NeoPill to reduce oral bacteria in people with fixed braces
Official title: Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances
Run by Neofunction d.o.o. · NCT07355400 · Data updated 2026-11-12
This trial will see if a single 30-second use of the NeoPill device can quickly lower oral bacterial counts in adults who wear fixed braces.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Neofunction d.o.o. Industry-sponsored |
| Locations | 1 site (Limassol) |
| Status | Recruiting |
| Started | December 9, 2025 |
| Main results expected | March 21, 2026 |
| Study ends | April 2026 |
| Registry record updated | April 9, 2026 |
| Trial ID | NCT07355400 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are currently wearing fixed orthodontic appliances and can attend a single in-person study visit are ideal candidates.
✕Probably not a fit
People with recent systemic antibiotic use, active oral infections, known immunocompromised status, or systemic conditions that affect oral flora may not benefit or be eligible for this evaluation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-arm, pre–post clinical evaluation enrolling about 15–20 adults with fixed orthodontic appliances at the German Medical Institute in Limassol, Cyprus. Baseline oral swabs will be taken from gingival areas and around brackets, followed by a standardized 30-second application of the reusable, battery-operated NeoPill device and immediate post-treatment swab collection. Samples will be cultured in an accredited microbiology lab to quantify aerobic colony-forming units (CFUs) and the primary outcome is the change in CFU counts pre- versus post-application. Participants will also complete a brief questionnaire on usability, comfort, and overall experience to generate preliminary user-experience data.
Why it matters
Potential benefit: If successful, NeoPill could offer a quick, reusable mechanical option to lower bacteria and help improve oral hygiene around braces.
How similar studies have gone: Mechanical cleaning tools like powered toothbrushes and oral irrigators have shown benefit for plaque control, but the NeoPill's specific design and very short single-application use are novel and not established in published trials.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
German Medical Institute
Limassol, Cyprus Recruiting
Study contacts
- Study coordinator: Georgina Kyriakoudes
- Email: aria@myaria.health
- Phone: +35795112337
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.