Thanks for visiting TheraBreath.com to learn more about the recent study conducted by PRINCETON CONSUMER RESEARCH using the test article, TheraBreath Toothpaste.
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 49 subjects completed the study. Eight subjects were removed from the study for non-compliance or withdrew due to 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 | 6.06 | 6.11 | 6.06 | 6.11 | 6.08 |
| Mean Group 2 | 5.83 | 5.72 | 5.72 | 5.72 | 5.75 |
| Mean Group 3 | 5.75 | 5.69 | 5.44 | 5.50 | 5.59 |
1 hour treatment assessments:
| J1 | J2 | J3 | J4 | Average | |
|---|---|---|---|---|---|
| Mean Group 1 | 3.67 | 3.56 | 3.22 | 4.06 | 3.63 |
| Mean Group 2 | 3.50 | 3.33 | 3.22 | 3.28 | 3.33 |
| Mean Group 3 | 5.50 | 5.50 | 5.25 | 5.13 | 5.34 |
13 hours treatment assessments:
| J1 | J2 | J3 | J4 | Average | |
|---|---|---|---|---|---|
| Mean Group 1 | 4.06 | 4.00 | 4.00 | 4.06 | 4.03 |
| Mean Group 2 | 4.17 | 3.94 | 4.06 | 4.06 | 4.06 |
| Mean Group 3 | 6.13 | 6.13 | 5.88 | 5.88 | 6.00 |
Within-treatment P-value Assessments:
| 1 | 2 | 3 | |
|---|---|---|---|
| bl vs 1 | 2.57E-09 | 5.94E-11 | 3.73E-02 |
| bl vs 13 | 1.30E-06 | 3.89E-04 | 7.09E-02 |
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, LLCATTN: Clinical Study Request
5802 Willoughby Ave
Los Angeles, CA 90038