Effect of Oral Health Educational Program on Oral Health Quality of Life of Group of Type1 Diabetes Children
NCT ID: NCT06721728
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-01-01
2025-07-01
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Type 1 diabetes mellitus children
children diagnosed with type 1 diabetes mellitus will receive an educational program with oral hygiene measures and diet advice related to their condition.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age from 8 to 10 years old
* Diagnosed with type 1 diabetes mellitus
Exclusion Criteria
* Parents who refuse participation
8 Years
10 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Farida Mohsen Abd El Satar
dentist
Central Contacts
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Other Identifiers
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CEBD-CU-2024-11-07
Identifier Type: -
Identifier Source: org_study_id