Thanks for visiting TheraBreath.com to learn more about the recent study conducted by PRINCETON CONSUMER RESEARCH using the test article, TheraBreath Icy Mint Oral Rinse.
A randomized, double blind study in 64 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:
64 subjects were recruited into the study and completed the study. 6 subjects withdrew from the study for reasons unrelated to 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 |
6.05
|
6.00
|
5.95
|
6.16
|
6.04
|
Mean Group 2 |
5.89
|
5.95
|
5.63
|
5.74
|
5.80
|
Mean Group 3 |
5.50
|
5.70
|
5.60
|
5.85
|
5.66
|
1 hour treatment assessments:
J1 | J2 | J3 | J4 | Average | |
Mean Group 1 |
3.00
|
3.32
|
3.26
|
2.74
|
3.08
|
Mean Group 2 |
2.79
|
2.79
|
2.84
|
2.84
|
2.82
|
Mean Group 3 |
5.50
|
6.00
|
6.10
|
5.95
|
5.89
|
13 hours treatment assessments:
J1 | J2 | J3 | J4 | Average | |
Mean Group 1 |
3.63
|
3.32
|
3.37
|
3.84
|
3.54
|
Mean Group 2 |
4.16
|
4.21
|
3.74
|
4.00
|
4.03
|
Mean Group 3 |
6.15
|
6.00
|
6.35
|
6.35
|
6.21
|
P-value Assessments:
1 | 2 | 3 | |
bl vs 1 |
1.89E-12
|
5.94E-11
|
3.51E-02
|
bl vs 13 |
1.36E-11
|
4.51E-06
|
7.73E-05
|
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