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CTRI Number  CTRI/2017/11/010515 [Registered on: 15/11/2017] Trial Registered Retrospectively
Last Modified On: 24/06/2015
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to assess the burden of ill effects of tobacco abuse and oral precancer in rural areas of Sangli district 
Scientific Title of Study   “Clinical and epidemiologic study of potentially malignant lesions and conditions of oral cavity in rural areas of Sangli district” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mrs Priya S Joshi 
Designation  Professor And Head 
Affiliation  Vasantdada Patil Dental College And Hospital, Sangli 
Address  b-3, Avani Apartment, Datta Nagar, 80 Feet road, Vishrambag, Sangli, Maharashtra, India

Sangli
MAHARASHTRA
416415
India 
Phone  9890712016  
Fax  0233-2364404  
Email  sangeetakov@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mrs Priya S Joshi 
Designation  Professor And Head 
Affiliation  Vasantdada Patil Dental College And Hospital, Sangli 
Address  b-3, Avani Apartment, Datta Nagar, 80 Feet road, Vishrambag, Sangli, Maharashtra, India

Sangli
MAHARASHTRA
416415
India 
Phone  9890712016  
Fax  0233-2364404  
Email  sangeetakov@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Mrs Priya S Joshi 
Designation  Professor And Head 
Affiliation  Vasantdada Patil Dental College And Hospital, Sangli 
Address  b-3, Avani Apartment, Datta Nagar, 80 Feet road, Vishrambag, Sangli, Maharashtra, India

Sangli
MAHARASHTRA
416415
India 
Phone  9890712016  
Fax  0233-2364404  
Email  sangeetakov@yahoo.co.in  
 
Source of Monetary or Material Support  
Maharashtra University of Health Sciences, Dindori Road, Mhasrul, Nashik, Maharashtra, India, pin 422004 
 
Primary Sponsor  
Name  Maharashtra University Of Health Sciences 
Address  MUHS, Nashik, Vani- Dindori road, Mhasrul, Nashik Maharashtra, India,  
Type of Sponsor  Other [ Maharashtra University of Health Sciences, Nashik ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mrs Priya S Joshi  Dept. of Oral Pathology and Microbiology , Vasantdada Patil Dental Ciollege And Hospital, Sangli  Taluka-Kavalapur, district- Miraj Pin-416306
Sangli
MAHARASHTRA 		 9890712016

sangeetakov@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  To survey approximately total 2500 or more patients with habit of tobacco chewing in any form in five rural areas and note the icidence and prevalence of oral premalignant conditions and lesions 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1) Subjects with habit of chewing tobacco or areca nut, smoking tobacco, or alcohol consumption or any other habit
2) having signs of Oral premalignant lesions and conditions like leukoplakia, erythroplakia, oral submucus fibrosis and lichen planus  
 
ExclusionCriteria 
Details  Patients with white or red lesions other than oral premalignant lesions and conditions
Patients with oral cancer
Subjects not willing to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence and prevalence of oral precancer lesions and conditions  Period of 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
epidemiological study of oral precancer in western maharashtra  2 years 
 
Target Sample Size   Total Sample Size="2500"
Sample Size from India="2500" 
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   Phase 1 
Date of First Enrollment (India)   26/01/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  26/01/2015 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Oral cancer has become a global health problem and its increasing incidence and mortality rates are particularly relavant in certain parts of India. 
Worldwide, oral cancer has one of the lowest survival rates that remain unalterd despite recent therapeutic advances. Early detection is widely recognized as the corner stone to reduce diagnostic delay and thus to improve survival. In many instances a significant proportion of oral squamous cell carcinomas developed from premalignant lesions and conditions such as leukoplakia, submucous fibrosis and lichen planus. 
Identification of this oral premalignant lesions is very important in order to prevent malignant transformation and its related morbodity and mortality. The demographic details, sites and type of lesions, habits and its frequency of consumption, duration and type of habits including smoking and non smoking form, mixed habits and alcohol consumption can be studied in this respect and these hold much promice in creating awareness about association of these habits with oral precancer and cancer. Western Maharashtra is one of the important hub for tobacco manufacturing and studies have reported increased incidence of oral cancer in association with tobacco usage. Not many epidemiological studies have been conducted regarding oral precancer and hence our project aims to study the same in the rural areas of Sangli district and to creat awareness amongst the population about the deleterious effects of consumption of tobacco, areca nut and alcohol.
This cross sectional study will be carried out  in the rural areas of Sangli district. Informed written consent will be obtained prior to beginning of the study. Demographic details, socioeconomic status, information related to consumption of tobacco, areca nut and alcohol or other habits will be recorded. Oral examination of all the patients will be conducted day light with help of the diagnostic instruments. Patient awareness education will be given regarding the habits and its deleterious effects. All records entered will be cross- checked for correctness. The entire data obtained will be entered in MS Excel and analyzed in statistical package for social sciences (SPSS)


 
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