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Effect of Cannabis and Cigarette Smoking on Oral Mucosa

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ClinicalTrials.gov Identifier: NCT03334279
Recruitment Status : Not yet recruiting
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Ali Abdelwahed Kotb, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment
Field Cancerization for Cannabis Smokers Other: Cigarette smokers Other: Simultaneous cigarette and cannabis smokers

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.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Detection of Field Cancerization in the Clinically Normal Oral Mucosa of Cannabis and Cigarette Smokers (Ex-vivo Study)
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
routine patients already coming for simultaneous dental or surgical procedures..
Criteria

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

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Responsible Party: Ali Abdelwahed Kotb, assistant lecturer, oral and maxillofacial pathology- cairo university, Cairo University
ClinicalTrials.gov Identifier: NCT03334279     History of Changes
Other Study ID Numbers: CEBD-CU_2017-10-27
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders