Collection of Training Data for LuminX Probe AI Models
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LuminX Probe System.
- Who it may be relevant to
- Registry conditions: Data Collection for AI Training of Dental Prob. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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.
Interventions
- Device LuminX Probe System
Intraoral optical scan of patient's mouth in order to collect optical imaging data from LuminX Probe
Primary outcome measures
- Dataset Completion - Successful acquisition of intraoral image dataset to allow AI training and validation [Time frame: Day 1]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 3 centers
- Miles Madison, DDS Inc./ Beverly Hills Periodontal Institute — Beverly Hills
- Modern Day Smiles — Tampa
- Cornerstone Dental Arts — Knoxville
Identifiers
NCT: NCT07565480 · DMS-7867