NCT06721728

Brief Summary

The study is a before and after study made to assess the oral health related quality of life after oral health educational program on children with type1 diabetes mellitus. The main questions it aims to answer are:

  • oral health related quality of life
  • caries experience Participants will answer oral health quality of life questionnaire and will be checked for DMF and def indices and then given an oral health education program and followed up after 3 months.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

November 27, 2024

Last Update Submit

December 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • oral health related quality of life

    change in oral health related quality of life before and after the educational program measured in percentage

    Measured before the educational program and then after 3 months from receiving the educational program

Secondary Outcomes (1)

  • caries experience

    Measured before the educational program and then after 3 months from receiving the educational program

Study Arms (1)

Type 1 diabetes mellitus children

EXPERIMENTAL

children diagnosed with type 1 diabetes mellitus will receive an educational program with oral hygiene measures and diet advice related to their condition.

Behavioral: Oral health educational program

Interventions

Flyer distributed on the children with data about oral hygiene measures as well as diet advice related to their condition, in addition to modeling the correct tooth brushing habits using a cast and tooth brush.

Type 1 diabetes mellitus children

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children of both sexes
  • Age from 8 to 10 years old
  • Diagnosed with type 1 diabetes mellitus

You may not qualify if:

  • Children with other systemic diseases
  • Parents who refuse participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Farida M Kassem, Bachelor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dentist

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 6, 2024

Study Start

January 1, 2025

Primary Completion

March 1, 2025

Study Completion

July 1, 2025

Last Updated

December 6, 2024

Record last verified: 2024-12