| CTRI Number |
CTRI/2025/07/090532 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
observational diagnostic test evaluation |
| Study Design |
Other |
|
Public Title of Study
|
To identify oral potentially malignant disorders and oral cancer using photos in AI. |
|
Scientific Title of Study
|
Detection of oral potentially malignant disorders and oral cancer using AI assisted application based on photograph images |
| 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 Minha Gupta |
| Designation |
PG Student |
| Affiliation |
Government Dental College and Hospital, Jamnagar |
| Address |
Department no. 2, Ground floor, Oral Medicine and Radiology Department, Government Dental College and Hospital, Navagam, Pathikashram road, Jamnagar
Jamnagar GUJARAT 361008 India |
| Phone |
8920842813 |
| Fax |
|
| Email |
minhagupta@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Reeta Jha |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Dental College and Hospital, Jamnagar |
| Address |
Oral Medicine and Radiology Department, Government Dental College and Hospital, Navagam, Pathikashram road, Jamnagar
Jamnagar GUJARAT 361008 India |
| Phone |
9429272080 |
| Fax |
|
| Email |
reetajha01@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Minha Gupta |
| Designation |
PG Student |
| Affiliation |
Government Dental College and Hospital, Jamnagar |
| Address |
Department no. 2, Ground floor, Oral Medicine and Radiology Department, Government Dental College and Hospital, Navagam, Pathikashram road, Jamnagar
Jamnagar GUJARAT 361008 India |
| Phone |
8920842813 |
| Fax |
|
| Email |
minhagupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Jamnagar, Pathikashram Main Road, Navagam, Jamnagar, Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Dr. Minha Gupta |
| Address |
Department no. 2, Ground floor,Government Dental College and Hospital, Navagam, Pathikashram road, Jamnagar, Gujarat- 361008 |
| Type of Sponsor |
Other [Self] |
|
|
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 Minha Gupta |
Government Dental College and Hospital, Jamnagar |
Department no. 2, Ground floor, Government Dental College and Hospital, Navagam, Pathikashram road, Jamnagar Jamnagar GUJARAT |
8920842813
minhagupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, M.P. Shah Government Medical College and Guru Gobind Singh Hospital, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L948||Other specified localized connective tissue disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Leukoplakia |
White, non scrapable patch with crack mud appearance seen on oral mucosa in patients with leukoplakia |
| Comparator Agent |
Lichen planus |
White striae present on oral mucosa in patients with lichen planus |
| Comparator Agent |
Oral cancer |
Exophytic growth present on oral mucosa in patients with oral cancer |
| Comparator Agent |
Oral submucous fibrosis |
Blanching or marble mottled appearance of oral mucosa in patients with oral submucous fibrosis |
| Comparator Agent |
Tobacco pouch keratosis |
Wrinkled appearance with brownish color seen in oral vestibule in patients with tobacco pouch keratosis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Include images of patients with clinical diagnosis of oral potentially malignant disorders and oral cancer |
|
| ExclusionCriteria |
| Details |
Exclude image with poor quality, low clarity, blurred and distorted images. Exclude images without proper flash and poor lighting. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Detection of oral potentially malignant disorders and oral cancer using AI assisted application. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Detection of oral lesions and oral cancer |
18 months |
|
|
Target Sample Size
|
Total Sample Size="2000" Sample Size from India="2000"
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)
|
20/07/2025 |
| 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="1" 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 potentially malignant disorders
(OPMDs) are conditions that carry an increased risk of progressing into
malignant lesions, including oral cancer. These disorders can manifest in
various forms, such as white, red, or mixed red-white lesions, appearing as
verrucous, papillary, or ulcerated. Many oral cancers, particularly those
linked to habits, often develop from pre-existing OPMDs. Studies indicate that
between 0.1% and 40% of leukoplakia cases may progress to oral cancer.
Diagnosing OPMDs can be challenging as conditions like frictional keratosis,
leukoedema, and candidiasis share similar clinical features. Early
identification is crucial to preventing malignant transformation and improving
treatment outcomes. Oral cancers share common risk factors and genetic changes
with OPMDs, but while the oral cavity is accessible for visual inspection,
diagnosis remains subjective and often requires biopsy for confirmation.
Technological advances like chemifluorescence, liquid biopsy, and Velscope have
improved cancer detection but remain costly and not widely available.
Artificial intelligence (AI) has the potential to assist in identifying these
lesions through low-cost, non-invasive methods. Studies have applied AI to
detect various oral diseases, with promising results, yet practical
applications for detecting oral cancer remain scarce. This study aims to
develop AI-assisted application to detect OPMDs and oral cancer using
photographs. The AI models, including convolutional neural networks (CNNs), aim
to identify suspicious lesions. By using AI, the study aims to improve early
detection, making screening more efficient, especially for high-risk
individuals in areas with limited access to specialized care. |