Li Cheng1, Wen Liu2, Tao Zhang3, Ting Xu4, Yi-Xuan Shu5, Bo Yuan6, Ying-Ming Yang7, Tao Hu8. 1. State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, 14#, 3rd Section, Renmin South Road, Chengdu 610041, Sichuan, China. Electronic address: dentistcl@foxmail.com. 2. State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, 14#, 3rd Section, Renmin South Road, Chengdu 610041, Sichuan, China; Department of Pediatric, Jinan Stomatology Hospital, Jinan, China. Electronic address: 836446179@qq.com. 3. State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, 14#, 3rd Section, Renmin South Road, Chengdu 610041, Sichuan, China. Electronic address: 417608201@qq.com. 4. State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, 14#, 3rd Section, Renmin South Road, Chengdu 610041, Sichuan, China. Electronic address: 515403879@qq.com. 5. State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, 14#, 3rd Section, Renmin South Road, Chengdu 610041, Sichuan, China. Electronic address: 1228856810@qq.com. 6. State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, 14#, 3rd Section, Renmin South Road, Chengdu 610041, Sichuan, China. Electronic address: 404658344@qq.com. 7. State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, 14#, 3rd Section, Renmin South Road, Chengdu 610041, Sichuan, China. Electronic address: ymyang@scu.edu.cn. 8. State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, 14#, 3rd Section, Renmin South Road, Chengdu 610041, Sichuan, China. Electronic address: hutao@scu.edu.cn.
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE: Pudilan is a famous traditional Chinese medicine compound which contains several Chinese herbal ingredients, and has been 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 treatment 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 were identical as the toothpaste used by the experiment group, except for not containing the Pudilan extract. 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 the control group (both p < 0.001). Moreover, after using the toothpaste for 4, 8, and 12 weeks, the decline of the PI and GI in the experiment group were significantly higher than the control group (p < 0.001, except 4weeks PI p = 0.011). After 12 weeks, the PI of the experiment group decreased 35.73% (p < 0.001) whereas the GI decreased 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 34.33% (p < 0.001) and BOP% decreased 54.71% (p < 0.001). CONCLUSION:Toothpaste with Pudilan extract demonstrated good effect on relieving symptoms of chronic gingivitis by inhibiting plaque formation, reducing gingival inflammation and the degree of bleeding, and the bleeding rate. Toothpaste containing Pudilan extract has prospective application potentials in the prevention and treatment of chronic gingivitis.
RCT Entities:
ETHNOPHARMACOLOGICAL RELEVANCE: Pudilan is a famous traditional Chinese medicine compound which contains several Chinese herbal ingredients, and has been 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 treatment 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 were identical as the toothpaste used by the experiment group, except for not containing the Pudilan extract. 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 the control group (both p < 0.001). Moreover, after using the toothpaste for 4, 8, and 12 weeks, the decline of the PI and GI in the experiment group were significantly higher than the control group (p < 0.001, except 4weeks PI p = 0.011). After 12 weeks, the PI of the experiment group decreased 35.73% (p < 0.001) whereas the GI decreased 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 34.33% (p < 0.001) and BOP% decreased 54.71% (p < 0.001). CONCLUSION: Toothpaste with Pudilan extract demonstrated good effect on relieving symptoms of chronic gingivitis by inhibiting plaque formation, reducing gingival inflammation and the degree of bleeding, and the bleeding rate. Toothpaste containing Pudilan extract has prospective application potentials in the prevention and treatment of chronic gingivitis.
Authors: Mengying Xia; Niya Zhuo; Shirui Ren; Hongyu Zhang; Yingming Yang; Lei Lei; Tao Hu Journal: BMC Oral Health Date: 2022-09-20 Impact factor: 3.747