Thanks for visiting TheraBreath.com to learn more about the recent study conducted by PRINCETON CONSUMER RESEARCH using the test article, TheraBreath Mild Mint Oral Rinse.
A randomized, double blind study in 63 subjects to evaluate the efficacy of one test article to control the breath odour 13 hours after a single use compared to an untreated control group and a positive control group using hedonic assessments
The study concluded: "that for the test articles the claims of 'breath freshening' and 'freshens breath for over 12 hours' are valid."
Summary of Results
LOCATION AND DATES OF THE STUDY:
The study was performed at Princeton Consumer Research, Princeton Forrestal Center, 307 College Road East, Princeton, NJ, 08540, USA, between 13th October 2014 and 24th October 2014.
SUBJECTS:
63 subjects were recruited into the study and completed the study.
ADVERSE EVENTS, ADVERSE REACTIONS AND SUBJECTS NOT COMPLETING THE STUDY:
No adverse events or reactions were reported. All subjects completed the study.
ASSESSMENTS:
There was no statistically significant difference for the pre-treatment assessments between the test groups for any of the judges or between judges (p>0.05) so the study can be considered valid. Both the Test Article and Positive Control showed a highly statistically significant difference to the untreated baseline sites (p<0.005) in all assessments. All judges were statistically similar at all-time points and sites (p>0.05) and so assessments can be considered as accurate.
STATISTICAL OVERVIEW:
Baseline treatment assessments:
| J1 | J2 | J3 | J4 | Average | |
| Mean Group 1 |
5.89
|
5.42
|
5.95
|
5.63
|
5.72
|
| Mean Group 2 |
6.73
|
6.55
|
6.55
|
6.77
|
6.65
|
| Mean Group 3 |
6.82
|
6.35
|
6.53
|
7.12
|
6.71
|
1 hour treatment assessments:
| J1 | J2 | J3 | J4 | Average | |
| Mean Group 1 |
2.11
|
1.89
|
2.32
|
2.26
|
2.14
|
| Mean Group 2 |
2.32
|
2.23
|
2.55
|
2.36
|
2.36
|
| Mean Group 3 |
7.06
|
6.59
|
7.12
|
7.41
|
7.04
|
13 hours treatment assessments:
| J1 | J2 | J3 | J4 | Average | |
| Mean Group 1 |
2.84
|
3.16
|
3.53
|
2.89
|
3.11
|
| Mean Group 2 |
3.41
|
3.59
|
3.41
|
3.27
|
3.42
|
| Mean Group 3 |
8.24
|
7.53
|
7.94
|
8.00
|
7.93
|
P-value Assessments:
| 1 | 2 | 3 | |
| bl vs 1 |
1.04E-07
|
5.94E-11
|
4.02E-02
|
| bl vs 13 |
1.09E-05
|
1.96E-10
|
5.39E-06
|
CONCLUSIONS:
It can be concluded that for the test articles the claims of "breath freshening" and "freshens breath for over 12 hours" are valid.
For a complete copy of this study, please send a written request to:
Dr. Harold Katz, LLC
ATTN: Clinical Study Request
5802 Willoughby Ave
Los Angeles, CA 90038