Preliminary Registration Detail

Research Registry No : PLRID-00997_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 : 2020-12-02
 
Principle Investigator : Than Oo
 
Co-Investigators : Dr. Myint Shwe, Dr. Sann Win
 
Title of Research : Comparative study of serum C-reactive protein levels in patients with oral potentially malignant disorders and oral squamous cell carcinoma
 
Field of Research : Dentistry
 
Preliminary Research Design : Descriptive Study
 
Preliminary Research Type : Applied
 
Preliminary Justification : As the incidence and death rate due to cancer have shown a sharp acceleration since the last two decades, more intense efforts are required to fight against this life threating disease. If early detection and prompt treatment can be done, the incidence of death rates due to OSCC can be reduced considerably. Serum CRP can be used as a marker for inflammation and independent prognostic factor for the progression of many cancers. Therefore, the role of serum CRP level in histological grades of OSCC patients will be a key determinant in aggressive clinical behavior of the tumor and selection for favorable treatment in OSCC patient. Oral squamous cell carcinoma is a multistage disease that develops over a long period; it passes through stages of pre-malignancy. Even after the cessation of irritants such as tobacco chewing and smoking, the risk of malignant transformation of patients with OPMDs increases day by day due to complexity of disease processes including tumor and host’s response to inflammation. Detection and management of the disease at early pre-invasive stage offer the best prognosis. It has been reported that serum CRP levels in patients with OPMDs and OSCC can identify the aggressive behavior of OPMDs and OSCC and facilitate the clinical decision in further intervention and management. Therefore, this study aimed to determine and compare serum CRP levels in healthy controls, patients with OPMDs and OSCC. Serum CRP is a reliable, easily identifiable and less expensive biomarker. This study also purposed to confirm the role of serum CRP in the determination of aggressive clinical behavior and prognostic prediction of patients with OPMDs and OSCC. Serum CRP will be used as one of valuable markers for detection of malignant potential for OPMDs. Therefore, the present study will support an association between serum CRP and patients with OPMDs and OSCC with potential implications for future treatment progressions.
 
Preliminary Aim : To study serum C-reactive protein levels in patients with oral potentially malignant disorders and oral squamous cell carcinoma
 
Preliminary Objectives : (1) To describe clinical characteristics among study groups (2) To determine and compare mean serum C-reactive protein levels in healthy controls, patients with oral potentially malignant disorders and oral squamous cell carcinoma (3) To compare mean serum C-reactive protein levels in patients with oral leukoplakia, oral lichen planus and oral submucous fibrosis (4) To compare mean serum C-reactive protein levels in relation to histological staging of oral squamous cell carcinoma
 
Preliminary Sample Size : Minimum sample size of at least 17 patients in each group will be needed for the study
 
Preliminary Study Duration : One year
 
Preliminary Study Area : (1) Department of Oral Medicine, University of Dental Medicine, Mandalay (2) Department of Oral and Maxillofacial Surgery, University of Dental Medicine, Mandalay (3) Mandalay General Hospital
 
Preliminary Study Method : Consecutive sampling method
 
Preliminary Research Outcome : The levels of serum C-reactive protein are higher in patients with oral squamous cell carcinoma than patients with oral potentially malignant disorders and healthy controls
 
Preliminary Research Finding : Ongoing research
 
Preliminary Progress Report : Ongoing
 
Study Starting Date : 2020-10-01
IRB/PRC/ERC Approval Date : 2020-08-26
 
Placement of IRB/PRC/ERC : University of Dental Medicine, Mandalay
 
IRB/PRC/ERC Approval Letter/Document : 02122020133614128239186_664818187542088_8854740173899076424_n.pdf
 
Pre-existing Registration ID : -
 
Pre-existing Name of Organization : -
 
Pre-existing Name of Organization Website : -