Histological Results and Clinical Use of Pure Phase Beta-Tricalcium Phosphate

Now we have we have three people coming on to stay on the stage. Mauro Marincola from the the University of Cartagena, Jack Lemons, who we’ve already heard from the University of Alabama, and Ziedonis Skobe from the Forsyth Institute. Zie’s not going to speak until questions. So please welcome Mauro, Jack, and Zie to the podium. Doctor Jack Lemons. They will correct my English. That’s the reason why they are here. That’s right? Okay. And so the flowchart you see on the screen would show you only where our beta tricalcium phosphate is located. Everybody knows this flowchart. Let’s focus on the synthetic bone substitutes. Material is a pure phase bioactive ceramic, which is completely substituted by bone. And the period of time we are focusing on is depending for sure on this factor, which is the type of bone in which we place our bone grafts, the type of defects we find, the location of the bone defect, and for sure the extension of the bone defects like lateral sinus lift. We can have different kinds and types of difficulties in the bone grafting. But related to this, we can say that the beta tricalcium phosphate is transformed to autogenous bone in between three and twenty four months. The advantage. We focus now actually very fast on this first issue, which is the mechanical stability of the material, even when this material is transforming, still transforming to vital bone. So this is a very important issue. The other advantage we will talk about once we see this video, which is telling you about the clinical application of the beta tricalcium phosphate in case of a lateral sinus lift elevation. Now, we have a lot of oral surgeons for sure that will do a controversy about how and from where to take the blood. In this case, you see we prefer to take the blood from the patient’s oral cavity, priorly sterilized with chlorhexidine for sure, because of what? The beta tricalcium phosphate has to be mixed with patient’s blood only. Now in case of lateral sinus lift elevation, for sure the patient maybe give you the consent to do the venipuncture and the arm level or at the hand level. But for sure you will see the beta tri calcium phosphate is not only for lateral sinus lift elevation, but also for defects, bony defects, small bony defects. And for sure the patient don’t agree very much if you have to take the blood from other regions outside the oral cavity. And so this is the best way to get the patient’s blood to mix with a better tricalcium. The flaps. What kind of flaps? Important that it’s a full thickness flap. The kind of techniques it’s up to you which one is more comfortable. The most important always is that the is away the cut of the flap is far away from your osteotomy. About the osteotomy, what we can say about the osteotomy, they are, once again, different techniques. And once again, I will tell you, it’s up to you, which technique is more comfortable for you and for your personal hand and your personal skills. We use this Brasseler bur surrounding the lateral cortical wall of the sinus lift excuse me, of the sinus cavity. In this case, most of the clinician are scared about a perforation or laceration of the the Schneiderian membrane. But don’t forget, if you don’t push, and if you don’t try to cut deeper as you have to do, there’s no big difficulties to cut off the bone from the lateral wall. The extension of the osteotomy. This is another important issue we have to discuss here, how much you have to extend. Normally you do bigger and more extended preparation like you see here in this case, but we want to show you this particular osteotomy because in case of the better tri calcium phosphate combined with the Bicon implants, you don’t have to forget that we don’t have to fill the whole sinus lift to get our eight, nine millimeters of vertical augmentation. Because we have the chance to use the short implants you saw the whole morning talking about. And this gives us the advantage to do a lateral sinus elevation with a minor invasion of the sinus. So what we need is mostly retention of different walls, a reduction of the entrance of the bone graft, and we have to make sure that we have to elevate eight, nine millimeters. That’s all we need to place our Bicon implants. So the old techniques, you know, and you saw before, and most of you are doing, filling almost all the whole cavity of the lateral sinus is not anymore needed. Now the beta tricalcium phosphate, once again, is a material which has to mix only with the patient’s blood. It’s very important to know this. You don’t have to mix it with autogenous bone, neither with tetracycline, because of the fact that the first reaction of this material inside the blood environment is a releasing of the calcium and phosphate particles, which are assumed, which are absorbed immediately by the osteoblasts. And you will have a faster healing reaction. Now, talking about what we did in our studies, and related to the histology, Dr. Jack Lemons and Doctor. Will show you later on. We did in the University of Cartagena thirty six different cases of lateral sinus elevation. And what we used for, we used three different groups, which were the group A in bone grafting, and trephining after six months. And the group B, bone grafting and trephining after nine months. And group C, bone grafting and trephining after three months. In all three groups, once we tree find and we took out the core, we placed immediately the implant. And three months after implant placement, we restored them. What we saw from a clinical standpoint, now we will see what happened with the histology. From a clinical standpoint, the most important factor is, like you see in this case, mixing the tri calcium phosphate with the patient’s blood, we will have a very consistent material which is mechanically stable. And we will have, after three months, a very tough material, which for sure is not bone. But from a clinical standpoint, our interest is to have a bone graft, which gives us the stability, and the mechanical stability mostly, to place an implant. And then to wait two, three months before we load them. What happened, and you saw it in the beautiful lecture of Doctor. What happened is always, we don’t have to have mature bone in the graft. What we have to have is the mechanical retention to place the implant first, and then to let mature both the tri calcium phosphate to transform to vital bone, and the implant to give the chance to the implant and to the implant surface to be accepted by this new grown bone inside the graft. So like you see in that case, very important is, from a clinical perspective, that you pack that material, and you have a good consistency in the first time of the surgery. Now the grafting, the trephines. What we did here, we trephine after three, six, and nine months, like I told you, to see which are the difference between one and the other grafts. There is no big difference in what we want to see if there is tissue inside the grafting material. And so after three months, you will see we will have most of the material still in place, but part of the material transformed in newly formed bone. And this makes us for sure comfortable, mostly, that once we place the implant around this implant, you will have a reorganization of the bone once mostly we load the implant. So until now, didn’t do one important thing, which I think I will do after Muthu’s lecture, to load immediately these implants inside the graft after three months. Because for sure, like he says, and he showed us when we stimulate mechanically the implants, something happened very fast with a new bone. And so in the future, we will see if we can do this. That’s the grafting material excuse me, that’s a core we took out from one of the patients. And the histological evaluation will be explained by Dr. Jack Lemons and by Dr. Ziedonis Skobe. Please. [Dr. Jack Lemons speaking] I was given the opportunity a number of years ago to evaluate an earlier form of the tricalcium phosphate that subsequently was approved as an orthograph material, which we followed both in the laboratory and clinically. So having evaluated that histology in former years and more recently, I’ll provide the descriptions of the histological material. Here we see one of the sections, and these are the studies at Forsyth, where we’re looking, at the bone combination with the grafting material showing at three months, as anticipated, some amount of the grafting material continuing to be present at the site. And what’s critical in this particular slide and the others that we show is in a hematoxylin and eosin, and other stains that have been done, we’re seeing what appears to be a normal bone by the criteria used from histological perspective. Next slide, please. Subsequently, in another magnification, looking at the area, again the question is, the maturation and character of the combined matrix of the grafting material and the cellular reaction, whether we have a significant foreign body reaction or whether we would have a characteristic of granulation tissue. And once again, what we see is a healthy, normal, trabecular like structure, osteoblastic and osteoclastic, normal living bone. Next slide please. Again, an area where we have more reaction, stroma. The cellular reactions you would see which would be normal to a grafting material in the resorption process as the bone turns over, and the tissue area turns over subsequently for maturation and growth. Next slide, please. Once again, we see our higher magnification where you can see more cellular detail. And the importance here is in the combination of the grafting material. We’re not seeing what we would anticipate to be foreign body reaction other than anticipated for a biocompatible grafting material. Next slide please. Here we see once again the character of the bone, the nature of the bone, the nature of the osteocyte location, the nature of the osteoblastic lining, and again, not an infiltration of some round cell local to the graft material. Next slide. Once again, and the reason that I show you or we have showed you these multiple sites, these are different regions of the bone as prepared at Forsyth, again showing what would be a healthy and normal bone. This providing the opportunity for structural support then for implant placement and biomechanical stability. Next please. What we’ve done now in the second group, is there’s the beginning of what would be the micro CT structures. And this is one of nine, which is a characteristic example. And here you see the external surface showing again what would be the bony section that would be present in this particular implant. Again, these sections being a hundred and fifty micron, one to another as we pass through the three-dimensional structure of the implant. Could we go to the other movie, please? What’s critical in this particular movie is that we’re now passing through the structure of this particular plug that was removed from this site. And the critical issue is the nature, presence or absence of trabecular bone structure or bony structure within the three dimension. This being the site where the implant subsequently would be placed. And what you see in these serial sections walking through the implant, which we have seen now in the nine sections that we have evaluated, is a dense, relatively dense, if you will, bony structure, trabeculation, a characteristic structure we would be anticipating for a healing site. Now the ongoing study with these will be relative density comparisons where we can separate the graft material, but I think it’s quite obvious to all in this section that we have a normal bony characteristic with the healing site within these particular grafted areas for the tricalcium phosphate material. Thank you very much. I think we now will have conclusions. My conclusions, looking at the histology, looking at the micro CT, is it’s a normal pathway of healing and provides the opportunity, for not only continued healing but stability. Additionally, from Forsyth, there has been an examination of nine month implants or essentially trephines taken from the bone, showing that there’s a continued resorption of the material over time, which is what we have seen previously with the tricalcium phosphate materials. The other comment from a material science standpoint, Mr. Driskell has improved the stoichiometric chemistry characteristics of this particular tricalcium phosphate, compared to the material that we had investigated previously. And by all indications, it’s a significant improvement for applications in dentistry. Comments? We didn’t get a chance to show you were the later times. And what happens at six to nine months is that the fibrous material as well as the implant material is no longer present. And the cortical bone is much thicker and much more stabilized. So in my opinion, you know, after anytime after three months, it’s a very stable site. Thank you. Thank you very much.