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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Attitude focused on measuring oral-health-awareness, Diabetes

Eligibility Criteria

6 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Children aged 6-8 years old.
  2. Cooperative children.
  3. Both genders.
  4. Insulin Dependent Diabetes Mellitus children

Exclusion Criteria:

  1. Children with any other medical condition.
  2. Children undergoing orthodontic treatment.
  3. 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

    First Posted
    May 17, 2017
    Last Updated
    May 26, 2017
    Sponsor
    Cairo University
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    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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