Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances

Recruiting now · Not applicable

Conditions studied: Dental Plaque

In brief

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.

Key facts

Study ID

NCT07355400

Run by

Neofunction d.o.o.

People needed

15

Starts

2025-12-09

Expected to finish

2026-04-01

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• German Medical Institute — Limassol, Cyprus (enrolling)

Full record on ClinicalTrials.gov

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