Effect of Oral Health Educational Program on Oral Health Quality of Life of Group of Type1 Diabetes Children
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: Oral health educational program.
- Кому может быть актуально
- Состояния в реестре: Oral Health Related Quality of Life. Базовые параметры: 8 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
- Список центров уточняется — проверьте первичный протокол.
- 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
Effect of Oral Health Educational Program on the Oral Health-Related Quality of Life of a Group of Children With Type-1 Diabetes Mellitus: A Before and After Pilot Study
Обзор
The study is a before and after study made to assess the oral health related quality of life after oral health educational program on children with type1 diabetes mellitus. The main questions it aims to answer are: * oral health related quality of life * caries experience Participants will answer oral health quality of life questionnaire and will be checked for DMF and def indices and then given an oral health education program and followed up after 3 months.
Подробное описание
The oral health educational program will be conducted in Arabic in the form of flyers given to the children and their parents plus modeling on brushing habits on a cast and tooth brush.The educational program will emphasize on three main messages (brushing twice daily, healthy diet compatible with their disease and regular dentist visits).
Data in the flyer contained dietary tips as well as oral hygiene habits, design was made by the primary investigator.
The child oral health related quality of life will be measured by the validated Arabic child perception questionnaire (CPQ8-10)
Dental history, def and DMF indices will be measured by dental chart that will be modified to include a section for current medications.
To avoid selection bias all participants matching inclusion criteria in examination day will be included and all outcomes will be reported to avoid reporting and detection bias.
Study size: To the best of our knowledge there are no other studies found in literature to estimate a sample size so this study is going to be a pilot study with sample size of 50 child.
Statistical method: Categorical data will be represented as frequency (n) and percentage (%) and will be analyzed using chi square test. Numerical data will be investigated for normality by checking the data distribution, calculating the mean and median values and using Kolmogorov-Smirnov and Shapiro-Wilk tests. If the data was normally distributed, it will be shown as mean and standard deviation values and an independent t-test will be used for analysis. If the assumption of normality was violated; the data will be presented as median and range values and will be analyzed using Mann-Whitney U test. The significance level will be set at p ≤0.05 for all tests. Statistical analysis will be performed with IBM® SPSS® Statistics Version 26 for Windows.
Вмешательства
- Поведенческое Oral health educational program
Flyer distributed on the children with data about oral hygiene measures as well as diet advice related to their condition, in addition to modeling the correct tooth brushing habits using a cast and tooth brush.
Первичные конечные точки
- oral health related quality of life [Срок оценки: Measured before the educational program and then after 3 months from receiving the educational program]
Вторичные конечные точки (1)
- caries experience [Срок оценки: Measured before the educational program and then after 3 months from receiving the educational program]
Критерии участия
Критерии включения
- Children of both sexes
- Age from 8 to 10 years old
- Diagnosed with type 1 diabetes mellitus
Критерии исключения
- Children with other systemic diseases
- Parents who refuse participation
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06721728 · CEBD-CU-2024-11-07