| CTRI Number |
CTRI/2025/05/086454 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
AI for early detection of oral cancer using 1000 radiographs |
|
Scientific Title of Study
|
Artificial intelligence for detection of oral potentially malignant and malignant conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bodapati Bharathi |
| Designation |
Undergraduate student |
| Affiliation |
Sibar institute of dental sciences |
| Address |
room no : 1 , oral medicine and radiology department
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9985489649 |
| Fax |
|
| Email |
bodapatibharathi107@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrYalamanchili samata |
| Designation |
HOD And professor of oral medicine and radiology department |
| Affiliation |
Sibar institute of dental sciences |
| Address |
room no 1 ,oral medicine and radiology department
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9391307194 |
| Fax |
|
| Email |
drsamathaoralmed@sids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Bodapati Bharathi |
| Designation |
Undergraduate student |
| Affiliation |
Sibar institute of dental sciences |
| Address |
room no 1 , oral medicine and radiology department
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9985489649 |
| Fax |
|
| Email |
bodapatibharathi107@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian council of medical research |
|
|
Primary Sponsor
|
| Name |
Indian council of medical research |
| Address |
v.Ramalingaswami Bhawan,ansari nagar,New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Bodapati bharathi |
Sibar institute of dental sciences |
no-1 oral medicine and radiology department,sibar institute of dental sciences
Guntur
ANDHRA PRADESH |
9985489649
bodapatibharathi107@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutiona ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
subjects with oral potentially malignant and malignant conditions |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy of AI -assisted oral cancer detection compared to traditional methods |
as it is a cross sectional study no specific points |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Impact of AI-assisted oral cancer screening on patient anxiety & compliance with follow -up appointments |
as it is a cross sectional study there are no time points |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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="3"
Months="0"
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
|
The study aims to develop an AI- based computer vision algorithm to detect potentially malignant and malignant disorders of the oral cavity.
The study will use 1000 anonymized clinical photographs of potentially malignant and malignant lesions obtained from dental archives. These images will be annotated by oral medicine specialists and used to train a Convolutional Neural Network (CNN) algorithm.
The performance of the AI model will be evaluated using sensitivity, precision and F1 scores on a validation dataset.
The study suggests that this AI network could improve the accuracy of detecting oral conditions and serve as the an adjuvant for dentists and an early indicator for patients to take necessary action
|