| 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
|
|
|
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
|
|
|
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
|
|
|
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 SurÂvey 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.
|