Steve Pardue and Hayley Buckner from Elevate Oral Care share the inside scoop on bringing silver diamine fluoride to the US market, what it means for patients, and how your dental practice can begin to use it right away.
This episode of The Dental Experience Podcast is sponsored by Trident Lab. Dental Experience podcast listeners - that's you - you can write the code Dental Experience on your first case, and you can save up to $50. Simply visit tridentlab.com/dep for more details.
The Dental Experience Podcast is hosted by Ryan Vet and is edited by Earfluence.
Steve Pardue and Hayley Buckner from Elevate Oral Care share the inside scoop on bringing silver diamine fluoride to the US market, what it means for patients, and how your dental practice can begin to use it right away.
This episode of The Dental Experience Podcast is sponsored by Trident Lab. Dental Experience podcast listeners - that's you - you can write the code Dental Experience on your first case, and you can save up to $50. Simply visit tridentlab.com/dep for more details.
The Dental Experience Podcast is hosted by Ryan Vet and is edited by Earfluence.
Voiceover: Today on The Dental Experience podcast.
Ryan Vet: Let's talk about the history.
Steve Pardue: The ABA has put out guidelines that says, if you have an active lesion, you don't have to restore it.
Hayley Buckner: It's the first oral product to ever receive that designation from the FDA.
Steve Pardue: It looks just like an old silver filling does if it's arrested.
Ryan Vet: Let's talk about billing codes, everyone's favorite thing to talk about, right?
Steve Pardue: We'd probably have better opportunity if we went ahead and filed for breakthrough therapy designation as a drug.
Hayley Buckner: As of January 1st of this year, 2021, there is a new code available.
Steve Pardue: Stay tuned for a lot more information and research coming out.
Voiceover: This is The Dental Experience podcast. Here's your host, Ryan Vet.
Ryan Vet: And welcome to another episode of The Dental Experience podcast. This is the final episode of season three. I want to thank you all for listening to another season and the great feedback and interactions we've had so far. I'm excited to have an episode brought to you today by Elevate Oral Care, and we're going to have a really important episode that's talking about some new and exciting things that are coming out. And I've got two very special guests with me, Steve Pardue and Hayley Buckner. Steve and Haley, welcome to the show.
Steve Pardue: Thank you very much, happy to be here.
Hayley Buckner: Thank you.
Ryan Vet: Now. Haley, I would love to start with you in a brief intro. Who are you, and why are you excited to be here today? And then Steve, we'll turn it over to you.
Hayley Buckner: Sure, yeah. So my name is Haley Buckner, and I'm a registered dental hygienist, and I'm also the professional relations manager for Elevate Oral Care. And I'm excited to be here today to share some of the exciting updates around silver diamine fluoride.
Ryan Vet: Awesome, thank you so much. And Steve, tell us about yourself.
Steve Pardue: My name's Steve Pardue, I'm one of the managing members here at Elevate Oral Care. Spend most of my time in product development, product training, and also any developments in the preventive world as far as preventive dentistry is concerned. I spent the past 20 years in preventive dentistry. Before this, with 3m Espy and before 3m with Omni Oral Pharmaceuticals.
So, a long history in prevention, and looking forward to what we can bring here today.
Ryan Vet: Great. Well, thank you both for the intro. And I'm excited because we have two very experienced people in dental. Steve, your background in dental from a product standpoint and just working with so many different companies over the years is certainly impressive, and you have brought a lot to the industry, and I know today what we're going to talk about is exciting. Haley, you as a hygienist and just your, your work to care for patients. So, I love both of the experiences and perspectives from the product and clinical side that we get to chat about today. So, let's talk about the history, let's just kind of chat about why we're here today and what exciting things Elevate has been working on and how it can benefit the dental industry.
Hayley Buckner: Sure. Yeah. So, as far as the history of silver diamine fluoride that you brought up in the beginning, you know, silver diamine fluoride has been around for several decades.
It was first investigated from dentists in Japan, doctor Machino, as part of her thesis at Osaka University, and I believe that dates back to around 1969, and she started looking to combine the anti-microbial properties of silver with the benefits of high dose fluoride. Through this, she found that there was also a benefit that this occluded dentinal tubules and really relieved dentinal hypersensitivity.
So, shortly after that, silver diamine fluoride was granted approval in Japan and was marketed in Japan for a long time as saforide, and then it's still a fairly new here in the United States. It gained clearance from the FDA back in August of 2014 as a class two medical device, and it is FDA cleared here as a dental hypersensitivity treatment.
But back in October of 2016, the FDA awarded Advantage Arrest, our silver diamine fluoride, breakthrough therapy designation based on its arrest of dental decay in children and adults. And that breakthrough therapy designation was a really, pretty big deal because it's the first oral product to ever receive that designation from the FDA.
Ryan Vet: That's great. Now, let's talk about some of the, the maybe the indications that SDF's used for commonly, and like, what type of patients - and as a quick refresher, I know most listeners are probably familiar with it, but we do have a nonclinical members on our episodes that listen. So, let's talk about who should we even be talking about or thinking about when we're talking about silver diamine fluoride.
Silver
Hayley Buckner: diamine fluoride can be used on patients of all ages and really patients of all risk levels. You can use it for a number of different indications. It can be used to arrest a K, it can be used to treat sensitivity like we just talked about, it can be used as a liner under new restorations.
It can even be used as an occlusal barrier, like a sealant, and there's lots of great research and exciting new code that we're going to share today around using silver diamine fluoride for prevention, just site specifically at any high risk sites that a patient may have for preventative benefits as well, so lots of great different indications to use it.
Ryan Vet: That's great. And we talked a little bit about the FDA approval in 2014. I know WHO kind of looked at this in 2009 as a widely recognized, as safe and effective. So, Steve, I'm going to turn it over to you a little bit. Let's talk about the clearance to the FDA and what the FDA looks like and where you all are today at Elevate.
Steve Pardue: Okay. The clearance through the FDA for silver diamine fluoride took a little bit of time. The -product was actually originally contemplated by Dr. Peter Milgrom and Dr. Mike Shirtcliff. They were looking for ways to effectively treat, manage care patient populations in their insurance system, in the state of Oregon.
This was one of the most cost effective treatments that they knew about at the time, but it wasn't yet cleared through the FDA. So, they worked to complete the toxicological studies, get the data in order and make a submission to the FDA, combining all that data and doing all those submissions took upwards of about seven or eight years.
So, it was a long path to getting clearance through the FDA, but it did gain clearance as a dental hypersensitivity treatment. Then, the data on silver diamine fluoride was so good, even in things on coating surfaces, such as occlusal surfaces to prevent tooth decay. Dr. Milgrom and Elevate Oral Care looked at going back to the FDA to gain clearance as a sealant, but in speaking with them, we found that we probably have better opportunity if we went ahead and filed for breakthrough therapy designation as a drug. We put together the filing work, submitted that to the FDA. In 2016, they granted us breakthrough therapy designation. That means they'll help us fast track our clinical trials to gain clearance as a drug for caries arrest.
So, we've been in process for that for the number of years. We're actually nearing the wrap-up of our phase three clinical trial. As soon as that's completed, we can compile the data submitted to the FDA and hopefully it will clearance as caries arresting agent. So, we're looking very much forward to that.
Ryan Vet: That's exciting. That's a huge breakthrough. Even as the FDA's classified it a huge breakthrough technology, that's really going to make an impact. So Haley, I'm going to turn it back to you and let's talk about billing codes. Everyone's favorite thing to talk about, right? Let's talk about the current coverage of existing billing codes and what it can be used for the implications of Medicaid.
And then we'll talk about if there's any holes in that, Steve, but first let's, let's really just talk about kind of what, what the current codes are and what the implications of using those might be.
Hayley Buckner: Sure, yeah. I would say the most common way to use silver diamine fluoride is to arrest these active lesions.
And there's been a code available since January of 2016, which is the D 1354 code. And the nomenclature for that code is that it is an interim caries arresting medicament application. So, it's described as a conservative treatment on an active, nonsymptomatic, curious lesion by applying a caries arresting medicament, and without the mechanical removal of any sound tooth structure.
And that is a per tooth code. Again, that became available back in 2016. And not long after I believe, Steve, we saw Medicaid coverage within the first six months of that code being available.
Steve Pardue: That's correct, yes.
Hayley Buckner: Okay, yeah. And since then, we've just seen the coverage grow. I mean, now we know that over half the state Medicaid programs are covering that D 1354 code, and I believe we see about a third of private insurance plans covering that now as well.
Ryan Vet: That's great. One of the downsides, and maybe you're getting to this Haley, is the fact that it's only for existing lesions, that current code, is that correct?
Hayley Buckner: That is correct, yeah. That with that code specifically, that was the only way that you can really use that code when you're applying silver diamine fluoride.
And there's a lot of great research out about the preventative benefits of silver diamine fluoride as well. And so, that's one of the exciting updates that we want to share today is that as of January 1 of this year, 2021, there is a new code available. It is D 1355, and that is a code that is available to be used - it's described as it caries preventive madigma application and is a per tooth code as well, just like the 1355. So this code is used for primary prevention, or remineralization, and it does not include topical fluoride. So, that includes silver diamine fluoride, as well as a couple of other products like silver nitrate, thymal chlorhexadine varnish as well as topical povidone iodine can be used with that code.
Ryan Vet: That's great, Hayley. And I think there's a lot of positive applications. And Steve, I want to chat with you more about that in just a second, but before we do, I want to pause and hear from our sponsors.
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And we're back. And Steve, I've had a question for you. We were just talking about, before the break, about the new acceptance of a dental billing code. And I don't even know what that's like, that seems like it's a big undertaking, but the implications are massive and have a huge impact on patient benefit and patient care as well as the way of practice can bill.
So, could you talk about the application process of D 1355 and talk about how long it took to get accepted and all of that?
Steve Pardue: Absolutely. We'll start with the code itself. D 1355 was, was a great improvement in the use of silver diamine fluoride, and a few other medicaments as well. So, our nitrate would fit in that category, povidone iodine products would fit in that category, final chlorhexadine groups would fit in that category. So, it's not just limited to silver diamine fluoride. It's really filling a gap for use of any of these materials that can be used applied to high-risk surfaces that don't yet have lesions, but are very prone to gain lesions.
So it's a, it's a gap that a typical fluoride code wouldn't fit, and the existing D 1354 wouldn't fit. Getting new CDT codes through the coding committee can be a process that takes anywhere from months to years. In a couple of other examples, fluoride varnishes hit the market in the United States in about 1997 or 1998.
It took until 2006 for a code to be put in place for D 1206 for fluoride varnishes. In contrast to that, silver diamine fluoride was introduced in the market in 2015 and by 2016 we had insurance code for D 1354. The difficult thing was the D 1354 and D 1355 is silver diamine fluoride is a bit of a departure from traditional dentistry.
This is the first time that the ADA has put out guidelines that says, if you have an active lesion, you don't have to restore it. In fact, you can apply silver diamine fluoride, and you should offer it as an option to your patients. That's a big step and a big departure. So, sometimes it takes some time for dentistry and insurance coding to catch up to those trends and the research to support it. And in this case, it happened very quickly with D 1354. Took about two years with D 1355 and two attempts to get through the CDC coding group. But, it does provide a lot of opportunities for clinicians in the general dental marketplace. You can use this on occlusal surfaces, smooth surfaces, pediatric teeth, adult teeth, and apply this to any at-risk surface after the use of a diagnosis code for high risk, which is D 0603.
So once that high-risk code is applied to that patient, you can apply this to any surface you deem to be at risk. So it's a great, great step forward and prevention. The product does not stain in those applications, so you don't have to worry about discolorations, unless there's an existing lesion that you weren't able to see 'cause it was so small and so minute. So, it's fantastic. And the application process is extremely simple. Simply dry the surface, apply the silver diamine fluoride, allow it to soak in on that surface for about 60 seconds and then blot it dry with a two by two or cotton roll. So, very easy to use.
Ryan Vet: That's great.
And just for clarification, the D 1355 is in fact different than the D 1354, so you're not replacing that. Is that, is that correct?
Steve Pardue: That is correct. This is an addition to, and they do cover different applications of material.
Ryan Vet: So can they be used at the same time, or at the same visit in the same patient? Or how does that work?
Steve Pardue: They can be used at the same appointment on different surfaces. So, if you have an existing lesion on one tooth, you can use D 1354 and high-risk prevention on a different tooth there's D 1355. You can also use those in conjunction with D 1206 or other fluoride codes as well, using one doesn't rule the other out.
Ryan Vet: Okay, that makes sense. Now, one of the big things in anything when it comes to dentistry, or medicine, or sciences, is they're supporting research. And so, Haley, I would love to hear from you as on the clinical side, and then Steve, from you on kind of the product side. What, what's the supporting research behind this? And what about research for other indications?
Hayley Buckner: Yeah, absolutely. There is all sorts of research out on silver diamine fluoride and all of the different ways that it can be utilized. As far as some of the other ways that it can be utilized, there was a recent study where researchers from Texas A&M University.
They were looking to backup observational reports of general health improvement that is seeing following these STF applications, whether that was for carie's arrest or prevention. So they conducted a study, a smaller study of 25 geriatric patients who had active Gingervitis, and they applied silver diamine fluoride advantage arrest specifically to both the labial and buccal surfaces of the teeth.
And they saw significant improvement in the general health of the active, whereas the advantage arrest was applied versus the placebo. So, we're now starting to see, not only these hard tissue solutions with silver diamine fluoride, but we're also seeing a great positive effect on soft tissue as well.
Ryan Vet: That's great. Are there other areas, Hayley, I think you just sort of hit on it, where, where you've seen SDF being used and you hit on some of it, but are there any others?
Hayley Buckner: Yeah, so, one that both Steve and I kind of mentioned as well was, um, using the silver diamine fluoride as an occlusal barrier.
So very similar to a sealant, which is a really great and unique application. You know, oftentimes sealants are done in children as we're starting to see permanent teeth come in. Um, so not necessarily so much in primary teeth, but we're seeing where children will have primary teeth with. Active decay or these deep pits and fissures.
So silver diamine fluoride can be applied to occlusal surfaces and, and as long as it's reapplied, every six months, it can act as an occlusal barrier because that application of the silver diamine fluoride creates. Anti-microbial tooth structure. So bacteria is not colonizing there and it's not demineralizing that.
So by continuously reapplying, every six months, it'll do a very similar job as an occlusal sealant does, um, in the fact that it acts as that occlusal barrier. So there's some great research out on that. And then as far as Carrie's arrest, you know, lots of decades old research on that, and then also around the preventive pieces of silver diamine fluoride as well.
Ryan Vet: That's great. Now, uh, we, we talked a little bit about kids. Are there any other common populations or patient groups where it's used
Steve Pardue: patient populations can actually be any patient? I think some of the initial groups that were quick to jump on board with silver diamine fluoride use for pediatric dentists for the uncooperative kids, pre co-operative kids, and some might say.
But it absolutely is a great option for pediatric patients. Assisted living facilities have jumped on board quickly. Many of those patients can't leave the facility to go get care, and this can be done in their facility, public health facilities. And now general dentistry is jumping on board. So I think at the patient populations all across the board, many patients don't mind having a, an arrested lesion with a discoloration in the back areas of their mouth and the posterior teeth.
It looks just like an old silver filling does if it's arrested and if it's used in a preventive fashion, like for D 1355, there's no stain at all. So it can really be for any population.
Ryan Vet: That's great. Well, this has been super exciting and I love innovation. I love taking things and taking science and taking research and figuring out new ways to improve patient care and make practices more efficient.
So I love all that you are doing at Elevate and just the way you're, you're making a difference. So what, uh, what specific or any closing remarks that you have for the listeners here that they should know about the developments that you've done? Uh,
Steve Pardue: I think just stay tuned for a lot more information and research coming out on silver diamine fluoride.
We've got that phase three clinical trial that we'll be finishing up in the next year. So let me some great data coming out of that. There are always new research articles coming out on different uses that we've not heard about before. For example, some recent articles talk about its use for improving ginger will help.
There are numbers of different things that are being looked at right now. And most importantly, the current thing that I would say look for is the D 1355 ADA guide to recording carries, prevented the Dyckman application. You can just go online and search for that, and you'll be able to find it very easily, but it'll, it'll walk you through all of the steps of using this new code.
Ryan Vet: That's great. Well, I appreciate both of your times today. How do people get in touch with you to ask questions? How do they find research based on things we've talked about or even products to bring this into their own practice? Uh, of
Steve Pardue: course visit our website, Elevate Oral Care.com. There are plenty of information pages.
There are lots of downloads. And if there's specific information or research that you're interested in, give us a call. We'll be happy to provide information and email packets of research out to you and provide any support that we can or request a staff meeting. And we'd be happy to come into your practice.
Ryan Vet: That's awesome. Well, Haley and Steve, I want to thank you so much for being on this episode. And as always at The Dental Experience podcast, we strive for five. We strive for providing you education, providing you new insights, new innovations. And I think we've heard that here today, and I am excited for what is to come.
I want to thank you all for being loyal for three seasons. We're now in over 25 countries and with regular listeners, thousands of listeners a week. And over 40,000 subscribers on our email list to get our episodes. I am just so grateful and thankful for each one of you. And we look forward to our next season in season four.
Thank you for tuning into The Dental Experience podcast. Thank you for listening to The Dental Experience podcast for show notes, to ask a question or for more information, visit www.thedentalpodcast.com. The ideas discussed during this episode are the opinions of the participants and do not serve as legal, financial, or clinical advice until next time, this is The Dental Experience.