NCT06428474

Brief Summary

Oral diseases are most prevalent among children. Orphans children are one of the most vulnerable groups to diseases especially oral diseases. Knowledge toward oral cavity and oral hygiene measures is low among this group, leading to poor practice of oral hygiene measures, which outcomes to oral diseases. Implementation of health education program orphan children who are living in orphanages is important. the aim of this study is to evaluate the effectiveness of health education program on the knowledge and practice of orphan children. 80 children were enrolled in this study from different orphanages in Alexandria, Egypt. Knowledge and practice were evaluated before and after intervention using predesigned questionnaire, and oral hygiene was evaluated using simplified oral hygiene index

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 9, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 9, 2024

Last Update Submit

May 22, 2024

Conditions

Keywords

Oral health educationknowledgepracticeoral hygiene

Outcome Measures

Primary Outcomes (1)

  • Knowledge will be assessed using predesigned questionnaire

    The questionnaire consisted of 8 questions to collect data about the children knowledge about teeth number in each dentition, the parts of teeth and its function, causes of oral disease, and how to prevent it.

    Knowledge was measured immediately and after 6 months

Secondary Outcomes (2)

  • Practice will be assessed using predesigned questionnaire

    Practice was evaluated after 6 months

  • oral hygiene

    oral hygiene was evaluated after 6 months

Study Arms (1)

children who are living in orphanages

EXPERIMENTAL

Orphan children aged 6-12

Other: Health education

Interventions

Oral health education program designed for orphans children

children who are living in orphanages

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Orphan children aged between 6-12 years old

You may not qualify if:

  • children suffering from any systemic diseases acute or chronic, congenital abnormalities, psychological or behavioral problems, or receiving medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharos University in Alexandria

Alexandria, 536733, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Inas M Karawia

    Pharos University in Alexandria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Faculty of Dentistry, Pharos University

Study Record Dates

First Submitted

May 9, 2024

First Posted

May 24, 2024

Study Start

September 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 30, 2024

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations