Preliminary Registration Detail

Research Registry No : PLRID-00986_V1
 
Postgraduate Research : local
 
Name of University : University Of Dental Medicine, Mandalay
 
Degree : B.D.S
 
University Departmental Research : Yes
 
Name of University : University of Dental Medicine, Mandalay
 
Department : Department of Oral Medicine
 
Registration Date : 2020-12-04
 
Principle Investigator : Niang Hau Cing
 
Co-Investigators : Prof. Dr Myint Shwe, Dr. Khin Soe
 
Title of Research : Detection of apoptotic cells in oral leukoplakia and oral squamous cell carcinoma
 
Field of Research : Dentistry
 
Preliminary Research Design : Descriptive Study
 
Preliminary Research Type : Applied
 
Preliminary Justification : Apoptosis is a vital cellular process, which is necessary for proper maintenance of the healthy organisms and adaptation to environmental changes. In normal healthy tissue, it occurs mostly in the suprabasal layers of oral epithelium but becomes generalized in advanced dysplasia. Imbalanced condition between the process of apoptosis and cell proliferation represents a major causative factor in the development and progression of cancer. Over the years, several methods have been developed to detect apoptosis. Among them, assessment of apoptotic cells and apoptotic bodies in normal oral tissues, OPMDs and OSCC can be done on hematoxylin and eosin (H and E) stained sections using ordinary light microscope. H and E staining is routinely used and is still popular with its simple procedure, good contrast and long-lasting staining. In addition, greater number of apoptotic cells had been associated with different grades of dysplasia in oral leukoplakia and degree of cell differentiation in OSCC. This inspires to search the related factors for malignant transformation and tumor aggressiveness. Therefore, it is possible that detection of apoptotic cells and apoptotic bodies could serve as a biomarker not only to identify the individuals who are at a greater risk of developing carcinomas, but also carry a significant prognostic value and represent a good model of tumor development. Taken together from this study, it could be beneficial for early detection of malignant transformation from premalignant lesions, timely surgical intervention, less deformity rate and significant reduction of mortality and morbidity rate in the oral cancer patient.
 
Preliminary Aim : To detect apoptotic cells in oral leukoplakia and oral squamous cell carcinoma
 
Preliminary Objectives : 1. To describe age, gender and location among study groups 2. To determine mean apoptotic cell count among normal oral mucosa, oral leukoplakia and OSCC 3. To compare mean apoptotic index in relation to grades of epithelial dysplasia in oral leukoplakia 4. To compare mean apoptotic index in relation to histological grading of OSCC 5. To compare mean apoptotic index among normal mucosa, oral leukoplakia and OSCC
 
Preliminary Sample Size : Patients in each group with normal oral tissue, histologically confirmed oral leukoplakia and oral squamous cell carcinoma who comes to UDMM / Minimum sample size of at least 21 patients in each group will be needed for the study. Therefore, total sample size will be 63.
 
Preliminary Study Duration : From September 2020 to August 2021
 
Preliminary Study Area : • Department of Oral Medicine, University of Dental Medicine, Mandalay • Department of Oral and Maxillofacial surgery, University of Dental Medicine, Mandalay
 
Preliminary Study Method : Consecutive sampling procedure will be used
 
Preliminary Research Outcome : Apoptotic index is directly proportional to increasing grades of dysplasia in oral leukoplakia and oral squamous cell carcinoma
 
Preliminary Research Finding : Ongoing
 
Preliminary Progress Report : Ongoing
 
Study Starting Date : 2020-09-01
IRB/PRC/ERC Approval Date : 2020-08-26
 
Placement of IRB/PRC/ERC : University of Dental Medicine, Mandalay
 
IRB/PRC/ERC Approval Letter/Document : 04122020030319Erc.pdf
 
Pre-existing Registration ID : ongoing
 
Pre-existing Name of Organization : ongoing
 
Pre-existing Name of Organization Website : ongoing