Effect of Theaflavin on Oral Bacteria in Japanese Subjects: A Randomized, Placebo-Controlled, Double-Blind Study.

Black tea is a popular beverage worldwide. Theaflavins (TFs), which are active functional components of black tea, are potentially valuable for preventing and/or treating the progression of periodontal diseases. Our previous pilot study showed that TF intake decreases the number of Porphyromonas gingivalis (P. gingivalis) bacteria in the saliva. In this study, we aimed to determine whether TF intake improves periodontal disease attributed to oral bacteria in a randomized, placebo-controlled, and double-blind study. A total of 56 healthy subjects without periodontal diseases were enrolled and assigned to the placebo and TF groups (n = 28). TF intake for 6 weeks did not significantly alter the clinical evaluation of subjects. There was no significant adverse effect among the subjects. The number of P. gingivalis and Fusobacterium nucleatum (F. nucleatum) bacteria, which was the primary endpoint in this study, was not impacted by TF intake. The change ratio of Prevotella intermedia was significantly decreased by TF intake (P = .043) when compared with the placebo group. Collectively, our findings suggest that TFs have beneficial effects on oral bacteria for the prevention of periodontal disease. The study protocol was registered in the University Hospital Medical Information Network (UMIN000020049).