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

RecruitingNAAges 18 Years - anyAllNeofunction d.o.o.
NCT07355400 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • NeoPill Oral Hygiene Device
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Where

1 site
German Medical Institute
Limassol, Cyprus
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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