Data Collection for AI Training of Dental ProbNCT07565480
Collection of Training Data for LuminX Probe AI Models
A study testing LuminX Probe System in people with Data Collection for AI Training of Dental Prob, run by LuminX at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Data Collection for AI Training of Dental Prob
- What is being tested?
- LuminX Probe System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Jun 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed consent.
- Age ≥18 years.
- Periodontal condition ranging from health/gingivitis to periodontitis (Stage I-IV).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Miles Madison, DDS Inc./ Beverly Hills Periodontal Institute
Beverly Hills, California, 90212
Cornerstone Dental Arts
Knoxville, Tennessee, 37923
Modern Day Smiles
Tampa, Florida, 33607
About this study
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.
Read the 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.
- Being tested
- LuminX Probe System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuminX Probe SystemDevice
Intraoral optical scan of patient's mouth in order to collect optical imaging data from LuminX Probe
| Study group | Role | What they receive |
|---|---|---|
| LuminX Prob System | Experimental | A trained dental professional will perform a scan of patient's mouth in order to collect images for the AI training Receives: Device: LuminX Probe System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dataset Completion - Successful acquisition of intraoral image dataset to allow AI training and validation
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start3 Jun 2026
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Data Collection for AI Training of Dental ProbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multi-center, single-arm, open-label data collection study. Subjects undergo a single intraoral imaging session using the LuminX Probe handpiece (without probing tip) to collect optical imaging data for AI model training and validation.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LuminX
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565480
- Sponsor's protocol ID
- DMS-7867
- Status last verified
- Sep 2026
- First submitted
- 17 Apr 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Data collection study for AI model validation. Not sure it will be needed.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Training Data for LuminX Probe AI Models
- ClinicalTrials.gov ID
- NCT07565480
- Acronym / sponsor ID
- DMS-7867
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- LuminXIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-center, single-arm, open-label data collection study. Subjects undergo a single intraoral imaging session using the LuminX Probe handpiece (without probing tip) to collect optical imaging data for AI model training and validation.
| Arm | Type | Receives |
|---|---|---|
| LuminX Prob System | Experimental | Device: LuminX Probe SystemA trained dental professional will perform a scan of patient's mouth in order to collect images for the AI training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed consent.
- Age ≥18 years.
- Periodontal condition ranging from health/gingivitis to periodontitis (Stage I-IV).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LuminX Probe SystemIntraoral optical scan of patient's mouth in order to collect optical imaging data from LuminX Probe | Device | LuminX Prob System |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided. Data collection study for AI model validation. Not sure it will be needed.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LuminX Probe System in people with Data Collection for AI Training of Dental Prob, run by LuminX at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dataset Completion - Successful acquisition of intraoral image dataset to allow AI training and validation (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.