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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03334279
Study type Observational
Source Cairo University
Contact
Status Not yet recruiting
Phase N/A
Start date January 2018
Completion date March 2020