Oral DiseaseNCT03679988
Prevalence of Oral Mucosal Alterations in Mucocutaneous Ocular Disorders
An observational study of Oral Disease and Muco-Cutaneo-Ocular Syndrome, run by Sherin Alaa Eldin Eisa Elsayed.
Trial summary
The patients will be selected from the pool of the Clinics (Rheumatology, Ophthalmology and Dermatology) of Faculty of Medicine and (Diagnostic center and Oral Medicine) of Faculty of Dentistry -Cairo University. For each eligible participant, a full history will be obtained followed by thorough clinical examination. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Disease, Muco-Cutaneo-Ocular Syndrome
- How many people
- 380 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Aug 2019
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: A convenience sample of adult patients diagnosed with mucocutanous oculer disorders attending to Clinics (Rheumatology, Ophthalmology and Dermatology) of Faculty of Medicine and (Diagnostic center and Oral Medicine) of Faculty of Dentistry -Cairo University will be enrolled in the study in a consecutive order.
Who may be able to join
- Adult patients diagnosed with one of the mucocutaneous disorder.
- Patient who will agree to participate in the study.
- Patients who will accept to sign the informed consent.
Who cannot join
- Patients not physically able to participate in survey or clinical oral examination.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence of Oral Mucosal Alterations in a Sample of Egyptian Patients With Mucocutaneous Ocular Disorders: A Hospital Based Cross Sectional Study
The patients will be selected from the pool of the Clinics (Rheumatology, Ophthalmology and Dermatology) of Faculty of Medicine and (Diagnostic center and Oral Medicine) of Faculty of Dentistry -Cairo University. For each eligible participant, a full history will be obtained followed by thorough clinical examination.
- Conditions
- Oral Disease, Muco-Cutaneo-Ocular Syndrome
- Keywords
- oral health status, oral findings, oral manifestations, patient with mucocutaneous ocular disorders, mucocutaneous ocular disorders
- Medical subject headings
- Mouth Diseases, Oral Manifestations
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying and recording oral mucosal alterations
clinical examination according to World Health Organization guidelines
Measured: 10 min
Secondary outcomes (1)
Identifying the oral health-related quality of life: OHIP-14
using Oral Health Impact Profile-14 (OHIP-14) Slade G. and Spencer A.: Development and evolution of the oral health impact profile.
Community Dent Health, 11 (1): 3-11, 1994 Response categories for the five-point scale are: "Very often", "Fairly often", "Occasionally", "Hardly ever" and "Never".
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study startOct 2018 (estimated)
- Primary completion30 May 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral DiseaseStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherin Alaa Eldin Eisa Elsayed
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Sherin Alaa Eldin Eisa Elsayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679988
- Sponsor's protocol ID
- MCO oral alterations
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 25 Sep 2018
- 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 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Oral Mucosal Alterations in a Sample of Egyptian Patients With Mucocutaneous Ocular Disorders: A Hospital Based Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03679988
- Acronym / sponsor ID
- MCO oral alterations
- Conditions
- Oral Disease, Muco-Cutaneo-Ocular Syndrome
- Keywords
- oral health status, oral findings, oral manifestations, patient with mucocutaneous ocular disorders, mucocutaneous ocular disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Sherin Alaa Eldin Eisa ElsayedUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Oct 2018 (estimated)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 21 Sep 2018 (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 patients will be selected from the pool of the Clinics (Rheumatology, Ophthalmology and Dermatology) of Faculty of Medicine and (Diagnostic center and Oral Medicine) of Faculty of Dentistry -Cairo University. For each eligible participant, a full history will be obtained followed by thorough clinical examination.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- A convenience sample of adult patients diagnosed with mucocutanous oculer disorders attending to Clinics (Rheumatology, Ophthalmology and Dermatology) of Faculty of Medicine and (Diagnostic center and Oral Medicine) of Faculty of Dentistry -Cairo University will be enrolled in the study in a consecutive order.
Key inclusion criteria (3 listed)
- Adult patients diagnosed with one of the mucocutaneous disorder.
- Patient who will agree to participate in the study.
- Patients who will accept to sign the informed consent.
Key exclusion criteria (1 listed)
- Patients not physically able to participate in survey or clinical oral examination.
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
Identifying and recording oral mucosal alterations
Time frame: 10 min
clinical examination according to World Health Organization guidelines
1 secondary outcome
Identifying the oral health-related quality of life: OHIP-14
Time frame: 10 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Disease and Muco-Cutaneo-Ocular Syndrome, run by Sherin Alaa Eldin Eisa Elsayed.
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 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 25 Sep 2018. 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 sherin alaa eldin eisa elsayed, BDS (+201000036620, dr.sherin.alaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying and recording oral mucosal alterations (time frame: 10 min). 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 25 Sep 2018.