Antibacterial and clinical effectiveness of a mouthwash with a novel active system of amine + zinc lactate + fluoride: a randomized controlled trial

Objectives To support the daily oral hygiene of patients experiencing gum inflammation, a new mouthwash was developed containing an amine + zinc lactate + fluoride system. In vitro and clinical efficacy was assessed using traditional methods as well as using novel site-specific and subject-specific analyses of the clinical data. Materials and methods This mouthwash was evaluated in a 12-h biofilm regrowth assay against a negative control mouthwash and in a 6-month plaque and gingivitis clinical study as compared to a negative control mouthwash. Analyses of healthy versus inflamed sites, visible plaque versus non-visible plaque sites, as well as subject-level evaluations bring new perspectives to the overall performance of this mouthwash and its significance from a patient outcome perspective. Results Studies demonstrated that this new mouthwash provided long-term (12-h) antibacterial activity after single application in vitro and reduced clinically all plaque and gingivitis parameters after 3 months and 6 months of use when compared to the negative control mouthwash. Examination of site-level and subject-level data determined that this mouthwash significantly increased the number of healthy sites in the oral cavity and significantly improved the gum health of subjects in the study, as compared to the negative control mouthwash. Conclusions In vitro and clinical research has demonstrated the antibacterial and clinical benefits of this mouthwash containing an amine compound + zinc lactate + fluoride system. Clinical relevance Our subject-specific and site-specific analyses provide the dental practitioner with tools that can be used to guide patients who suffer from gingivitis toward optimal product selection and use. Clinical trial registration The trial was registered at ClinicalTrials.gov (reference no. NCT05821712).