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Clinical Trials/CTRI/2025/07/090873
CTRI/2025/07/090873Not yet recruitingNot Applicable

Comparative evaluation of accuracy between conventional method and artificial neural network modelling method (AI) in the diagnosis of gingivitis .

Dr Panshul Kharche1 site in 1 country1,000 target enrollmentStarted: July 25, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
1,000
Locations
1
Primary Endpoint
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.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

Time Frame: 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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr Panshul Kharche
Sponsor Class
Other [researcher]
Responsible Party
Principal Investigator
Principal Investigator

Dr Panshul Kharche

NIMS Dental College

Study Sites (1)

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