Eurofins Ats - 710506

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STUDY REPORT
These results concern only the samples tested in the laboratory which are defined here after.
The samples will be kept in our premises during 2 months from the date mentioned below.
The sample and the information regarding sample have been provided by the client. All information related to the sample are under liability of the client
and have not been checked by the Eurofins ATS company.
EUROFINS BioPharma Product Testing

Spain S.L.U.
C/ Josep Argem 13 Esplugues de
Llobregat
08028 BARCELONA ESPAGNE
07/09/2015
ASSESSMENT OF THE ORAL TOLERANCE AND OF THE QUALITIES OF A

PRODUCT, APPLIED ONCE AT THE LABORATORY, IN NORMAL CONDITIONS OF
USE, BY 20 ADULT VOLUNTEERS: Use Test
nd
This report replaces and cancels the report N710506A01 dated 2 of September, 2015 which has to be
destroyed. The laboratory should not be hold as responsible in case of the previous report is used. The
present report modifies the study sponsor and deletes the quotation number according to sponsor request.
Study sponsor:
LABORATORIO BONIQUET
Study manager:
Marion HARO
Tested product:
Product 1
Name
Product code
ATS reference
Product 2
INSTANT SMILE
59991732 59991733 - WHITENING
PRETREATMENT
GEL
525668
525667
Brand
Product type
Study n:
Pretreatment gel
Whitening gel
145TUTE20V15
The copy of this report is only authorized by unabridged edition.
It is made of 33 pages.
Eurofins ATS -Ple d'activit d'Aix-en-Provence - Actimart - 1140, Rue Ampre - 13851 Aix-en-Provence Cedex 3 - France
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AUTHENTICITY OF THE STUDY REPORT
The study concerned by this report was carried out under my responsibility, according to
the experimental protocol, the quality plan of EUROFINS ATS laboratory, and in
accordance with the good clinical practices.
All observations and data taken during this study are reported in this report.
Study Manager, Marion HARO
I certify the rereading of this report and I agree with its content,
Quality Assurance Reader, Sandrine GOBARD
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STUDY SUMMARY
ASSESSMENT OF THE ORAL TOLERANCE AND OF THE QUALITIES OF A
PRODUCT, APPLIED ONCE AT THE LABORATORY, IN NORMAL CONDITIONS OF
USE, BY 20 ADULT VOLUNTEERS: Use Test
Tested products:
Product 1
Name
INSTANT SMILE
59991732 59991733 - WHITENING
PRETREATMENT
GEL
Product code
Study sponsor:
Product 2
LABORATORIO BONIQUET
Objective:
The aim of the study is to assess the oral tolerance and the
qualities of the INSTANT SMILE product, applied once at the laboratory used in normal
conditions of use, by 20 adult volunteers.
Investigator:
Frederic BIANCHI, M.D Dentist
Place of the study:
EUROFINS ATS, ACTIMART

4 alle des Informaticiens
1140 rue Andr Ampre
13851 AIX EN PROVENCE cedex 3
FRANCE
Study dates:
Session 1: 05/08/2015
Session 2: 06/08/2015
Method:
Directions for use:

Area of application: Teeth
Quantity of product: As much as necessary
Frequency and duration: Once at the laboratory
Conditions of application:
1. Brush the teeth with regular toothpaste. The toothpaste used is Signal Integral 8.
2. Charge the fluorescent bite under a direct light source (ideally sun light) for at least
5 minutes.
3. Press slightly the pre-treatment tube to soak the sponge and apply it over the
external face of the teeth.
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4. Apply a thin stripe of the gel Instant Smile inside the fluorescent bite. Cover the
whole internal face of the bite.
5. Fold the bite and put it inside your mouth by covering the teeth. Bite it directly and
close the lips for a better fluorescent effect.
6. Leave it for 15 minutes.
Assessment methods:
Oral tolerance: clinical observations are made by the Dentist to assess the oral intolerance
reactions (assessment of the functional and clinical signs) at the beginning and at the end
of the study.
Bleaching efficacy: The Dentist assessed the teeth whiteness thanks to the R-20
Bleaching shade guide at the beginning (T0) and after the use (Timm).
Acceptability: assessment of the qualities and performances of the product is made by the
volunteers, using a suitable questionnaire.
Panel:
22 healthy female and male adult volunteers with yellowed teeth aged from 19 to 70 years
old.
The assessment of the oral tolerance was made on 22 volunteers.
The bleaching efficacy was assessed in 22 volunteers.
The product acceptability was evaluated by the 22 volunteers.
Results:
- Assessment of the bleaching efficacy by clinical scoring
After a single use, the teeth whiteness increased for 22 volunteers (100% of the panel).
The average bleaching efficacy is equivalent to a benefit of 5.4 shades (2.7 grades) in the
22 volunteers. These results allow highlighting a bleaching efficacy of the product after a
single use.
- Assessment of the oral tolerance
Assessment of the oral tolerance by the Dentist (clinical signs):
No clinical manifestation was noticed, by the Dentist, after a single use, on the 22
volunteers.
Discomfort manifestations (functional signs):
No discomfort manifestation was reported to the dentist by any of the 22 volunteers.
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However, 2 volunteers (9%) reported the following discomfort manifestations on their

acceptability questionnaire:
- Moderate tingling inside the mouth, during the whole time of use, by the volunteer
n15.
- Slight tingling on the lips, during a few minutes, by the volunteer n21.
- Assessment of the acceptability
The INSTANT SMILE product was globally very well appreciated by the 22 volunteers who
took part in the study, with a satisfaction rate of 82% and 18% are not satisfied. Moreover,
64% of the volunteers who were involved in the study would like to buy this product.
The qualities of the product were assessed by the volunteers through an acceptability
questionnaire. The positive answers obtained are presented in the following table.
USE TEST PARAMETERS
1. The whitening kit is easy to use
Added % of totally
agree and agree
91%
2. The whitening kit is pleasant to use
55%
3. During the use, the whitening kit gives a pleasant freshness feeling
91%
4. After use, your teeth are whiter
77%
5. The whitening kit provides a fresh breath
100%
6. The whitening kit is gentle to the gums
95%
7. Your gums feel protected
100%
8. The product is gentle to the teeth enamel
91%
9. The product improves visibly the whiteness of your teeth
73%
10. At the end of the study, you would like to keep using the product
68%
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Conclusion:
To conclude, the INSTANT SMILE product, referenced 59991732 - PRETREATMENT
and referenced 59991733 - WHITENING GEL, used in normal conditions of use, a
single use at the laboratory, by 22 healthy female and male adult volunteers, with
yellowed teeth, is considered as well tolerated regarding the oral tolerance.
The INSTANT SMILE product, led to a bleaching teeth improvement in 100% of the
volunteers with a mean benefit of 5.4 shades (i.e. 2.7 grades).
The performances and the qualities of the product were globally very well
appreciated by the 22 volunteers who participated in the study, with a satisfaction
rate of 82% and a purchase intention of 64%.
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TABLE OF CONTENT
AUTHENTICITY OF THE STUDY REPORT .................................................................. 2
STUDY SUMMARY ........................................................................................................ 3
TABLE OF CONTENT ................................................................................................... 7
1
OBJECTIVE............................................................................................................. 8
METHODOLOGY .................................................................................................... 8
3
ETHIC AND REGULATORY CONSIDERATIONS CONCERNING PROTECTION
OF PERSONS .................................................................................................................. 9
3.1 Legislative and regulatory references ................................................................... 9
3.2 Ethic considerations .............................................................................................. 9
3.3 Confidentiality ..................................................................................................... 10
3.4 Archiving ............................................................................................................. 10
4
QUALITY CONTROL AND INSURANCE ............................................................. 11
STUDIED PANEL .................................................................................................. 11

5.1 Number of volunteers.......................................................................................... 11
5.2 Recruitment, selection and final admittance of volunteers for a study ................ 11
5.3 Inclusion criteria .................................................................................................. 12
5.4 Non-inclusion criteria .......................................................................................... 12
5.5 Banning and restrictions ..................................................................................... 12
5.6 Volunteers withdrawal ......................................................................................... 13
TESTED PRODUCTS ............................................................................................ 13
7.1
7.2
7.3
7.4
CLINICAL STUDY ................................................................................................. 14

Applying .............................................................................................................. 14
Study protocol ..................................................................................................... 14
Clinical assessments .......................................................................................... 15
Data analysis and results interpretation .............................................................. 16
RESULTS .............................................................................................................. 18
8.1 Description of the panel ...................................................................................... 18
8.2 Study exits .......................................................................................................... 18
8.3 Results analysis .................................................................................................. 19
APPENDIX I ................................................................................................................. 21
Individual results of the clinical scoring by the Dentist ................................... 22
APPENDIX II ................................................................................................................ 23
Assessment of the oral tolerance after a single application in the laboratory
(functional and clinical signs) ................................................................................... 24
APPENDIX III ............................................................................................................... 26
Global satisfaction and purchase intention graphs .......................................... 27
Acceptability table ............................................................................................... 28
Acceptability histogram ...................................................................................... 29
APPENDIX IV ............................................................................................................... 30
Answers to open questions ................................................................................ 30

APPENDIX V ................................................................................................................ 31
List of the personnel who participated in the study ......................................... 31
APPENDIX VI ............................................................................................................... 32
Results authenticity ............................................................................................. 33
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OBJECTIVE
The aim of the study is to assess the oral tolerance and the qualities of the INSTANT
SMILE product, used in normal conditions of use, applied once at the laboratory, by 20
healthy volunteers, presenting with yellowed teeth, aged from 18 to 70 years old.
METHODOLOGY
Clinical observations are made by the Dentist at the beginning of the study to confirm
the inclusion criteria and to examine the area that will be put in contact with the tested
product.
The product is applied by the volunteers at the laboratory, according to the normal
conditions of use.
The oral tolerance (clinical signs) is assessed by the Investigator, by clinical
examination after the single application at the laboratory.
The subjective tolerance (functional signs) is assessed by the volunteers from
predefined criteria (teeth or gums sensitive to cold/hot, mouth ulcer, cracks, bleeding,
itching, bad breath) in presence of the Dentist, after the single application at the
laboratory.
The qualities of the product are assessed by the volunteers using a suitable
questionnaire, developed with the study sponsor, before the beginning of the study.
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3.1
ETHIC AND REGULATORY CONSIDERATIONS CONCERNING PROTECTION OF

PERSONS
Legislative and regulatory references
The French law relative to the Public Health n 2004-806 of August 9, 2004 (articles 88 to
97) applied by the French Decree n 2006-477 of April 26, 2006 for the research integrates
the dispositions regarding the biomedical researches and replaces the French law of
December 20, 1988 relative to the protection of persons who take part in biomedical
researches called Law Huriet-Serusclat". All tests carried out within EUROFINS ATS,
even if they are not submitted to this law, are carried out according to this law.
The studies are carried out according to the most recent recommendations of the World
Medical Association (Helsinki Declaration 1964, in its current version), and to the
AFSSAPS recommendations relative to the biomedical researches on cosmetic products
entering in the application field of the French law relative to the Public Health n 2004-806
of August 9, 2004 (Version of September 7, 2006).
However, no information is sent to the national folder of people who takes part in
biomedical research and the opinion of the Committee of Persons Protection is not
asked.
The studies follow the Guidelines for the Assessment of Skin Tolerance of Potentially
Irritant Cosmetic Ingredients, COLIPA, Edition of 1997.
3.2
Ethic considerations
The ethic requirements, necessary to studies on Human, are respected:

The volunteers are selected according to inclusion and non-inclusion criteria.
All volunteers are informed of the aim and the type of the study, of the possible risks
they are taken by participating in this study and give their free and informed consent
before the beginning of the study.
Before volunteers are exposed to the tested product, minimum information regarding
the safety of the product is asked to the sponsor.
All care is taken in order to avoid excessive oral or skin reactions or undesired effects
on the volunteers health during the study.
Safety procedures are taken in case of bad reactions.
The volunteers are paid in compensation for the time spent and the risks due to the
study.
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3.3
Confidentiality
The complete data regarding the health of the volunteers, collected during their final
admittance in the volunteers database of EUROFINS ATS and necessary when recruiting
and selecting them for the studies, are strictly confidential and submitted to the medical
secret according to the article 378 of the Penal Code and to the article 4 of the Medical
Ethics Code (R-4127-1 to R-4127-112 of the Public Health Code of December 14,
2006). The anonymity of the volunteers is respected within all studies carried out in our
laboratories. However, each volunteer can be easily identified by the Investigator, the
doctors and all the persons in charge of the study, thanks to its personal volunteers code.
According to the article R. 5121-13 of the Public Health Code, the product type studied,
the trials, the volunteers, and the results are strictly confidential and the secret is
respected by the Doctors and all the persons working with them.
EUROFINS ATS ensures not to divulge all the data and results collected during a study.
Treatment of personal data is declared to CNIL.
3.4
Archiving
All data related to the study will be stored in the archives of EUROFINS ATS (Ple
dactivits dAix les Milles - ACTIMART 4 alle des Informaticiens, 1140 rue Andr
Ampre 13851 AIX EN PROVENCE) and at a service providers, Socit Gnrale
dArchives (ZI Les Estroublans - 49 boulevard de lEurope 13127 VITROLLES), for 10
years.
At the end of this period, the study sponsor will have to specify whether the data related to
the study should be thrown away or restored to him. Eurofins ATS can also consider
extending the storage period of these documents, at the study sponsors expenses.
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QUALITY CONTROL AND INSURANCE
In order to meet client expectations and legal and regulatory requirements, EUROFINS
ATS established all necessary resources for the management of its structural
organizations and methods. With a constant client satisfaction policy, EUROFINS ATS
chooses to follow the ISO 9001 requirements in order to establish the company
organisation.
In this direction, this study was carried out in accordance with the procedures defined in
the quality system. In order to insure results reliability, quality auto-controls are made all
through the process.
Thus, during this study, all the documents, materials, environment and raw data were
checked in order to avoid deviations from the protocol.
In the same way, under quality policy, the clinical tests laboratory is audited every year in
order to assess that the procedures and instructions are well applied and to check their
conformity with our internal requirements and process efficiency.
5
5.1
STUDIED PANEL
Number of volunteers
The product was tested by 22 volunteers. The test was carried out in open.
5.2
Recruitment, selection and final admittance of volunteers for a study
All volunteers recruited in this study come from the volunteers data base of EUROFINS
ATS, and answer the inclusion and non inclusion criteria presented in the paragraphs
below.
Their final admittance was determined by the study manager from the answers given in a
pre-study questionnaire and after a preliminary interview. During this interview, the
following information is explained to the volunteers: title, objective, protocol, planning of
the study, payment methods, as well as the possible effects expected and the study
constraints. The admittance of the volunteers is validated by the signature of the
Information Note and a free and informed consent, by the investigator and the volunteers.
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5.3
Inclusion criteria
The volunteers corresponding to the following criteria are included:
Age : 18-70 years old,

Gender: female and male,
Teeth: yellowed,
Social welfare: the volunteers must be affiliated at National insurance (French law :
Public Health Code article L1121-11),
No oral lesion on the studied area,
Volunteers having a proof of home address,
Volunteers able to understand French and the study requirements.
5.4
5.5
Non-inclusion criteria
Volunteers not answering the previous inclusion criteria,
Volunteers which used a whitening kit at home,
Volunteers within an exclusion period between two tests,
Minors or majors protected by the law and people admitted in a sanitary or social
institution for other purpose than research (French law : Public Health Code article
L1121-7),
Persons deprive of liberty by legal or administrative decision, patients in emergency
situation (French law : Public Health Code article L1121-6),
Pregnant or breastfeed women (French law : Public Health Code article L1121-5)
Volunteers presenting an evolutive oral pathology or a known contact allergy to one of
the ingredients of the tested product,
Volunteers who refused to give their free and informed consent,
Volunteers under antihistaminic, corticoids, desensitizing treatment and/or under any
treatment which could interfere with the oral metabolism.
Banning and restrictions
For the whole length of the study, it is asked to volunteers:

Not to modify their alimentary and health habits,
Not to use another product from the same category than the one tested,
Not to take aspirin, anti-histamines, corticoids or anti-inflammatories that could
interfere with the test results.
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5.6
Volunteers withdrawal
Volunteers may be excluded from the study for the following reasons:
They no longer follow the requirements and constraints of the study, explained during
the signing of the consent,
They suffer from an illness developed during the study which may interfere with the
objectives of the study,
They no longer wish to participate in the study.
TESTED PRODUCTS
Product 1
Product name
Reference
ATS reference
Presentation (galenic,
colour)
Packaging
Number of samples
received
Use by date
Storage conditions
Product 2
INSTANT SMILE
59991732 59991733 - WHITENING
PRETREATMENT
GEL
525668
525667
Blue liquid
Transparent gel
Plastic tube
Plastic tube
25
>30 months
room temperature, away from light and heat
A sample of the tested product is kept in EUROFINS ATS laboratory, during 2 months
after the end of the study. After this date and except contrary order from the study
sponsor, the product will be destroyed.
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7
7.1
CLINICAL STUDY
Applying
The applications are made by the volunteer, at the laboratory, according to the following
recommendations (developed with the study sponsor).
7.2
Area of application: Teeth

Quantity of product: As much as necessary
Frequency and duration: Once at the laboratory
Conditions of application:
1. Brush the teeth with regular toothpaste. The toothpaste used is Signal Integral 8.
2. Charge the fluorescent bite under a direct light source (ideally sun light) for at least
5 minutes.
3. Press slightly the pre-treatment tube to soak the sponge and apply it over the
external face of the teeth.
4. Apply a thin stripe of the gel Instant Smile inside the fluorescent bite. Cover the
whole internal face of the bite.
5. Fold the bite and put it inside your mouth by covering the teeth. Bite it directly and
close the lips for a better fluorescent effect.
6. Leave it for 15 minutes.
Study protocol
2 weeks before D0:

Selection of the volunteers from the data base, an appointment is taken.
D0:
Welcoming of the volunteers, signature of the information and consent form, by the
volunteers and the Study Manager. The volunteers also complete medical auto
questionnaire confirmed by the Investigator.
Clinical exam at the beginning of the study: the Dentist examines individually the
volunteers and assesses the mouth areas put in contact with the tested product.
Teeth colour is scored by the Dentist using the R-20 Bleaching Shade guide.
Using of the whitening kit according to the normal conditions of use.
D0Timm:
Clinical observations of end of study: the Dentist examines individually the volunteers
and assesses the mouth areas put in touch with the product.
Teeth colour is scored by the Dentist using the R-20 Bleaching Shade guide.
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Volunteers interview: the volunteers describe the discomfort manifestations (functional

signs) they may have felt during the study from predefined criteria and in presence of
the Dentist.
Recovery of the acceptability questionnaire.
7.3
Clinical assessments
Assessment of the oral tolerance by the Dentist:

The oral tolerance is assessed by the Investigator, starting from macroscopic examination
(clinical signs: inflammation, oedema, mouth ulcer, bleeding, crack) of the mouth areas in
contact with the product.
The subjective tolerance (functional signs) is assessed by the volunteers from predefined
criteria (sensitive to cold/hot teeth or gingiva, mouth ulcer, bleeding, itching, cracks, bad
breath) during the consultation with the Dentist at the end of the study.
Clinical and functional signs are graded with the following scale:
. 0 => No
. 1 => Slight
. 2 => Moderate
. 3 => Intense
Evaluation of the product acceptability by the volunteers:

The qualities and the performances of the product are assessed by the volunteers, through
a suitable questionnaire developed with the study sponsor, after the use of the product in
normal conditions, once in the laboratory.
Assessment of the whitening efficacy by the Dentist:
The teeth colour is scored by the Dentist, using the R-20 Bleaching Shade guide. This
guide allows ranking the teeth whitening level for each volunteer on D0 and D0Timm.
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Figure 1: R-20 Bleaching Shade guide

7.4
Data analysis and results interpretation
The results obtained are collected, analysed and interpreted by the study manager
according to the normal conditions of use and of the effects investigated by the study
manager.
Assessment of the oral tolerance by the Dentist:
Depending on the percentage of volunteers that showed clinical signs or reported
functional signs, the product global tolerance is determined according to the scale found in
table 1. For each conclusion line, only one criterion has to be reached to lead to the
corresponding conclusion. If the conclusion given by the percentage of volunteers that
showed clinical signs is different from the conclusion given by the percentage of volunteers
that reported functional signs, the global tolerance will be determined by the worst result.
For example, if 10% of the volunteers showed clinical signs of slight or moderated intensity
(good tolerance) and 50% of the volunteers reported functional signs of slight or moderate
intensity (moderate tolerance), the conclusion on the product global tolerance will be of
moderate tolerance.
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Table 1: Tolerance evaluation regarding the percentage of volunteers that showed

intolerance reactions
% of volunteers that showed
clinical signs of intensity:
% of volunteers that reported

functional signs of intensity:
Global
tolerance
Slight or moderate
Intense
Slight or moderate
Intense
Very well
0%
0%
0%
0%
Well
]0%-10%]
0%
]0%-30%]
0%
Moderate
]10%-20%]
]0%-10%]
]30%-50%]
]0%-30%]
Bad
>20%
>10%
>50%
>30%
Evaluation of the product acceptability (qualities and performances) by the

volunteers:
The global volunteers satisfaction regarding the product they tested is determined
according to the positive answers obtained for the following question: Globally are you
satisfied with the product you tested. The scale presented in table 2 is used to determine
the global satisfaction according to the calculated satisfaction rate.
Table 2: Scale to determine product global satisfaction
Added % of totally agree
and agree
Global satisfaction
[80%-100%]
Product very well appreciated
[60%-80%[
Product well appreciated
[40%-60%[
Product moderately appreciated
[20%-40%[
Product little appreciated
[0%-20%[
Product badly appreciated
Assessment of the whitening efficacy by the Dentist:

For each volunteer, the variation of shade is calculated.
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RESULTS
8.1
Description of the panel
This study was carried out on 05/08/2015 and on 06/08/2015 and includes 22 healthy
female and male adult volunteers, whom characteristics are presented in table 3:
Table 3: Volunteers characteristics and events occurred during the study
VOL
VOL CODE
Gender
Age (years)
Yellowed teeth
Events occurred during the

study
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
GEODA
MALEL
MOCLA
BLAMI
BLAMA3
PASFA1
EL TA
FANMI
ZANCA
GIAMI1
VIDJO
CARLA11
RIBST
SERVA1
MAGNA
ALTAN
DELCL
BOUME1
BOUZO
BOUAI1
CANJU
LESCO
F
F
F
F
F
M
M
F
F
F
F
F
F
F
F
F
F
F
F
M
F
F
70
58
48
19
48
43
62
65
25
65
64
47
35
45
53
53
65
37
42
51
19
41
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Average
48
None of the volunteers selected took a treatment contraindicated with the study.
8.2
Study exits
The 22 volunteers who participated in this study gave their opinion regarding the tested
product through the acceptability questionnaire.
The oral tolerance assessment was made on 22 volunteers.
The bleaching efficacy was assessed on 22 volunteers.
The product acceptability was evaluated by the 22 volunteers.
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8.3
Results analysis
- Assessment of the bleaching efficacy by clinical scoring

After a single use, the teeth whiteness increased for 22 volunteers (100% of the panel).
The average bleaching efficacy is equivalent to a benefit of 5.4 shades (2.7 grades) in the
22 volunteers. These results allow highlighting a bleaching efficacy of the product after a
single use.
Appendix I presents the individual results of the clinical scoring by the Dentist.
- Assessment of the oral tolerance
Assessment of the oral tolerance by the Dentist (clinical signs):
No clinical manifestation was noticed, by the Dentist, after a single use, on the 22
volunteers.
Discomfort manifestations (functional signs):
No discomfort manifestation was reported to the dentist by any of the 22 volunteers.
However, 2 volunteers (9%) reported the following discomfort manifestations on their
acceptability questionnaire:
- Moderate tingling inside the mouth, during the whole time of use, by the volunteer
n15.
- Slight tingling on the lips, during a few minutes, by the volunteer n21.
Appendix II presents the results of the oral tolerance assessment by the Dentist.
- Assessment of the acceptability
The INSTANT SMILE product was globally very well appreciated by the 22 volunteers who
took part in the study, with a satisfaction rate of 82%. Moreover, 64% of the volunteers
who were involved in the study would like to buy this product.
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The qualities of the products were assessed by the volunteers through an acceptability
questionnaire. The positive answers are presented in table 4:
Table 4: Acceptability
USE TEST PARAMETERS
Added % of totally
agree and agree
91%
55%
91%
77%
100%
95%
100%
91%
9. The product improves visibly the whiteness of your teeth
73%
68%
Appendix III presents the graphs of global satisfaction, the purchase intention and the
acceptability graph and table.
Conclusion:
To conclude, the INSTANT SMILE product, referenced 59991732 - PRETREATMENT
and referenced 59991733 - WHITENING GEL, used in normal conditions of use, a
single use at the laboratory, by 22 healthy female and male adult volunteers, with
yellowed teeth, is considered as well tolerated regarding the oral tolerance.
The INSTANT SMILE product, led to a bleaching teeth improvement in 100% of the
volunteers with a mean benefit of 5.4 shades (i.e. 2.7 grades).
The performances and the qualities of the product were globally very well
appreciated by the 22 volunteers who participated in the study, with a satisfaction
rate of 82% and a purchase intention of 64%.
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APPENDIX I
Individual results of the clinical scoring by the Dentist
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Assessment of the whitening efficacy by the Dentist
APPENDIX I
Product: INSTANT SMILE

59991732 - PRETREATMENT /
59991733 - WHITENING GEL
ATS sample n: 525668 / 525667
Reference:
Starting date :
05/08/2015
End date :
06/08/2015
Study code: 145TUTE20V15
WHITENING EFFICACY
INCLUSION
NUMBER
VOLUNTEER
CODE
Whiteness onT0
Whiteness on Ti
Ti-T0
GEODA
28
22
-6
MALEL
28
24
-4
MOCLA
22
16
-6
BLAMI
14
12
-2
BLAMA3
32
26
-6
PASFA1
26
16
-10
EL TA
26
18
-8
FANMI
30
26
-4
ZANCA
16
12
-4
10
GIAMI1
30
24
-6
11
VIDJO
28
16
-12
12
CARLA11
16
12
-4
13
RIBST
22
16
-6
14
SERVA1
24
22
-2
15
MAGNA
24
22
-2
16
ALTAN
26
24
-2
17
DELCL
32
26
-6
18
BOUME1
26
16
-10
19
BOUZO
26
22
-4
20
BOUAI1
32
28
-4
21
CANJU
14
10
-4
22
LESCO
26
22
-4
Average
-5,40
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APPENDIX II
Assessment of the oral tolerance after a single application in the laboratory
(functional and clinical signs)
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APPENDIX II
Starting date : 05/08/2015
Product INSTANT SMILE

Reference 59991732 - PRETREATMENT / 59991733 - WHITENING GEL
Study code : 145TUTE20V15
Number of volunteers :
22
Product imputability
D0Ti
D0T0
End date : 06/08/2015
ATS sample n 525668 / 525667
CLINICAL SIGNS
inflammation
dema
mouth ulcer
bleeding
D0T0 D0Ti D0Ti - D0 D0T0 D0Ti D0Ti - D0 D0T0 D0Ti D0Ti - D0 D0T0 D0Ti D0Ti - D0
INCLUSION
NUMBER
VOLUNTEER
CODE
GEODA
MALEL
MOCLA
BLAMI
BLAMA3
PASFA1
EL TA
FANMI
ZANCA
10
GIAMI1
11
VIDJO
12
CARLA11
13
RIBST
14
SERVA1
15
MAGNA
16
ALTAN
-1
-1
17
DELCL
18
BOUME1
19
BOUZO
20
BOUAI1
-1
-1
21
CANJU
22
LESCO
crack
D0T0 D0Ti D0Ti - D0
other
D0T0 D0Ti D0Ti - D0
18
20
20
22
22
22
22
22
22
18
20
20
22
22
22
22
22
22
Number of slight reactions
Number of moderate reactions
Number of intense reactions
No reaction
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ASSESSMENT OF THE ORAL TOLERANCE: evaluation of the clinical signs by the Dentist
Location
D0T0
D0Ti
comments
D0Ti
* scale from 0 to 3 : 0 = no, 1 = slight, 2 = moderated, 3 = intense
710506A01v2.xlsx
APPENDIX II

End date : 06/08/2015
Product INSTANT SMILE

Reference 59991732 - PRETREATMENT / 59991733 - WHITENING GEL
Study code 145TUTE20V15

INCLUSION VOLUNTEER
NUMBER
CODE
1
Number of volunteers :
22
ATS sample n 525668 / 525667
VISIBLE FUNCTIONAL SIGNS

mouth ulcer
bleeding
bad breath
D0T0 D0Ti D0Ti - D0 D0T0 D0Ti D0Ti - D0 D0T0 D0Ti D0Ti - D0
other
D0T0 D0Ti D0Ti - D0
sensitive teeth to cold

D0T0 D0Ti D0Ti - D0
FELT FUNCTIONAL SIGNS

sensitive teeth to hot
sensitive gingiva
itching
other
D0T0 D0Ti D0Ti - D0 D0T0 D0Ti D0Ti - D0 D0T0 D0Ti D0Ti - D0 D0T0 D0Ti D0Ti - D0
GEODA
-1
-2
-2
-1
MALEL
MOCLA
BLAMI
-1
-1
BLAMA3
PASFA1
-1
-1
-1
EL TA
EL TA
FANMI
10
GIAMI1
-1
-1
11
VIDJO
12
CARLA11
-1
13
RIBST
-1
14
SERVA1
-1
-1
-1
15
MAGNA
-1
-1
16
ALTAN
-2
-1
17
DELCL
18
BOUME1
19
BOUZO
-1
20
BOUAI1
21
CANJU
22
LESCO
-1
18
0
0
0
16
1
0
0
22
0
0
0
16
0
0
0
22
1
0
0
22
0
0
0
22
0
0
0
17
1
0
0
22
0
0
0
17
0
0
0
20
1
0
0
22
0
0
0
20
0
0
0
18
1
0
0
22
0
0
0
18
0
0
0
22
1
0
0
22
0
0
0
22
0
0
0
22
1
0
0
22
0
0
0
22
0
0
0
21
22
21
18
22
Number of slight reactions
1
0
0
1
0
Number of moderate reactions 0
0
0
0
0
Number of intense reactions
0
0
0
0
0
* scale from 0 to 3 : 0 = no, 1 = slight, 2 = moderated, 3 = intense
No reaction
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ASSESSMENT OF THE ORAL TOLERANCE: functional signs reported to the Dentist by the volunteers
Location
D0T0
Duration
D0Ti
D0T0
Frequency
D0Ti
D0T0
comments
D0Ti
D0T0
D0Ti
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APPENDIX III
Global satisfaction and purchase intention graphs
Acceptability table
Acceptability histogram
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APPENDIX III
Satisfaction rate and purchase intention
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End date : 06/08/2015
Product : INSTANT SMILE

Reference : 59991732 - PRETREATMENT / 59991733 - WHITENING GEL
Registration : 525668 / 525667
SATISFACTION RATE
Unsatisfied
18%
Satisfied
82%
PURCHASE INTENTION
NO
36%
YES
64%
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Acceptability table

End date : 06/08/2015

USE TEST PARAMETERS
Totally agree
Agree
Disagree
Totally disagree
55%
36%
9%
0%
45%
9%
27%
18%
55%
36%
9%
0%
36%
41%
23%
0%
77%
23%
0%
0%
59%
36%
5%
0%
41%
59%
0%
0%
41%
50%
9%
0%
9.The product improves visibly the whiteness of your teeth
27%
45%
27%
0%
41%
27%
23%
9%
710506A01v2.xlsx
APPENDIX III
Acceptability histogram

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End date : 06/08/2015
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
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APPENDIX IV
Answers to open questions
Reasons why volunteers would buy the

product (64%)
For much clearer appearance of the teeth and clean
appearance
Pleasant sensation of freshness
product
Easy to apply and pleasant taste
Ease of Use
Whiteness visible effect
Because it works
My teeth look a little whiter
I have whiter teeth
It provides a feeling of freshness and slightly
whitened my teeth.
Feeling fresh and whitens teeth
Teeth Whitening
Reasons why volunteers would not buy

the product (36%)
It does not whiten teeth
complex use
Unpleasant to use
Always present tasks / whiter teeth on the
top but not down
I do not know. I did not see any difference,
but normal for one use
Unpleasant to use. Little visible results
Inefficiencies at certain spots on the lower
teeth
Unpleasant (exposure time)
It does not whiten teeth
Remarks and suggestions reported by volunteers regarding the investigational

product
Some mandatory application
Difficult to close the mouth which causes an unpleasant sensation use. Problem if not properly applied, the
teeth do not have the same color
Very nice
Difficulty keeping your mouth closed without swallowing
Swallowing light towards the end of the exposure time. Unconvinced.
Bleaching is not uniform, he laundered some of my teeth
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APPENDIX V
List of the personnel who participated in the study
Main investigator:
Name:
Frederic BIANCHI, M.D Dentist
Address:
ACTIMART
1140 rue Andr Ampre
Phone:
04 42 39 30 92
Study Manager:
Name:
Marion HARO
Address:
ACTIMART
1140 rue Andr Ampre
Phone:
04 42 37 16 21
Laboratory technician, production assistant:

Name:
Camille RAVON
Address:
ACTIMART
1140 rue Andr Ampre
Phone:
04 42 39 30 92
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APPENDIX VI
Results authenticity
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710506A01

EUROFINS BioPharma Product Testing

ASSESSMENT OF THE ORAL TOLERANCE AND OF THE QUALITIES OF A

AUTHENTICITY OF THE STUDY REPORT

Study Manager, Marion HARO

Frederic BIANCHI, M.D Dentist

Place of the study:

EUROFINS ATS, ACTIMART

Directions for use:

However, 2 volunteers (9%) reported the following discomfort manifestations on their

2. The whitening kit is pleasant to use

4. After use, your teeth are whiter

5. The whitening kit provides a fresh breath

6. The whitening kit is gentle to the gums

7. Your gums feel protected

8. The product is gentle to the teeth enamel

9. The product improves visibly the whiteness of your teeth

QUALITY CONTROL AND INSURANCE ............................................................. 11

STUDIED PANEL .................................................................................................. 11

TESTED PRODUCTS ............................................................................................ 13

CLINICAL STUDY ................................................................................................. 14

Answers to open questions ................................................................................ 30

ETHIC AND REGULATORY CONSIDERATIONS CONCERNING PROTECTION OF

The ethic requirements, necessary to studies on Human, are respected:

QUALITY CONTROL AND INSURANCE

Recruitment, selection and final admittance of volunteers for a study

The volunteers corresponding to the following criteria are included:

Age : 18-70 years old,

For the whole length of the study, it is asked to volunteers:

room temperature, away from light and heat

Area of application: Teeth

2 weeks before D0:

Volunteers interview: the volunteers describe the discomfort manifestations (functional

Assessment of the oral tolerance by the Dentist:

Evaluation of the product acceptability by the volunteers:

Figure 1: R-20 Bleaching Shade guide

Data analysis and results interpretation

Table 1: Tolerance evaluation regarding the percentage of volunteers that showed

% of volunteers that reported

Evaluation of the product acceptability (qualities and performances) by the

Product very well appreciated

Product well appreciated

Product moderately appreciated

Product little appreciated

Product badly appreciated

Assessment of the whitening efficacy by the Dentist:

Description of the panel

Events occurred during the

- Assessment of the bleaching efficacy by clinical scoring

2. The whitening kit is pleasant to use

4. After use, your teeth are whiter

5. The whitening kit provides a fresh breath

6. The whitening kit is gentle to the gums

7. Your gums feel protected

8. The product is gentle to the teeth enamel

9. The product improves visibly the whiteness of your teeth

Assessment of the whitening efficacy by the Dentist

Product: INSTANT SMILE

Study code: 145TUTE20V15

Starting date : 05/08/2015

Product INSTANT SMILE

Study code : 145TUTE20V15

End date : 06/08/2015

ATS sample n 525668 / 525667