Oral Health Awareness and Oral Hygiene in Insulin Dependent Diabetes Mellitus

Study Overview
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Brief Summary
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This study is designed to evaluate the effect of oral health educational program on the awareness and oral health status of children with Insulin Dependent Diabetes Mellitus.

Detailed Description
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First visit: (baseline) Awareness questionnaire is given to parent or caregiver to fill. Child information will be recorded in the diagnosis chart of Pediatric Dentistry and Public Health Department Intra-oral and extra-oral examination to all children included and recording Oral Hygiene Index simplified. Intervention group will receive: Supra-gingival scaling Oral Health Educational Program through life demonstration of tooth brushing on a model, power point presentation and a poster. Package containing tooth brush, tooth paste, poster and follow-up chart. Second and third visits: (every month) Oral hygiene index simplified will be recorded for both groups. Follow-up chart is collected from intervention group. Forth visit: (final visit) Awareness questionnaire is given for parents of both groups. Oral Hygiene Index simplified is recorded for both groups. Follow up charts is collected from intervention Control group will receive the same program after collection all data. Number of visits & follow up period: Four visits, time interval between each visit is one month and the follow up period is three months

Official Title
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Effect of Oral Health Educational Program on Awareness and Oral Health Status of Children With Insulin Dependent Diabetes Mellitus: A Randomized Clinical Trial

Conditions
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Health Attitude, Diabetes type1

Intervention / Treatment
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* Behavioral: Oral Health Educational Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 6-8 years old. Cooperative children. Both genders. Insulin Dependent Diabetes Mellitus children Exclusion Criteria: Children with any other medical condition. Children undergoing orthodontic treatment. Parents unable to give informed consent

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Professional tooth cleaning (scaling) Oral Health educational program | Behavioral: Oral Health Educational Program<br>* Oral Hygiene methods learned<br>|
| No Intervention: Control<br>NO program or scaling done | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient awareness | Questionnaire about oral health | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral hygiene | Oral Hygiene Index- Simplified | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral-health-awareness, Diabetes