LuminX Probe System: Intraoral optical scan of patient's mouth in order to collect optical imaging data from LuminX Probe
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Dataset Completion - Successful acquisition of intraoral image dataset to allow AI training and validation — 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.
Trial sites (3)
Facility
City
Region
Status
Miles Madison, DDS Inc./ Beverly Hills Periodontal Institute
Beverly Hills
California
Modern Day Smiles
Tampa
Florida
Cornerstone Dental Arts
Knoxville
Tennessee
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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