Effect of Cannabis and Cigarette Smoking on Oral Mucosa

Cairo University (CU)

Status: Unknown

Conditions: Field Cancerization for Cannabis Smokers

Treatments: Other: Simultaneous cigarette and cannabis smokers; Other: Cigarette smokers

Study type: Observational

Funder types: Other

Identifiers

NCT03334279

CEBD-CU_2017-10-27

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 3 patient groups

non smokers

cigarette smokers

Description:

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.

Treatment:

Other: Cigarette smokers

simultaneous cigarette and cannabis smokers

Description:

frequent cigarette smokers (at least 10 cigarettes a day) and frequent cannabis smoker (at least 3 times/week) for not less than 5 years.

Treatment:

Other: Simultaneous cigarette and cannabis smokers