NCT06838221

Brief Summary

Conducting a research with an interactive oral health educational program and assessing knowledge of caregivers using a questionnaire will help in collecting information about the oral health educational program for children with intellectual disability and the extent of knowledge of care givers in Egypt. This will aid in identifying the knowledge gap, interest, attitude, and practice challenges regarding the children with intellectual disability.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

February 14, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 14, 2025

Last Update Submit

February 18, 2025

Conditions

Keywords

Interactive oral health educational program

Outcome Measures

Primary Outcomes (1)

  • Oral health of children

    Oral health of children: Gingival index (GL) * Before starting the educational program. * At the end of the educational program. Score from 0,1,2,3 and Plaque index (PL) * Before starting the educational program. * At the end of the educational program. Score from 0,1,2,3

    3 months

Secondary Outcomes (1)

  • Secondary outcome Knowledge of Care givers Questionnaire chart

    3 months

Study Arms (1)

intellectual disability children and their care givers

oral health educational interactive program of intellectual disabilitry and their care givers

Other: A Before and After studyOther: before and after study

Interventions

interactive oral health educational program for children with intellectual disability and their care givers

intellectual disability children and their care givers

To evaluate the oral health of a group of children with disability and determine the effectiveness of the interactive oral health education program on oral health of children and care givers' oral health knowledge.

intellectual disability children and their care givers

Eligibility Criteria

Age7 Months - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

intellectual disability children and their care givers

You may qualify if:

  • children with intellectual disability
  • care givers
  • IQ(mild)50-69
  • IQ(moderate) 35-49

You may not qualify if:

  • IQ(severe) 20-34
  • refusal to get enrolled in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Da'aj, S.T., Al-Bayati, S., Al-Karawi, A.J., & Hameed, A.S. (2023). Oral Health Education (OHE) Program on Adolescents before and after Teacher's Training in Diyala City: A Comparative Clinical Study. The Egyptian Journal of Hospital Medicine.

    RESULT

MeSH Terms

Conditions

Intellectual DisabilityCaregiver Burden

Interventions

Lead

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetals

Central Study Contacts

Marnal Ahmed Elbanna, master's researcher

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 20, 2025

Study Start

February 14, 2025

Primary Completion

August 1, 2025

Study Completion

January 1, 2026

Last Updated

February 20, 2025

Record last verified: 2025-02