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.
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.
To evaluate the effectiveness and safety of Pudilan extract-containing toothpaste in controlling plaques and reducing chronic gingivitis.
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.
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 < 0.001). Moreover, after using the toothpaste for 4, 8, and 12 weeks, the mean rate of the PI and GI decline compared with the baseline values in the experiment group were significantly higher than the control group (both p < 0.001, except 4 weeks PI p = 0.011). At 12 weeks, the PI of the experiment group decreased by 35.73% (p < 0.001) whereas the GI decreased by 29.04% (p < 0.001). BI and BOP decline rates were statistically significant when compared to those of the control group at 8 and 12 weeks (both p < 0.001). Moreover, at 12 weeks, the BI of the experiment group decreased by 34.33% (p < 0.001) and BOP% decreased by 54.71% (p < 0.001).
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.