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WS/T 326.2-2010

Chinese Standard: 'WS/T 326.2-2010'
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BASIC DATA
Standard ID WS/T 326.2-2010 (WS/T326.2-2010)
Description (Translated English) Efficacy evaluation of toothpaste. Part 2: Guidelines for anti-caries efficacy evaluation
Sector / Industry Health Industry Standard (Recommended)
Classification of Chinese Standard C05
Classification of International Standard 11.020
Word Count Estimation 5,521
Date of Issue 2010-12-03
Date of Implementation 2012-12-03
Quoted Standard GB 8372; WS/T 326.1
Drafting Organization School of Stomatology, Sichuan University Huaxi
Administrative Organization ?PRC Ministry of Health
Regulation (derived from) ?Health-Communication [2010] 25
Summary This standard specifies the anti-caries efficacy assessment and evaluation methods toothpaste. This section applies to claim to have anti-caries efficacy, and the physical and chemical properties, health and safety indicators in line with national standards for appropriate toothpaste products.

WS/T 326.2-2010
WS
HEALTH INDUSTRY STANDARD
OF THE PEOPLE'S REPUBLIC OF CHINA
ICS 11.020
C 05
Efficacy evaluation of toothpaste –
Part 2. Guidelines for anti-caries efficacy evaluation
牙膏功效评价 第 2部分. 防龋
ISSUED ON. DECEMBER 3, 2010
IMPLEMENTED ON. DECEMBER 3, 2012
Issued by. Ministry of Health of the People 's 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 Evaluation method ... 5 
Foreword
WS/T 326-2010 Efficacy evaluation of toothpaste consists of 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 Part is the second part of WS/T 326.
This Part refers to the American Dental Association (ADA) Guidelines for the
Validation of Fluoride Toothpaste in the Guidelines for the Safety and Efficacy
of Oral Health Products - “ Guidance on Acknowledgment of Fluoride
Toothpaste by the American Dental Association Scientific Committee,
November 2005”.
This Part was proposed by Chinese Journal of Stomatology.
This Part was approved by the Ministry of Health of the People's Republic of
China.
The drafting organizations of this Part. West China College of Stomatology of
Sichuan University, Peking University School of Stomatology and Sun Yat-sen
University Guanghua School of Stomatology.
Main drafters of this Part. Hu Deyu, Wang Xiaoling, Wang Qin, Lin Huancai,
Zhang Boxue.
Efficacy evaluation of toothpaste –
Part 2. Guidelines for anti-caries efficacy evaluation
1 Scope
This Part of WS/T 326 specifies efficacy evaluation and evaluation method of
anti-caries of toothpaste.
This Part applies to toothpaste products that claim to have anti-caries efficacy
and physical and chemical properties, health and safety indicators in line with
the corresponding national standards.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB 8372 Toothpaste
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 specified in WS/T
326.1 apply.
4 Efficacy evaluation
4.1 Evaluation principle
a) To verify the efficacy of dental fluoridation toothpaste, it should be carried
out by the laboratory evaluation method required in 5.1.
b) To evaluate the anti-caries efficacy of product containing non-fluoride, a
clinical trial is carried out according to requirements of 5.2.
4.2 Efficacy determination

WS/T 326.2-2010
Efficacy evaluation of toothpaste.Part 2. Guidelines for anti-caries trials evaluation
ICS 11.020
C05
People's Republic of China health industry standards
Evaluation of toothpaste efficacy - Part 2. Caries prevention
2010-12-03 released
2012-12-03 Implementation
Issued by the Ministry of Health of the People's Republic of China
Preface
WS/T 326-2010 "Toothpaste efficacy evaluation" is divided into the following sections.
- Part 1. General;
- Part 2. Caries prevention;
- Part 3. inhibition of plaque and/or reduction of gingival inflammation;
- Part 4. Sensitive to dentin.
This part is part 2 of WS/T 326.
This section refers to the recognition of fluoride toothpaste in the guidelines for the safety and efficacy of oral health products developed by the American Dental Association (ADA).
South "American Dental Association Scientific Committee of the fluorine toothpaste approved project guide, November.2005".
This part is made by the Chinese Society of Stomatology.
This part is approved by the Ministry of Health of the People's Republic of China.
This part of the drafting unit. Sichuan University, West China Institute of Stomatology, Peking University School of Stomatology and Sun Yat-sen Guanghua School of Stomatology.
The main drafters of this part. Hu Deyu, Wang Xiaoling, Wang Qin, Lin Huancai, Zhang Bo Xue.
Evaluation of toothpaste efficacy - Part 2. Caries prevention
1 Scope
This part of WS/T 326 specifies the evaluation and evaluation of toothpaste efficacy of toothpaste.
This part applies to toothpaste products that claim to have anti-caries effect and have physical and chemical properties, health and safety indicators in line with the corresponding national standards.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the date of the date applies to this
file. For undated references, the latest edition (including all modifications) applies to this document.
GB 8372 toothpaste
Evaluation of Efficacy of Toothpaste Part 1. General
3 terms and definitions
The terms and definitions defined in WS/T 326.1 apply to this document.
4 Efficacy evaluation
4.1 Principles of evaluation
a) Verify that the anti-caries effect of fluoride toothpaste should be carried out in accordance with the laboratory evaluation method required by 5.1.
b) Evaluate the anti-caries efficacy of non-fluorinated products, subject to clinical trials as required by 5.2.
4.2 Efficacy judgment
4.2.1 in accordance with the 5.1 anti-caries efficacy of the laboratory evaluation method, after the experiment to meet the fluorine fluoride toothpaste free fluorine or soluble fluorine content
≥ 500mg/kg, the product has anti-caries effect.
4.2.2 In accordance with the clinical trial requirements of the anti-caries efficacy of 5.2, at the beginning of the trial, the middle of the trial and the end of the trial, the test group and positive
The control group (in accordance with the provisions of the standard total fluoride 1100mg/kg ~ 1450mg/kg of fluoride toothpaste, excluding other active ingredients) were tested
The changes in the value of the indicators after the change, and the two groups between the time period, the changes in the statistical analysis of the indicators. By statistical tests,
The indexes of the test group were not lower than the positive control group, and the product had anti-caries effect.
5 Evaluation method
5.1 Laboratory evaluation methods
5.1.1 Determination of fluorine fluoride toothpaste product after aging test free fluorine or soluble fluorine content, measured according to GB 8372 specified fluorine method
carried out.
5.1.2 aging of the product experimental methods to choose a natural aging or accelerated aging of one of the methods can be.
a) natural aging method. According to the shelf life of the fluorine toothpaste product, the natural aging of the room under the conditions of natural storage
The free fluorine or soluble fluoride concentration in the toothpaste sample was measured on the day of the end of the shelf life.
b) Accelerated aging method.
1) will be measured fluoride toothpaste into 40 ℃, humidity 75% ± 5% of the incubator, 12 weeks after the removal of the toothpaste sample
Free fluorine or soluble fluorine concentration, this accelerated aging method is considered equivalent to 25 ℃ at room temperature for 2 years.
2) will be measured fluoride toothpaste into 40 ℃, humidity 75% ± 5% of the incubator, 24 weeks after the removal of the toothpaste sample
Of the free fluorine or soluble fluorine concentration, this accelerated aging method is considered equivalent to 25 ℃ at room temperature for 3 years.
5.2 Clinical trial evaluation methods
5.2.1 Principles of test design
Randomized, controlled and blinded clinical trials should be used. The trial should have a positive control.
5.2.2 Test period
The test lasts for at least 2 years. The caries status was examined and recorded at baseline, at the end of the trial and at the end of the trial.
5.2.3 Test subjects
5.2.3.1 According to product characteristics and claims, select the appropriate test population and inspectio......
Related standard:   WS/T 326.1-2010  WS/T 326.3-2010
   
 
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