Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances
Neofunction d.o.o.
15 participants
Dec 9, 2025
INTERVENTIONAL
Conditions
Summary
This study evaluates the effectiveness of the NeoPill oral hygiene device in reducing oral bacterial load in adults wearing fixed orthodontic appliances. Maintaining oral hygiene is challenging for orthodontic patients due to limited access around brackets and wires, and current solutions often rely on chemical-based products and disposable tools. NeoPill is a reusable, battery-operated oral device designed to provide mechanical cleansing of the oral cavity. In this single-arm clinical evaluation, participants will undergo oral swab sampling before and immediately after a single 30-second application of the NeoPill device. The primary outcome is the change in aerobic bacterial load, measured as colony-forming units (CFUs), between pre- and post-treatment samples. Participants will also complete a short questionnaire to assess usability, comfort, and overall experience with the device. The study aims to generate preliminary clinical and user-experience data to support further development of the NeoPill device.
Eligibility
Inclusion Criteria4
- Adults aged 18 years or older
- Currently wearing fixed orthodontic appliances
- Able and willing to provide written informed consent
- Able to comply with study procedures during a single study visit
Exclusion Criteria4
- Use of systemic antibiotics within the past 2 weeks
- Presence of active oral infections
- Known immunocompromised status
- Presence of systemic medical conditions that may affect oral bacterial flora
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The NeoPill is a reusable, battery-operated oral hygiene device applied intraorally for a standardized duration of 30 seconds. In this study, the device is applied once by trained study personnel. The intervention involves no chemical agents and no systemic exposure. The device is used to mechanically clean the oral cavity prior to post-intervention oral swab collection.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07355400