NeoPill to reduce oral bacteria in people with fixed braces
Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Neofunction d.o.o. Industry-sponsored |
| Locations | 1 site (Limassol) |
| Trial ID | NCT07355400 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Limassol
- German Medical Institute — Limassol, Cyprus (Recruiting)
Study contacts
- Study coordinator: Georgina Kyriakoudes
- Email: aria@myaria.health
- Phone: +35795112337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.