| CTRI Number |
CTRI/2025/10/096452 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of tobacco habits and oral cancer- An epidemiological survey |
|
Scientific Title of Study
|
Prevalence of tobacco habits and oral potentially malignant lesions- An epidemiological survey |
| 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 Abhay Kolte |
| Designation |
Professor, Head and Dean |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur |
| Address |
Ranjeet Deshmukh Dental College and Research Centre Digdoh hills Hingna road Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Deshpande |
| Designation |
Assistant Professor |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur |
| Address |
Ranjeet Deshmukh Dental College and Research Centre Digdoh hills Hingna road Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9096093470 |
| Fax |
|
| Email |
docneha85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Deshpande |
| Designation |
Assistant Professor |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur |
| Address |
Ranjeet Deshmukh Dental College and Research Centre Digdoh hills Hingna road Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9096093470 |
| Fax |
|
| Email |
docneha85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College Research Centre Digdoh hills Hingna road Nagpur |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Abhay Kolte |
Saoner and Kalmeshwar |
Saoner 441107 Kalmeshwar 441501 Maharashtra
Nagpur
MAHARASHTRA |
9011071467
drabhaypkolte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
tobacco habits |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
NIL |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the prevalence of tobacco habits and pre cancerous lesions |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="150000"
Sample Size from India="150000"
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)
|
10/11/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 cancers is on a rise worldwide, especially in India. The study aims to asses the prevalence of tobacco consumption habits, its awareness and its potential to cause malignant lesions. A large population will be screened to assess the habits and its deleterious effect on health which in turn will provide beneficial to the society. |