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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Egypt
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Wadi Hof Orphanage children
Orphan children at that Wadi Hof Branch
Other: Oral health educational program
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
Other: Oral health educational program
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
Other: Oral health educational program
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
Other: Oral health educational program
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
Other: Oral health educational program
Oral health educational program about oral hygiene, prevention of dental caries and techniques of tooth brushing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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