Effect of Cannabis and Cigarette Smoking on Oral Mucosa
NCT ID: NCT03334279
Last Updated: 2017-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
20 participants
OBSERVATIONAL
2018-01-31
2020-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
non smokers
No interventions assigned to this group
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.
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.
Simultaneous cigarette and cannabis smokers
frequent cigarette and cannabis smoking for not less than 5 years
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cigarette smokers
frequent cigarette smoking for not less than 5 years
Simultaneous cigarette and cannabis smokers
frequent cigarette and cannabis smoking for not less than 5 years
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* un-clear smoking history.
* medically compromised patients
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ali Abdelwahed Kotb
assistant lecturer, oral and maxillofacial pathology- cairo university
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CEBD-CU_2017-10-27
Identifier Type: -
Identifier Source: org_study_id