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CTRI Number  CTRI/2020/02/023507 [Registered on: 21/02/2020] Trial Registered Prospectively
Last Modified On: 20/02/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Outcome of Tobacco related habits and occurrence of Oral Precancerous Condition 
Scientific Title of Study   Prevalence of Oral submucous fibrosis in and around population of Vadodara and its relation to type , duration and frequency of habit: A Hospital based observational study. 
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 Manjiri Joshi 
Designation  Professor and Head 
Affiliation  MPDental College 
Address  Department of Oral Medicine and Radiology Manubhai Patel Dental College and Hospital
Department of Oral Medicine and Radiology Manubhai Patel Dental College and Hospital
Vadodara
GUJARAT
390011
India 
Phone  08460584727  
Fax    
Email  maitri.joshi2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjiri Joshi 
Designation  Professor and Head 
Affiliation  MPDental college 
Address  Department of Oral Medicine and Radiology Manubhai Patel Dental College and Hospital
Department of Oral Medicine and Radiology Manubhai Patel Dental College and Hospital
Vadodara
GUJARAT
390011
India 
Phone  08460584727  
Fax    
Email  maitri.joshi2@gmail.com  
 
Details of Contact Person
Public Query
 
Name  dr manjiri joshi 
Designation  Professor and Head 
Affiliation  MPDental College 
Address  Department of Oral Medicine and Radiology Manubhai Patel Dental College and Hospital
Department of Oral Medicine and Radiology Manubhai Patel Dental College and Hospital
Vadodara
GUJARAT
390011
India 
Phone  08460584727  
Fax    
Email  maitri.joshi2@gmail.com  
 
Source of Monetary or Material Support  
Manubhai Patel Dental College  
 
Primary Sponsor  
Name  MP Dental College 
Address  Munjmahuda 
Type of Sponsor  Research institution and hospital 
 
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 Manjiri Joshi  Manubhai Patel Dental college  Department of Oral Medicine and Radiology, Manubhai Patel Dental College and Hospital, Munjmahuda, near Vishwajyoti Aaram,vadodara
Vadodara
GUJARAT 
84600584727

maitri.joshi2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC MP Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D103||Benign neoplasm of other and unspecified parts of mouth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All Patients diagnosed with different grades of oral submucous fibrosis Clinically and having habit of chewing different forms of areca nut would be included 
 
ExclusionCriteria 
Details  Patients with no areca nut related habits and without evidence of OSMF would be excluded from study.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Very few prevalence studies for Oral submucous fibrosis are carried out in Gujarat population. Also its relation to various types of habit and their actual frequency and duration is not established.
This study would be amongst one of the epidemiological studies with large data over the period of 5 years.
 
5years
 
 
Secondary Outcome  
Outcome  TimePoints 
Relationship between dose of Tobacco related habits consumped and its relation towards occurence of lesions can be evaluated  5 Years 
 
Target Sample Size   Total Sample Size="4000"
Sample Size from India="4000" 
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)   22/02/2020 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not published yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Oral submucous fibrosis (OSF) is now accepted globally as an Indian disease, having highest malignant potential than any other oral premalignant lesions. Epidemiological evidence strongly indicate the association of the betel quid (BQ) habit and OSF. Other etiological factors suggested are chillies, lime, tobacco, nutritional deficiencies such as iron and zinc, immunological disorders, and collagen disorders. The male-to-female ratio of OSMF varies by region. Recent data suggests that prevalence of OSMF in India has increased from 0.03% to 6.42%.

The hallmark of the disease is submucosal fibrosis that affects most parts of the oral cavity, pharynx and upper third of the esophagus leading to dysphagia and progressive trismus due to rigid lips and cheeks.

Epidemiological survey conducted in Bhavnagar district, Gujarat state diagnosed as suffering from OSMF with a prevalence of 3.2%.

According to the National Report of Global Adult Tobacco Sur­vey conducted in India , the current prevalence of smokeless tobacco use is 25.9 %. There are 30 different types of smokeless products available in India  including zarda, which contains dried and boiled tobacco leaves, limes, areca nut, additives, spices, and tannins.

The hallmark of the disease is submucosal fibrosis that affects most of the parts of oral cavity, pharynx and upper third of the esophagus.

Very few prevalence studies for Oral submucous fibrosis are carried out in Gujarat population. Also its relation to various types of habit and their actual frequency and duration is not established.

This study would be amongst one of the epidemiological studies with large data over the period of 5 years
 
 
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