NCT03299634

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
840

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
29 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

September 28, 2017

Last Update Submit

October 18, 2017

Conditions

Smokers

Outcome Measures

Primary Outcomes (1)

  • oral mucosal lesions

    Identifying and recording oral mucosal lesions

    one year

Secondary Outcomes (2)

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

    one year

  • dysplasia

    one year

Interventions

printed questionnaireOTHER

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Histopathological evaluation of clinically suspicious oral lesions to detect dysplasia (Warnakulasuriy et al., 2007 and Rastogi et al., 2013).

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

September 28, 2017

First Posted

October 3, 2017

Study Start

November 1, 2017

Primary Completion

November 30, 2018

Study Completion

December 1, 2018

Last Updated

October 20, 2017

Record last verified: 2017-10