Chronic Kidney Disease(CKD)CKDNCT06879223
Effect of Oral Health Educational Program on the Oral Health Related Quality of Life in a Group of Children with Chronic Kidney Disease
A study testing Oral Health Educational Program in people with Chronic Kidney Disease(CKD), run by Cairo University at 1 site in Egypt.
Trial summary
Children with CKD are at higher risk for poor oral health28 due to factors such as compromised immunity, medication side effects, and dietary restrictions. Poor oral health can lead to pain, infection, and difficulties in eating and speaking, which in turn negatively affects their quality of life. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Chronic Kidney Disease(CKD)
- What is being tested?
- Oral Health Educational Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2025to 15 Sep 2025
- Phase
- Interventional
- 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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8-10 years old.
- Diagnosed with Chronic Kidney Disease
Who cannot join
- Children with other systemic diseases.
- Parents that refuse the participation of their children.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Oral Health Educational Program on the Oral Health-Related Quality of Life in a Group of Children with Chronic Kidney Disease: a Before and After Pilot Study
Children with CKD are at higher risk for poor oral health28 due to factors such as compromised immunity, medication side effects, and dietary restrictions. Poor oral health can lead to pain, infection, and difficulties in eating and speaking, which in turn negatively affects their quality of life. This study is designed to address this gap by exploring how an oral health educational program could improve the oral health-related quality of life (OHRQoL) in this group.
- Conditions
- Chronic Kidney Disease(CKD)
- Being tested
- Oral Health Educational Program
- Keywords
- CKD OHRQL, OHEP
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Health Educational ProgramBehavioural
Providing the children with an educational program through a data show presentation when and how to brush their teeth, causes of dental caries and how to prevent its occurrence. A flyer will be distributed including simple language about preventive measure of dental caries and schedule of teeth brushing to ensure retention of information.
| Study group | Role | What they receive |
|---|---|---|
| Children with CKD | Experimental | Not described Receives: Behavioral: Oral Health Educational Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health related quality of life
it will be assessed using a questionnaire and the measurement unit is percentage
Measured: 3 months
Secondary outcomes (3)
Developmental enamel defect.
it will be assessed using the DDE (Developmental Defects of Enamel) index and the measurement unit is Mean SD.
The DDE index categorizes defects into three main types:
Opacities: Changes in enamel translucency, which can be diffuse or demarcated. Hypoplasia: A quantitative defect where enamel is thinner or missing in certain areas.
Discoloration: Changes in enamel color due to structural abnormalities. higher scores means worse outcome.
Measured: 3 months
Caries experience.
it will be assessed using the def(decayed, extracted,filled) index and the measurement unit is Mean SD.
The def score is the sum of these values, providing an indication of oral health in children before their permanent teeth emerge.
higher scores means worse outcome.
Measured: 3 months
Caries experience
it will be assessed using the DMF (Decayed, Missing, Filled) index and the measurement unit is mean SD.
The DMF score is the sum of these values, indicating the overall caries experience in an individual or population. Unlike the def index, which applies to primary teeth, the DMF index is used for permanent teeth.
higher scores means worse outcome.
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 posted17 Mar 2025
- Study start15 Jun 2025 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease(CKD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebaallah Samy Gamil Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879223
- Sponsor's protocol ID
- Educational program on CKD
- Acronym
- CKD
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Health Educational Program on the Oral Health-Related Quality of Life in a Group of Children with Chronic Kidney Disease: a Before and After Pilot Study
- ClinicalTrials.gov ID
- NCT06879223
- Acronym / sponsor ID
- CKD / Educational program on CKD
- Conditions
- Chronic Kidney Disease(CKD)
- Keywords
- CKD OHRQL, OHEP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 17 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.
Children with CKD are at higher risk for poor oral health28 due to factors such as compromised immunity, medication side effects, and dietary restrictions. Poor oral health can lead to pain, infection, and difficulties in eating and speaking, which in turn negatively affects their quality of life. This study is designed to address this gap by exploring how an oral health educational program could improve the oral health-related quality of life (OHRQoL) in this group.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with CKD | Experimental | Behavioral: Oral Health Educational Program |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 8-10 years old.
- Diagnosed with Chronic Kidney Disease
Key exclusion criteria (2 listed)
- Children with other systemic diseases.
- Parents that refuse the participation of their children.
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 ProgramProviding the children with an educational program through a data show presentation when and how to brush their teeth, causes of dental caries and how to prevent its occurrence. A flyer will be distributed including simple language about preventive measure of dental caries and schedule of teeth brushing to ensure retention of information. | Behavioural | Children with CKD |
Primary outcome
Oral health related quality of life
Time frame: 3 months
it will be assessed using a questionnaire and the measurement unit is percentage
3 secondary outcomes
Developmental enamel defect.
Time frame: 3 months
Caries experience.
Time frame: 3 months
Caries experience
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 17 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Health Educational Program in people with Chronic Kidney Disease(CKD), 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 2 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 17 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?
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 HebaAllah Samy Dentist (+20 1125450657, hebaallah.samy@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 related quality of life (time frame: 3 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 17 Mar 2025.