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CTRI Number  CTRI/2025/05/087963 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 05/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Salivary biomarker Human Beta Defensins 2 and 3 levels in oral cancer patients 
Scientific Title of Study   A comparative analysis of Salivary human beta defensin 2 and 3 as a biomarker in diagnosis of Oral potentially malignant disorders and Oral cancer cases.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akanksha Tiwari 
Designation  Post Graduate Student  
Affiliation  Manipal College Of Dental Sciences  
Address  Department Of Oral Medicine and Radiology Manipal College Of Dental Sciences Manipal Madhav Nagar Eshwar Nagar Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  09811494122  
Fax    
Email  akanksha.tiwari1898@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yogesh Chhaparwal 
Designation  Professor and Head 
Affiliation  Manipal College Of Dental Sciences,Manipal  
Address  Department Of Oral Medicine and Radiology Manipal College Of Dental Sciences Manipal Madhav Nagar Eshwar Nagar Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9986454730  
Fax    
Email  yogesh.chhaparwal@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Akanksha Tiwari 
Designation  Post Graduate Student  
Affiliation  Manipal College Of Dental Sciences  
Address  Department Of Oral Medicine and Radiology Manipal College Of Dental Sciences Manipal Madhav Nagar Eshwar Nagar Karnataka 576104


KARNATAKA
576104
India 
Phone  09811494122  
Fax    
Email  akanksha.tiwari1898@gmail.com  
 
Source of Monetary or Material Support  
Department of Oral Medicine and Radiology Manipal College of Dental Sciences Manipal 
 
Primary Sponsor  
Name  Dr Akanksha Tiwari 
Address  Department of Oral Medicine and Radiology Manipal College of Dental Sciences Madhav Nagar Eshwar Nagar Manipal 
Type of Sponsor  Other [Primary Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijetha Shenoy Belle  Kasturba Medical College,Manipal  Department of Biochemistry
Udupi
KARNATAKA 
9844667820

vijetha.shenoy@manipal.edu 
Dr Akanksha Tiwari  Manipal College of Dental Sciences,Manipal   Department of Oral Medicine and Radiology, Room No.1
Udupi
KARNATAKA 
9811494122

akanksha.tiwari1898@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KasturbaMedicalCollegeandKasturbaHospitalInstitutionalEthicsCommittee2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Control without any oral cavity lesion infection ulcers inflammation  
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Group 1 Patients having habit of betel quid chewing with areca nut chewing, smoking and smokeless forms of tobacco consumption without any clinical evidence of lesion in oral cavity aged between 20 to 80 years.
Group 2 Patients with any inflammatory and infectious oral conditions like moderate to severe periodontitis, ulcers aged between 20 to 80 years.
Group 3 Inclusion criteria for Oral Potentially Malignant Disorders-
1 Clinically diagnosed cases of leukoplakia/non homogenous leukoplakia and or erythroplakia with histopathological diagnosis of hyper or para keratosis with or without dysplasia falling withing age group of 20-80 years
2 Clinically diagnosed cases of OSMF falling withing age group of 20-80 years.
3 Clinically and histo-pathologically proven cases of erosive variant of oral lichen planus of patients within age group 20-80 years.
Inclusion criteria for oral cancer group-
4 Histopathologically diagnosed cases of Oral squamous cell carcinoma, Invasive carcinoma and carcinoma insitu in patients aged between 20-80 years.
Inclusion criteria for control group-
Patients with no oral habits of tobacco consumption, patients in good systemic health, not taking any medication for systemic illnesses aged between 20-80 years.
Patients who demonstrate good oral hygiene and were free from any oral infection or inflammation like oral ulcers or inflamed gums aged between 20-80 years.
 
 
ExclusionCriteria 
Details  • Patients who do not give consent to participate in the study.
• Patients who have underlying systemic diseases, other malignancies apart from Oral squamous cell carcinoma.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The Up regulation and/or down regulation of these salivary defensin biomarkers may validate its efficacy as a useful early screening or diagnostic tool.  Outcomes will be assessed quarterly and Final Outcome will be assessed after 18 months  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Oral cancer ranks as the third most prevalent cancer among both sexes in the country is with high disease related mortality and morbidity. It is the most common cancer among men, accounting for 15.6% of all cases, and the fourth most common among women, making up 5% of all cancers.  The incidence of oral cancer is India is reported to be 1,413,316, with a 5-year prevalence of 3,258,518 case as per GLOBOCON 2022. The 5-year survival rate for early-stage oral cancer is around 90%, but it drops to 59%-60% for advanced stages. In metastatic cases, the survival rate is 52% for the lip and 20% for the floor of the mouth. These statistics highlight the importance of early detection and treatment to improve survival rates. Early detection of any cancer can result in: higher survival rates, less aggressive treatment with better treatment outcomes, cost-effectiveness. Early detection can reduce the overall cost of healthcare by avoiding more complex and costly treatments.

The identification of protein markers that can predict the risk of malignant transformation in pre malignant lesions/conditions is a crucial area of research in oncology. By detecting these markers early, healthcare providers can intervene sooner, potentially improving patient outcomes and reducing the morbidity of the disease. This approach could lead to more personalized treatment plans, better survival rates, and a decrease in the overall burden of cancer on patients and healthcare systems.

Human beta-defensin is group of cationic antimicrobial peptide of the innate immune system, typically found in the highly proliferative epithelial cells of the stratum basale in the oral mucosa. Oral epithelium expresses hBD-1, -2, -3. While hDB-3 specifically activates tumour-associated macrophages that promotes tumour development and progression and it has a crucial role in the tumorigenesis of primary Oral Squamous Cell Carcinoma, hBD-2 is known to be upregulated in cancers of oesophagus, cervix and skin and downregulated in colon and oral cancer.

 
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