NCT07355400 Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances
| NCT ID | NCT07355400 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Neofunction d.o.o. |
| Condition | Dental Plaque |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-12-09 |
| Primary Completion | 2026-03-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-12-09 with a primary completion date of 2026-03-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Constantinos Zamboglou
STUDY DIRECTOR
GMIC
Frequently Asked Questions
Who can join the NCT07355400 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dental Plaque. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07355400 currently recruiting?
Yes, NCT07355400 is actively recruiting participants. Contact the research team at aria@myaria.health for enrollment information.
Where is the NCT07355400 trial being conducted?
This trial is being conducted at Limassol, Cyprus.
Who is sponsoring the NCT07355400 clinical trial?
NCT07355400 is sponsored by Neofunction d.o.o.. The principal investigator is Constantinos Zamboglou at GMIC. The trial plans to enroll 15 participants.