Actively Recruiting
AI-Based Colorimetric System for Objective Diagnosis of Peri-Implant Mucosal Erythema and Its Impact on Clinician Performance
Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2026-01-16
200
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an artificial intelligence (AI)-based colorimetric system to improve the diagnosis of peri-implant mucosal erythema, a key sign of inflammation around dental implants. This study aims to develop and validate objective tools including a color index and AI models that automatically detect and localize redness from digital intraoral scan images. The study also assesses how AI assistance affects the accuracy and confidence of clinicians with different levels of experience. The study involves adult patients who have received intraoral scans of their dental implants using a specialized scanner. The AI system is developed and tested in three phases: initial development using internal scan data, external validation on a separate patient group, and a clinical utility phase where clinicians diagnose images both with and without AI help. The AI provides a color index value and highlights suspected inflamed areas on images to support diagnosis. Participants include patients contributing their de-identified dental images for AI training and validation, and clinicians who complete diagnostic tests using these images. Researchers measure the accuracy of AI detection, agreement with expert diagnoses, and improvements in clinician performance when aided by AI. The main outcome is the diagnostic accuracy of the AI system measured about three months after study start. The study duration and participant involvement vary across phases, with ongoing assessments of diagnostic reliability and utility.
CONDITIONS
Brief Title
AI-Assisted Colorimetric Diagnosis of Peri-Implant Mucosal Erythema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years and above
- Have single or splinted implant-supported restorations
- Visiting for regular implant maintenance at the Department of Oral and Maxillofacial Implantology
- Able and willing to provide written informed consent
You will not qualify if you...
- Pregnant or intending to become pregnant
- Having systemic diseases or conditions that contraindicate dental implant treatment
- Unable or unwilling to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Approximately 3 months
Participants either contribute de-identified digital dental images for AI model development or clinicians diagnose peri-implant mucosal images with and without AI assistance to assess the AI system's diagnostic accuracy and clinical utility.
1 to 2 visits depending on participant role
Trial Site Locations
Total: 1 location
1
Department of Oral Maxillofacial Implantology Shanghai Ninth People's Hospital
Shanghai, China
Actively Recruiting
Research Team
J
Junyu Shi, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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