- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03679988
Prevalence of Oral Mucosal Alterations in Mucocutaneous Ocular Disorders
September 22, 2018 updated by: Sherin Alaa Eldin Eisa Elsayed
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
380
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients not physically able to participate in survey or clinical oral examination.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identifying and recording oral mucosal alterations
Time Frame: 10 min
|
clinical examination according to World Health Organization guidelines
|
10 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identifying the oral health-related quality of life: OHIP-14
Time Frame: 10 min
|
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". |
10 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2018
Primary Completion (Anticipated)
May 30, 2019
Study Completion (Anticipated)
August 1, 2019
Study Registration Dates
First Submitted
September 19, 2018
First Submitted That Met QC Criteria
September 20, 2018
First Posted (Actual)
September 21, 2018
Study Record Updates
Last Update Posted (Actual)
September 25, 2018
Last Update Submitted That Met QC Criteria
September 22, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCO oral alterations
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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