The effect of a toothpaste containing oleanolic acid in reducing plaque and gingivitis: a proof-of-concept randomized trial.

Objectives To assess the safety and efficacy of an oleanolic acid (OA)-containing toothpaste in reducing gingival inflammation and plaque in patients with gingivitis. Methods This proof-of-concept parallel, double-blind, randomized controlled clinical trial included 99 patients. Following a 1-week washout, patients were randomized into three groups: OA group (fluoride toothpaste containing 0.1% OA and placebo mouthwash); negative control (fluoride toothpaste and placebo mouthwash); and CHX group (fluoride toothpaste and 0.12% chlorhexidine mouthwash). Patients were clinically assessed at inclusion, pre-washout visit, baseline and after 4 days, 1 week and 2 weeks of twice-daily use of the products. Patients received a diary for documentation of bleeding on brushing and provided unstimulated saliva samples. Results After two weeks, all groups showed significant reductions in all clinical parameters. The CHX group exhibited significantly greater reductions in gingival index and interproximal gingival index scores at week 2, as compared to patients in the negative control (p = 0.04). In contrast, reductions in gingival index scores did not differ between CHX and OA groups and between OA and negative control groups at week 2. The CHX group had significantly greater reductions in plaque index scores at day-4, 1-week and 2-week evaluations, as compared to the negative control and OA groups. The frequency of adverse events was similar among the groups. None of the groups reduced salivary transferrin levels. Finally, the OA group had the lowest percentage of self-reported bleeding events. Conclusion OA toothpaste failed to provide antiplaque and antigingivitis effects superior to those of a fluoride toothpaste after 2 weeks of use.