Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07349095

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Diagnostic Evaluation

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

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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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