SINGLE-CELL SAFETY AND EFFICACY EVALUATION
OF TEETH WHITENING PRODUCT

Teeth Whitening Gel Formula #502-1014-A 35%cp


1.0 OBJECTIVE

The objective of this study was to determine if the use of a teeth whitening product whitened the teeth immediately following a single use in a panel of 35 male and female subjects, aged 18-45 years.The majority of subject were to be individuals with stained teeth who were smokers, wine drinkers and/or carbonated beverage drinkers.



3.0 CLINICALLY INVESTIGATORS

Study Director:


Principle Investigator::


Medical Investigator:

Annemarie E. Hollenback, BA
Laboratory Manager

Toni F. Miller, PhD, DABT, BCFE
Scientific Director

Stuart Isler, DMD



4.0 CLINICAL TESTING FACILITY

Essex Testing Clinic, Inc.
799 Bloomfield Avenue
Verona, NJ 07044



5.0 STUDY SATES

Group 1: 11/12/10
Group 2: 11/19/10

Essex Testing Clinic, Inc. ________________________
Amended 3/16/11



6.0 ETHICS


6.1 Ethical Conduct of the Study

This was conducted in accordance with the intent and purpose of Good Clinical Practice regulations described in Title 21 of the U.S. Code of Federal Regulations (CFR), the Declaration of Helsinki and/or Essex Testing Clinic (ETC) Standard Operating Procedures (SOPs).


6.2 Subject Information and Consent

This study was conducted in compliance with CFR Title 21, Part 50 (Informed Consent of Human Subjects). Informed Consent was obtained from each subject in the study and documented in writing before participation in the study. A copy of the informed Consent was provided to each subject.





7.0 TEST ARTICLE

It was received on October 14, 2010 and identified as follows:

ETC
Enty No.
19076

Qty
Received
45 kits


Test Article I.D.
Teeth Whitening Gel Formula
#502-1014-A 35%cp

Physical
Description
Each kit contained:
2 syringes, 1 mouth tray, 1 light device and 4 aloe And vitamin E swabs



8.0 TEST SUBJECTS

A sufficient number of male and female subjects raging in age from 18 to 45 years were to be empanelled for the testing procedures so that approximately 35 subjects would complete the study.

Essex Testing Clinic, Inc. ________________________
Amended 3/16/11



9.0 STUDY DESIGN (CONT’D)


9.2 Test Procedure

The study was designed as a 1-day, single-use study in which the test article was used by each of the test panelists according to Sponsor’s use instructions.

Subjects reported to the Testing Facility for the baseline visit. The Medical Investigator examined the teeth and gums of each subject to determined the subject did not have any-existing irritation or condition present which would have precluded use of the test article. Additionally, the Medical Investigator also assigned a Vita® shade grade to each of four selected teeth. The location of teeth that were selected and the Vita® shade grade assigned to each tooth was recorded on each subject data sheet. A trained technician took digital photographs of each subject.

Ordinal changes in shade values were calculated using the conversion defined in Table 1. The numerical equivalent of the Vita® shade guide evaluations were used for ordering sequence. By this scale, B1 (lightest) = 1 and C4 (darkest) = 16. Hence, the larger shade guide values are darker.


Table 1

Ordinal Designation of tooth Shades

Shade Number Designation
1 B1
2 A1
3 B2
4 D2
5 A2
6 C1
7 C2
8 D4
9 A3
10 D3
11 B3
12 A3.5
13 B4
14 C3
15 A4
16 C4

Essex Testing Clinic, Inc. ________________________



10.0 RESULT AND DISCUSSION

Thirty-five (35) subject, 6 males and 29 female between the age 18 and 46 years, were empanelled. A protocol deviation occurred when one (1) test subject was enrolled outside of the age ranged specified in the protocol. (Subject No. 11 was 46 years of age.) This deviation did not affect the integrity of the study. Subject demographics are presented in Appendix 1.


10.1 Vita® shade Grading

Prior to product application and following a single use of the test product, the study dentist examined the teeth of each subject and assigned a Vita® shade grade to each of four selected teeth. Ordinal changes in shade guide values were calculated using the conversion defined in the table found in Section 9.2. The numerical equivalent of the Vita® shade guide evaluation were for ordering sequence. By this scale, B1 (lightest) = 1 and C4 (darkest) = 16. Hence, the larger shade guide value are darker. Individual Vita® shade values and statistical analysis are presented in Appendix 2, Table 1-4.

  The following table presented a summary of mean Vita® shade scores.

Mean Vita® shade Scores ( ± Standard Deviation [S.D.])
and Mean % Improvement from Baseline

Pre-Application
Men Score
Post-Application
Mean Score
P-Value Mean % Improvement
from Baseline
Tooth #1 4.1 ± 2.1 3.4* ± 2.1 0.001 18%
Tooth #2 3.8 ± 2.2 3.0* ± 1.8 0.008 14%
Tooth #3 3.8 ± 2.2 3.1* ± 1.7 0.006 10%
Tooth #4 4.1 ± 2.1 3.3 ± 2.1 0.006 14%

*statistically significant difference from baseline, p≤0.05

When Vita® shade grades assigned prior to product application were compared to grades assigned following a single use of the test product, there was:

  • • An 18% improvement in Vita® shade scores for tooth #1 following a single application of the test product;
  • • A 14% improvement in Vita® shade scores for tooth #2 following a single application of the test product;
  • • A 10% improvement in Vita® shade scores for tooth #3 following a single application of the test product; and
  • • A 14% improvement in Vita® shade scores for tooth #4 following a single application of the test product.

The improvement observed for each tooth were statistically significant (p≤0.05) when compared with baseline.

Essex Testing Clinic, Inc. ________________________


10.0 RESULT AND DISCUSSION (CONT’D)


10.3 Irritation Evaluation

Prior to product application and following a single use of the test products, the study dentist examined the mouth, teeth and gums of each subject for irritation. Individual irritation scores are presented in Appendix 4.

There was no irritation observed on the mouth, teeth or gums of any subject prior to or following a single use of the test product.



11.0 CONCLUSIONS

A single-cell safety and efficacy study was conducted with 35 male and female subject to determine if Test Article: Teeth Whitening Gel Formula #502-1014A 35%cp whitened the teeth immediately following a single, 15-minutes use of the test product.

Vita® Shade Grade were significantly improved on four selected teeth following a single use of the test product, with up to a6 shade improvement observed.

Tooth Color was significantly lightened, based on image analysis, on both the upper right and left incisors, following a single use of the test product.

There was no irritation observed during the course of the study.



Essex Testing Clinic, Inc. ________________________
Amended 3/16/11



ETC Panel No.: 10307

ETC Entry No.: 19076

APPENDIX 1
SUBJECT DEMOGRAPHICS
Test Article: Teeth Whitening Gel Formula #502-10140-A 35%cp

Subject No. Initials Age Sex Race
1 KLJ 38 F BA
2 CET 19 F BA
3 D-C 42 F CA
4 KMD 30 F CA
5 ASC 26 M BA
6 SAP 21 F CA
7 R-C 42 M CA
8 B-C 44 F CA
9 JMC 22 F CA
10 L-M 42 F CA
11 SCW 46 F CA
12 JPK 20 F CA
13 F-S 43 F CA
14 A-H 28 F BA
15 M-M 44 F CA
16 Z-M 18 M CA
17 L-D 44 F CA
18 SOG 31 F CA
19 LMS 42 F CA
20 S-F 42 F CA
21 A-J 44 F HS
22 KIB 42 F CA
23 CAZ 31 F CA
24 J-Z 29 F HS
25 JPD 22 M CA
26 MET 41 M CA
27 YKL 41 F BA
28 TML 38 F BA
29 MLT 30 F BA
30 AHA 35 F BA
31 JAS 19 F CA
32 SAF 24 F BA
33 A-G 27 F BA
34 JKC 31 M BA
35 JMC 25 F CA

BA = Black
CA = White (Non-Hispanic)
HS = Hispanic

Essex Testing Clinic, Inc. ________________________
Amended 3/16/11



ETC Panel No.: 10307

ETC Entry No.: 19076

APPENDIX 4
IRRITATION EVALUATION
Test Article: Teeth Whitening Gel Formula #502-1014A 35%cp

Subject No. Are the subject’s mouth, teeth and gums free of any condition that would prohibit use of the test product? Is there any irritation preset in subject’s mouth. Teeth and gums free of any conditions that you would attribute to use of the test product?
1 Yes No
2 Yes No
3 Yes No
4 Yes No
5 Yes No
6 Yes No
7 Yes No
8 Yes No
9 Yes No
10 Yes No
11 Yes No
12 Yes No
13 Yes No
14 Yes No
15 Yes No
16 Yes No
17 Yes No
18 Yes No
19 Yes No
20 Yes No
21 Yes No
22 Yes No
23 Yes No
24 Yes No
25 Yes No
26 Yes No
27 Yes No
28 Yes No
29 Yes No
30 Yes No
31 Yes No
32 Yes No
33 Yes No
34 Yes No
35 Yes No

Essex Testing Clinic, Inc. ________________________
Amended 3/16/11

SINGLE-CELL SAFETY AND EFFICACY EVALUATION
OF TEETH WHITENING PRODUCT

Teeth Whitening Gel Formula #502-1014-A 35%cp


1.0 OBJECTIVE

The objective of this study was to determine if the use of a teeth whitening product whitened the teeth immediately following a single use in a panel of 35 male and female subjects, aged 18-45 years.The majority of subject were to be individuals with stained teeth who were smokers, wine drinkers and/or carbonated beverage drinkers.



3.0 CLINICALLY INVESTIGATORS

Study Director:


Principle Investigator::


Medical Investigator:

Annemarie E. Hollenback, BA
Laboratory Manager

Toni F. Miller, PhD, DABT, BCFE
Scientific Director

Stuart Isler, DMD



4.0 CLINICAL TESTING FACILITY

Essex Testing Clinic, Inc.
799 Bloomfield Avenue
Verona, NJ 07044



5.0 STUDY SATES

Group 1: 11/12/10
Group 2: 11/19/10

Essex Testing Clinic, Inc. ________________________
Amended 3/16/11



6.0 ETHICS


6.1 Ethical Conduct of the Study

This was conducted in accordance with the intent and purpose of Good Clinical Practice regulations described in Title 21 of the U.S. Code of Federal Regulations (CFR), the Declaration of Helsinki and/or Essex Testing Clinic (ETC) Standard Operating Procedures (SOPs).


6.2 Subject Information and Consent

This study was conducted in compliance with CFR Title 21, Part 50 (Informed Consent of Human Subjects). Informed Consent was obtained from each subject in the study and documented in writing before participation in the study. A copy of the informed Consent was provided to each subject.





7.0 TEST ARTICLE

It was received on October 14, 2010 and identified as follows:

ETC
Enty No.
19076

Qty
Received
45 kits


Test Article I.D.
Teeth Whitening Gel Formula
#502-1014-A 35%cp

Physical
Description
Each kit contained:
2 syringes, 1 mouth tray, 1 light device and 4 aloe And vitamin E swabs



8.0 TEST SUBJECTS

A sufficient number of male and female subjects raging in age from 18 to 45 years were to be empanelled for the testing procedures so that approximately 35 subjects would complete the study.

Essex Testing Clinic, Inc. ________________________
Amended 3/16/11



9.0 STUDY DESIGN (CONT’D)


9.2 Test Procedure

The study was designed as a 1-day, single-use study in which the test article was used by each of the test panelists according to Sponsor’s use instructions.

Subjects reported to the Testing Facility for the baseline visit. The Medical Investigator examined the teeth and gums of each subject to determined the subject did not have any-existing irritation or condition present which would have precluded use of the test article. Additionally, the Medical Investigator also assigned a Vita® shade grade to each of four selected teeth. The location of teeth that were selected and the Vita® shade grade assigned to each tooth was recorded on each subject data sheet. A trained technician took digital photographs of each subject.

Ordinal changes in shade values were calculated using the conversion defined in Table 1. The numerical equivalent of the Vita® shade guide evaluations were used for ordering sequence. By this scale, B1 (lightest) = 1 and C4 (darkest) = 16. Hence, the larger shade guide values are darker.


Table 1

Ordinal Designation of tooth Shades

Shade Number Designation
1 B1
2 A1
3 B2
4 D2
5 A2
6 C1
7 C2
8 D4
9 A3
10 D3
11 B3
12 A3.5
13 B4
14 C3
15 A4
16 C4

Essex Testing Clinic, Inc. ________________________



10.0 RESULT AND DISCUSSION

Thirty-five (35) subject, 6 males and 29 female between the age 18 and 46 years, were empanelled. A protocol deviation occurred when one (1) test subject was enrolled outside of the age ranged specified in the protocol. (Subject No. 11 was 46 years of age.) This deviation did not affect the integrity of the study. Subject demographics are presented in Appendix 1.


10.1 Vita® shade Grading

Prior to product application and following a single use of the test product, the study dentist examined the teeth of each subject and assigned a Vita® shade grade to each of four selected teeth. Ordinal changes in shade guide values were calculated using the conversion defined in the table found in Section 9.2. The numerical equivalent of the Vita® shade guide evaluation were for ordering sequence. By this scale, B1 (lightest) = 1 and C4 (darkest) = 16. Hence, the larger shade guide value are darker. Individual Vita® shade values and statistical analysis are presented in Appendix 2, Table 1-4.

  The following table presented a summary of mean Vita® shade scores.

Mean Vita® shade Scores ( ± Standard Deviation [S.D.])
and Mean % Improvement from Baseline

Pre-Application
Men Score
Post-Application
Mean Score
P-Value Mean % Improvement
from Baseline
Tooth #1 4.1 ± 2.1 3.4* ± 2.1 0.001 18%
Tooth #2 3.8 ± 2.2 3.0* ± 1.8 0.008 14%
Tooth #3 3.8 ± 2.2 3.1* ± 1.7 0.006 10%
Tooth #4 4.1 ± 2.1 3.3 ± 2.1 0.006 14%

*statistically significant difference from baseline, p≤0.05

When Vita® shade grades assigned prior to product application were compared to grades assigned following a single use of the test product, there was:

  • • An 18% improvement in Vita® shade scores for tooth #1 following a single application of the test product;
  • • A 14% improvement in Vita® shade scores for tooth #2 following a single application of the test product;
  • • A 10% improvement in Vita® shade scores for tooth #3 following a single application of the test product; and
  • • A 14% improvement in Vita® shade scores for tooth #4 following a single application of the test product.

The improvement observed for each tooth were statistically significant (p≤0.05) when compared with baseline.

Essex Testing Clinic, Inc. ________________________


10.0 RESULT AND DISCUSSION (CONT’D)


10.3 Irritation Evaluation

Prior to product application and following a single use of the test products, the study dentist examined the mouth, teeth and gums of each subject for irritation. Individual irritation scores are presented in Appendix 4.

There was no irritation observed on the mouth, teeth or gums of any subject prior to or following a single use of the test product.



11.0 CONCLUSIONS

A single-cell safety and efficacy study was conducted with 35 male and female subject to determine if Test Article: Teeth Whitening Gel Formula #502-1014A 35%cp whitened the teeth immediately following a single, 15-minutes use of the test product.

Vita® Shade Grade were significantly improved on four selected teeth following a single use of the test product, with up to a6 shade improvement observed.

Tooth Color was significantly lightened, based on image analysis, on both the upper right and left incisors, following a single use of the test product.

There was no irritation observed during the course of the study.



Essex Testing Clinic, Inc. ________________________
Amended 3/16/11



ETC Panel No.: 10307

ETC Entry No.: 19076

APPENDIX 1
SUBJECT DEMOGRAPHICS
Test Article: Teeth Whitening Gel Formula #502-10140-A 35%cp

Subject No. Initials Age Sex Race
1 KLJ 38 F BA
2 CET 19 F BA
3 D-C 42 F CA
4 KMD 30 F CA
5 ASC 26 M BA
6 SAP 21 F CA
7 R-C 42 M CA
8 B-C 44 F CA
9 JMC 22 F CA
10 L-M 42 F CA
11 SCW 46 F CA
12 JPK 20 F CA
13 F-S 43 F CA
14 A-H 28 F BA
15 M-M 44 F CA
16 Z-M 18 M CA
17 L-D 44 F CA
18 SOG 31 F CA
19 LMS 42 F CA
20 S-F 42 F CA
21 A-J 44 F HS
22 KIB 42 F CA
23 CAZ 31 F CA
24 J-Z 29 F HS
25 JPD 22 M CA
26 MET 41 M CA
27 YKL 41 F BA
28 TML 38 F BA
29 MLT 30 F BA
30 AHA 35 F BA
31 JAS 19 F CA
32 SAF 24 F BA
33 A-G 27 F BA
34 JKC 31 M BA
35 JMC 25 F CA

BA = Black
CA = White (Non-Hispanic)
HS = Hispanic

Essex Testing Clinic, Inc. ________________________
Amended 3/16/11



ETC Panel No.: 10307

ETC Entry No.: 19076

APPENDIX 4
IRRITATION EVALUATION
Test Article: Teeth Whitening Gel Formula #502-1014A 35%cp

Subject No. Are the subject’s mouth, teeth and gums free of any condition that would prohibit use of the test product? Is there any irritation preset in subject’s mouth. Teeth and gums free of any conditions that you would attribute to use of the test product?
1 Yes No
2 Yes No
3 Yes No
4 Yes No
5 Yes No
6 Yes No
7 Yes No
8 Yes No
9 Yes No
10 Yes No
11 Yes No
12 Yes No
13 Yes No
14 Yes No
15 Yes No
16 Yes No
17 Yes No
18 Yes No
19 Yes No
20 Yes No
21 Yes No
22 Yes No
23 Yes No
24 Yes No
25 Yes No
26 Yes No
27 Yes No
28 Yes No
29 Yes No
30 Yes No
31 Yes No
32 Yes No
33 Yes No
34 Yes No
35 Yes No

Essex Testing Clinic, Inc. ________________________
Amended 3/16/11