Oral Mucosal Lesions Among Smokers in an Egyptian Populat... | NCT03299634

Studies
Oral Mucosal Lesions Among Smokers in an Egyptian Population Study.

NCT03299634

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Oct 20, 2017Actual

Enrollment

840Estimated

Phase

Not provided

Conditions

Smokers

Interventions

printed questionnaire

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

Oct 2017

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

Nov 1, 2017Estimated

Primary Completion Date

Nov 30, 2018Estimated

Completion Date

Dec 1, 2018Estimated

First Submitted Date

Sep 28, 2017

First Submission Date that Met QC Criteria

Oct 2, 2017

First Posted Date

Oct 3, 2017Actual

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

Oct 18, 2017

Last Update Posted Date

Oct 20, 2017Actual

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

This cross-sectional study will assess the prevalence of oral changes among smokers in an Egyptian cohort (patients attending to the hospital of Faculty of Dentistry - Cairo University), aiming that this study can serve as a baseline for future studies with the goal of finding ways to improve oral health and increase awareness of the hazards of smoking in Egypt

Detailed Description

The participants will be selected from the pool of the Clinics of Oral Medicine, Periodontology and Diagnosis Department and the Diagnostic center, Faculty of Dentistry - Cairo University. For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.

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

Retention

Enrollment

840Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
printed questionnaire	Other	For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
oral mucosal lesions	Identifying and recording oral mucosal lesions	one year

Secondary Outcomes

Measure	Description	Time Frame
Oral health-related quality of life (OH-QoL) evaluation	using Oral Health Impact Profile (OHIP)	one year
dysplasia	Histopathological evaluation of clinically suspicious oral lesions to detect dysplasia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gender: males and females.
Age: all age groups.
Smokers.
Individuals who agreed to sign the informed consent.

Exclusion Criteria:

Individuals suffering from any systemic disease.
Individuals on medications.
Non-Egyptians.

Accepts Healthy Volunteers

Yes

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

Sampling Method

Probability Sample