Actively Recruiting
Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances
Led by Neofunction d.o.o. · Updated on 2026-04-09
15
Participants Needed
1
Research Sites
16 weeks
Total Duration
On this page
Sponsors
N
Neofunction d.o.o.
Lead Sponsor
G
German Oncology Center, Cyprus
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
German Medical Institute
Limassol, Cyprus, 4108
Actively Recruiting
Research Team
G
Georgina Kyriakoudes
CONTACT
C
Constantinos Zamboglou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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