AI-Assisted Colorimetric Diagnosis of Peri-Implant Mucosal Erythema

NCT ID: NCT07349095

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-02-27

Brief Summary

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 AI models using an internal dataset.

Phase 2 (External Technical Validation): Prospective validation of the trained AI models on an independent cohort of patients from a separate branch of the hospital.

Phase 3 (Clinical Utility Assessment): A prospective, controlled, observer study where clinicians perform diagnoses with and without AI assistance.

4. Participants and Methods

Data Source: Adult patients with dental implants who received intraoral scans using a 3Shape TRIOS 3 scanner.

Image Data: Two formats are used: 1) Processed 3D surface files (PLY format) for colorimetric analysis, and 2) Standardized 2D screenshots from the 3Shape software for object detection.

Reference Standards: Expert consensus on erythema (primary) and Bleeding on Probing (BOP, clinical inflammatory standard).

AI Development: Deep learning models (e.g., convolutional neural networks) will be trained for index calculation, image-level diagnosis, and region localization.

Observer Study: Participating clinicians (experts, general dentists, and students) will diagnose a set of test images both unaided and with AI assistance (which displays the color index value and/or bounding boxes).

5. Key Outcome Measures

Diagnostic Accuracy: Area under the receiver operating characteristic curve (AUC), sensitivity, specificity (with 95% confidence intervals).

Technical Performance: Intraclass correlation coefficient (ICC) for automated measurement agreement; Mean Average Precision (mAP) and Dice Similarity Coefficient for object detection.

Clinical Impact: Change in diagnostic accuracy (AUC), inter-observer agreement (Kappa), and diagnostic confidence scores when using AI assistance.

6. Significance This study seeks to translate a subjective clinical sign into an objective, AI-powered diagnostic biomarker. If successful, the proposed system could become a valuable decision-support tool in daily practice and clinical research, promoting earlier, more consistent, and standardized monitoring of peri-implant tissue health, ultimately improving patient care.

Conditions

Peri-implant Mucositis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

AI-Assisted Diagnostic Evaluation for Peri-Implant Mucosal Erythema

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.

Group Type: EXPERIMENTAL

AIa assisted diagnosis

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

AIa assisted diagnosis

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: lead

Responsible Party

Junyu Shi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Oral Maxillofacial Implantology Shanghai Ninth People's Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Junyu Shi, Professor

Role: CONTACT

sakyamuni_jin@163.com

021 5331 4050

Facility Contacts

Xinyu Wu, PhD

Role: primary

wuxinyu_dentist@hotmail.com

021 5331 4050

Other Identifiers

SH9H-2025-196-imp

Identifier Type: -

Identifier Source: org_study_id