Evaluation of the effect of a toothpaste containing Pudilan extract on inhibiting plaques and reducing chronic gingivitis: A randomized, double-blinded, parallel controlled clinical trial

Abstract Ethnopharmacological relevance Pudilan is a famous traditional Chinese medicine compound which contains several Chinese herbal ingredients, is wildly used to treat a variety of inflammatory diseases in China. Recently, it was reported that Pudilan extract had been used in the oral field, especially in the treat of minor oral ulcers for its anti-inflammatory, pain relieving, antibacterial, clearing heat, and detoxifying effects. Aim of the study To evaluate the effectiveness and safety of Pudilan extract-containing toothpaste in controlling plaques and reducing chronic gingivitis. Materials and methods A total of 120 patients with chronic gingivitis were randomized into an experiment group and a control group (n = 60 patients per group) based on a double-blinded method. Patients in the experiment group used a Pudilan extract-containing toothpaste, whereas patients in the control group used a Pudilan toothpaste simulator, which did not contain the Pudilan extract, however the remaining components were identical as the toothpaste used by the experiment group. The Plaque Index (PI), Gingival Index (GI), Bleeding Index (BI), and Bleeding On Probing proportion (BOP%) were recorded at baseline, 4 weeks, 8 weeks and 12 weeks after using the toothpaste. Results After using the toothpaste for 8 and 12 weeks, PI, BI, GI, and BOP% of the experiment group were significantly lower when compared to those of the control group (both p p p  = 0.011). At 12 weeks, the PI of the experiment group decreased by 35.73% ( p p p p p Conclusion Toothpaste with Pudilan extract showed good effect on relieving symptoms of chronic gingivitis by inhibiting plaque formation, reducing gingival inflammation and the degree of bleeding, and the bleeding rate. Furthermore, toothpaste containing Pudilan extract will have good application prospects in the prevention and treatment of chronic gingivitis.