TB/T 3548-2019Strength design and test accreditation specification for rolling stock-General (English PDF)

4.1 in two independent clinical trials, the experimental group is compared with the

control group; when the amount of plaque is reduced and statistically significant, then

it indicates that the subject product having inhibiting plaque efficacy.

4.3 When it meets 4.1 and 4.2 at the same time, it indicates that the product meet

the requirements when determining the effect, that the product has the efficacy to

inhibit plaque and (or) reduce the gingival inflammation.

5.1 Test Design Principles

5.1.1 It shall adopt the randomized, controlled, blind-design clinical trial method.

When products that contain certain active ingredients is validated for efficacy for the

first time, it shall be implemented at least two independent clinical trials.

5.1.4 When there are two (or more) examiners to participate in the trial, it shall adopt a

unified standard through calibration test (based on a more-experienced doctor as the

standard); Kappa value shall be above 0.6.If there is only one examiner, he/she shall

conduct, before the test, standard compliance rate test.

5.1.5 Control group may be another group of people whose age, sex, plaque and

gingivitis degree are similar to the conditions of experimental group; it may also take

the cross-repeat test of the testees; that is, testees are randomly grouped; use the

experimental group's products and the control group's products according to a certain

order.

5.1.6 It shall clearly specify the use and dosage of the product. It does not require to

change the brushing method of testees.

5.2 Test duration

5.2.1 For test of reducing plaque, before the test, it needs to conduct scaling to the

testees to remove tartar; on the day when test is started, use a rubber polishing cup to

remove plaque and debris; then start using the product. If it is under the strict

supervision to use the product, then, on the 5th ~ 7th day, it may assess the plaque

volume changes; due to the short period, it may adopt crossover experimental,

however, it must ensure the adequate washout period.

5.3 Experimental testees

5.3.1 Testees' selection

Testees are adult male and female who met the inclusion and exclusion criteria of

suffering from gingival inflammation; it shall be determined according to product

efficacy. The number of test people shall be estimated based on statistical methods

(meet enough statistical power (beta = 0.80) and 95% confidence level), however, the

number of cross-experiment people shall not be less than 30 people.

5.3.2 Inclusion criteria

5.3.3 Exclusion criteria

5.4 Examination indicators

5.4.1 Adopt the plaque index (such as Turesky and other modified Quigley-Hein PI) to

record plaque coverage area and thickness. It shall focus to observe the plaque near

the gingival and interproximal area.

5.4.2 It shall check and record the full-mouth all teeth; each tooth shall be checked at

six sites (buccal-mesial, buccal-central, buccal-distal, lingual-mesial, lingual-central,

and lingual-distal).

WS/T 326.3-2010

WS

HEALTH INDUSTRY STANDARD OF THE

PEOPLE'S REPUBLIC OF CHINA

ICS 11.020

C 05

Efficacy evaluation of toothpaste -

Part 3.Guidelines for efficacy evaluation on

the control of dental plaque or gingivitis

Issued on. DECEMBER 3, 2010

Implemented on. JUNE 3, 2012

Issued by. Ministry of Health of the People's Republic of China

Table of Contents

Foreword... 3

4.1 in two independent clinical trials, the experimental group is compared with the

control group; when the amount of plaque is reduced and statistically significant, then

it indicates that the subject product having inhibiting plaque efficacy.

4.3 When it meets 4.1 and 4.2 at the same time, it indicates that the product meet

the requirements when determining the effect, that the product has the efficacy to

inhibit plaque and (or) reduce the gingival inflammation.

5.1 Test Design Principles

5.1.1 It shall adopt the randomized, controlled, blind-design clinical trial method.

When products that contain certain active ingredients is validated for efficacy for the

first time, it shall be implemented at least two independent clinical trials.

5.1.4 When there are two (or more) examiners to participate in the trial, it shall adopt a

unified standard through calibration test (based on a more-experienced doctor as the

standard); Kappa value shall be above 0.6.If there is only one examiner, he/she shall

conduct, before the test, standard compliance rate test.

5.1.5 Control group may be another group of people whose age, sex, plaque and

gingivitis degree are similar to the conditions of experimental group; it may also take

the cross-repeat test of the testees; that is, testees are randomly grouped; use the

experimental group's products and the control group's products according to a certain

order.

5.1.6 It shall clearly specify the use and dosage of the product. It does not require to

change the brushing method of testees.

5.2 Test duration

5.2.1 For test of reducing plaque, before the test, it needs to conduct scaling to the

testees to remove tartar; on the day when test is started, use a rubber polishing cup to

remove plaque and debris; then start using the product. If it is under the strict

supervision to use the product, then, on the 5th ~ 7th day, it may assess the plaque

volume changes; due to the short period, it may adopt crossover experimental,

however, it must ensure the adequate washout period.

5.3 Experimental testees

5.3.1 Testees' selection

Testees are adult male and female who met the inclusion and exclusion criteria of

suffering from gingival inflammation; it shall be determined according to product

efficacy. The number of test people shall be estimated based on statistical methods

(meet enough statistical power (beta = 0.80) and 95% confidence level), however, the

number of cross-experiment people shall not be less than 30 people.

5.3.2 Inclusion criteria

5.3.3 Exclusion criteria

5.4 Examination indicators

5.4.1 Adopt the plaque index (such as Turesky and other modified Quigley-Hein PI) to

record plaque coverage area and thickness. It shall focus to observe the plaque near

the gingival and interproximal area.

5.4.2 It shall check and record the full-mouth all teeth; each tooth shall be checked at

six sites (buccal-mesial, buccal-central, buccal-distal, lingual-mesial, lingual-central,

and lingual-distal).

......