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
|Condition or disease||Intervention/treatment|
|Field Cancerization for Cannabis Smokers||Other: Cigarette smokers Other: Simultaneous cigarette and cannabis smokers|
Roles and Responsibilities:
- 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.
- 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.
- Eman Desoky (E.D.) sample size calculation, statistician,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Evidence Based Dentistry Committee (CEBD)help in reporting study protocol following SPIRIT guidelines,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- 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|
|Estimated Enrollment :||20 participants|
|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|
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
- 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