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Effect of Cannabis and Cigarette Smoking on Oral Mucosa

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03334279
Enrollment
20
Registered
2017-11-07
Start date
2018-01-31
Completion date
2020-03-31
Last updated
2017-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Field Cancerization for Cannabis Smokers

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.

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.

Interventions

OTHERCigarette smokers

frequent cigarette smoking for not less than 5 years

OTHERSimultaneous cigarette and cannabis smokers

frequent cigarette and cannabis smoking for not less than 5 years

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
P53 expression as a surrogate marker for field cancerizationnot less than 5 yearsThe areas containing the most uniformly stained tissues will be chosen for evaluation in area-area/area-percent measurments

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026