Clinical partners
Help refine the use case, comparator, recruitment criteria, and workflow.
CLAIR / Human oral-health program
Saliva evidence for
human oral-health research.
Our exploratory human program asks whether quantitative saliva measurements can add useful evidence alongside professional periodontal assessment in adult dental care.
Exploratory concept. The human panel and intended use are not finalized. Not for sale or clinical use. No diagnostic performance has been established.
The proposed clinical question
What can saliva add
to the assessment?
The starting point is a defined question in professional adult dental care.
Dental professionals use clinical examination, periodontal probing, patient history, and radiographs when indicated. The human CLAIR program will investigate whether a quantitative saliva measurement adds useful information alongside that assessment.
A saliva result would not replace examination, probing, or indicated imaging. The initial concept does not claim to diagnose caries, oral cancer, or systemic disease.
NIDCR: periodontal assessment ↗Human panel development
Select the question.
Then select the markers.
The veterinary candidate panel is not a validated human test. Human marker selection will follow dental input, literature review, and analytical feasibility studies.
- Clinical relevance
- A specific periodontal assessment question
- Saliva compatibility
- Recovery, sample volume, and collection conditions
- Analytical reliability
- Precision, stability, and interference
- Clinical added value
- Incremental information beyond standard assessment
Proposed professional workflow
A defined sample.
A controlled measurement.
- 01 / Collect
Standardize collection
Define collection timing, oral hygiene and food restrictions, storage, and sample-validity checks in the study protocol.
- 02 / Measure
Process and read
Develop the centrifugal assay disc and controlled optical readout around the selected human panel.
- 03 / Evaluate
Compare with assessment
Assess results against a prespecified periodontal reference assessment and intended clinical role.
Human evidence plan
A human study plan
for a human claim.
Timing, sample size, and performance targets require clinical, statistical, ethics, and regulatory input.
- 01
Definition and feasibility
Lock the intended question
Define adult population, dental setting, candidate markers, sample collection, comparator, and the decision a result could support. Study the human saliva matrix.
- 02
Clinical evaluation
Test added value independently
Use a prespecified protocol and appropriate ethics review and consent. Address confounders, blinded reference assessment, invalid results, and independent validation after locking the panel and thresholds.
- 03
Product and workflow
Establish the route to use
Evaluate professional usability, sample traceability, quality controls, manufacturing, and the appropriate regulatory pathway for the final intended use. No clearance or route is assumed.
Research and development partners
Dental expertise
shapes the program.
We welcome non-confidential discussions with dentists, periodontists, hygienists, dental schools, assay specialists, and aligned development partners.
Discuss the human program ↗Assay and engineering partners
Help evaluate human saliva compatibility, analytical methods, controls, and cartridge feasibility.
Commercial discovery
Test purchasing, pricing, utilization, and support assumptions with professional dental practices.
No human clinical partnerships, trial enrollment, funding, or commercial traction are claimed.