Efficacy and Safety of the "Neo Pill" Device for Keeping Oral Hygiene in Patients with Fixed Orthodontic Appliance

Background: Orthodontic appliances interfere with oral hygiene and contribute to plaque retention, gingival inflammation and demineralization of enamel. Current techniques for keeping oral hygiene (teeth brushing, rinsing oral cavity with 0.12% chlorhexidine, dental floss, interdental brush, Miswak) are not sufficiently effective (1). Up to 78% of patients do not follow instructions to keep oral hygiene with current methods which require discipline and effort (2). There is great need for some simple medical device to keep oral hygiene in an effective, safe and easy-to-use way. Objective: To evaluate efficacy and safety of NeoPill electrolysis device for keeping oral hygiene in patients with fixed orthodontic appliances. Hypotheses: (1) NeoPill electrolysis device in addition to standard oral hygiene techniques improves values of oral health indices (gingival bleeding index, papillary bleeding index, plaque index, and ortho-plaque index) and is associated with fewer white spots on enamel during and after 6 months of use in comparison to standard oral hygiene techniques only; (2) the adverse event rates in patients using the NeoPill electrolysis device and in patients keeping oral hygiene only with standard techniques is not significantly different; (3) quality of life in patients using the NeoPill electrolysis device is higher than in patients keeping oral hygiene only with standard techniques. Methods: The study is designed as prospective cohort investigation. Primary outcomes of the study are: the Turesky Modified Quigley Hein Plaque Index (TQHPI) for both anterior and posterior teeth Gingival Inflammation Score (GIS) for both anterior and posterior teeth, Papillary bleeding index (PBI), Ortho-Plaque Index (OPI), number of white spots on enamel, and safety (incidence of adverse events). Secondary outcomes are quality of life and overall costs of keeping oral hygiene. Main independent variable in the study is administration of the NeoPill electrolysis device produced by start-up innovative company Laviefarm, Belgrade, Serbia. The device causes detachment of bacteria from fixed orthodontic appliances and teeth, which are then washed out with mouth rinse, and swallowed or spitted out. Implications and significance: If proved effecive and safe, the NeoPill electrolysis device will make major contribution to improvement of oral hygiene in patients with fixed orthodontic appliances.

NCT Number	NCT06834139
Lead Sponsor	University of Kragujevac
Conditions	Oral Hygiene
Enrollment	143 participants
Start Date	2024-07-01
Primary Completion	2025-12-01 (estimated)
Study Completion	2026-11-01 (estimated)
Updated on ClinicalTrials.gov	2025-02-19