Evaluation of a Targeted Oral Microbiome Treatment in an Older Adult Population

Gingivitis is highly prevalent among older adults and is associated with systemic diseases. Accessible and effective interventions are needed, particularly for underserved populations facing barriers to conventional dental care, such as older adults. This study evaluated the efficacy of a novel, multi-component lozenge (PTx800) designed to modulate the oral environment through blockade of sugar-to-acid and sugar-to-biofilm production of the oral microbiota. A six-week, double-blind, randomized, active placebo-controlled pilot trial was conducted with older adults (final sample n=20) residing in Cleveland, Ohio. Participants were randomized to receive either PTx800 or an active placebo lozenge containing sugar alcohols, used three times daily. Primary outcomes included Modified Gingival Index (MGI), Plaque Index (PI), Bleeding on Probing (BOP), Periodontal Probing Depth (PPD), and changes in oral pathogen load assessed by quantitative PCR. The PTx800 group demonstrated a 100% reduction in BOP, achieving complete resolution of bleeding sites, compared to an 82% reduction in the active placebo group. PPD was stabilized in the PTx800 group and slightly worsened in the control group. Microbiological analysis revealed a significant reduction in the total bacterial load in the PTx800 group, with pronounced decreases in key red complex periodontal pathogens, including Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf), and Treponema denticola (Td). PTx800 lozenges significantly improved clinical and microbiological measures of gingival health in older adults compared to active placebo. These findings suggest that PTx800 is a promising, non-antibiotic approach for managing oral inflammation and dysbiosis in aging populations, with potential implications for reducing oral pathogens strongly linked to systemic diseases.