NeoPill
Clinical Validation of an Innovative Oral Hygiene Device
Using Aria to support a clinical study combining microbiological testing with participant-reported experience to generate evidence for an innovative health product.
- Medical Device Validation
- Clinical Study
- Biological Samples
- Laboratory Data
- CNBC Ethics Approved
- ClinicalTrials.gov Registered
EIT Health SPICE Project · Delivered through Aria’s role as an Official Validation Partner of EIT Health
01
The Challenge
Maintaining oral hygiene can be particularly challenging for people with fixed orthodontic appliances, where brackets and wires make areas of the mouth harder to clean effectively.
NeoPill developed a reusable oral hygiene device designed to provide mechanical cleansing without relying on chemical rinses or single-use products.
The company needed clinical evidence to assess whether use of the device could produce a measurable reduction in oral bacterial load, while also understanding how participants experienced the product.
The study therefore needed to bring together objective microbiological measurements and participant feedback within a structured clinical evaluation.
02
The Study
As an Official Validation Partner of EIT Health, Aria was selected to support the clinical validation of NeoPill through the EIT Health SPICE programme.
Working with NeoPill and the German Medical Institute, Aria supported a single-arm, pre-post clinical evaluation involving adults wearing fixed orthodontic appliances.
Each participant attended a clinical study visit where an oral swab was collected immediately before use of the NeoPill device. The device was then applied for a standardised 30 seconds by trained study personnel, followed by a second oral swab.
The samples were analysed to measure changes in aerobic bacterial load, using colony-forming unit (CFU) counts to compare bacterial levels before and after device use.
Participants also provided structured feedback on areas including usability, comfort and their overall experience with the device.
The study received bioethics approval and was registered on ClinicalTrials.gov before participant recruitment and data collection were completed.
03
Aria Enabled
Biological Sample & Laboratory Data Integration
Microbiological results from pre- and post-use oral swabs were linked with participant study data to create a structured dataset for analysis.
Multi-Source Study Data
Objective laboratory measurements and participant-reported experience were brought together within the same research workflow.
Pseudonymised Data Management
Study-specific identifiers enabled clinical, laboratory and participant data to be linked while protecting participant identity.
Structured Participant Feedback
Usability, comfort and overall product experience were captured alongside objective clinical measurements.
04
The Results
Participant recruitment and data collection were successfully completed, generating paired pre- and post-intervention microbiological data together with participant experience data.
The completed study results were submitted to the NeoPill consortium in Q1 2026, completing the clinical validation programme from regulatory preparation through to final data delivery.
EIT Health Validation Study Completed
Delivered through Aria’s role as an Official Validation Partner of EIT Health, the NeoPill study progressed through bioethics approval, ClinicalTrials.gov registration, participant recruitment, clinical data collection, laboratory analysis and final reporting.
05
Why It Matters
Validating a health product can require more than understanding what participants think or how they feel.
NeoPill demonstrated how Aria can support studies that combine objective clinical and laboratory measurements with participant-reported data, bringing different evidence sources together within one structured research workflow.
For health innovators, this creates a practical way to generate clinical evidence around a product’s performance while also understanding the experience of the people using it.
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