STUDY/PRODUCT REFERENCES: 17-1015/0 / 17.

0363

ASSESSMENT IN HUMAN OF THE TOOTH WHITENING EFFECT

OF A COSMETIC TREATMENT

-Objective evaluation-

SPONSOR: GRUPO BONIQUET SPARCHIM S.A.

TEST TREATMENT:
INSTANT SMILE REF: 59991732 PRETREATMENT/
599991733 WHITENING GEL

Preliminary results

Barcelona, July 27th, 2017

3 pages in this document

EUROFINS EVIC PRODUCT TESTING SPAIN, S.L.U. / R .M . Ba r c e lo n a , T o m o 4 5 . 4 27 , F o l io 1 0 2, H o j a B 2 04 5 4 3, I n s c r i p c i n 1 4, C . I .F . B- 6 2 07 4 7 37

Ausis March, 148-150 08013 Barcelona - Spain - Tel. +34 93 285 14 46 - www.evichispania.com - E-mail: EurofinsEvicSpain@eurofins.com

EV-107/033-B
 Study ref.: 17-1015/0 / 17.0363

RESULTS / DISCUSSION

Assessment of the tooth whitening effect

1) Descriptive analysis

The tooth whitening effect of the treatment was assessed objectively and semi-quantitatively, by
clinical score of the tooth colour shade following the R-20 Bleaching Shade guide, performed by a
dentist before and after treatment.

The following table shows the mean values and standard deviations obtained for each experimental
time and its variation.

(n= 19 subjects)

Tooth colour shade

Mean SD Variations

D0/Timm- D7/T0- D7/Timm- D7/Timm-

D0/T0 D0/Timm D7/T0 D7/Timm
D0/T0 D0/T0 D7/T0 D0/T0

21 5 15 4 13 4 11 3 -6 -8 -2 -10

Discussion:

Immediately after the first application, it was observed a mean decrease of 6 points in the tooth
colour shade indicating that the treatment has a tooth whitening effect.

After 6 consecutive applications (one per day) the tooth colour shade decreased a mean of 8 points.

Immediately after the last application performed on D7, the tooth colour shade has a mean decrease
of 2 points in relation to the basal value obtained this day.

After 7 consecutive applications (one per day) the tooth colour shade decreased a mean of 10 points.

2) Statistical analysis

The statistical analysis (Wilcoxons signed exact rank test) allowed to compare the variation of the
parameter before and after treatment.

Wilcoxons signed exact Significance of the

W value p value
rank test difference*

D0/Timm- D0/T0 190 3.82x10-6 S

D7/T0- D0/T0 190 3.82x10-6 S

D7/Timm- D7/T0 105 0.00012 S

D7/Timm- D0/T0 190 3.82x10-6 S

*S=significant if p < 0.05 NS=non significant

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Conclusion:

The statistical analysis shows a statistically significant decrease of the tooth colour shade after a
single application and after 6 and 7 consecutive applications (one per day) indicating that the
treatment has a tooth whitening effect.

CONCLUSION

According to the experimental conditions adopted and taking into account the evolution of the
parameter, the treatment INSTANT SMILE REF: 59991732 PRETREATMENT /
599991733 WHITENING GEL has a statistically significant tooth whitening effect:

- after a single application reducing 6 points the tooth colour shade

- after 6 consecutive applications (one per day) reducing 8 points the tooth colour shade
- after 7 consecutive applications (one per day) reducing 10 points the tooth colour shade

EV-107/033-B 3