AI-assisted colorimetric detection of implant gum redness
A Diagnostic Study to Develop and Validate an Artificial Intelligence-Based Colorimetric System for the Objective Diagnosis of Peri-Implant Mucosal Erythema and to Evaluate Its Impact on Clinician Performance
This project will test whether an AI tool can use color information from dental scans to detect redness around implant-supported gums in adults who come for implant maintenance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07349095 on ClinicalTrials.gov |
What this trial studies
Researchers will develop a quantitative colorimetric index from digital intraoral scan data to measure mucosal erythema and then train an AI model to provide a yes/no diagnosis at the image level. A second AI model will be trained to localize erythematous regions on the scans using object-detection techniques. The models will be validated against clinician-labeled images from consecutive adult patients with single or splinted implant-supported restorations at Shanghai Ninth People's Hospital. Pregnant patients, those with systemic contraindications to implant treatment, or those unwilling to consent are excluded.
Who should consider this trial
Good fit: Adults (18+) with single or splinted implant-supported restorations who attend the Department of Oral and Maxillofacial Implantology at Shanghai Ninth People's Hospital for routine implant maintenance are eligible.
Not a fit: People who are pregnant, have systemic conditions that contraindicate dental implants, are unwilling to give written consent, or do not have implant-supported restorations are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, this tool could give dentists an objective, repeatable way to spot and track implant gum inflammation earlier and more consistently.
How similar studies have performed: AI and colorimetric approaches have shown promise in related dermatologic and oral imaging tasks, but applying them specifically to peri-implant mucosal erythema is relatively new.
Eligibility criteria
Show full inclusion / exclusion criteria
Consecutive patients aged 18 and above, with single or splinted implant-supported restorations visiting the Department of Oral and Maxillofacial Implantology Shanghai Ninth People's Hospital for regular implant maintenance will be included. Participants were excluded if i) pregnancy or intention to become pregnant; ii) with any systemic diseases/conditions that are contraindications to dental implant treatment; and iii) inability or unwillingness to give written informed consent.
Where this trial is running
Shanghai
- Department of Oral Maxillofacial Implantology Shanghai Ninth People's Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Junyu Shi, Professor
- Email: sakyamuni_jin@163.com
- Phone: 021 5331 4050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.