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WS/T 326.1-2010: Efficacy evaluation of toothpaste - Part 1: General principles Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsWS/T 326.1-2010: Efficacy evaluation of toothpaste - Part 1: General principles---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/WST326.1-2010WS HEALTH INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.020 C 05 Efficacy evaluation of toothpaste - Part 1.General principles Issued on. DECEMBER 3, 2010 Implemented on. DECEMBER 3, 2010 Issued by. Ministry of Health of the People’s Republic of China Table of ContentsForeword... 3 1 Scope... 4 2 Terms and definitions... 4 3 Efficacy evaluation scope... 4 4 General principles of efficacy evaluation... 5 5 Clinical trial requirements... 6ForewordWS/T 326-2010 "toothpaste effect evaluation" is divided into the following parts. - Part 1.General principles; - Part 2.Guidelines for anti-caries efficacy evaluation; - Part 3.Guidelines for efficacy evaluation on the control of dental plaque or gingivitis; - Part 4.Guidelines for efficacy evaluation on dentin hypersensitivity. This is part 1 of WS/T 326. Clinical trials in this Part references to the clinical trial’s design principle guidelines "American Dental Association Scientific Committee - Accreditation Program - Clinical Trial Program Guide, 2003" that was formulated by American Dental Association (ADA). This Part was proposed by Chinese Stomatological Association. This Part was approved by Ministry of Health of the People's Republic of China. Drafting organizations of this Part. Huaxi School of Stomatology of Sichuan University, School of Stomatology of Peking University, and School of Stomatology of Capital Medical University. Main drafters of this Part. Hu Deyu, Cao Caifang, Wang Xiaoling, Yang Shenghui, and Liu Xuenan. Efficacy evaluation of toothpaste - Part 1.General principles1 ScopeThis Part of WS/T 326 specifies the definition of toothpaste effectiveness, efficacy evaluation’s scope and general principles, and clinical trial requirements. This Part applies to the toothpaste products which claim to have some effect, and of which the physiochemical properties and health-safety indicators comply with relevant national standards.2 Terms and definitionsThe following terms and definitions apply to this document. 2.1 efficacy of anti-caries The efficacy that the products, through inhibiting enamel demineralization or promoting the remineralization of teeth, achieve to control the formation of dental caries; or through reducing plaque bacterial and acid production so as to achieve to prevent the generation of dental caries. 2.2 efficacy of control dental plaque or gingivitis The efficacy that the products, through chemical composition, generate the inhibition of plaque and (or) reduction of gingival inflammation such as swelling and bleeding.3 Efficacy evaluation scopeAnti-caries efficacy, inhibiting dental plaque and (or) reducing the efficacy of gingival inflammation, anti-dentine hypersensitivity efficacy.4 General principles of efficacy evaluation4.1 Experimental Design Principles 4.2 Experimental target population 4.2.1 Oral and general health of selected people shall represent the target population. 4.2.2 The testees shall be voluntary; it shall obtain the consent in writing of testees. 4.2.3 It shall clarify the inclusion criteria and exclusion criteria of experimental population. 4.2.4 Testees may freely exit at any stage of the test; it shall explain the exit-reasons in the report. 4.3 Tester requirements 4.3.1 Oral dentist who possesses an oral bachelor degree and above, job title. attending doctor and above, and with clinical trial experience.5 Clinical trial requirements5.1 When a product containing certain active ingredients is trialed for efficacy evaluation for the first time, it shall be carried out at least two independent clinical trials. 5.2 When a known-efficacy active ingredient is claimed to have new efficacy, it requires at least two additional independent clinical trials. 5.3 The products containing the same active ingredient which has been validated by clinical trial, shall prove its efficacy through the following methods. WS/T 326.1-2010 WS HEALTH INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.020 C 05 Efficacy evaluation of toothpaste - Part 1.General principles Issued on. DECEMBER 3, 2010 Implemented on. DECEMBER 3, 2010 Issued by. Ministry of Health of the People’s Republic of ChinaTable of ContentsForeword... 3 1 Scope... 4 2 Terms and definitions... 4 3 Efficacy evaluation scope... 4 4 General principles of efficacy evaluation... 5 5 Clinical trial requirements... 6ForewordWS/T 326-2010 "toothpaste effect evaluation" is divided into the following parts. - Part 1.General principles; - Part 2.Guidelines for anti-caries efficacy evaluation; - Part 3.Guidelines for efficacy evaluation on the control of dental plaque or gingivitis; - Part 4.Guidelines for efficacy evaluation on dentin hypersensitivity. This is part 1 of WS/T 326. Clinical trials in this Part references to the clinical trial’s design principle guidelines "American Dental Association Scientific Committee - Accreditation Program - Clinical Trial Program Guide, 2003" that was formulated by American Dental Association (ADA). This Part was proposed by Chinese Stomatological Association. This Part was approved by Ministry of Health of the People's Republic of China. Drafting organizations of this Part. Huaxi School of Stomatology of Sichuan University, School of Stomatology of Peking University, and School of Stomatology of Capital Medical University. Main drafters of this Part. Hu Deyu, Cao Caifang, Wang Xiaoling, Yang Shenghui, and Liu Xuenan. Efficacy evaluation of toothpaste - Part 1.General principles1 ScopeThis Part of WS/T 326 specifies the definition of toothpaste effectiveness, efficacy evaluation’s scope and general principles, and clinical trial requirements. This Part applies to the toothpaste products which claim to have some effect, and of which the physiochemical properties and health-safety indicators comply with relevant national standards.2 Terms and definitionsThe following terms and definitions apply to this document. 2.1 efficacy of anti-caries The efficacy that the products, through inhibiting enamel demineralization or promoting the remineralization of teeth, achieve to control the formation of dental caries; or through reducing plaque bacterial and acid production so as to achieve to prevent the generation of dental caries. 2.2 efficacy of control dental plaque or gingivitis The efficacy that the products, through chemical composition, generate the inhibition of plaque and (or) reduction of gingival inflammation such as swelling and bleeding.3 Efficacy evaluation scopeAnti-caries efficacy, inhibiting dental plaque and (or) reducing the efficacy of gingival inflammation, anti-dentine hypersensitivity efficacy.4 General principles of efficacy evaluation4.1 Experimental Design Principles 4.2 Experimental target population 4.2.1 Oral and general health of selected people shall represent the target population. 4.2.2 The testees shall be voluntary; it shall obtain the consent in writing of testees. 4.2.3 It shall clarify the inclusion criteria and exclusion criteria of experimental population. 4.2.4 Testees may freely exit at any stage of the test; it shall explain the exit-reasons in the report. 4.3 Tester requirements 4.3.1 Oral dentist who possesses an oral bachelor degree and above, job title. attending doctor and above, and with clinical trial experience.5 Clinical trial requirements5.1 When a product containing certain active ingredients is trialed for efficacy evaluation for the first time, it shall be carried out at least two independent clinical trials. 5.2 When a known-efficacy active ingredient is claimed to have new efficacy, it requires at least two additional independent clinical trials. 5.3 The products containing the same active ingredient which has been validated by clinical trial, shall prove its efficacy through the following methods. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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