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Идёт набор NCT04567030

Using Artificial Intelligence-platform on Plaque Control and Periodontal Treatment Outcome in Patients With Periodontal Disease-Preliminary Results

Без фазы С лечением Periodontal Diseases

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: Dental monitoring (DM).
Кому может быть актуально
Состояния в реестре: Periodontal Diseases. Базовые параметры: 35 лет — 65 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
Тайвань
Следующий шаг
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Обзор

The aim of this study was to evaluate the long-term effectiveness of an AI dental monitoring intervention on patients' periodontal disease, preventive behaviors and motivation. This randomized controlled trial included experimental group: AI group (EG-A), AI-humanized group (EG-B) and control group(CG), respectively. The EG-A and EG-B received AI dental monitoring intervention by taking mouth image at home once a week for six month. Baseline and follow-up surveys were used to collect the data in periodontal index, periodontal preventive behavior and motivation.

Подробное описание

A randomized experimental design was used. Patients with periodontal disease whose aged 35-65 years were recruited through department of Periodontics in Kaohsiung Medical University Hospital.

Each group was expected for 100 per group, patients will be randomized into each group. G\*Power (version 3.1.9.4) was used for power analysis.

All patients will underwent periodontal examination at baseline and at 1-month, 3-month, 6-month follow-ups.

Each patients will be diagnosed periodontal disease by dentist and have more than 16 functional teeth.

Each patients will completed the questionnaire at baseline and at 1-month, 3-month and 6-month follow-up.

Вмешательства

  • Устройство Dental monitoring (DM)
    DM is the first APP system used in orthopedics patients in the world,it has been widely used in Asian countries (Taiwan, Hong Kong, Singapore, Japan, etc.) and has been used by 2140 patients so far. DM allows patients to take in-mouth photos at home, and uses AI as a background analysis to evaluate the patient's current oral condition (including oral hygiene and gum status) based on the photo.

Первичные конечные точки

  • gingival index (GI) [Срок оценки: Change from Baseline GI at 1-month after intervention]
  • gingival index (GI) [Срок оценки: Change from Baseline GI at 3-month after intervention]
  • gingival index (GI) [Срок оценки: Change from Baseline GI at 6-month after intervention]
  • plaque index (PI) [Срок оценки: Change from Baseline PI at 1-month after intervention]
  • plaque index (PI) [Срок оценки: Change from Baseline PI at 3-month after intervention]
  • plaque index (PI) [Срок оценки: Change from Baseline PI at 6-month after intervention]
  • Probing Pocket Depth (PPD) [Срок оценки: Change from Baseline PPD at 1-month after intervention]
  • Probing Pocket Depth (PPD) [Срок оценки: Change from Baseline PPD at 3-month after intervention]
  • Probing Pocket Depth (PPD) [Срок оценки: Change from Baseline PPD at 6-month after intervention]
  • Clinical Attachment Loss(CAL) [Срок оценки: Change from Baseline CAL at 1-month after intervention]
Вторичные конечные точки (6)
  • oral self-care behavior [Срок оценки: Change from Baseline at 1 month after intervention]
  • oral self-care behavior [Срок оценки: Change from Baseline at 3 month after intervention]
  • oral self-care behavior [Срок оценки: Change from Baseline at 6 month after intervention]
  • OHIP-14T scales [Срок оценки: Change from Baseline at 1 month after intervention]
  • OHIP-14T scales [Срок оценки: Change from Baseline at 3 month after intervention]
  • OHIP-14T scales [Срок оценки: Change from Baseline at 6 month after intervention]

Критерии участия

Критерии включения

  • Age between 35-65 years old
  • Diagnosed periodontal disease by dentist (Comprehensive Periodontal Treatment Project)
  • More than 16 functional teeth

Критерии исключения

  • Have received periodontal treatment within 3 months
  • Patient has disease related to periodontal disease (ex. Drug-related excessive gum growth or blood clotting problems, pregnancy, mental illness)
  • Disability patients

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Тайвань · 1 центр
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City

Публикации

  • Shen KL, Huang CL, Lin YC, Du JK, Chen FL, Kabasawa Y, Chen CC, Huang HL. Effects of artificial intelligence-assisted dental monitoring intervention in patients with periodontitis: A randomized controlled trial. J Clin Periodontol. 2022 Oct;49(10):988-998. doi: 10.1111/jcpe.13675. Epub 2022 Jul 10. PMID 35713224

Идентификаторы

NCT: NCT04567030 · KMUHIRB-E(I)-20190141

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗