Efficacy and Safety of Adding Electrolysis Device to Standard Methods of Maintaining Oral Hygiene in Patients with Fixed Orthodontic Appliance

Background/Objectives: Fixed orthodontic appliances interfere with oral hygiene and contribute to plaque retention, gingival inflammation and demineralization of enamel. Standard techniques for keeping oral hygiene (tooth brushing, mouthwashes, dental floss, interdental brush, etc.) are not sufficiently effective. The aim of this study was to investigate the effectiveness, safety, tolerability, and influence on quality of life of an electrolysis device being added to standard techniques of oral hygiene in orthodontic patients, compared to standard methods only. Methods: This 6-month study was designed as an observational prospective-cohort investigation. Primary outcomes of the study were indices of gingival inflammation and bleeding, dental plaque indices, the number of white spots on enamel, and safety (incidence of adverse events). Secondary outcomes were quality of life and overall costs of keeping oral hygiene. Results: The addition of the Neo Pill device to standard oral hygiene maintenance measures was associated with improvements in oral health indices after 6 months; however, given the non-randomized, preference-driven design, these findings reflect an association and should not be interpreted as evidence of causal efficacy. After 6 months, the primary outcomes of the study were significantly reduced compared to the application of only standard oral hygiene methods (from 21 to 55% reduction); the quality of life related to oral health was higher (for 14%), the tolerability of maintaining oral hygiene was the same as with standard measures and the costs of maintaining oral hygiene consumables were lower in the Neo Pill group (median difference 30%); however, this figure excludes the acquisition cost of the device itself, which was donated to all participants by the manufacturer, and the 95% confidence interval for this difference includes zero. Conclusions: The addition of an electrolysis device to standard oral hygiene maintenance measures in people wearing fixed orthodontic appliances was associated with improvements in gingival inflammation, papillary bleeding, and dental plaque indices—outcomes measured with established clinical instruments. Apparent reductions in white-spot lesion counts were also observed but should be considered exploratory given the absence of calibrated or blinded lesion assessment. These findings are preliminary and do not establish causal efficacy.