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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
Sponsor study identifier
interventional
200
1 country
1
Study Start
September 1, 2025
Actual (reported)Primary Completion
January 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 27, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 27, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2025
Actual (reported)January 9, 2026
Actual (reported)January 16, 2026
Actual (reported)January 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 27, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Diagnostic accuracy of the AI system for detecting peri-implant mucosal erythema, as measured by the Area Under the Receiver Operating Characteristic Curve (AUC).
The primary outcome is the diagnostic accuracy of the AI-based colorimetric system in classifying an image as showing erythema or not. Accuracy is quantified by the Area Under the Receiver Operating Characteristic Curve (AUC), with expert visual diagnosis serving as the reference standard. The AUC, along with its 95% confidence interval, will be calculated separately for the internal development set and the independent external validation set to assess model performance and generalizability.
At the completion of image analysis for the external validation set, approximately 3 months after study start
Participants in this single-arm study undergo evaluation using the investigational AI-based colorimetric system. The study involves two distinct participant roles: 1) Patient Participants who have previously received intraoral scans contribute their de-identified digital dental images (3D surface files and 2D screenshots) for AI model development and validation. 2) Clinician Participants (including experts, general dentists, and students) take part in a prospective observer study. In a controlled, crossover manner, they diagnose a standardized set of peri-implant mucosal images first without any aid, and then with the assistance of the AI system, which provides an objective color index value and visual bounding boxes around suspected erythematous regions. The primary aim for this arm is to assess the diagnostic accuracy, reliability, and clinical utility of the AI system across both technical (vs. expert reference) and human (clinician performance enhancement) endpoints.
Participants in this single-arm study undergo evaluation using the investigational AI-based colorimetric system. The study involves two distinct participant roles: 1) Patient Participants who have previously received intraoral scans contribute their de-identified digital dental images (3D surface files and 2D screenshots) for AI model development and validation. 2) Clinician Participants (including experts, general dentists, and students) take part in a prospective observer study. In a controlled, crossover manner, they diagnose a standardized set of peri-implant mucosal images first without any aid, and then with the assistance of the AI system, which provides an objective color index value and visual bounding boxes around suspected erythematous regions. The primary aim for this arm is to assess the diagnostic accuracy, reliability, and clinical utility of the AI system across both technical (vs. expert reference) and human (clinician performance enhancement) endpoints.
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Department of Oral Maxillofacial Implantology Shanghai Ninth People's Hospital
Shanghai, China
First Submitted
January 9, 2026
First Posted
January 16, 2026
Study Start
September 1, 2025
Actual (reported)Primary Completion
January 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 27, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 16, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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