Amabrush August News
Yes, everything is still on track, and we were able to gather all delivery dates for all countries you have pre-ordered from! Please have a look at the following chart for specific delivery dates:
As we have told you in a previous update, we are in constant exchange with FDA, the U.S. Federal Food and Drug Administration, to ensure compliance with all applicable laws and regulations. Earlier this year, we’ve asked them to tell us what laws and regulations apply to our innovative product, as new products often don’t fall under pre-existing categories of law. Since then, we worked closely together, in order to achieve our goal of producing a device, that complies with all regulations and requirements. Several days ago we got our final statement and start-signal from the FDA, which means that we can move forward with timely US deliveries as previously anticipated and communicated.
Many patients took part in our dental studies, which took place on 3 different dates with a minimum interval of 24 hours. The tests were performed and evaluated by independent dentists. Amabrush was tested simultaneously with two different institutions and two different sets of patients.
The TQHPI (Turesky modified Quigley Hein Plaque Index) which we used as the method determines how much plaque was present on the teeth - the lower the value, the less plaque on the teeth.
We compared the Amabrush with a manual toothbrush in the first studies. This is the common way to evaluate toothbrushes. The next step will be to compare Amabrush with other power and electric toothbrushes.
1.) 24 hours before the test, participants were not allowed to brush their teeth. For the plaque test, the patients chewed plaque disclosing tablets so that the dentist could then determine the initial plaque values (tablet is used to make plaque visible).
2.) Patients had to brush their teeth with a regular manual toothbrush for at least two minutes. The remaining plaque values were determined afterwards.
3.) The same process was repeated for the second appointment one week later, but this time with using the Amabrush instead of the manual toothbrush. Teeth were cleaned for just 10 seconds and the dentist determined the plaque values again.
The plaque index decreased statistically significant and there was no statistically significant difference between Amabrush (with 10 seconds brushing time) compared to a regular manual toothbrush.
These results make us truly proud and show us that hard work, clever engineering and patience pays off for all of us. We hope that you also like those results, which we would have never reached without your support, help, and feedback!
Our next goal is to publish those studies on our channels and on professional journals, as well as redoing those studies with comparisons between Amabrush and electric toothbrushes.
Thank you again for reading our updates and your participation. We really enjoy all your comments, feedback and support, and are always endeavored to answer all your requests in a timely manner!
Best, Your Amabrush Team :)