Evaluation of Artificial Intelligence Models for Periodontitis Diagnosis and Gingival Inflammation Monitoring at Tooth and Patient Levels: A Diagnostic Accuracy Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 900
- Locations
- 1
Study Overview
Brief Summary
Background and Objective:
Periodontitis and gingivitis are highly prevalent oral diseases that require accurate diagnostic classification and continuous gingival health monitoring. This study aims to develop, internally validate, and externally evaluate the diagnostic accuracy of artificial intelligence (AI) models for periodontitis staging and gingival inflammation assessment at both tooth and patient levels.
Study Design:
This is a multi-center observational study utilizing a large-scale primary clinical dataset for model development. To rigorously evaluate the generalizability of the trained AI models, two distinct pathways of independent external validation will be implemented across multiple clinical sites.
Research Phases & Validation Architecture:
Phase 1 (Periodontitis Diagnosis via Probing): Development of an AI model to diagnose periodontitis (binary classification: stage 0/I vs. stage II/III/IV) at both tooth and patient levels, using comprehensive clinical periodontal probing as the gold standard. External Validation I will be performed using an independent cohort from another campus of the primary hospital to test the model's diagnostic accuracy.
Phase 2 (Periodontitis Diagnosis via Radiographs): Development of an AI model to diagnose periodontitis (binary classification: stage 0/I vs. stage II/III/IV) at both tooth and patient levels, using digital panoramic radiographs as the reference standard. External Validation II will be conducted using distinct, independent image datasets acquired from two separate regional hospitals to evaluate geographic generalizability.
Phase 3 (Gingival Inflammation Monitoring): Development of an AI model to monitor and assess gingival inflammation at both tooth and patient levels, based on Probing Depth (PD) and Bleeding on Probing (BOP) as the gold standard. This model's performance will also be evaluated through External Validation I using the independent dataset from the primary hospital's alternative campus.
Significance:
By validating the AI models across varied institutional workflows and imaging systems, this study will provide high-level evidence on the clinical utility and robustness of AI-driven digital systems for automated periodontal screening and long-term health monitoring.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients aged > 18 years at the time of their clinical periodontal examination.
- •Availability of complete full-mouth periodontal charting records, which must include Probing Depth (PD) and Bleeding on Probing (BOP) documented at 6 sites per tooth.
- •Availability of a digital panoramic radiograph of acceptable diagnostic quality, taken within one months of the clinical periodontal examination.
Exclusion Criteria
- •Patients who are completely edentulous or those who have undergone full-arch dental implant rehabilitation (not applicable for natural teeth periodontitis staging).
- •Panoramic radiographs with severe image degradation, including major motion artifacts, severe positioning errors, or poor contrast/exposure that obscures the alveolar bone crest.
- •Presence of extensive metal artifacts or massive bilateral multiple fixed crowns/bridges that completely shadow the marginal bone level of interest.
- •Incomplete clinical electronic medical records or missing core diagnostic descriptors required to establish the clinical gold standard for periodontitis staging or gingival inflammation.
Investigators
Junyu Shi
Professor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University