Prevalence of Oral Mucosal Alterations in Mucocutaneous O... | NCT03679988

Studies
Prevalence of Oral Mucosal Alterations in Mucocutaneous Ocular Disorders

NCT03679988

Sponsor

Sherin Alaa Eldin Eisa Elsayed

Status

Unknown status

Last Update Posted

Sep 25, 2018Actual

Enrollment

380Estimated

Phase

Not provided

Conditions

Oral Disease
Muco-Cutaneo-Ocular Syndrome

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2018Estimated

Primary Completion Date

May 30, 2019Estimated

Completion Date

Aug 2019Estimated

First Submitted Date

Sep 19, 2018

First Submission Date that Met QC Criteria

Sep 20, 2018

First Posted Date

Sep 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2018

Last Update Posted Date

Sep 25, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sherin Alaa Eldin Eisa Elsayed, principle investigator , oral medicine department, Cairo UniversitySponsor-Investigator

Lead Sponsor

Sherin Alaa Eldin Eisa ElsayedOTHER

Collaborators

Name	Class
Cairo University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

380Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identifying and recording oral mucosal alterations	clinical examination according to World Health Organization guidelines	10 min

Secondary Outcomes

Measure	Description	Time Frame
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".	10 min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
sherin alaa eldin eisa elsayed, BDS	Contact	+201000036620		dr.sherin.alaa@gmail.com
wessam abd el moneim	Contact	+201207033303		wesammhs@yahoo.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009059	Mouth Diseases
D009912	Oral Manifestations

Ancestor Terms

ID	Term
D009057	Stomatognathic Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided