Condition: Peri-implant Mucositis · Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1. Background and Rationale The visual diagnosis of peri-implant mucosal erythema (redness), a key sign of inflammation, is highly subjective and varies significantly among clinicians, leading to inconsistencies in early detection and monitoring of peri-implant diseases. There is a critical need for an objective, quantitative, and reliable tool to standardize this assessment. Recent advances in artificial intelligence (AI) and colorimetric analysis of digital intraoral scans offer a promising solution to this clinical challenge. 2. Primary Objectives This diagnostic study aims to: Develop and validate a core colorimetric index that objectively quantifies mucosal erythema from digital intraoral scan data. Develop and validate an AI model that automatically calculates this index and provides a binary diagnosis (erythema present/absent) at the image level. Develop and validate a second AI model for precise localization (object detection) of erythematous regions on standard clinical software screenshots. Evaluate the clinical utility of the AI system by assessing its impact on the diagnostic accuracy, consistency, and confidence of clinicians with varying experience levels. 3. Study Design This is a multiphase diagnostic accuracy study conducted at a single academic center. It comprises three sequential phases with independent validation: Phase 1 (Development \& Internal Validation): Analysis of intraoral scans to derive the color index and train the A…
This description comes directly from the study's public registry record.
Junyu Shi, Professor · 021 5331 4050 · sakyamuni_jin@163.com
Always discuss trial participation with your own doctor first.
| Department of Oral Maxillofacial Implantology Shanghai Ninth People's Hospital | Shanghai, China | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07349095