Efficacy of an all-natural polyherbal mouthwash in patients with periodontitis: A single-blind randomized controlled trial

Aim: This study aimed to evaluate the anti-inflammatory effect and the incidence of adverse effects of an all-natural polyherbal mouthwash in patients with periodontitis, after 3 months of use. These aims were accomplished by using full mouth bleeding score (FMBS), full mouth plaque score (FMPS), probing depth (PD) clinical attachment level (CAL) and a questionnaire recording any adverse events. Methods: The present randomized controlled clinical study considered 40 patients with moderate or severe periodontitis, randomized in two groups: a test group (TG) and a control group (CG). TG was instructed to use a polyherbal mouthwash composed of Propolis resin extract, Plantago lanceolata, Salvia officinalis leaves extract, and 1.75% of essential oils and the CG was given a placebo mouthwash. Both groups were instructed to rinse for 2 min, twice daily after their routine oral home care with the different mouthwashes. Clinical measurements of FMBS, FMPS, PD and CAL were recorded at baseline (T0) and after 3 months (T1). The incidence of adverse outcomes was recorded at every follow-up. Mann-Whitney U test and Wilcoxon signed-rank test were used for the statistical analysis (p < 0.05). Results: The final study sample consisted of 34 healthy individuals, 17 individuals in each of the two groups. TG and CG showed a statistically significant reduction in FMBS (p = 0.001 TG; p = 0.002 CG), FMPS (p = 0.001 TG; p = 0.003 CG), PD (p = 0.001 TG; p = 0.011 CG) and CAL (p < 0.001 TG; p = 0.020 CG) values from baseline to 3 months. The TG showed a statistically significant decrease in FMBS and FMPS compared with the CG. No adverse events or side effects were reported or observed in both groups. Conclusion: The use of polyherbal mouthwash in patients with moderate or severe periodontitis has proved safe and effective in reducing bleeding score and plaque accumulation, after 3 months, compared with placebo, although no difference between the two groups were reported on PD and CAL (both improving at T1).