Oral Health Related Quality of LifeNCT06721728
Effect of Oral Health Educational Program on Oral Health Quality of Life of Group of Type1 Diabetes Children
A study testing Oral health educational program in people with Oral Health Related Quality of Life, run by Cairo University.
Trial summary
The study is a before and after study made to assess the oral health related quality of life after oral health educational program on children with type1 diabetes mellitus. The main questions it aims to answer are: oral health related quality of life caries experience Participants will answer oral health quality of… Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Oral Health Related Quality of Life
- 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
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jul 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
- Children of both sexes
- Age from 8 to 10 years old
- Diagnosed with type 1 diabetes mellitus
Who cannot join
- Children with other systemic diseases
- Parents who refuse participation
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: Effect of Oral Health Educational Program on the Oral Health-Related Quality of Life of a Group of Children With Type-1 Diabetes Mellitus: A Before and After Pilot Study
The study is a before and after study made to assess the oral health related quality of life after oral health educational program on children with type1 diabetes mellitus.
The main questions it aims to answer are:
- oral health related quality of life
- caries experience
Participants will answer oral health quality of life questionnaire and will be checked for DMF and def indices and then given an oral health education program and followed up after 3 months.
Read the detailed description
The oral health educational program will be conducted in Arabic in the form of flyers given to the children and their parents plus modeling on brushing habits on a cast and tooth brush.The educational program will emphasize on three main messages (brushing twice daily, healthy diet compatible with their disease and regular dentist visits).
Data in the flyer contained dietary tips as well as oral hygiene habits, design was made by the primary investigator.
The child oral health related quality of life will be measured by the validated Arabic child perception questionnaire (CPQ8-10)
Dental history, def and DMF indices will be measured by dental chart that will be modified to include a section for current medications.
To avoid selection bias all participants matching inclusion criteria in examination day will be included and all outcomes will be reported to avoid reporting and detection bias.
Study size: To the best of our knowledge there are no other studies found in literature to estimate a sample size so this study is going to be a pilot study with sample size of 50 child.
Statistical method: Categorical data will be represented as frequency (n) and percentage (%) and will be analyzed using chi square test. Numerical data will be investigated for normality by checking the data distribution, calculating the mean and median values and using Kolmogorov-Smirnov and Shapiro-Wilk tests. If the data was normally distributed, it will be shown as mean and standard deviation values and an independent t-test will be used for analysis. If the assumption of normality was violated; the data will be presented as median and range values and will be analyzed using Mann-Whitney U test. The significance level will be set at p ≤0.05 for all tests. Statistical analysis will be performed with IBM® SPSS® Statistics Version 26 for Windows.
- Conditions
- Oral Health Related Quality of Life
- Being tested
- Oral health educational program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral health educational programBehavioural
Flyer distributed on the children with data about oral hygiene measures as well as diet advice related to their condition, in addition to modeling the correct tooth brushing habits using a cast and tooth brush.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes mellitus children | Experimental | children diagnosed with type 1 diabetes mellitus will receive an educational program with oral hygiene measures and diet advice related to their condition. 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
change in oral health related quality of life before and after the educational program measured in percentage
Measured: Measured before the educational program and then after 3 months from receiving the educational program
Secondary outcomes (1)
caries experience
Caries experience will be measured using DMF and def indices before and after the educational program and will be represented by mean and standard deviation
Measured: Measured before the educational program and then after 3 months from receiving the educational program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health Related Quality of LifeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farida Mohsen Abd El Satar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721728
- Sponsor's protocol ID
- CEBD-CU-2024-11-07
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. 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 of a Group of Children With Type-1 Diabetes Mellitus: A Before and After Pilot Study
- ClinicalTrials.gov ID
- NCT06721728
- Acronym / sponsor ID
- CEBD-CU-2024-11-07
- Conditions
- Oral Health Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 6 Dec 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.
The study is a before and after study made to assess the oral health related quality of life after oral health educational program on children with type1 diabetes mellitus.
The main questions it aims to answer are:
- oral health related quality of life
- caries experience
Participants will answer oral health quality of life questionnaire and will be checked for DMF and def indices and then given an oral health education program and followed up after 3 months.
Detailed description
The oral health educational program will be conducted in Arabic in the form of flyers given to the children and their parents plus modeling on brushing habits on a cast and tooth brush.The educational program will emphasize on three main messages (brushing twice daily, healthy diet compatible with their disease and regular dentist visits).
Data in the flyer contained dietary tips as well as oral hygiene habits, design was made by the primary investigator.
The child oral health related quality of life will be measured by the validated Arabic child perception questionnaire (CPQ8-10)
Dental history, def and DMF indices will be measured by dental chart that will be modified to include a section for current medications.
To avoid selection bias all participants matching inclusion criteria in examination day will be included and all outcomes will be reported to avoid reporting and detection bias.
Study size: To the best of our knowledge there are no other studies found in literature to estimate a sample size so this study is going to be a pilot study with sample size of 50 child.
Statistical method: Categorical data will be represented as frequency (n) and percentage (%) and will be analyzed using chi square test. Numerical data will be investigated for normality by checking the data distribution, calculating the mean and median values and using Kolmogorov-Smirnov and Shapiro-Wilk tests. If the data was normally distributed, it will be shown as mean and standard deviation values and an independent t-test will be used for analysis. If the assumption of normality was violated; the data will be presented as median and range values and will be analyzed using Mann-Whitney U test. The significance level will be set at p ≤0.05 for all tests. Statistical analysis will be performed with IBM® SPSS® Statistics Version 26 for Windows.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes mellitus children | Experimental | Behavioral: Oral health educational programchildren diagnosed with type 1 diabetes mellitus will receive an educational program with oral hygiene measures and diet advice related to their condition. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children of both sexes
- Age from 8 to 10 years old
- Diagnosed with type 1 diabetes mellitus
Key exclusion criteria (2 listed)
- Children with other systemic diseases
- Parents who refuse participation
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 programFlyer distributed on the children with data about oral hygiene measures as well as diet advice related to their condition, in addition to modeling the correct tooth brushing habits using a cast and tooth brush. | Behavioural | Type 1 diabetes mellitus children |
Primary outcome
oral health related quality of life
Time frame: Measured before the educational program and then after 3 months from receiving the educational program
change in oral health related quality of life before and after the educational program measured in percentage
1 secondary outcome
caries experience
Time frame: Measured before the educational program and then after 3 months from receiving the educational program
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 6 Dec 2024.
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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?
A study testing Oral health educational program in people with Oral Health Related Quality of Life, 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 3 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 6 Dec 2024. 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 Farida M Kassem, Bachelor (01007790256 ext. +2, Farida_mohsen@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: Measured before the educational program and then after 3 months from receiving the educational program). 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 6 Dec 2024.