Evaluation of the NeoPill Device to Reduce Oral Bacteria in Adults Wearing Fixed Braces

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 devices 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.

Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances