FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090873 [Registered on: 14/07/2025] Trial Registered Prospectively
Last Modified On: 11/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study evaluating the accuracy of conventional clinical methods and artificial intelligence-based modeling in the diagnosis of gingivitis. 
Scientific Title of Study   Comparative evaluation of accuracy between conventional method and artificial neural network modelling method (AI) in the diagnosis of gingivitis .  
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 Panshul Kharche 
Designation  3rd Year Post Graduate  
Affiliation  NIMS Dental College  
Address  Department of Periodontology,NIMS University, Delhi - Jaipur Expressway Highway, Jugalpura
Department of Periodontology,NIMS University, Delhi - Jaipur Expressway Highway, Jugalpura
Jaipur
RAJASTHAN
303121
India 
Phone  08296075475  
Fax    
Email  panshulkharche@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neetha Bhargava 
Designation  Professor and Head of Department  
Affiliation  NIMS Dental College  
Address  Department of Peridontology,NIMS Dental College,NIMS Unvieristy, Delhi - Jaipur Expressway Highway, Jugalpura
Department of Peridontology,NIMS Dental College,NIMS Unvieristy, Delhi - Jaipur Expressway Highway, Jugalpura
Jaipur
RAJASTHAN
303121
India 
Phone  8050497427  
Fax    
Email  doctoryadentist@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Panshul Kharche 
Designation  3rd Year Post Graduate  
Affiliation  NIMS Dental College  
Address  Department of Peridontology,NIMS Dental College,NIMS Unvieristy, Delhi - Jaipur Expressway Highway, Jugalpura
Department of Peridontology,NIMS Dental College,NIMS Unvieristy, Delhi - Jaipur Expressway Highway, Jugalpura
Jaipur
RAJASTHAN
303121
India 
Phone  08296075475  
Fax    
Email  panshulkharche@gmail.com  
 
Source of Monetary or Material Support  
self funded 
 
Primary Sponsor  
Name  Dr Panshul Kharche 
Address  nims dental college and hospital, jaipur, rajasthan 
Type of Sponsor  Other [researcher] 
 
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 
Panshul Kharche  NIMS DENTAL COLLEGE AND HOSPITAL  Department of Periodontology,NIMS Dental College and Hospital ,NIMS UNIVERSITY, Jugalpura, 11C Delhi- Jaipur Highway, Jaipur, Rajasthan 303121
Jaipur
RAJASTHAN 		 8296075475

panshulkharche@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OFFICE OF THE INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  no systemic illness 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Artificial Neural Networking Modelling Method  Artificial Neural Network Modelling Method for analysing the intra oral photographs to give out a diagnosis 
Comparator Agent  Conventional Method   Conventional Method using Williams periodontal probe and mouth mirror according to Silliness and Loe Plaque Index and Loe and Silliness Gingival Index  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of age 14-75yrs groups are included.
2.Patients of all genders are included.
3.Patients with normal occlusion.
4.Patients who diagnosed to have gingivitis and have 24 or more teeth. 
 
ExclusionCriteria 
Details  1.Patients under the age of 14 yrs are not included in the study.
2.Patients with other gingival diseases such as localized periodontitis , aggressive periodontitis,
chronic periodontitis, and necrotizing periodontal diseases
3.Patients with all systemic diseases and pre historic medications are not included in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the diagnostic accuracy of an Artificial Neural Network (AI-based tool) with conventional clinical methods (Gingival Index and Plaque Index) for the detection of gingivitis in patients.  Single time point:
Diagnostic evaluations (both conventional and AI-based) were performed during the same outpatient visit, without any follow-up.

T0 (Baseline): On the day of enrollment, each patient underwent:

Clinical examination using Gingival Index & Plaque Index

Intraoral imaging for AI-based diagnosis 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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)   25/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/07/2025 
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)   Completed 
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  

This study aims to evaluate the diagnostic accuracy of an AI-based mobile application developed to detect gingivitis from standardized intraoral photographs, compared with the traditional clinical probing method. Patients will be assessed using both the AI tool and conventional periodontal probing to determine gingival inflammation. The primary objective is to assess sensitivity, specificity, and agreement between the AI-based diagnosis and clinician-based probing, thereby validating the utility of the app as a non-invasive screening tool for gingivitis in clinical and community settings.

 
Close