Email from Clinical Research
FluoriMax is kind of a hot topic right now. As you mentioned their claims are quite aggressive and we are looking into the validity of those claims right now. What we do know is that the way they are reporting their uptake numbers isn't the standard for the industry which causes a lot of confusion. They report their uptake in that µgF/g varnish and the standard is µgF/cm³.
FluoriMax fluoride varnish is a little bit of a different product. It's a 2.5% sodium fluoride. It's not in a resin like most varnishes and uses what they call a "shellac" in place of colophony like we do. They sell it in a 12mL bottle and unit dose ampules. This is the only varnish on the market
that uses this concept of food grade shellac as a delivery method.
Application is pretty standard, just paint it on, but the product is a lot runnier than most resin based varnishes and you have to shake it for 10-15 seconds. Their IFU does say that if you apply to much it will cause a bitter taste and stinging sensation. Two flavors, mint and bubblegum. In their marketing materials they claim a really high fluoride uptake, but it's a little confusing because their unit of measurement is different than what we typically see with other products.
We've tried this here in the clinic and the clinicians hated it. It's too runny and difficult to apply. You have to hold the cheek away from the teethor 3 seconds which is also kind of a pain.
I would also point out that the fluoride uptake they report, while not incorrect, may make it look like their fluoride uptake is far superior to ours but it's only because they report in a different unit of measure. In addition, their studies do not give a timeline so if all the fluoride they claim is released happens all at once it's unlikely the tooth is actually absorbing that. Does this shellac delivery system really adhere to the tooth as well as a resin based varnish? Nothing in their marketing material would indicate that it does. Enamelast is proven to adhere to the tooth for up to 48 hours so the patient is getting fluoride uptake for a pretty long period
of time. And lastly, experience, have they actually tried it? What was their experience? Given our experience here in the office, it might not be as positive as Elevate Oral Care would have you believe.
We are meeting in a couple weeks to formulate an official statement regarding FluoriMax which I will send to you as soon as it's ready.
Answer
First and foremost the ugF/g was a misprint. It’s been corrected on our website, and the correct measurement is now in place. We can also provide the supporting data/study from Therametrics (you should already have it) which has the correct measurement in it. Test method FDA 40 is the standard and that’s what we used.
Regarding the flavor and application, if FluoriMax is applied like other varnishes, the clinician will likely not like it. If they take the time and apply as we instruct with one swipe from posterior to anterior by quadrant with no repetitive swipes, it will be great. They also need to leave the teeth moist, which is a departure from other products.
We find that we can tell clinicians this, and then watch them apply it and they still do it using their old method because they are so used to doing it that way. The application process is different, and in fact its easier and faster than other products. It’s just… different.