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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  
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 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  
Status 
Not Applicable 
 
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.

 
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