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Набор скоро начнётся NCT06381700

Effectiveness of MySmile App for Improving the Oral Health of Secondary School Children:

Без фазы С лечением Oral Disease Gingival 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: MySmile app, Control.
Кому может быть актуально
Состояния в реестре: Oral Disease, Gingival Diseases. Базовые параметры: 15 лет — 17 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
Малайзия
Следующий шаг
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Официальное название

Effectiveness of MySmile App for Improving the Oral Health of Secondary School Children: A Cluster Randomised Controlled Trial

Обзор

The goal of this cluster-randomised control trial is to assess the effectiveness of the MySmile app for improving oral health in secondary school children. The main questions it aims to answer are: 1. Will the MySmile app be more effective in improving secondary school children's dental plaque and gingival health over and above the existing school dental service (SDS)? 2. Will the MySmile app be more effective in improving secondary school children's oral health knowledge, attitudes, and behaviours over and above the existing SDS? 3. Is the MySmile app easy to use by secondary school children? 4. Is the MySmile app acceptable to use from the perspective of secondary school children? Participants in the intervention group will receive the SDS and MySmile app. The control group will receive SDS only. Therefore the researcher will compare between the intervention and control group in terms of dental plaque, gingival health, oral health knowledge, oral health attitudes and oral health behaviours.

Подробное описание

The selection of schools into the study will involve three (3) sampling levels. At the first level, acknowledging the division of secondary schools in the district into urban and rural, one matched-pair will be randomly selected from urban area, and another matched pair will be randomly selected from rural area. At the second level, randomisation of the school is carried out. The 2 schools in each of the matched-pair will be randomly allocated to intervention and control group. At the third level, six (6) classrooms from moderate academic performance level will be selected (2 classrooms from Form 3, Form 4, and Form 5, respectively). Students who fulfil the inclusion criteria will be invited to participate in the study. The randomisation sequence will be carried out by the statistician at the Faculty of Dentistry, Universiti Malaya

Вмешательства

  • Другое MySmile app
    The MySmile app contains several features: A) Knowledge Hub 1. "Do You Know" section: This section consists of seven (7) topics where users can learn about oral health knowledge. 2. "Quiz time" section: In this section, school children can play games and challenge themselves. B) Track yourself Brushing diary Diet diary C) Get help 1. Ask an expert 2. Find your dentist 3. Friendly reminders
  • Другое Control
    This will receive the usual School Dental Service. School Dental Service provide students who need dental treatment and will be called to be given treatment. Among the treatments given include: * Dental filling * Full mouth scaling * Dental extraction * Preventive treatment, such as topical fluoride application All treatment is free of charge except for dentures, crown/bridge work and orthodontics. Treatment for school children is based on normative needs assessment as determined by the denti

Первичные конечные точки

  • The mean decrement in plaque score will be assessed using the Plaque Control Record developed by O'Leary Drake and Naylor in 1972 [Срок оценки: after 4 weeks and 12 weeks post-intervention]
  • The mean increment in gingival health will be assessed using Gingival Index developed by Silness and Loe in 1963 [Срок оценки: after 4 weeks and 12 weeks post-intervention]
Вторичные конечные точки (1)
  • The mean increment of oral health knowledge, attitude and practice using validated questionnaires. [Срок оценки: after 4 weeks and 12 weeks post-intervention.]

Критерии участия

  • Inclusion criteria for school
  • Government-funded secondary school
  • Received SDS from the mobile dental squad/school dental clinic at least once a year.
  • High-risk schools with all indicators not meeting the district's benchmark.
  • Inclusion criteria for the participants:
  • Secondary school children aged 15-17 years old.
  • Medium to high dental plaque level - Plaque score more than 50%
  • Healthy with no chronic medical history and physical disabilities
  • Understand the English language.
  • Own a smartphone// have access to an Android-based smartphone

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Малайзия · 1 центр
  • Muhammad Hamidie bin Saari — Kuala Lumpur

Идентификаторы

NCT: NCT06381700 · DF CO2405/0014 (P)

Первоисточники (государственные реестры)

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