FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/11/097083 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 06/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Diagnostic accuracy 
Study Design  Other 
Public Title of Study   A mobile app for health workers to help detect oral cancer and conditions that look like oral cancer. 
Scientific Title of Study   A model for early identification of potentially malignant and malignant lesions using a mobile based application by community health workers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shubhra Chandan Saha 
Designation  Post Graduate Trainee 
Affiliation  Institute Of Dental Sciences 
Address  Department Of Public Health Dentistry, Institute Of Dental Sciences, Siksha O Anusandhan Deemed to be University, Bhubaneshwar

Khordha
ORISSA
751003
India 
Phone  06002048169  
Fax    
Email  drshubhracsaha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dharmshree Satyarup 
Designation  Professor 
Affiliation  Institute Of Dental Sciences 
Address  Department Of Public Health Dentistry, Institute Of Dental Sciences, Siksha O Anusandhan Deemed to be University, Bhubaneshwar

Khordha
ORISSA
751003
India 
Phone  06002048169  
Fax    
Email  dharmashrees@soa.ac.in  
 
Details of Contact Person
Public Query
 
Name  Shubhra Chandan Saha 
Designation  Post Graduate Trainee 
Affiliation  Institute Of Dental Sciences 
Address  Department Of Public Health Dentistry, Institute Of Dental Sciences, Siksha O Anusandhan Deemed to be University, Bhubaneshwar

Khordha
ORISSA
751003
India 
Phone  06002048169  
Fax    
Email  drshubhracsaha@gmail.com  
 
Source of Monetary or Material Support  
Institute Of Dental Sciences, Siksha O Anusandhan Deemed to be University , Bhubaneswar , Odisha , India , Pin 751003 
 
Primary Sponsor  
Name  Institute Of Dental Sciences 
Address  Department Of Public Health Dentistry, Institute Of Dental Sciences, SUM Hospital, Bhubaneshwar, odisha ,India, pin 751003 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Shubhra Chandan Saha  Department Of Public Health Dentistry, Institute Of Dental Sciences, SUM Hospital, Bhubaneshwar 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shubhra Chandan Saha  Institute of Dental Scinces  Department Of Public Health Dentistry, Room no. 9, Institute of Dental Scinces, Siksha O Anusandhan UDeemed to be university, khordha,Bhubaneshwar
Khordha
ORISSA 
06002048169

drshubhracsaha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC- INSTITUTE OF DENTAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  any one of 15 years or above consenting for the study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mobile Based Application   The mobile application-based questionnaire (using modified Fagestrom Questionnaire) will be administered by the CHW using an App developed for android and iOS mobile phones which will categorise the individual based on severity of tobacco consumption. Those categorised as high risk will be indicated for a clinical picture to be captured by the CHW with autofocus and auto-flash mode using the mobile phone camera, of buccal and labial mucosa, palate, dorsal and ventral surface of tongue. The clinical pictures which are deemed as suspicious (red/white patch or ulcers) by an oral health expert, will be notified through the app to the health care worker as in need of TB staining.  
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All participants aged more than 15 years residing in the selected villages regardless of habit history will be invited to participate from their homes 
 
ExclusionCriteria 
Details  Those not consenting to be a part of the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
effectiveness of a mobile-based application operated by Community Health Workers (CHWs) for early detection of Oral Pre-Malignant Lesions (OPMLs) and Malignant Lesions (MLs) among tobacco users.
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Sensitivity & Specificity  8 months 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/12/2025 
Date of Study Completion (India) 25/04/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

TITLE: A Model for Early Identification of Potentially Malignant and Malignant Lesions Using a Mobile-Based Application by Community Health Workers.

Intro: Oral cancer rates in South Asia, particularly in India, are among the highest globally, with India alone bearing 7.8 percent of the worldwide cancer burden. Nearly half of oral cancer cases are detected in advanced stages due to limited healthcare access and patient neglect, leading to high mortality rates. Early detection is essential, as over 80 percent of cases develop from precancerous lesions, which are detectable with proper screening. mHealth and teledentistry offer promising solutions, utilizing mobile technology for remote diagnosis and specialist support. These digital health innovations enable Community Health Workers  to conduct cost-effective screenings, breaking down geographical and financial barriers. The  app is designed to empower CHWs in identifying, assessing, and referring oral lesions, addressing India’s low dentist-to-population ratio. Beyond detection, the app facilitates data collection for predictive modeling and risk assessment, enhancing data-driven decision-making for better oral health outcomes in underserved areas.

Objective:

     I.         Training of CHW for awareness, identification and counselling of tobacco users and presence/absence of oral lesions using a mobile based application

   II.         Use of HCW in identification and presence/ absence of tobacco related Pre-Malignant Lesions and malignant lesions.

 III.         To establish a path for early diagnosis, counselling , referral and treatment for the inaccessible  masses using existing health care system.

Methodology

The sample was calculated to be 294 and rounded off to 300. Patients will be screened for presence of OPMLs and MLs by CHWS from the villages of Khordha block until the desired sample size is achieved.

 

 

Data Collection-

All the Community Health Workers of the included villages will be trained at the tertiary centre by two specialists using power point presentation and dental models that will include:

         Information on harms of tobacco consumption, oral cancer burden, prevention, habit cessation.

        Oral cavity and parts of the mouth and it’s clinical examination

      Toluidine Blue  staining protocol to identify tobacco-associated mucosal lesions.

All participants aged more than 15 years residing in the selected villages regardless of habit history will be invited to participate from their homes, but those who refuse consent will be excluded.

The mobile application-based questionnaire using modified Fagestrom Questionnaire will be administered by the CHW using a  mApp for android and iOS mobile phones which will categorise the individual based on severity of tobacco consumption based on the Fagerstrom Test for Nicotine Dependence . FTND is a standard instrument for assessing the intensity of person’s physical addiction to nicotine. Those categorised as high risk having scored more than 5 in FTND will be indicated for a clinical picture to be captured by the CHW with autofocus and auto-flash mode using the mobile phone camera, of buccal and labial mucosa, palate, dorsal and ventral surface of tongue. The clinical pictures which are deemed as suspicious , red/white patch or ulcers by an oral health expert, will be notified through the app to the health care worker as in need of TB staining.

Pictures of the stained lesions will be uploaded by the CHW through the app for further diagnosis by the expert. The images will be uploaded in real-time, remote specialist will serially review the images. The results will be communicated to the CHW via the app under the following categories:

 

1.No Lesion,

2. Lesion.

 

 

 

Patient with lesions will be referred to tertiary care using specially designed referral slips to for histo pathological examination and further treatment.

After a brief counselling by CHW for all participants with a habit history, they will be referred them to the ‘Institution Tobacco Control Cell’, to seek further help to quit.

 

 

 

 

IMPLICATIONS

Odisha has long been endemic to malignant and malignant lesions of oral cavity due to various reasons like social acceptance of chewing tobacco, low awareness and low accessibility to specialists. The mortality of oral cancer is high primarily due to late diagnosis , as patients are usually unaware of a lesion developing in their oral cavity and only report when there is precipitation of symptoms. With “SAH-AI’ we aim to  screen , diagnose and treatment at the earliest level to reduce  mortality, and reduce incidence by awareness and counselling.

 

 

 

 

 

 
Close