Effect of Cannabis and Cigarette Smoking on Oral Mucosa

November 2, 2017 updated by: Ali Abdelwahed Kotb, Cairo University

Detection of Field Cancerization in the Clinically Normal Oral Mucosa of Cannabis and Cigarette Smokers (Ex-vivo Study)

The aim of this study is to detect P53 expression in clinically normal oral mucosa of cigarette smokers, simultaneous cigarette and cannabis smokers and non-smokers as a surrogate marker for field cancerization.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Roles and Responsibilities:

  1. Ali Abd El Wahed Abd El Fatah Kotb (A.K.) operator, data enterer, Assistant lecturer, Oral and Maxillofacial Pathology, Faculty of Oral and Dental Medicine, Cairo university, Egypt.
  2. Professor Dr. Heba Dahmoush (H.D.) main supervisor, data monitoring,auditing professor, Oral and Maxillofacial Pathology, Faculty of Oral and Dental Medicine, Cairo university, Egypt.
  3. Eman Desoky (E.D.) sample size calculation, statistician,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  4. Evidence Based Dentistry Committee (CEBD)help in reporting study protocol following SPIRIT guidelines,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  5. Research Ethics Comittee (CREC)protocol reviewer in order to protect the right, safety, dignity and well-being of the participants, Faculty of Oral and Dental Medicine, Cairo University, Egypt.

1- Intervention: A.K. will collect specimens from cigarette smokers and simultaneous cigarette and cannabis smokers. then the expression of p53 as a marker for field cancerization will be investigated in formaline fixed paraffine embedded specimens of mucosal biopsies obtained from the oral mucosa of both groups.

2-comparator: mucosal biopsies from non smokers will be investigated as a copmaratitive to smokers group.

Study Type

Observational

Enrollment (Anticipated)

20

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

routine patients already coming for simultaneous dental or surgical procedures..

Description

Inclusion Criteria:

  • frequent smokers (at least 10 cigarettes a day) for a period not less than 5 years.
  • Simultaneous smokers to be included in the study must be frequent cigarette smokers (at least 10 cigarettes a day) for a period not less than 5 years plus frequent cannabis smoker (at least 3 times per week) for a period not less than 5 years.

Exclusion Criteria:

  • Exposure to other carcinogens.
  • un-clear smoking history.
  • medically compromised patients

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

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
non smokers
cigarette smokers
Cigarette smokers to be included in the study must be frequent smokers (at least 10 cigarettes a day) for a period not less than 5 years.
Other: Cigarette smokers
frequent cigarette smoking for not less than 5 years
simultaneous cigarette and cannabis smokers
frequent cigarette smokers (at least 10 cigarettes a day) and frequent cannabis smoker (at least 3 times/week) for not less than 5 years.
Other: Simultaneous cigarette and cannabis smokers
frequent cigarette and cannabis smoking for not less than 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
P53 expression as a surrogate marker for field cancerization
Time Frame: not less than 5 years
The areas containing the most uniformly stained tissues will be chosen for evaluation in area-area/area-percent measurments
not less than 5 years

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)

January 1, 2018

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

October 21, 2017

First Submitted That Met QC Criteria

November 2, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU_2017-10-27

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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