Oral Mucosal Lesions Among Smokers in an Egyptian Population Study.

October 18, 2017 updated by: Amira Mohamed Abdel-aziz, Cairo University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

840

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

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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.

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
oral mucosal lesions
Time Frame: one year
Identifying and recording oral mucosal lesions
one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

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)

November 1, 2017

Primary Completion (Anticipated)

November 30, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 28, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (Actual)

October 3, 2017

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 18, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • CEBC-CU-2017-08-05

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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