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CompletedNCT03299595Updated Jan 8, 2021

Oral Mucosal Lesions Among Smokers in an Egyptian Population.

An observational study in Smokers, sponsored by Cairo University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2021-01-08.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
824
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Smokers
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Individuals suffering from any systemic disease.
  • Individuals on medications.
  • Non-Egyptians.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
824 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Interventions

  • Otherprinted questionnaire

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

05

What researchers measure

Primary outcomes

  1. oral mucosal lesions

    Identifying and recording oral mucosal lesions

    Time frame: one year

Secondary outcomes

  1. Oral health-related quality of life (OH-QoL) evaluation

    using Oral Health Impact Profile (OHIP)

    Time frame: one year

  2. histopathological evaluation

    light microscope

    Time frame: one year

06

Study locations

1 site
  • Faculty of Dentistry
    Cairo, 11728, Egypt
07

Registry details

Key details

Study ID
NCT03299595
Lead sponsor
Cairo University
Responsible party
Alaa Shousha (resident, Cairo University) — Principal investigator
First posted
Oct 3, 2017
Start date
Nov 1, 2017
Primary completion
Mar 30, 2019
Completion
Jun 30, 2019
Last update
Jan 8, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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