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NCT Number: NCT07565480

Collection of Training Data for LuminX Probe AI Models

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miles Madison, DDS Inc./ Beverly Hills Periodontal Institute, Beverly Hills, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

LuminX Probe System

Device

Intraoral optical scan of patient's mouth in order to collect optical imaging data from LuminX Probe

Primary outcomes

  1. Dataset Completion - Successful acquisition of intraoral image dataset to allow AI training and validation

    Time frame: Day 1

    The same intervention and same images are collected from all study participants. In order to allow diversity of data, the protocol has pre-defined enrollment targets to achieve a minimum representation of demographic and clinical subgroups, including periodontal disease stages I-IV, age bands, sex, and race/ethnicity, in alignment with Good Machine Learning Practice (GMLP) principles.

Study contacts

Contact information is provided by the study sponsor or research team.

Zachi Lehr, MD

CONTACT

[email protected]

972544418854

Sponsors and collaborators

Lead sponsor

LuminX

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.