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
1 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
Researchers are evaluating the NeoPill oral hygiene device to see if it can reduce the amount of aerobic bacteria in the mouths of adults wearing fixed orthodontic appliances like braces. Maintaining good oral hygiene can be difficult for these patients due to limited access around brackets and wires. This single-arm clinical evaluation aims to provide preliminary data on how well the device works and how users experience it. The NeoPill is a reusable, battery-operated device that mechanically cleans the mouth without using chemicals. In this study, trained staff will apply the NeoPill inside the mouth for 30 seconds during a single visit. Oral swab samples will be taken immediately before and after using the device to measure changes in bacterial load. Participants will also complete a questionnaire about the device's comfort, usability, and overall experience. Participants will provide oral swab samples from specific areas around their braces, which are sent to a laboratory to count bacterial colonies. The main measurement is the difference in bacterial load before and after device use. Safety is monitored by noting any temporary discomfort. The study collects and stores data securely and anonymizes results. The entire participation occurs in one visit, focusing on both laboratory results and user feedback.
CONDITIONS
Brief 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single 30-second application of the NeoPill oral hygiene device. Oral swabs are collected immediately before and after device use to assess bacterial load changes. Participants also complete a questionnaire about device comfort and usability.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
German Medical Institute
Limassol, Cyprus, 4108
Actively Recruiting
Research Team
G
Georgina Kyriakoudes
C
Constantinos Zamboglou
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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