WS/T 326.4-2010 PDF English
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Efficacy evaluation of toothpaste - Part 4: Guidelines for efficacy evaluation on dentin hypersensitivity
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WS/T 326.4-2010: Efficacy evaluation of toothpaste - Part 4: Guidelines for efficacy evaluation on dentin hypersensitivity
---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/WST326.4-2010
WS
HEALTH INDUSTRY STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.020
C 05
Efficacy evaluation of toothpaste -
Part 4.Guidelines for efficacy evaluation on
dentin hypersensitivity
Issued on. DECEMBER 3, 2010
Implemented on. DECEMBER 3, 2011
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 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 4 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 Shanghai
Jiaotong University.
Main drafters of this Part. Hu Deyu, Zhang Boxue, and Shu Chenbin.
Efficacy evaluation of toothpaste -
Part 4.Guidelines for efficacy evaluation on dentin
hypersensitivity
1 Scope
This Part of WS/T 326 specifies the efficacy’s classification, evaluation and clinical
trial requirements for toothpaste products on anti-dentin hypersensitivity.
This Part applies to toothpaste products that claim having efficacy of anti-dentin
hypersensitivity, and of which the physiochemical properties and health-safety
indicators comply with relevant national standards.
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 The evaluation shall be according to anti-dentin hypersensitivity’s product
classification; in accordance with this Part to carry out the clinical trials at different
times; depending on the situation of test sensitivity mean changes, before and after
the use of subject product (experimental group) and control group product; and
through statistical analysis.
4.2 During the test, the mean of dentin hypersensitivity indicators of the experimental
group shall be significantly lower, and have statistical significance compared with the
negative control group.
5 Clinical Trial Requirements
5.1 Test Design Principles
It shall adopt randomized, blind-method, parallel or crossover experimental design’s
clinical trial methods. After conducting a baseline examination, it shall be balanced to
allocate the testees, including gender, age and the number of teeth of the testees.
5.2 Test duration
The trial period shall be from the time when the subject product claims effective,
lasting for more than four weeks. Claiming that effectively reducing dentine
hypersensitivity needs to determine the test period based on product characteristics.
5.3 Test objects
5.3.1 Testees’ requirements
Healthy adult male and female who meet the inclusion and exclusion criteria shall be
determined based on the efficacy and principle of the product. And it shall meet a
sufficient statistical power (β = 0.80) and 95% confidence level; generally, the number
of people in each group to complete the whole process of the test shall be more than
30 people.
5.3.3 Exclusion criteria
a) Testee has severe oral diseases, chronic diseases or allergy to subject products.
b) During the progress of periodontal disease, or in the past year there was an
periodontal treatment received (including periodontal surgery).
c) The loosening of sensitive teeth is greater than 1.
d) there is a large area of dental filling body or crown, suspected pulpitis, caries,
cracked enamel, removable partial denture abutment.
e) Testee has allergies or idiosyncratic reactions to oral care products or its
ingredients.
f) Allergy to toothpaste and ingredients.
5.4 Evaluation indicators
5.4.2 Probing sensitivity evaluation
a) It may use an electronic pressure-sensitive probe (Yepple probe) that has been
calibrated. This instrument can quantitatively measure the pressure applied to
the tooth surface (g).
b) When testing sensitivity, the probe shall contact the selected buccal exposed
surface, located at the junction of dentinal and enamel essence; use the
original-preset 10g force to probe; then increment the force 10g each time; the
maximum force is 80g; record the sensitivity threshold, that is, the pressure
value when testee indicates that there is an uncomfortable feeling. Higher value
of probing force indicates that the tooth sensitivity is at lower level, and vice
versa.
5.4.3 Cold-air blown sensitivity evaluation
Use dental station’s air-gun to blow the sensitive teeth for 1s, at 1cm away;
compressor pressure is 413 kPa ± 35 kPa; blowing temperature is 19°C ~ 21°C; when
blowing, place the finger on the adjacent teeth to avoid the neighboring teeth’s
symptoms to affect the accuracy of the results. Use Schiff cold-air sensitive indicator
for evaluation; scoring is as follows.
WS/T 326.4-2010
WS
HEALTH INDUSTRY STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.020
C 05
Efficacy evaluation of toothpaste -
Part 4.Guidelines for efficacy evaluation on
dentin hypersensitivity
Issued on. DECEMBER 3, 2010
Implemented on. DECEMBER 3, 2011
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 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 4 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 Shanghai
Jiaotong University.
Main drafters of this Part. Hu Deyu, Zhang Boxue, and Shu Chenbin.
Efficacy evaluation of toothpaste -
Part 4.Guidelines for efficacy evaluation on dentin
hypersensitivity
1 Scope
This Part of WS/T 326 specifies the efficacy’s classification, evaluation and clinical
trial requirements for toothpaste products on anti-dentin hypersensitivity.
This Part applies to toothpaste products that claim having efficacy of anti-dentin
hypersensitivity, and of which the physiochemical properties and health-safety
indicators comply with relevant national standards.
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 The evaluation shall be according to anti-dentin hypersensitivity’s product
classification; in accordance with this Part to carry out the clinical trials at different
times; depending on the situation of test sensitivity mean changes, before and after
the use of subject product (experimental group) and control group product; and
through statistical analysis.
4.2 During the test, the mean of dentin hypersensitivity indicators of the experimental
group shall be significantly lower, and have statistical significance compared with the
negative control group.
5 Clinical Trial Requirements
5.1 Test Design Principles
It shall adopt randomized, blind-method, parallel or crossover experimental design’s
clinical trial methods. After conducting a baseline examination, it shall be balanced to
allocate the testees, including gender, age and the number of teeth of the testees.
5.2 Test duration
The trial period shall be from the time when the subject product claims effective,
lasting for more than four weeks. Claiming that effectively reducing dentine
hypersensitivity needs to determine the test period based on product characteristics.
5.3 Test objects
5.3.1 Testees’ requirements
Healthy adult male and female who meet the inclusion and exclusion criteria shall be
determined based on the efficacy and principle of the product. And it shall meet a
sufficient statistical power (β = 0.80) and 95% confidence level; generally, the number
of people in each group to complete the whole process of the test shall be more than
30 people.
5.3.3 Exclusion criteria
a) Testee has severe oral diseases, chronic diseases or allergy to subject products.
b) During the progress of periodontal disease, or in the past year there was an
periodontal treatment received (including periodontal surgery).
c) The loosening of sensitive teeth is greater than 1.
d) there is a large area of dental filling body or crown, suspected pulpitis, caries,
cracked enamel, removable partial denture abutment.
e) Testee has allergies or idiosyncratic reactions to oral care products or its
ingredients.
f) Allergy to toothpaste and ingredients.
5.4 Evaluation indicators
5.4.2 Probing sensitivity evaluation
a) It may use an electronic pressure-sensitive probe (Yepple probe) that has been
calibrated. This instrument can quantitatively measure the pressure applied to
the tooth surface (g).
b) When testing sensitivity, the probe shall contact the selected buccal exposed
surface, located at the junction of dentinal and enamel essence; use the
original-preset 10g force to probe; then increment the force 10g each time; the
maximum force is 80g; record the sensitivity threshold, that is, the pressure
value when testee indicates that there is an uncomfortable feeling. Higher value
of probing force indicates that the tooth sensitivity is at lower level, and vice
versa.
5.4.3 Cold-air blown sensitivity evaluation
Use dental station’s air-gun to blow the sensitive teeth for 1s, at 1cm away;
compressor pressure is 413 kPa ± 35 kPa; blowing temperature is 19°C ~ 21°C; when
blowing, place the finger on the adjacent teeth to avoid the neighboring teeth’s
symptoms to affect the accuracy of the results. Use Schiff cold-air sensitive indicator
for evaluation; scoring is as follows.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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