TSG 21-2016Supervision Regulation on Safety Technology for Stationary Pressure Vessel (English PDF)

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.

5.1 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 (beta = 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

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

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.

5.1 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 (beta = 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

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.

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