Introducing the NobelProcera Zirconia Implant Bridge

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Transcript

Speaker 1
Well first off, thank you Alan for the great presentation here. This is what a great opportunity and thank you for your partnership. I got to say it’s a bit humbling to be working with a group that is so innovative as ROE and your entire group over there, and it’s just really nice to be associated and a part of this and what I’ll be talking about first and foremost is more about the product itself, so how it relates some of the features, benefits and how that can help in a clinical environment. Then I’ll hand it over to Alan. He’s going to get more into really the nitty gritty of this and the process of the product itself and some of the new innovations that ROE has incorporated to produce this product in a really, really unique way. So this would be a lot of fun. I’ll spend about 15 minutes or so going through some of these things a little bit into the science as to how we go to market with the product, some of a little bit of a history lesson as to where it came from and then go into some of the features and benefit.

So without further ado, I’ll get started. So really the idea behind this product was truly in a partnership of our clinicians and our laboratory partners. The idea here is really to give the ultimate flexibility of a product as it relates to clinical application and then goes into the laboratory to allow that teamwork to really collaborate and become a strong partnership. Oftentimes we know that a patient presents themselves not in an ideal situation, and there’s a lot of different things that clinically can be done to fix some of those situations, but always it’s not always readily available to work through that and the laboratories sometimes get presented with some almost impossible scenarios to overcome. That’s the idea behind this product and specifically to some of the flexibility pieces that we have with it. So in order to kind of look at where we are now, we also want to take a look at where we were in the process of this product and we’ve been manufacturing full arch zirconia for quite some time, well over 12 years actually in fact.

And we came to market about 12 years ago with our original Noble Procera Zirconia implant bridge, and this was unique for the market at the time. This was actually the first one that foregone the use of any titanium cylinders. We manufactured these direct to implants both to multi-units and to direct fixture on the implant. I was about, there’s two to 14 units, so we had a capability of going full large. Obviously Angulate screw channel technology had not been incorporated into dentistry at that time yet, so there was no ability to change the angulation on that. It was strong. It was very strong for the time, about a thousand megapascals of flexual strength. But one limiting factor here was the aesthetics here, fairly low translucency and today’s age, very, very low translucency and only available in four shades. What this would mean is the amount of manual labor that it took for a dental technician to come through and put this case into fruition was pretty extensive.

And so we know we needed to adapt and move into more zirconia options, but in 2017, we took kind of that 2.0 stance of the implant bridge, looking more at the aesthetics outcome of the product here due to some of the manufacturing limitations that we had due because of the material itself, we were then relegated not to go into full-arch but only two to five units. But what we did incorporate then was the angulated screw channel specifically to our conical connection implant fair. A little lower strength than this, a little under a thousand mega pascals, but the product was much, much more aesthetic. This was an HTML zirconia product and we up this into six shades, obviously looking for more opportunity to grow the aesthetics outcomes as we had with that. And then we go into our third iteration of the implant bridge called this 3.0 if you will, taking all of that learning and that manufacturing process and bringing that forward with a third iteration here and bringing it back up to 14 units completely cement free restoration.

And we’ve also incorporated angulated screw channel not only on our conical connection implant, but we actually essentially had a dual launch here and are able to do a prosthetic, angulated screw channel on top of our multi-unit abutments as well. Some of the additional benefits of not only the material being so stable and able to be manufactured, we actually upped the flexual strength and over 1200 mega passels of flexual strength, much higher translucency as compared to either one of our previous bridges. And we’re also now fully in line with a Vita shade guide and actually 12 guides shades that are available now. So with all of that, obviously with the manufacturing capabilities that we have holding onto warranty claims, making that simpler to process and go through it really does save a lot of time both clinically and in the laboratory. I talked a little bit about the additional product that we’re able to introduce with this implant bridge, and if you take a look at the implant on your left hand side as compared to the one on your right hand side, you’ll see the ability for a multi-unit abutments obviously coming at straight angulation, 17 degree angulations and 30 degree angulations to accompany are all-in-four cases that we have.

But additionally, what we’re able to do now due to the multi-unit prosthetic screw launch that we came out with this product, we’re actually able to angulate an additional 25 degrees of free angulation on top of that multi-unit abutment. This also works direct to fixture as well, but when you add in that 30 degree change of angulation to that multi-unit abutment with the additional 25 degrees available on that prosthetic screw, we’re able now to get a perfect perfect emergence from that screw channel at up to 55 degrees of angulation fixation. So what we’re able to do is ensure that screw channel is absolutely in the optimal position clinically. A byproduct of this as well is actually the screw angle and the screw hole is actually 25% smaller. What that does for us is that having a smaller screw hole actually makes it more aesthetic and easier to hide that screw hole.

In addition, it also helps with the strength because we’re not limiting the size of the zirconia around that zirconia or around that screw channel. So stronger and more aesthetic is the outcome from byproduct of that additional launch. And it gives some perspective of real life application of what this looks like. And I don’t think anyone would say that the implant bridge down at the bottom is not a fantastic work there. I mean you can see just how beautiful the work was done on that product. The one thing that we’re trying to avoid and fix for the patients is the flexibility to then overcome some of these angulation issues. Obviously there is nothing that could be done with a product like this if a case is being presented like this. So the technicians did a marvelous job with that approach for it. But if we’re able to have a little bit more flexibility in how we move through the case both clinically and the laboratory setting, then I think we can all agree that this is going to be something that would be beneficial to the patient, to our clinicians, to our laboratory partners.

So this is one of the other issues we’re looking to help resolve. We know from a macro perspective, we see a lot of cases that come in with catastrophic failures around the titanium bases that we see on the implant. This is more or less due to the fact that we actually have to take that titanium base and actually hollow out the zirconia. What happens when you hollow out that zirconia is you get a little potential for cracking and chipping on that because you’re thinning out that zirconia so much to make room for not only that titanium cylinder but also for the cement to bond that those two pieces together. And what we’re trying to do here is to ensure that everything is held through the preload of that screw and not the cement bonding to that titanium cylinder. If you take a look at that picture down on the bottom left hand side, this is a laboratory friend of ours that kind of just was having some issues with the cases that then they were trying to overcome the issues and said, I had this one failure here.

Look at the distal implant that we have. And upon further investigation, it has actually failed well before the catastrophic failed that the patient had experienced. If you see every single one of those cylinders surrounding that type titanium sleeve is actually either sheared or cracked. And so the final catastrophic failure happened when the entire case was lost from the patient, but ultimately this was inevitable. This was going to happen one way or the other and it just happened to happen on the fourth implant as well. So what makes this possible? We have, what’s important to understand is some of the products needed to restore these and we want to make it as simple as possible. We have now angulated screw channel that goes directly to our implants themselves and we also have this new innovation that’s coming from our multi-unit abutments with the angulated screw channel technology.

What this requires for us is actually to have multiple implant drivers to work with those types of screws that we have. Obviously a prosthetic screw on a multi-unit driver or multi-units going to be much, much smaller, and that’s the way that we can get it down. Because of that, the multi-unit takes up a lot of that room, so we can’t go all the way down into the implant, we just have to work on top of the button itself. So that requires brand new armamentarium. So what we’ve done here is launched the OmniGrip mini driver as well. This is for our multi-unit abutments. This is that prosthetic screw with the angulated screw channel. You can see the difference between this by a small black line that’s on the shaft of that implant of that driver and that in comparison to our already launched OmniGrip driver for direct to implant that has a blue stripe on that shaft.

And both of these are available in manual drivers as you see pictured here. You also have the ability for a generic de-shank torque wrench as well so that you can torque the screws down appropriately to the implants. But it’s very, very important to make sure that you have these. Nobel Biocare will be happy to get these products out to you. Actually on your very first case, we have promotions to provide you and your laboratory with the appropriate OmniGrip mini drivers to make sure that you’re ready, prepared to treat those cases as you see them. So one of the nuances of this product is truly the difference between a cement retained restoration, a screw retained restoration. It seems like there’s not a lot of difference in some of the pictures that we’re seeing here on the screen right now, but it’s all in the nuance in how this plays through.

And basically the picture right down the center is how our technology works. And this is a direct to implant interface of how this works. And that’s, and that is not a titanium base as you see there in gold. It’s actually a titanium adapter that allows the zirconia to have to sit on a nice solid table and allow all those pressures and that torque to release. Its all the way down and to be held truly and only by the preload of that screw itself as comparison to what you see there on the right hand side, this is your typical base ti-base of restoration. As you can see, there’s no application for the screw down onto this zirconia itself. That’s only holding down the ti-base that’s holding the entire restoration by definition as a cement retained restoration because there’s no other way to hold that zirconia down onto that titanium base.

So what we’re doing is completely removing the need for that cement and removing the need for that ti-base as well and utilizing a prosthetic adapter for that table and then holding that screw all the way down into the implant as well. And a couple little things here as well is zirconia does not like right angles. We avoid right angles like the plague when we work with zirconia as well. And as you can see how we hold that screw down onto that zirconia and all the way down and all of the milling parameters that we have, we’re holding that true to form all the way through. So the application of that torque is provided at an angulated portion. So we’re sharing that load down throughout the entire restoration. So a little bit about what that means. If you take a look picture on the right hand side, we utilize preload as our engineering fundamentals at Nobel Biocare, but we believe very strongly and the use of preload outside of cement is the best way to restore dental implants.

And basically what preload is, it’s a screw retained system that applies tensional force down through the screw when it’s tightened. And what happens is there’s a elongation of the screw that happens at that torque value that we provide on those screws. One once that does, you start to share all of those portions of contact with both the zirconia implant, the titanium adapter and the prosthesis. So all of those points on the right hand side of those arrows coming together is that sharing of that preload all the way through. And it’s truly a systematic approach to restoring dental implant safety with the health of the patient and the health of the implant in mind as well, not just the prosthesis. And we’re looking at better ways that we can apply that torque in as many areas because as we know if we apply or over torque in some areas that can cross create stress not only on the prosthesis but also the implant themselves.

So one thing we also look at is when we get into our evaluations of our products is taking a look at our testing and what a fundamental ideology that we have is looking at the worst case scenario for our evaluations. And one thing that some don’t realize is when you do over angulatr something on an above that creates two unintended consequences. First and foremost, you have to decrease the amount of zirconia that’s around there to make room for that additional space for the screw channel. So what that does cause content potentially weaken zirconia as well. The other side is potentially the loss of some of that torque value on that screw holding that piece together. So when we do our testing, we do that always with a worst case scenario in mind, and we do that with a max angulation off of that. And just a little look at some of the ways that we study single unit implant restoration.

It’s an ISO standard process here. ISO the International Organization for Standardization. This is how we test our abutments moving forward. But this is really applicable for our single units. And this is kind of a higher or a closer look at what we do. Basically create a load cell at 30 degrees angulation and we just pound that and as if it was mastication and a saline solution at 2 million cycles and then test the products afterwards. So what we’ve done here is really, this is another picture of this actually being applied in our facility, but what we’re done with this is applied what we’ve learned on single unit restorations and taken that to the multi-unit restorations. Well, there’s quite a different scenario here and a different way to look at it. And so if you look here on the left hand side, we’ve taken that load cell and we’ve put that at the farthest portion of our distal extension.

This is creating a number of forces on the implants themselves. There’s extrusion forces that are happening on the distal implant. There’s actually pulling forces that are happening in the anterior implant and all of those have consequences potentially if the system hasn’t been engineered appropriately. So there’s a bit of bending compression forces that are happening not just on the implants but also on the zirconia itself. And again, the same ideology here is looking at it from a worst case scenario. Implants angulation are provided at the highest angulation possible to make sure that the most difficult scenario is being tested. And we also look at the furthest distal extension possible with the thinnest amount of zirconia. So we make sure that all in all it is completely safe both for the prosthesis and the implant. Kind of look at what that zirconia looks like. As you can see just how extensive that angulation is on that zirconia, just how much it’s been kind of bored out.

And that’s in order to make room for that considerable screw channel that’s being provided there. And then what we do here is we take a look and we test all of the products. Then from out, we take it apart and take a look at all the products and it’s on the left hand side. We see here it’s an example of an implant level at a runout sample. A runout sample is 2 million cycles of loading that saline solution. We take a look at signs of wear on the screws, we take a look at signs of wear on the adapters, on the zirconia and also on the implant themselves. And all of those are just as important as the other. Take a look at the multi-unit level on the runout sample on your right hand side, we do the same thing. We take a look at the multi-unit abutment one’s where it’s connected to the implant as well as where it’s connected to the zirconia implant bridge.

We take a look at the sections around the zirconia to make sure that there’s no fractures or signs of where there as well. Again, we take a look at the implants and where those connections help and we take that as our evaluation for lifecycle and living, the lifecycle of the patient. And as you can see here, just great examples of nowhere, and this comes down to obviously passivity and things like that, and that’s a prerequisite for the success of a case like this. But the signs are very well. There’s no signs of any warpage or wear to either the titanium or the zirconia or the implants themselves. So from a ease of use standpoint, the product’s very, very flexible. As we talked about before, I’d like to call it a yes product. If you ask a question of what it can do, the answer is typically yes from a design standpoint, you can have cutback type of restoration, you can have a symbol, you can have a full contour or traditional framework as well.

All those are done in the software. None of this is done manually. This is completely a digital product itself. And again, it’s two to fourteen units, so you can always work on an entire span and you can actually go up to 10 implants, which is pretty amazing when you think about manufacturing to this high complexity and getting to 10 implants on up to 14 units and 14 tooth units. So it’s remarkable that we’re able to do that. But this goes down to some of our manufacturing processes from a software standpoint, very flexible as well. We have two routes into the implant bridge ourselves. We have DME files written for 3shape software. We also have our ExoCAD based software. That’s DTX Studio Lab software. That’s a CAD software. Both of those are free to come in and utilize for our implant bridge as well.

DMA files are available on the 3shape download center, and you can just go in there, download, and you’re ready to order the products directly through our Mahwah facility. From a material standpoint, obviously talking about the incredible strength of the product itself, 1230 megapascals of flexural strength, 3000 megapascals of compressive strength. Very, very high strength product all the way through. Obviously this has been completely tested for everything that we’ve talked about for. And again, we have now an additional shade for the VitaShade guide, so it’s very flexible for the technician to match your needs. This is a busy slide. We’re not going to get into all of this, but the main thing I want to take away here is we actually utilize a blank that’s not commercially available in the market. This is very purposeful. What we want to make sure is that when the case presents itself that we’re able to manufacture it.

And so we have a very large blank that we work off. It’s 98 to 38 millimeters, which is much, much larger than anything commercially available. And at the time of this slide, we had launched in Europe well before we came to the US market, and with over 4,000 implant bridges produced, there actually wasn’t a situation where we were limited by size. And that’s another scenario that becomes very difficult when it comes to end that manufacturing with some of the limitations of the puck sizes and some of the milling technologies that they have. They just don’t have the commercial type of grade manufacturing that we’re able to take advantage of in our Mahwah facility.

And so what’s delivered to the laboratory as they process the product itself, basically everything that you need, they receive the titanium adapters, they receive authenticity labels. This is very important for our patients. We received three authenticity labels, one’s for the laboratory, one’s for the patient. And so we want to make sure that the patients receive those. If anything was to happen, there’s a QR code there that is directly linked to that product itself so that we can handle any type of warranty claims that either the patient or the doctor or the laboratory brings to us. So it’s a nice way to look at that. Everything that you need is is there ready to go. You have your screws, you have your adapters, all your clinical armamentarium is ready to go for you. We do always ask that our laboratory partners utilize laboratory screws, laboratory components whenever possible.

There’s a lot of reasons for that. A big, big reason is our screw technology that we take advantage of at Noble Biocare, we have a system called Torque Tight on those screws. What we do want to make sure is that torque tight gets utilized in the clinical environment and not the laboratory environment. So we always look for those clinical screws to be ready to go in their original packaging when delivered with the implant bridge. But everything else is ready to go. You don’t need to think about any of the other products. And obviously the experts at ROE are very well attuned to handling those situations as well. But that’s what I have. I tried to get in as much as possible in a short period of time there, but I will stop sharing my screen and hand it on over.

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