NCT03170089

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 30, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

May 17, 2017

Last Update Submit

May 26, 2017

Conditions

Health AttitudeDiabetes type1

Keywords

oral-health-awareness, Diabetes

Outcome Measures

Primary Outcomes (1)

  • Patient awareness

    Questionnaire about oral health

    Baseline

Secondary Outcomes (1)

  • Oral hygiene

    3 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Professional tooth cleaning (scaling) Oral Health educational program

Behavioral: Oral Health Educational Program

Control

NO INTERVENTION

NO program or scaling done

Interventions

Oral Health Educational ProgramBEHAVIORAL

Oral Hygiene methods learned

Intervention

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6-8 years old.
  • Cooperative children.
  • Both genders.
  • Insulin Dependent Diabetes Mellitus children

You may not qualify if:

  • Children with any other medical condition.
  • Children undergoing orthodontic treatment.
  • Parents unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Fatma El-Shehaby, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Samar Haikal, Bachelor

CONTACT

+201141999343s.a.haikal@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 30, 2017

Study Start

June 30, 2017

Primary Completion

October 30, 2017

Study Completion

December 30, 2017

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share