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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03299595
Other study ID # CEBC-CU-2017-08-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date June 30, 2019

Study information

Verified date January 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 824
Est. completion date June 30, 2019
Est. primary completion date March 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
printed questionnaire
For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.

Locations

Country Name City State
Egypt Faculty of Dentistry Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary oral mucosal lesions Identifying and recording oral mucosal lesions one year
Secondary Oral health-related quality of life (OH-QoL) evaluation using Oral Health Impact Profile (OHIP) one year
Secondary histopathological evaluation light microscope one year
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