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.
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
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
Neofunction d.o.o.
Lead sponsor
German Oncology Center, Cyprus
Collaborator