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 efficacy evaluation and evaluation methods on the control of dental plaque or gingivitis.
This part is applicable to toothpaste products that are labeled to control dental plaque or gingivitis through chemical action, and of which the physical and chemical properties, hygiene and safety indexes meet the corresponding national standards. The efficacy evaluation of removing or reducing dental plaque by mechanical removal is not in the scope of this part.
2 Normative references
The following referenced documents are indispensable for the application of this standard. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
WS/T 326.1 Efficacy evaluation of toothpaste—Part 1: General principles
3 Terms and definitions
For the purposes of this document, the terms and definitions given in WS/T 326 Part 1 apply.
4 Efficacy evaluation
4.1 In two separate clinical tests, when the plaque quantity of the test group decrease compared with that of the control group and it is statistically significant, it indicates that the test product have plaque controlling effect.
4.2 In each negative or placebo control clinical tests and for the comparison of the final values of each index between the control group and the test group, each test shall meet (control-test)/control ≥12%, and has the statistical significance; and both tests shall satisfy that the arithmetic mean of reduction percentage ≥15%, indicating that the test product has the effect of reducing gingivitis.
4.3 When the effect judgment requirements of 4.1 and 4.2 are met at the same time, it indicates that the product has the effect of controlling dental plaque and/or gingivitis.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Efficacy evaluation
5 Clinical test requirements
