Collection of Training Data for LuminX Probe AI Models

LuminX

Status: Not yet enrolling

Conditions: Data Collection for AI Training of Dental Prob

Treatments: Device: LuminX Probe System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07565480

DMS-7867

Details and patient eligibility

About

The purpose of this study is to prospectively collect fit-for-purpose, representative intraoral optical data using the LuminX Probe system to support development and validation of AI-enabled LuminX Probe software functions (AI-DSF). The collected data will be used for model training, validation, and future performance monitoring, in alignment with Good Machine Learning Practice (GMLP) principles.

Full description

This study is observational and is not intended to evaluate the diagnostic performance or safety and effectiveness of LuminX Probe; rather, it focuses on generating high-quality images across clinically meaningful subgroups to support robust and unbiased AI model development.

For the purpose of this data collection study, only part of the system will be in use, including the handpiece, camera and off the shelf FDA approved nylon cover, without the actual probe tip.

Consented eligible subjects will undergo a set of intra-oral imaging using the LuminX Probe. A trained dental professional will perform a scan of patient's mouth in order to collect optical imaging data from LuminX Probe (images/video/3D scans), and metadata for machine learning (tooth, site, orientation, operator ID, etc.).

Estimated procedure duration: ~15 minutes. All data will go through a de-identification process prior to storage and processing, with no identifiable patient information collected.

No follow-up visits are required.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Signed Informed consent.
2. Age ≥18 years.
3. Periodontal condition ranging from health/gingivitis to periodontitis (Stage I-IV).

Exclusion criteria

1. Participation in another study within 30 days that may interfere with data collection.
2. Pregnant or lactating women.
3. Recent tooth extraction or implant removal (less than 4 weeks pre-procedure)
4. Recent periodontal surgery (less than 4 weeks pre-procedure).
5. Currently undergoing chemotherapy, radiotherapy to the head/neck, or immunosuppressive therapy.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

LuminX Prob System

Experimental group

Description:

A trained dental professional will perform a scan of patient's mouth in order to collect images for the AI training

Treatment:

Device: LuminX Probe System