Dental CariesNCT06428474
Implementation of Oral Health Educational Program on Orphan Children
A study testing Health education in people with Dental Caries and Knowledge, run by Pharos University in Alexandria at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Dental Caries, Knowledge, Practice
- What is being tested?
- Health education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 30 Mar 2024
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Orphan children aged between 6-12 years old
Who cannot join
- children suffering from any systemic diseases acute or chronic, congenital abnormalities, psychological or behavioral problems, or receiving medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Oral Health Educational Program on the Knowledge and Practice of Institutionalized Orphan Children in Alexandria, Egypt
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
Read the detailed description
Background: Dental caries is a lifetime disease, with highest priority risk group between 11-14 years of age group. Environmental factors such as culture, socioeconomic status, life style and dietary pattern can have a greater impact on caries-resistance or development. It has been well-documented in dentistry and other health areas that correct health information or knowledge alone does not necessarily lead to desirable health behaviors. However knowledge gained may serve as a tool to empower population groups with accurate information about health and health care technologies, enabling them to take action to protect their health. According to global review of oral health, despite great improvements in the oral health of populations in several countries, the oral problem persists. This is particularly among underprivileged groups, in both developed and developing countries. One of the known high-risk groups is orphans. An orphan is defined as a child under 18 years, who has lost his father, mother, or both In developing countries like Egypt, there is little access to oral healthcare due to a lack of knowledge, insufficient financial resources, and inadequate dental manpower in the national healthcare system Aim of the study: is to evaluate the effectiveness of oral health education programs on knowledge and practice of participated orphan children Materials and Methods: A specially designed questionnaire was used to assess the dental problems and existing oral hygiene maintenance practice among children between 6 - 12 years of age (n=80) in orphanages. DMFT [Decayed Missing Filled Teeth index (for permanent teeth)] and dft [ decayed filled teeth index ( for primary teeth) ], pre- and post-interventional intra-oral examinations was carried out to check their oral hygiene status which included and OHIS (Simplified Oral Hygiene Index).
Information regarding tooth cleaning habits was obtained by a questionnaire to the children themselves, before, immediately and after 6 months.
Statistical analysis Collected data will be analyzed using SPSS software
- Conditions
- Dental Caries, Knowledge, Practice
- Being tested
- Health education
- Keywords
- Oral health education, knowledge, practice, oral hygiene
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationOther
Oral health education program designed for orphans children
| Study group | Role | What they receive |
|---|---|---|
| children who are living in orphanages | Experimental | Orphan children aged 6-12 Receives: Other: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Knowledge was measured immediately and after 6 months
Secondary outcomes (2)
Practice will be assessed using predesigned questionnaire
practices were measured using a predesigned questionnaire, consisting of 6 questions to collected data about the children's practices regarding tooth brushing, flossing and eating habits.
Measured: Practice was evaluated after 6 months
oral hygiene
Oral hygiene was evaluated using the simplified oral hygiene index - scores were ranged from 0-6 and 6 is the poorest oral hygiene score
Measured: oral hygiene was evaluated after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Sep 2023
- Primary completion1 Mar 2024
- Study completion30 Mar 2024
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharos University in Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inas Karawia, Pharos University in Alexandria
- Investigators
- Inas M Karawia, Principal investigator, Pharos University in Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428474
- Sponsor's protocol ID
- UREAC-04-3-219
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Oral Health Educational Program on the Knowledge and Practice of Institutionalized Orphan Children in Alexandria, Egypt
- ClinicalTrials.gov ID
- NCT06428474
- Acronym / sponsor ID
- UREAC-04-3-219
- Conditions
- Dental Caries, Knowledge, Practice
- Keywords
- Oral health education, knowledge, practice, oral hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pharos University in AlexandriaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 24 May 2024 (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.
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
Detailed description
Background: Dental caries is a lifetime disease, with highest priority risk group between 11-14 years of age group. Environmental factors such as culture, socioeconomic status, life style and dietary pattern can have a greater impact on caries-resistance or development. It has been well-documented in dentistry and other health areas that correct health information or knowledge alone does not necessarily lead to desirable health behaviors. However knowledge gained may serve as a tool to empower population groups with accurate information about health and health care technologies, enabling them to take action to protect their health. According to global review of oral health, despite great improvements in the oral health of populations in several countries, the oral problem persists. This is particularly among underprivileged groups, in both developed and developing countries. One of the known high-risk groups is orphans. An orphan is defined as a child under 18 years, who has lost his father, mother, or both In developing countries like Egypt, there is little access to oral healthcare due to a lack of knowledge, insufficient financial resources, and inadequate dental manpower in the national healthcare system Aim of the study: is to evaluate the effectiveness of oral health education programs on knowledge and practice of participated orphan children Materials and Methods: A specially designed questionnaire was used to assess the dental problems and existing oral hygiene maintenance practice among children between 6 - 12 years of age (n=80) in orphanages. DMFT [Decayed Missing Filled Teeth index (for permanent teeth)] and dft [ decayed filled teeth index ( for primary teeth) ], pre- and post-interventional intra-oral examinations was carried out to check their oral hygiene status which included and OHIS (Simplified Oral Hygiene Index).
Information regarding tooth cleaning habits was obtained by a questionnaire to the children themselves, before, immediately and after 6 months.
Statistical analysis Collected data will be analyzed using SPSS software
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children who are living in orphanages | Experimental | Other: Health educationOrphan children aged 6-12 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Orphan children aged between 6-12 years old
Key exclusion criteria (1 listed)
- children suffering from any systemic diseases acute or chronic, congenital abnormalities, psychological or behavioral problems, or receiving medications
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 |
|---|---|---|
| Health educationOral health education program designed for orphans children | Other | children who are living in orphanages |
Primary outcome
Knowledge will be assessed using predesigned questionnaire
Time frame: Knowledge was measured immediately and after 6 months
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.
2 secondary outcomes
Practice will be assessed using predesigned questionnaire
Time frame: Practice was evaluated after 6 months
oral hygiene
Time frame: oral hygiene was evaluated after 6 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 24 May 2024.
- Individual participant dataSharing planned: No
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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.
Inas M Karawia principal investigator
Pharos University in Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education in people with Dental Caries and Knowledge, run by Pharos University in Alexandria 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 1 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 24 May 2024. 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?
Knowledge will be assessed using predesigned questionnaire (time frame: Knowledge was measured immediately and after 6 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 24 May 2024.