Oral Health Awareness and Oral Hygiene in Insulin Dependent Diabetes Mellitus

NCT ID: NCT03170089

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2017-12-30

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)

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

Conditions

Health Attitude; Diabetes type1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Professional tooth cleaning (scaling) Oral Health educational program

Group Type: ACTIVE_COMPARATOR

Oral Health Educational Program

Intervention Type: BEHAVIORAL

Oral Hygiene methods learned

Control

NO program or scaling done

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oral Health Educational Program

Oral Hygiene methods learned

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Samar Ali Zein El Abdeen Haikal

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatma El-Shehaby, Professor

Role: STUDY_CHAIR

Cairo University

Central Contacts

Samar Haikal, Bachelor

Role: CONTACT

s.a.haikal@hotmail.com

+201141999343

Other Identifiers

S.Haikal

Identifier Type: -

Identifier Source: org_study_id