WS/T 326.2-2010Efficacy evaluation of toothpaste. Part 2: Guidelines for anti-caries efficacy evaluation (English PDF)
This is a limited preview
Buy now to download the full PDF (5 pages)
Need quotation for your management?
Get a formal quotation for WS/T 326.2-2010 in 30 minutes.
Issued by
Ministry of Health of the People 's Republic of China
Level / Type
National · Recommended
Issue date
December 3, 2010
Implementation date
December 3, 2012
Scope
WS/T 326.2-2010 (Efficacy evaluation of toothpaste. Part 2: Guidelines for anti-caries efficacy evaluation) is available as an English-translated PDF.
WS/T 326.2-2010 — 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.
Found what you need?
Document preview — WS/T 326.2-2010
National Standard of the People's Republic of China
- ICS
- 11.020
- Classification
- C 05
Issued by: Ministry of Health of the People 's Republic of China
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
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
4.2 Efficacy determination
4.2.1 According to 5.1 laboratory evaluation method of anti-caries efficacy,
after the experiment, when free fluorine or soluble fluorine content of fluoride
toothpaste is >= 500 mg/k, the product shall have anti-caries efficacy.
4.2.2 According to clinical trial requirements of 5.2 anti-caries efficacy, at
baseline, mid-trial, and at the end of the trial, respectively KEEP statistics on
the increase in the value of the indicators after the test for the experimental
group and the positive control group (fluoride toothpaste of total fluorine of 1100
mg/kg ~ 1450 mg/kg in accordance with this Standard, excluding other active
ingredients) and CARRY OUT the statistical analysis on the changes of each
index at any period between the two groups.
5 Evaluation method
5.1 Laboratory evaluation method
5.1.1 Determination of free fluoride or soluble fluorine content after fluoride-
containing toothpaste product aging test shall be carried out according to the
fluoride determination method specified in GB 8372.
5.2 Evaluation method of clinical trial
5.2.1 Principles for test design
Randomized, controlled, and blinded clinical trial methods should be used. The
test should be equipped with a positive control.
5.2.2 Duration of test
The test should be continued for at least 2 years. Caries status shall be checked
and recorded at baseline, at mid-trial, and at the end of the trial.
5.2.3 Test subject
5.2.4 Index checking or using
Crown caries. the use of decayed-missing-filled tooth (DMFT), distant
metastasis-free survival (DMFS), decayed-missing-filled tooth (dmft) and
distant metastasis-free survival (dmfs).
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
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
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
4.2 Efficacy determination
4.2.1 According to 5.1 laboratory evaluation method of anti-caries efficacy,
after the experiment, when free fluorine or soluble fluorine content of fluoride
toothpaste is >= 500 mg/k, the product shall have anti-caries efficacy.
4.2.2 According to clinical trial requirements of 5.2 anti-caries efficacy, at
baseline, mid-trial, and at the end of the trial, respectively KEEP statistics on
the increase in the value of the indicators after the test for the experimental
group and the positive control group (fluoride toothpaste of total fluorine of 1100
mg/kg ~ 1450 mg/kg in accordance with this Standard, excluding other active
ingredients) and CARRY OUT the statistical analysis on the changes of each
index at any period between the two groups.
5 Evaluation method
5.1 Laboratory evaluation method
5.1.1 Determination of free fluoride or soluble fluorine content after fluoride-
containing toothpaste product aging test shall be carried out according to the
fluoride determination method specified in GB 8372.
5.2 Evaluation method of clinical trial
5.2.1 Principles for test design
Randomized, controlled, and blinded clinical trial methods should be used. The
test should be equipped with a positive control.
5.2.2 Duration of test
The test should be continued for at least 2 years. Caries status shall be checked
and recorded at baseline, at mid-trial, and at the end of the trial.
5.2.3 Test subject
5.2.4 Index checking or using
Crown caries. the use of decayed-missing-filled tooth (DMFT), distant
metastasis-free survival (DMFS), decayed-missing-filled tooth (dmft) and
distant metastasis-free survival (dmfs).
......
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 5 pages — is available in the English PDF.
Referenced standards
Normative references
GB 8372
How to Download WS/T 326.2-2010
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
WS/T 326.1-2010 — Efficacy evaluation of toothpaste - Part 1: General principles
WS/T 326.3-2010 — Efficacy evaluation of toothpaste - Part 3: Guidelines for efficacy evaluation on the control of dental plaque or gingivitis
WS/T 326.4-2010 — Efficacy evaluation of toothpaste - Part 4: Guidelines for efficacy evaluation on dentin hypersensitivity
Secure payment via Stripe
Payments accepted
WS/T 326.2-2010
$80.00