- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06897956
Oral Health Educational Program on Oral Hygiene Knowledge and Practices in a Group of Orphan Children
March 20, 2025 updated by: Fatma Abdelgawad, Cairo University
Effect of Oral Health Educational Program on Oral Hygiene Knowledge and Practices in a Group of Orphan Children: A Before and After Study
An orphan is defined as "a child under the age of 18 whose mother, father, both parents, and a primary caregiver has died, and who is in need of care or protection".
Orphans, therefore, are considered disadvantaged and socially marginalized population whom diseases burden is high.
Egypt has 1.7 million orphaned children.
The number of children between the age of 0 and 17 who are currently registered in orphanages is 12,015.
Dental diseases especially plaque, gingival and dental caries are highly preventable, with the highest prevalence in the developing countries.
Profound disparities exist in oral health status across different social and economic divisions.
The pattern of orphanage living is quite different from family living as the latter provides physical security, food, and shelter but is devoid of psychological security.
High prevalence of dental caries, gingivitis and dental trauma has been observed in children of orphanages.
This has been attributed to many factors such as: lack of adequate staff, poor oral hygiene, improper nutrition and eating patterns, high consumption of sugary food, negligence of tooth brushing, moreover the children and caregivers knowledge, level of education and oral health illiteracy.
Untreated oral diseases could lead to psychological and general health problems, pain and loss in school time.
Recognition of these problems is essential to provide optimum oral health for these deprived children.
Health education is an important tool of public health and an effective primary preventive method especially for school aged children in controlling plaque, gingival and dental diseases.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to raise more awareness about the causes of dental diseases (plaque, gingival and dental caries and their prevention through implementing an educational program to the orphan children focusing on tooth brushing, proper use of fluoride products and proper nutrition.
The objectives of this study are to evaluate the impact of the oral health education program on the Knowledge and practices of the orphans and also its effect on the gingival health and dental caries among the children in different branches of orphanages in Egypt.
Study Type
Observational
Enrollment (Actual)
139
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 11559
- Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
This study is carried out at orphanages from different branches in Egypt.
The study was conducted using a convenient sample of orphan children aged 7years and above.
Description
Inclusion Criteria:
- Orphan Children aged 7 years old and above.
- Educated children.
- No learning difficulty.
- No medical conditions.
Exclusion Criteria:
- Any child that refuses to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Wadi Hof Orphanage children
Orphan children at that Wadi Hof Branch
|
Oral health educational program about oral hygiene, prevention of dental caries and techniques of tooth brushing
|
|
El-Doki Orphanage children
Orphan children at that El-Doki Branch
|
Oral health educational program about oral hygiene, prevention of dental caries and techniques of tooth brushing
|
|
Helwan Orphanage children
Orphan children at that Helwan Branch
|
Oral health educational program about oral hygiene, prevention of dental caries and techniques of tooth brushing
|
|
Misr Elgadida Orphanage children
Orphan children at that Misr Elgadida Branch
|
Oral health educational program about oral hygiene, prevention of dental caries and techniques of tooth brushing
|
|
6th October Orphanage children
Orphan children at that 6th October Branch
|
Oral health educational program about oral hygiene, prevention of dental caries and techniques of tooth brushing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral hygiene knowledge, and practices of the orphan children
Time Frame: Before the educational program and after 2 months
|
Questionnaire including 20 questions about the oral hygiene knowledge and practices of the children.
This questionnaire was used before the educational program and after 2 months from the program
|
Before the educational program and after 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dental Caries experience for permanent dentition
Time Frame: Before the educational program and after 2 months
|
DMF index for permanent teeth
|
Before the educational program and after 2 months
|
|
Dental Caries experience for mixed dentition
Time Frame: Before the educational program and after 2 months
|
Both dental caries indices (DMF and def) are used to provide the caries experience of each participant, they are not added together and reported separately as mixed dentition has both primary and permanent teeth, so we need to record primary teeth with def and permanent teeth with DMF
|
Before the educational program and after 2 months
|
|
Oral hygiene
Time Frame: Before the educational program and after 2 months
|
Oral Hygiene Index-Simplified which is assessed through scores from 0-3
|
Before the educational program and after 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 16, 2022
Primary Completion (Actual)
October 20, 2022
Study Completion (Actual)
January 15, 2023
Study Registration Dates
First Submitted
February 13, 2025
First Submitted That Met QC Criteria
March 20, 2025
First Posted (Actual)
March 27, 2025
Study Record Updates
Last Update Posted (Actual)
March 27, 2025
Last Update Submitted That Met QC Criteria
March 20, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-CU-2025-02-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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