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Oral Health Awareness and Oral Hygiene in Insulin Dependent Diabetes Mellitus

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Diabetes type1
Health Attitude

Treatments

Behavioral: Oral Health Educational Program

Study type

Interventional

Funder types

Other

Identifiers

NCT03170089
S.Haikal

Details and patient eligibility

About

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.

Full 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

Enrollment

44 estimated patients

Sex

All

Ages

6 to 8 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

Intervention
Active Comparator group
Description:
Professional tooth cleaning (scaling) Oral Health educational program
Treatment:
Behavioral: Oral Health Educational Program
Control
No Intervention group
Description:
NO program or scaling done

Trial contacts and locations

0

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Central trial contact

Samar Haikal, Bachelor

Data sourced from clinicaltrials.gov

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