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WS/T 326.3-2010 English PDF (WST326.3-2010)

WS/T 326.3-2010 English PDF (WST326.3-2010)

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WS/T 326.3-2010: Efficacy evaluation of toothpaste - Part 3: Guidelines for efficacy evaluation on the control of dental plaque or gingivitis

This Part of WS/T 326 specifies the assessment and evaluation methods of inhibiting dental plaque and (or) reducing the gingival inflammation efficacy.
WS/T 326.3-2010
WS
HEALTH INDUSTRY STANDARD OF THE
PEOPLE REPUBLIC OF CHINA
ICS 11.020
C 05
Efficacy evaluation of toothpaste -
Part 3 . Guidelines for efficacy evaluation on
the control of dental plaque or gingivitis
ISSUED ON. DECEMBER 3, 2010
IMPLEMENTED ON. JUNE 3, 2012
Issued by. Ministry of Health of the PEOPLE Republic of China
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 4
4 Efficacy Evaluation ... 4
5 Clinical Trial Requirements ... 5
Foreword
WS/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 3 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. School of Stomatology of Peking University, Huaxi School of Stomatology of Sichuan University, School of Stomatology of Peking University, and School of Stomatology of Shanghai Jiaotong University.
Main drafters of this Part. Cao Caifang, Hu Deyu, Zhang Boxue, Yang Shenhui, Liu Xuenan, and Shu Chenbin.
Efficacy evaluation of toothpaste -
Part 3 . Guidelines for efficacy evaluation on the
control of dental plaque or gingivitis
1 Scope
This Part of WS/T 326 specifies the assessment and evaluation methods of inhibiting dental plaque and (or) reducing the gingival inflammation efficacy.
This Part applies to the toothpaste products that claim, through chemical action, inhibiting dental plaque and reducing gum inflammation; and of which the physiochemical properties and health-safety indicators comply with relevant national standards. The efficacy evaluation of removing or reducing plaque by mechanical scavenging is not within the scope of this Part.
2 Normative References
The following document is essential for the application of this document. For the documents cited with dates, only that edition applies to this document. For undated references, the latest edition (including any amendments) applies to this document. WS/T 326.1 Efficacy evaluation of toothpaste - Part 1. General principles 3 Terms and Definitions
The terms and definitions defined in Part 1 of WS/T 326 apply to this document. 4 Efficacy Evaluation
4.1 in two independent clinical trials, the experimental group is compared with the control group; when the amount of plaque is reduced and statistically significant, then it indicates that the subject product having inhibiting plaque efficacy. 4.2 In each clinical trial that adopts negative control or placebo control, compare all final indexes?€? values between experimental group and control group; each test shall meet that (control - experiment) / control is ???12%, and with a statistical significance. Two tests shall meet that the arithmetic average of the percentage reduction is ???15%; this indicates that the subject product has the efficacy to reduce gingival inflammation. d) There is open caries or mucosal lesions in oral.
e) Suffer from severe periodontitis.
5.4 Examination indicators
5.4.1 Adopt the plaque index (such as Turesky and other modified Quigley-Hein PI) to record plaque coverage area and thickness. It shall focus to observe the plaque near the gingival and interproximal area.
The severity of gingival inflammation shall mainly select the objective indicators that reflect the bleeding gums, such as BI (bleeding index Mazza, 1981), BOP% (that is, after probing, the percentage of breeding sites accounting for full-mouth total sites) shall be ???50%, or gingival index (L??e and Silness GI). However, when using the latter, the mean of selected baseline shall not be too low.
5.4.2 It shall check and record the full-mouth all teeth; each tooth shall be checked at six sites (buccal-mesial, buccal-central, buccal-distal, lingual-mesial, lingual-central, and lingual-distal).

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