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Malodor Clinical Research
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Research Studies - Renhite Effects of Treatment on Oral Malodor in Dogs

Abstract
The purpose of the study is to collect and correlate data on the effect of a once daily systemic preparation (tablet) on oral malodor in dogs. The test will be comprised of an experimental pill regimen.

Introduction
For purposes of providing real-world studies of the product, Renhite is conducting a dog model research study for LaSenti-CF. This real-world study will provide LaSenti-CF and it's customers with a semi-controlled home environment. In a controlled environment all factors are carefully controlled and monitored. This study will be a more relevant and true to real-world example.

Method
This program is designed to evaluate a product, which has been designed for dogs and other pets. This product may have potential effects on improving the oral health of dogs and other animals by reducing the oral malodor. Furthermore, because the product may have potential to decrease oral malodor which is caused by tartar and plaque build-up, the product could improve the pets overall oral health. Due to the non-existence of suitable in vitro models for studies of this nature the dog is the appropriate model.

This study is designed as a two week test. The dog will be fed a nutritionally complete diet of dry dog food at approximately 10:00 a.m. and 5:00 p.m. daily (340 g). The test pills will be provided once daily at 7:00 a.m. for the entire two-week (14 day) duration of the test.

A Halimeter will be used to measure Volatile Sulfur Compounds (VSC). The meter will be turned on for at least 20 minutes prior to use. The sampling tube will be placed parallel to the buccal Maxillary P4. Cheek mucosa will be kept away from the end of the sampling tube and the animal's mouth closed. The highest reading after a stabilization period (10-15 seconds) will be recorded. Right and left anterior areas will be sampled. The Halimeter was introduced in the early 1990s as an adjunct method for determining halitosis (bad breath, oral malodor) levels; alongside human assessment of odor levels (the latter is considered the gold standard). The instrument measures parts per billion levels of hydrogen sulfide and, to a lesser extent, methyl mercaptan, two gases which were previously shown to be associated with bad breath using gas chromatograph by Dr. Joseph Tonzetich in the late 1960s.

Normal breath readings will be between 80-150 ppb. Below are other various levels of ppb and a description of their readings:

* 200-300 ppb, oral malodor is noticeable by an observer
* 350-400 ppb, the odor is noticeable by an observer standing several feet away
* 500-700 ppb, the odor is more noticeable due to foul smell
* 1000+ ppb, the odor will linger for several minutes after the patient leaves the room

All records, protocols, amendments, data will be maintained in electronic formats within the Renhite LabBase System.

Results
The results are quantitatively displayed and correlated to make viewing means and averages easier. The results are as follows:

Oral Malodor (ppb) Body Weight
(kg)
Dietary (g) % Change
Phase I (June 4-10)
Baseline 375 10 340 na
Day 3 341 10 340 34%
Day 7 283 10 340 58%
Phase II (June 11-17)
Baseline 230 10 340 53%
Day 3 180 10 340 50%
Day 7 136 10 340 44%
Total % Change 239%
Duration of Study (days) 14
Average ppb 258
Median ppb 257

Conclusions
We searched for a dog with a high level of odor. Overall LaSenti-CF has decreased odor up to 239% within a 14 day period. Conclusion of the study is that LaSenti-CF definitely normalizes odor. Therefore, we can safely say that LaSenti-CF reduces odor to the point of elimination.

Tablet manufacturer asked clinical operator and owner to give their practical opinions on the odor reduction. The pet owner noticed the odor was gone after the third day and the clinical operator noticed the odor was gone after the third day.

 

These statements have not been evaluated by the FDA. LaSenti-CF products are not intended to diagnose, treat, cure or prevent any disease or illness.

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