Oral Health Awareness and Oral Hygiene in Insulin Dependent Diabetes Mellitus

Diabetes type1 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03170089
• Other study ID #: S.Haikal
• Status: Not yet recruiting
• Phase: N/A
• First received: May 17, 2017
• Last updated: May 26, 2017
• Start date: June 30, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: May 2017
• Source: Cairo University
• Contact: Samar Haikal, Bachelor
• Phone: +201141999343
• Email: s.a.haikal[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes type1
• Health Attitude

Intervention

Behavioral:
• Oral Health Educational Program
Oral Hygiene methods learned

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient awareness	Questionnaire about oral health	Baseline
Secondary	Oral hygiene	Oral Hygiene Index- Simplified	3 months