Oral Mucosal Lesions Among Smokers in an Egyptian Population.

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03299595

Collaborator

(none)

824

Enrollment

Location

19.9

Actual Duration (Months)

41.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Smokers	Other: printed questionnaire

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.

Study Design

Study Type:

Observational

Actual Enrollment :

824 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Prevalence of Oral Mucosal Lesions Among Smokers in an Egyptian Cohort: A Hospital-based Cross-Sectional Study (II)

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Mar 30, 2019

Actual Study Completion Date :

Jun 30, 2019

Outcome Measures

Primary Outcome Measures

oral mucosal lesions [one year]
Identifying and recording oral mucosal lesions

Secondary Outcome Measures

Oral health-related quality of life (OH-QoL) evaluation [one year]
using Oral Health Impact Profile (OHIP)
histopathological evaluation [one year]
light microscope

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry	Cairo		Egypt	11728

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alaa Shousha, resident, Cairo University

ClinicalTrials.gov Identifier:

NCT03299595

Other Study ID Numbers:

CEBC-CU-2017-08-01

First Posted:

Oct 3, 2017

Last Update Posted:

Jan 8, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 8, 2021