Intellectual Disabilityoral programNCT06838221
Interactive Oral Health Educational Program for Children With Intellectual Disability and Their Caregivers
An observational study of Intellectual Disability and Caregiver Burden, run by Cairo University.
Trial summary
Conducting a research with an interactive oral health educational program and assessing knowledge of caregivers using a questionnaire will help in collecting information about the oral health educational program for children with intellectual disability and the extent of knowledge of care givers in Egypt. Read more about this study
- Who is it for?
- Ages 7 to 12 months
- Conditions the study is for
- Intellectual Disability, Caregiver Burden
- What is being tested?
- A Before and After study and before and after study
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 14 Feb 2025to 1 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 months
- All sexes
- No healthy volunteers
- Child
Study population: intellectual disability children and their care givers
Who may be able to join
- children with intellectual disability
- care givers
- IQ(mild)50-69
- IQ(moderate) 35-49
Who cannot join
- IQ(severe) 20-34
- refusal to get enrolled in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Interactive Oral Health Educational Program for Children With Intellectual Disability and Their Caregivers.
Conducting a research with an interactive oral health educational program and assessing knowledge of caregivers using a questionnaire will help in collecting information about the oral health educational program for children with intellectual disability and the extent of knowledge of care givers in Egypt. This will aid in identifying the knowledge gap, interest, attitude, and practice challenges regarding the children with intellectual disability.
Read the detailed description
For all children, oral health is a crucial component of overall health, but it is even more crucial for kids with particular medical requirements. Despite the high prevalence of dental disorders among them, people with disabilities or illnesses receive less oral treatment than the general population. According to reports, the largest unmet health need among disabled individuals is dental care. The general health and well-being of the body are closely linked to oral health. The quality of life is enhanced by good dental health. Mentally disabled patients have worse oral health than their normal counterparts, which makes it harder for them to use the oral cavity for activities like eating, swallowing, speaking, chewing, and drooling. This leads to malocclusion, compromised appearance, and poor overall health. Educating parents, guardians, and other caregivers on the causes and self-care prevention of dental disease is a critical part in lowering the caries/gingivitis rate among these children globally. Because of the insufficiency of oral health programs offered in institutions or schools for these particular children, parents and care givers usually have little knowledge about mouth health. they do not understand the significance of dental health, and the educational resources that are accessible to them are frequently insufficient and out-of-date
- Conditions
- Intellectual Disability, Caregiver Burden
- Being tested
- A Before and After study, before and after study
- Keywords
- Interactive oral health educational program
- Medical subject headings
- Intellectual Disability, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Before and After studyOther
interactive oral health educational program for children with intellectual disability and their care givers
before and after studyOther
To evaluate the oral health of a group of children with disability and determine the effectiveness of the interactive oral health education program on oral health of children and care givers' oral health knowledge.
| Study group | Role | What they receive |
|---|---|---|
| intellectual disability children and their care givers | oral health educational interactive program of intellectual disabilitry and their care givers Receives: Other: A Before and After study; Other: before and after study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health of children
Oral health of children:
Gingival index (GL)
- Before starting the educational program.
- At the end of the educational program. Score from 0,1,2,3 and Plaque index (PL)
- Before starting the educational program.
- At the end of the educational program. Score from 0,1,2,3
Measured: 3 months
Secondary outcomes (1)
Secondary outcome Knowledge of Care givers Questionnaire chart
Secondary outcome Knowledge of Care givers Questionnaire chart
- Before starting the educational program.
- At the end of the educational program. Score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start14 Feb 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intellectual DisabilityStudies 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
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marnal Ahmed Abdelal Elbanna, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838221
- Sponsor's protocol ID
- Educational program
- Acronym
- oral program
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Da'aj, S.T., Al-Bayati, S., Al-Karawi, A.J., & Hameed, A.S. (2023). Oral Health Education (OHE) Program on Adolescents before and after Teacher's Training in Diyala City: A Comparative Clinical Study. The Egyptian Journal of Hospital Medicine.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Oral Health Educational Program for Children With Intellectual Disability and Their Caregivers.
- ClinicalTrials.gov ID
- NCT06838221
- Acronym / sponsor ID
- oral program / Educational program
- Conditions
- Intellectual Disability, Caregiver Burden
- Keywords
- Interactive oral health educational program
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Feb 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 20 Feb 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.
Conducting a research with an interactive oral health educational program and assessing knowledge of caregivers using a questionnaire will help in collecting information about the oral health educational program for children with intellectual disability and the extent of knowledge of care givers in Egypt. This will aid in identifying the knowledge gap, interest, attitude, and practice challenges regarding the children with intellectual disability.
Detailed description
For all children, oral health is a crucial component of overall health, but it is even more crucial for kids with particular medical requirements. Despite the high prevalence of dental disorders among them, people with disabilities or illnesses receive less oral treatment than the general population. According to reports, the largest unmet health need among disabled individuals is dental care. The general health and well-being of the body are closely linked to oral health. The quality of life is enhanced by good dental health. Mentally disabled patients have worse oral health than their normal counterparts, which makes it harder for them to use the oral cavity for activities like eating, swallowing, speaking, chewing, and drooling. This leads to malocclusion, compromised appearance, and poor overall health. Educating parents, guardians, and other caregivers on the causes and self-care prevention of dental disease is a critical part in lowering the caries/gingivitis rate among these children globally. Because of the insufficiency of oral health programs offered in institutions or schools for these particular children, parents and care givers usually have little knowledge about mouth health. they do not understand the significance of dental health, and the educational resources that are accessible to them are frequently insufficient and out-of-date
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intellectual disability children and their care givers | – | Other: A Before and After study, Other: before and after studyoral health educational interactive program of intellectual disabilitry and their care givers |
Who may qualify
- Ages
- 7 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- intellectual disability children and their care givers
Key inclusion criteria (4 listed)
- children with intellectual disability
- care givers
- IQ(mild)50-69
- IQ(moderate) 35-49
Key exclusion criteria (2 listed)
- IQ(severe) 20-34
- refusal to get enrolled in the study.
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 |
|---|---|---|
| A Before and After studyinteractive oral health educational program for children with intellectual disability and their care givers | Other | intellectual disability children and their care givers |
| before and after studyTo evaluate the oral health of a group of children with disability and determine the effectiveness of the interactive oral health education program on oral health of children and care givers' oral health knowledge. | Other | intellectual disability children and their care givers |
Primary outcome
Oral health of children
Time frame: 3 months
Oral health of children: Gingival index (GL) * Before starting the educational program. * At the end of the educational program. Score from 0,1,2,3 and Plaque index (PL) * Before starting the educational program. * At the end of the educational program. Score from 0,1,2,3
1 secondary outcome
Secondary outcome Knowledge of Care givers Questionnaire chart
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Results publicationDa'aj, S.T., Al-Bayati, S., Al-Karawi, A.J., & Hameed, A.S. (2023). Oral Health Education (OHE) Program on Adolescents before and after Teacher's Training in Diyala City: A Comparative Clinical Study. The Egyptian Journal of Hospital Medicine.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Intellectual Disability and Caregiver Burden, run by Cairo University.
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 2 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: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marnal Ahmed Elbanna, master's researcher (00201005222055, marnal.elbanna@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral health of children (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06838221, which also lists 1 linked publication.
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 20 Feb 2025.