Oral Health Awareness and Oral Hygiene in Insulin Dependent Diabetes Mellitus

May 26, 2017 updated by: Samar Ali Zein El Abdeen Haikal, Cairo University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

First visit: (baseline)

  1. Awareness questionnaire is given to parent or caregiver to fill.
  2. Child information will be recorded in the diagnosis chart of Pediatric Dentistry and Public Health Department
  3. Intra-oral and extra-oral examination to all children included and recording Oral Hygiene Index simplified.

  4. 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)

  1. Oral hygiene index simplified will be recorded for both groups.
  2. Follow-up chart is collected from intervention group.

Forth visit: (final visit)

  1. Awareness questionnaire is given for parents of both groups.
  2. Oral Hygiene Index simplified is recorded for both groups.
  3. Follow up charts is collected from intervention
  4. 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

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intervention
Professional tooth cleaning (scaling) Oral Health educational program
Behavioral: Oral Health Educational Program
Oral Hygiene methods learned
NO_INTERVENTION: Control
NO program or scaling done

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Fatma El-Shehaby, Professor, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 30, 2017

Primary Completion (ANTICIPATED)

October 30, 2017

Study Completion (ANTICIPATED)

December 30, 2017

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 26, 2017

First Posted (ACTUAL)

May 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S.Haikal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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