Dental CariesNCT06897956
Oral Health Educational Program on Oral Hygiene Knowledge and Practices in a Group of Orphan Children
An observational study of Dental Caries and Knowledge, Attitudes, Practice, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Knowledge, Attitudes, Practice
- What is being tested?
- Oral health educational program
- Type of treatment
- Pill or oral medicine
- How many people
- 139 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Aug 2022to 15 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Orphan Children aged 7 years old and above.
- Educated children.
- No learning difficulty.
- No medical conditions.
Who cannot join
- Any child that refuses to participate
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University
Cairo, 11559
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Caries, Knowledge, Attitudes, Practice
- Being tested
- Oral health educational program
- Medical subject headings
- Dental Caries, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral health educational programOther
Oral health educational program about oral hygiene, prevention of dental caries and techniques of tooth brushing
| Study group | Role | What they receive |
|---|---|---|
| Wadi Hof Orphanage children | Orphan children at that Wadi Hof Branch Receives: Other: Oral health educational program | |
| El-Doki Orphanage children | Orphan children at that El-Doki Branch Receives: Other: Oral health educational program | |
| Helwan Orphanage children | Orphan children at that Helwan Branch Receives: Other: Oral health educational program | |
| Misr Elgadida Orphanage children | Orphan children at that Misr Elgadida Branch Receives: Other: Oral health educational program | |
| 6th October Orphanage children | Orphan children at that 6th October Branch Receives: Other: Oral health educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral hygiene knowledge, and practices of the orphan children
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
Measured: Before the educational program and after 2 months
Secondary outcomes (3)
Dental Caries experience for permanent dentition
DMF index for permanent teeth
Measured: Before the educational program and after 2 months
Dental Caries experience for mixed dentition
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
Measured: Before the educational program and after 2 months
Oral hygiene
Oral Hygiene Index-Simplified which is assessed through scores from 0-3
Measured: Before the educational program and after 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start16 Aug 2022
- Primary completion20 Oct 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Abdelgawad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897956
- Sponsor's protocol ID
- CEBD-CU-2025-02-13
- Status last verified
- Mar 2025
- First submitted
- 13 Feb 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Health Educational Program on Oral Hygiene Knowledge and Practices in a Group of Orphan Children: A Before and After Study
- ClinicalTrials.gov ID
- NCT06897956
- Acronym / sponsor ID
- CEBD-CU-2025-02-13
- Conditions
- Dental Caries, Knowledge, Attitudes, Practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Wadi Hof Orphanage children | – | Other: Oral health educational programOrphan children at that Wadi Hof Branch |
| El-Doki Orphanage children | – | Other: Oral health educational programOrphan children at that El-Doki Branch |
| Helwan Orphanage children | – | Other: Oral health educational programOrphan children at that Helwan Branch |
| Misr Elgadida Orphanage children | – | Other: Oral health educational programOrphan children at that Misr Elgadida Branch |
| 6th October Orphanage children | – | Other: Oral health educational programOrphan children at that 6th October Branch |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- Orphan Children aged 7 years old and above.
- Educated children.
- No learning difficulty.
- No medical conditions.
Key exclusion criteria (1 listed)
- Any child that refuses to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral health educational programOral health educational program about oral hygiene, prevention of dental caries and techniques of tooth brushing | Other | 6th October Orphanage children, El-Doki Orphanage children, Helwan Orphanage children, Misr Elgadida Orphanage children, Wadi Hof Orphanage children |
Primary outcome
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
3 secondary outcomes
Dental Caries experience for permanent dentition
Time frame: Before the educational program and after 2 months
Dental Caries experience for mixed dentition
Time frame: Before the educational program and after 2 months
Oral hygiene
Time frame: Before the educational program and after 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries and Knowledge, Attitudes, Practice, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral hygiene knowledge, and practices of the orphan children (time frame: Before the educational program and after 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.