagnostic Methods
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: intraoral scan with integrated caries detection tool.
- Кому может быть актуально
- Состояния в реестре: Caries Assessment, Caries; Dentin, Caries; Initial. Базовые параметры: от 18 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
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Clinical Performance of an Intraoral Scanner With Integrated Caries Detection
Обзор
The goal of this study is to evaluate if an intraoral scanning device with an integrated radiation-free caries detection tool (near-infrared light) can detect early tooth decay. The main questions it aims to answer are: Can the tool find tooth decay as accurately as traditional visual and X-ray examinations? How reliable is the tool when used by different dentists? Participants will: * Have one tooth scheduled for extraction. This tooth and its adjacent teeth need to be examined before the extraction by using the intraoral scanner with the caries detection tool, which takes about 5 extra minutes. Those results will be compared to the standard dental examination, including visual inspection and X-rays. * Allow investigators to check the extracted tooth and the neighboring teeth directly after extraction to see if any carious lesion is visible. This study does not involve any drugs or invasive procedures beyond the planned tooth extraction, and participants will not be exposed to extra radiation. The results will help dentists detect tooth decay, which may allow less invasive treatments and better prevention.
Вмешательства
- Диагностический тест intraoral scan with integrated caries detection tool
The intervention in this study is the addition of a non-invasive intraoral scan of the tooth scheduled for extraction and its adjacent teeth using the iTero Lumina device. This scan is CE-certified, performed according to the manufacturer's instructions, takes approximately 5 minutes, involves no radiation, and does not change the standard dental treatment. All other procedures, including visual examination, radiographs, and tooth extraction, are part of routine care and are not affected by the
Первичные конечные точки
- Performance of the caries detection tool, integrated in intraoral scanning system in terms of sensitivity, specificity and reliability. [Срок оценки: From the enrollment at four weeks.]
Критерии участия
Критерии включения
- All genders, minimum age for participation is 18 years
- Presence of a tooth, that is already scheduled for extraction (indication for extraction diagnosed during the normal clinical service independently of this study by a qualified dentist)
- Availability of a radiograph (X-ray) showing the tooth to be extracted along with adjacent teeth
- Signed informed consent after a comprehensive explanation of the study is available
Критерии исключения
- participants under the age of 18
- Addicts or participants with impaired cognitive abilities that do not allow the participant to assess the scope of the study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Швейцария · 1 центр
- University of Zurich - Center for Dental Medicine — Zurich
Идентификаторы
NCT: NCT07342595 · 2025-01988