Health AttitudeNCT03170089
Oral Health Awareness and Oral Hygiene in Insulin Dependent Diabetes Mellitus
A study testing Oral Health Educational Program in people with Health Attitude and Diabetes type1, run by Cairo University.
Trial summary
This study is designed to evaluate the effect of oral health educational program on the awareness and oral health status of children with Insulin Dependent Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Health Attitude, Diabetes type1
- 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
- 44 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2017to 30 Dec 2017
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-8 years old.
- Cooperative children.
- Both genders.
- Insulin Dependent Diabetes Mellitus children
Who cannot join
- Children with any other medical condition.
- Children undergoing orthodontic treatment.
- Parents unable to give informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Oral Health Educational Program on Awareness and Oral Health Status of Children With Insulin Dependent Diabetes Mellitus: A Randomized Clinical Trial
This study is designed to evaluate the effect of oral health educational program on the awareness and oral health status of children with Insulin Dependent Diabetes Mellitus.
Read the detailed description
First visit: (baseline)
- Awareness questionnaire is given to parent or caregiver to fill.
- Child information will be recorded in the diagnosis chart of Pediatric Dentistry and Public Health Department
- Intra-oral and extra-oral examination to all children included and recording Oral Hygiene Index simplified.
- Intervention group will receive:
- Supra-gingival scaling
- Oral Health Educational Program through life demonstration of tooth brushing on a model, power point presentation and a poster.
- Package containing tooth brush, tooth paste, poster and follow-up chart.
Second and third visits: (every month)
- Oral hygiene index simplified will be recorded for both groups.
- Follow-up chart is collected from intervention group.
Forth visit: (final visit)
- Awareness questionnaire is given for parents of both groups.
- Oral Hygiene Index simplified is recorded for both groups.
- Follow up charts is collected from intervention
- Control group will receive the same program after collection all data.
Number of visits \& follow up period:
- Four visits, time interval between each visit is one month and the follow up period is three months
- Conditions
- Health Attitude, Diabetes type1
- Being tested
- Oral Health Educational Program
- Keywords
- oral-health-awareness, Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Health Educational ProgramBehavioural
Oral Hygiene methods learned
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Professional tooth cleaning (scaling) Oral Health educational program Receives: Behavioral: Oral Health Educational Program |
| Control | No intervention | NO program or scaling done |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient awareness
Questionnaire about oral health
Measured: Baseline
Secondary outcomes (1)
Oral hygiene
Oral Hygiene Index- Simplified
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 posted30 May 2017
- Study start30 Jun 2017 (estimated)
- Primary completion30 Oct 2017 (estimated)
- Study completion30 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health AttitudeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Ali Zein El Abdeen Haikal, Cairo University
- Investigators
- Fatma El-Shehaby, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170089
- Sponsor's protocol ID
- S.Haikal
- Status last verified
- May 2017
- First submitted
- 17 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Health Educational Program on Awareness and Oral Health Status of Children With Insulin Dependent Diabetes Mellitus: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03170089
- Acronym / sponsor ID
- S.Haikal
- Conditions
- Health Attitude, Diabetes type1
- Keywords
- oral-health-awareness, Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jun 2017 (estimated)
- Primary completion
- 30 Oct 2017 (estimated)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 30 May 2017 (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.
This study is designed to evaluate the effect of oral health educational program on the awareness and oral health status of children with Insulin Dependent Diabetes Mellitus.
Detailed description
First visit: (baseline)
- Awareness questionnaire is given to parent or caregiver to fill.
- Child information will be recorded in the diagnosis chart of Pediatric Dentistry and Public Health Department
- Intra-oral and extra-oral examination to all children included and recording Oral Hygiene Index simplified.
- Intervention group will receive:
- Supra-gingival scaling
- Oral Health Educational Program through life demonstration of tooth brushing on a model, power point presentation and a poster.
- Package containing tooth brush, tooth paste, poster and follow-up chart.
Second and third visits: (every month)
- Oral hygiene index simplified will be recorded for both groups.
- Follow-up chart is collected from intervention group.
Forth visit: (final visit)
- Awareness questionnaire is given for parents of both groups.
- Oral Hygiene Index simplified is recorded for both groups.
- Follow up charts is collected from intervention
- Control group will receive the same program after collection all data.
Number of visits \& follow up period:
- Four visits, time interval between each visit is one month and the follow up period is three months
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Oral Health Educational ProgramProfessional tooth cleaning (scaling) Oral Health educational program |
| Control | No intervention | –NO program or scaling done |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6-8 years old.
- Cooperative children.
- Both genders.
- Insulin Dependent Diabetes Mellitus children
Key exclusion criteria (3 listed)
- Children with any other medical condition.
- Children undergoing orthodontic treatment.
- Parents unable to give informed consent
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 Hygiene methods learned | Behavioural | Intervention |
Primary outcome
Patient awareness
Time frame: Baseline
Questionnaire about oral health
1 secondary outcome
Oral hygiene
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- 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.
Fatma El-Shehaby, Professor study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Oral Health Educational Program in people with Health Attitude and Diabetes type1, 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 3 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: status not confirmed, as of the sponsor's last update on 30 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samar Haikal, Bachelor (+201141999343, s.a.haikal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient awareness (time frame: Baseline). 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 30 May 2017.