Oral Health Awareness and Oral Hygiene in Insulin Dependent Diabetes Mellitus
Primary Purpose
Health Attitude, Diabetes type1
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oral Health Educational Program
Sponsored by
About this trial
This is an interventional prevention trial for Health Attitude focused on measuring oral-health-awareness, Diabetes
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention
Control
Arm Description
Professional tooth cleaning (scaling) Oral Health educational program
NO program or scaling done
Outcomes
Primary Outcome Measures
Patient awareness
Questionnaire about oral health
Secondary Outcome Measures
Oral hygiene
Oral Hygiene Index- Simplified
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03170089
Brief Title
Oral Health Awareness and Oral Hygiene in Insulin Dependent Diabetes Mellitus
Official Title
Effect of Oral Health Educational Program on Awareness and Oral Health Status of Children With Insulin Dependent Diabetes Mellitus: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2017 (Anticipated)
Primary Completion Date
October 30, 2017 (Anticipated)
Study Completion Date
December 30, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Attitude, Diabetes type1
Keywords
oral-health-awareness, Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Professional tooth cleaning (scaling) Oral Health educational program
Arm Title
Control
Arm Type
No Intervention
Arm Description
NO program or scaling done
Intervention Type
Behavioral
Intervention Name(s)
Oral Health Educational Program
Intervention Description
Oral Hygiene methods learned
Primary Outcome Measure Information:
Title
Patient awareness
Description
Questionnaire about oral health
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Oral hygiene
Description
Oral Hygiene Index- Simplified
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samar Haikal, Bachelor
Phone
+201141999343
Email
s.a.haikal@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma El-Shehaby, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Health Awareness and Oral Hygiene in Insulin Dependent Diabetes Mellitus
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