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
Single group
NeoPill Oral Hygiene Device
DeviceThe 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.
Change in aerobic oral bacterial load
Difference in aerobic bacterial colony-forming unit (CFU) counts measured from oral swab samples collected immediately before and immediately after a single 30-second application of the NeoPill device.
Participant-reported usability and comfort of the NeoPill device
Participant-reported usability and comfort are assessed using a NeoPill Participant Usability and Comfort Questionnaire, a structured, study-specific survey administered immediately after device use. The composite usability score is derived from Likert-scale items assessing overall experience, discomfort/pain, and likelihood of future use. \- Overall experience is rated on a 5-point Likert scale ranging from 1 (Very Unpleasant) to 5 (Very Pleasant). Higher scores indicate a more positive user experience. \- Discomfort or pain during device use is rated on a 5-point Likert scale ranging from 1 (No Pain) to 5 (Severe Pain). Higher scores indicate greater discomfort. \- Likelihood of regular future use is rated on a 5-point Likert scale ranging from 1 (Very Unlikely) to 5 (Very Likely). Higher scores indicate greater acceptability and usability. Responses are combined descriptively to evaluate overall usability and comfort of the NeoPill device.
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Neofunction d.o.o.
Lead sponsor
German Oncology Center, Cyprus
Collaborator
