Teeth Whitening Efficacy of Gurunanda® Dual Chamber Whitening Mouthwash
Objective
The purpose of this study was to assess the teeth whitening efficacy of Gurunanda® Dual Chamber mouthwash.
Process
A single center, randomized, open-label clinical study was conducted to assess the teeth-whitening efficacy of Gurunanda® Dual Chamber Whitening Mouthwash over a period of 2 weeks. A total of 60 adult volunteers, encompassing both men and women, were enrolled based on their tooth shades, which were B2 or darker on a VITAPAN classic scale. These 60 eligible subjects were randomly assigned to either Group A or Group B, with 30 participants in each group. The allocation was determined using Computer Generated randomization. Group A received the active product, an ADA approved toothpaste and a toothbrush, whereas Group B served as the control group, and received only the toothpaste and toothbrush. Safety assessments and tooth shade evaluations were conducted at the beginning of the study and once again at a two-week interval. Throughout the study, oral safety assessments and measurements of tooth shade were conducted by a licensed dentist. Changes in mean tooth shade were subsequently calculated based on the scores provided by the dentist during the shade assessment.
Results
|
Active Group |
Control Group |
||
|
Subject Number |
Average Shade at 2 Weeks |
Subject Number |
Average Shade at 2 Weeks |
|
001 |
3 |
003 |
1 |
|
002 |
0 |
006 |
1 |
|
004 |
2 |
008 |
0 |
|
005 |
4 |
009 |
0 |
|
007 |
5 |
010 |
0 |
|
011 |
4 |
012 |
0 |
|
013 |
3 |
021 |
0 |
|
014 |
4 |
022 |
0 |
|
015 |
3 |
034 |
0 |
|
016 |
4 |
037 |
0 |
|
017 |
3 |
038 |
1 |
|
018 |
3 |
039 |
1 |
|
019 |
3 |
040 |
0 |
|
020 |
2 |
041 |
0 |
|
023 |
4 |
044 |
0 |
|
024 |
4 |
046 |
0 |
|
025 |
3 |
047 |
0 |
|
026 |
3 |
048 |
0 |
|
027 |
5 |
049 |
0 |
|
028 |
3 |
050 |
0 |
|
029 |
3 |
051 |
0 |
|
030 |
4 |
052 |
0 |
|
031 |
2 |
053 |
0 |
|
032 |
2 |
054 |
0 |
|
033 |
3 |
055 |
0 |
|
035 |
2 |
056 |
0 |
|
036 |
2 |
057 |
0 |
|
042 |
4 |
058 |
0 |
|
043 |
3 |
059 |
0 |
|
045 |
3 |
060 |
0 |
|
Average Shade Change |
3.10 |
|
0.13 |
Table1: Mean tooth shade score (Each average shade score corresponds to the mean of shade assessments conducted by a licensed dentist on a set of four maxillary teeth)
Conclusion
No adverse effects were reported during the course of this study. Based on the VITAPAN Classic shade guide, the active group (Group A), demonstrated an average change in tooth shade of 3.1. Conversely, the control group (Group B) displayed an average tooth shade change of 0.13. Refer to Table 1 for the detailed data table. The data additionally indicates that more than 75% of the subjects, specifically 23 out of 30, who used Gurunanda Dual Chamber Whitening Mouthwash, demonstrated an improvement of at least 3 shades compared to their baseline teeth shade scores.