Gingival Disease Due to BacteriaNCT04167826
Oral Health Status and Diet History Analysis Among Orphan House Children From 10-14 Years in Cairo Governorate.
An observational study of Gingival Disease Due to Bacteria, run by Cairo University.
Trial summary
the purpose of study to determine oral health status and dietary habits among group of orphan children from 10-14 years in Cairo Governorate. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Disease Due to Bacteria
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Sep 2020
- Phase
- Observational
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study will done for Orphan children in Resalaa charity organization in Cairo governorate in Egypt.
Who may be able to join
- Egyptian children aged from 10-14 years
- Cooperative children
Who cannot join
- Children with systemic disease , genetic disorders , or any disabilities
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Oral Health Status and Diet History Analysis Among Orphan House Children From 10-14 Years in Cairo Governorate : A Cross Sectional Study
the purpose of study to determine oral health status and dietary habits among group of orphan children from 10-14 years in Cairo Governorate.
Read the detailed description
The study's investigators will record all data related to oral health status of orphan children from 10-14 years and their dietary habits to describe usual food intake and its variation over a long period of time . the OHI-S will also recorded which has 2 components the Debris index and Calculus index .
- Conditions
- Gingival Disease Due to Bacteria
What is being measured
The primary outcome is the main question the study is designed to answer.
oral health status
Debris index
Measured: 3 months
oral health status
Calculus index
Measured: 3 months
Diet history analysis
Diet history chart
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 posted19 Nov 2019
- Study startNov 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Disease Due to BacteriaStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulrahman mohamed salah, Cairo University
- Investigators
- Sherine Ezz eldeen, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167826
- Sponsor's protocol ID
- CEBD-CU-2019-11-14
- Status last verified
- Nov 2019
- First submitted
- 14 Nov 2019
- Last updated
- 19 Nov 2019
- 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 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Status and Diet History Analysis Among Orphan House Children From 10-14 Years in Cairo Governorate : A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04167826
- Acronym / sponsor ID
- CEBD-CU-2019-11-14
- Conditions
- Gingival Disease Due to Bacteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 19 Nov 2019 (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 purpose of study to determine oral health status and dietary habits among group of orphan children from 10-14 years in Cairo Governorate.
Detailed description
The study's investigators will record all data related to oral health status of orphan children from 10-14 years and their dietary habits to describe usual food intake and its variation over a long period of time . the OHI-S will also recorded which has 2 components the Debris index and Calculus index .
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study will done for Orphan children in Resalaa charity organization in Cairo governorate in Egypt.
Key inclusion criteria (2 listed)
- Egyptian children aged from 10-14 years
- Cooperative children
Key exclusion criteria (1 listed)
- Children with systemic disease , genetic disorders , or any disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
oral health status
Time frame: 3 months
Debris index
oral health status
Time frame: 3 months
Calculus index
Diet history analysis
Time frame: 3 months
Diet history chart
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: Undecided
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.
Sherine Ezz eldeen, professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Disease Due to Bacteria, 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 2 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: status not confirmed, as of the sponsor's last update on 19 Nov 2019. 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 Abdulrahman mohamed salah, master (01061879577, Dr.arms7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral health status (time frame: 3 months). The study lists 3 primary outcomes in all. 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 19 Nov 2019.