Die "Trusted Quality Mark"
Wie kommt es, dass sich ein Zahnarzt ein Rasterelektronenmikroskop zulegt und wenige Jahre später eine der weltweit anerkanntesten „Trusted Quality Mark“ für Zahnimplantate etabliert und laufend verschiedene Forschungsprojekte durchführt?
In der zweiten Episode begrüßt Coco Volz den geschäftsführenden Direktor und Leiter der Forschungsabteilung der CleanImplant Foundation, Dr. Dirk Duddeck.
Dr. Dirk Duddeck erklärt, welche Arten von Verunreinigungen sich auf Implantaten (Titan und Keramik) finden, welche klinische Relevanz sie haben und was man als Implantathersteller im Bereich Quality Management tun kann.
Unser heutiger Gast
Dr. Dirk Duddeck
Geschäftsführer der Clean Implant Foundation
Zahnarzt und Biologe, der seit mehr als 10 Jahren die Folgen und die klinische Relevanz von vermeidbaren Kontaminationen und Qualitätsmängeln bei Zahnimplantaten erforscht. Ziel ist es, Kollegen mit dem nötigen Fachwissen zu unterstützen und alle Patienten vor vermeidbaren Risiken mit schwerwiegenden Folgen zu schützen.
Übergabe des CleanImplant Zertifikats an SDS SWISS DENTAL SOLUTIONS im Oktober 2021
Hello, and welcome to the second episode of the SDS podcast.
My name is Coco and today it’s my great pleasure to welcome to you, Dr. Dick Dudeck, who is the executive director and head of research of the clean implant foundation. Dr. Dudek will explain what kind of contaminants are found on implants, titanium, and ceramics, what clinical relevance they have, and what you can do as an implant manufacturer in the area of quality management.
He will also explain how the clean implants seal is a great benefit to dentists as it inspires confidence in patients and guarantees better healing and osseointegration of implants. Hello, Dr. Duddeck.
Thank you. thanks for having me on this new podcast.
Yes, it’s great to have you.
Before we talk about the importance of the project, the impact on the market, and the benefits for dentists in private practice, but also the concerns and resistance of some manufacturers.
When and how did this all start? Why did you decide to buy a scanning electron microscope? It’s not conventional for a dentist.
Was there any initial spike for the project?
Oh, these are some good questions. Good start. Yeah. Where should I start to answer? Um, I think it was about 15 years ago. I was working at the university of cologne in the dental department. When I first saw the problem by doing implants that they are not all on the same days.
They, you see as a dentist that some implants work quite well and others cause more or fewer problems by the handling or the outcome. This was the beginning when I started to, work with a scanning electron microscope. And to be honest at these at this time, I had very, very, let’s say small experience on, sophisticated, um, electron-microscope I saw something that I didn’t understand.
So that date sterile meant clean to me. If you buy in, um, medical device, like a dental implant as a dentist, you assume whatever incorrectly that these implants are not only sterile but clean, if they are delivered from. The manufacturer and a saw so many particles and the high magnification of the scanning electron microscope that I wondered.
Where did they come from? Is there a reason, did I make a mistake, made him take by, by joining the unpacking. This was the beginning. Um, more questions than answers to me. And at this time, the, um, I remember quite well, the European association of dental implantology, the BD as EDI, um, was supporting this project.
And, um, we made some publications that cost a lot of rumors, the data from some companies, they were. Angry. And, uh, wrote us emails through the association saying, oh, how can you dare to publish this kind of, uh, images? Because this is not the truth and so on and so on. Um, well later, a few years later I, uh, started to do the, uh, the third study, and I was were asking, Um, for support from the association and God knows why they didn’t support it because I had always to wait so long and the long queue of doctoral students, um, uh, on the scanning electron microscope in the clinic.
So I thought it was a clever idea to have an, an access full access to our 20 SCM because we had so many implants, to check. And, uh, well, this was the decision. To. A hundred, even 120,000 euros in his Kenny. Electro-microscope my, some friends of mine at these days invested in a fancy car and new boats or other hobbies.
Um, I decided to buy a scanning electron microscope in hindsight, this was the. Um, idea ever had, because this opened not only this offered, not only answers to the questions I have, it was kind of Pandora’s box opening and. So, this is kind of the initial spark when, when I’m driven by curiosity, actually, uh, that I wanted to know what are these particles are made of?
Why do you find so many particles these days?
We had 23 implants in my first research and even in my doctoral thesis. And, uh, more than 10 w showed some interesting, um, particles that were not supposed to be on a steroid clean dental implant. So this was the beginning of her.
Okay. Wow. This is very interesting.
So, um, let’s talk about the klim implant foundation. What is the goal of the clean implant foundation as a nonprofit foundation?
You have to do something for the benefit of all patients and not just one. Your colleagues about inferior medical. Yeah, the clean eminent foundation was the logical, the funding, the fund, the foundation of the, of the Cleveland Foundation.
Um, the start of this project was the logical consequence of all data we achieved, in the years before as we needed it. Uh, space, something like, like a, like a project, um, and this, um, the idea too, to, uh, develop this as a nonprofit organization, uh, is important because no one can buy a good result. Uh, if you do some research.
In a university environment. You, uh, it is, um, uh, not okay if companies give you some money, awaiting good results. So we, we always, um, try to, to produce non-biased data and. So this was the initial goal of the foundation was actually to give it a frame of the framework for this. Um, uh, let’s say the delicate topic of furious quality dental implants is a huge market.
It multi-billion dollar market. Um, and if someone. Comes around from Germany, looking through the eyes of, and scanning electron microscope, and see something that is not okay. And no one expected this kind of, um, uh, contaminants of, um, on, um, on a factory side reason. So, um, we, we decided, um, it wasn’t San Diego.
I just tried to remember. And then, uh, I see O. I gave a lecture, uh, for around 1,200 American dentists. And, um, I showed them some images and complained about the failure of the EU device regulation, because all implants I see under the microscope and not just from the lab or some kind of research and development, uh, department, they are.
Ready to use for the patient. These are the products that my colleagues see on their steroids, a table when they start the operation. I showed these images. And this conference. And I could see that some people took out their mobile phones. They see, oh, European implants who care for Europe. And then I said, okay, you get a good feeling as a lecturer.
If you kind of loses the audience, the attraction. And then I said, okay, give me one more minute. And then you guys can take your mobile phone, whatever you can speak. You can even leave, my lecture. I don’t care. I gave me one more minute and I’ll show you some more images. And the next images actually, as the M images from U S mate.
And it’s the moment I can still recall it. It was silent in these huge rooms. You could hear a needle fall. And from far, far back, you could see people shocking, just kicking the buddies next, sitting to them and saying, look at this and said, sorry guys, they are not safe on the USAW. These are implants with an FDA clearance and they look like this.
So some bad apples, even in Europe. And your basket here. And this was the moment after the lecture. I was surrounded by around 20 people. I’m complaining to start the next lecture because it looks like a big fan club and asking me for my business card, no one wants to see my business card.
They’ve all shouting names, like brand names. I said, okay, what about this ABC?
And they just dropping names. And I thought, Jesus Christ. If I start to do some thumbs up, thumbs down here. I will. I’m on, I cannot leave the US I mean, maybe in handcuffs. I don’t know.
So this was a threatening situation later on, by the way, I, um, a colleague came to me and said, okay, lucky, you, you had no brand names on all the dirty images or images of dirty.
Because, um, maybe you, you will have some legal problems as well here. I guess that from thousand people in the audience, at least one lawyer must be there. He was laughing at what, I know, seven lawyers, I saw the room. So all the big companies sent their legal advisors to see if there was something wrong with me.
At the beginning of this moment, I thought, we needed protection for this nonprofit project. Telling the truth, even in dentistry is something that is not as easy as it sounds. And then we decided to ask more and more people, renowned professors, to help us, to join the scientific advisory board, give us some rules and then.
By finding out a threshold. We came together. We. Um, people like Thomas, Albert, and Vanderburgh, um, uh, from Sweden, what does our grand scheme university, uh, even my connection, the, uh, former president of the American Academy of osteointegration, the AOA. So we asked them and all of them said, yes, we’re gonna help you.
This is an interesting topic. We, we see that you need protection. We give you a framework of what is it, a clean implant. Meant to be. So is there some other, thresholds and finding? In the end, some, uh, kind of, um, consensus paper, uh, you can download this and on the internet and, uh, www clean implant.org.
There’s a paper 20 pages long and shows bad, bad, and good examples. In the last two pages, we found a consensus about what is, um, uh, cleaned up and how many parties. Can still be accepted. So this was the thing, the question was the goal. And, um, as a nonprofit, we do have to do some benefit even for patients.
Yes. Making a, let’s say giving some pressure to the market that, um, beyond every FDA, um, um, uh, clearance is even in the European CE marking process. Some guys are looking at the end product and it’s this promise of a manufacturer all the way. Fulfilled with something real, a real clean implant. So this is sorry for the long answer to the short questions.
It’s very interesting, but, um, let’s talk a bit more about the contamination. In the meantime, you have examined well over 300 different implants in the SCM for contamination at the factory. What did you find on the sterile packaged implants? Is it only plastics or also foreign? Yeah, this is the shocking experience I made over the years.
Um, it’s not getting better. So, um, we informed always the manufacturers about the results, every company that sends us an implant, uh, receives an answer is at least a short information. And I find that. And total it’s more than 300 different implants from my, I think about 200 different manufacturers.
So I think we cover more than 90, 95% of the market. And what we find on the dental implants is, um, You see some organic contaminants in the material contrast image of a backscattered electron imaging. There’s a severe, various specific, uh, technical detail ever. You see when something is not made of the core material, if it’s either titanium or, um, it’s a corner, so we can see quite well as something that is.
Um, um, declared on the, on the paperwork for the implant. So is there a foreign material? And we find very easily my organic materials, it’s hard to differentiate what it is. Sometimes we see from the shape the, of the particles and the elemental signals in the, um, um, EDS, and out of this, um, We see that there’s a certain combination of elements.
If a bunch of go deeper and we are now, we now have an additional tool. It’s the time of flight, secondary, secondary EMS, spectrometry, tough Ziems, uh, even how to pronounce in German, by the way. Um, it’s we know not only is made of carbon or something, organic material, but we can also actually now see that this is.
Plastic material and what kind of plastic it is so good. We found poly at the tar, um, pull your Oxy method in the same, uh, P O M S the technical, uh, technical class of material. We found police Psylocke sands. We found, um, uh, even. Um, remnants from the cleaning process. Uh, this was, for example, this, if I have an implant and my doctor gives me an implant and he has no clue that this implant may contain on the surface daughter, sill Benson’s or phonics.
DVSA is a very aggressive cleaning solvent. They used to use to have it, this get rid of all the oil and all the, um, contribute nation during the process. And if we find even the remnants of the cleaning material, this is an aggressive surfactant. And according to the American environmental protection agency, EPA, it’s a hazardous substance.
This is a Telus tox cell toxic hazardous substance remaining on a sterile package infant. While we pay for this implant between 60 and $400 or Euro. Um, in addition, you ask about farm metals. Yeah. Interesting. Um, we find particles and on your one-on-one implant, we found more than a hundred particles made off with elements of iron nickel-chromium.
Remnants of the tank stand from, the turning machine. We find, um, metals, even small particles. We have to speak about, the amount of the size and the clinical relevance, but I find corporate tin, a hundred percent clear signal of a metal particle. Small enough for pharmacy chose us containing corporate 10, 10.
And God knows what 10 bronze does to the body. I don’t think it’s good for our integration to set a little bit sarcastic. So we found many different metals, um, from a, um, either contaminated blood. Um, material or from touching the implant during the process, even, uh, the tungsten remnants of, from the blasting nozzle, this, uh, in the Bronx is a very soft metal, most likely, uh, originating from the blasting ozone.
So we have plastics, we have metals and we have even hazardous substances. This is the bad news. The good news, by the way, is there’ll be still have under 300 different. At least two-thirds of the implants are not that bad. So we see a lot of implants that, um, really deserve our trust, that, um, producing on a very high level.
I have to speak about this later, but it’s not the, I can tell you, um, uh, it’s not the general, um, uh, quality of a dental implant nowadays. It varies. I won’t give my cat two beautiful super-clean implants. Okay. So you see a very high, uh, range of, of different, um, contaminants in these, let’s say total 300 implants.
Okay. But I have a question for you. How big are these particulates usually does the size of the particle play a role in the possible foreign body rate? Of course, of course, as fast as I remember from my basic study. And you can read this in many, in many public patients, the size of a bit of a, of a particle that is okay for faculty told us.
So macrophages come to. No, let us start it another way around. If, if a buddy sees a foreign body, it always leads to a foreign body reaction. Even an implant is a foreign body by definition, but this is a controlled foreign body erection. I was integration is nothing else than a controlled foreign body reaction.
We see some smaller particles with more or less, um, They are not. So, uh, bio-inert, um, like, like, uh, cells are the bodies who are acting in getting rid of these materials. It’s a foreign body. So we have CFR, we had a foreign body reaction with the foreign body giant cells. We can detect and see a macrophage.
And in macrophages, uh, have a, have a nice appetite for these particles and the size of the limitation is about eight to 10 miles. So if people tell me are dark, these parties, cause you find are so small, they, they don’t, their biologic reaction is, is, is not worth to mention because they are so small as my answer, they are so dangerous because if they are smaller than 10 microns, they most likely they will be, um, intake by these, uh, macrophages by focus.
He chose us. The follow-up leads to an increase of osteoclast and osteo cluster janitors. In other words, by trying to do a sort of cleaning of the contaminated implant by the biology of the patient. We have a follow-up reaction with an increase of osteoclasts taking away the bone in the moment and in the area we wanted to have the best bone seal.
So usually we have an accumulation of these particles in the shoulder area. If you draw, if you take an implant inside the bone with forces up to 17 Newton centimeters, um, there might be some particles detached from the surface and they will all accumulate in the shoulder. And this is the place where you want to have eight, uh, Like from a clinical point of view, see a lack of, of, of, uh, Austin integration.
But you are forcing the condominium, that implant is forcing the body to, um, increase there, the osteoclast cells. And not only take away these particles by macrophages and pharmacy told us, but also by taking away the bone as well. So this is the start of, um, some cases, I guess, a lot of cases of peri-implantitis induced by, by.
Uh, voidable factory-related contamination, I’d say very slowly, because this is the core message of this complete interview, I guess.
Okay. Yes. So what would you say is the general feedback by, um, toxicologists about your results? Do they say that the particulates play any role at all in the healing phase?
Meaning do they have any clinical relevance?
I had this question for years. Um, all my friends say, what are you doing for kind of crazy research? Nobody cares. Um, you have to keep in mind that we have, uh, You have to see the the the most recent FDA numbers failed implants. There are, there are, there are some statistics that CR an incline and a failed implant, but there must be some reason.
And I want you to know this. Exactly the question. Thank you for giving me the question here. Um, I took a flight to Brisbane. In Australia, uh, and visited, uh, one of the most renowned toxicologists professor, Jack, Angie, I don’t know how to pronounce this, whatever. Um, he’s on the board of American toxicology and I asked him the same question.
We see a very local. The areas that we are not contaminating the whole body because he’s a specialist in, in an environmental, um, uh, intoxication. So some from water, uh, lead and water and something like this. So I ask him is how can these particles have an effect? And he agreed on this, this might be only with a question mark, uh, a local effect.
There is, um, always air reaction. He confirmed that there will be some, maybe some local effects and we, as dentists take care of local effects. I don’t want to have an implant where the body has to do the cleaning work, uh, um, by doing a 50% OS integration and the I’ll say a less good than it could be with a cleaning plant.
So he. Well, the answer is quite easy. Um, there is a kind of foreign body equilibrium. That means there is no technical threshold for how big can the size of a, of a, of a, of contamination be. How big is the particle? Um, do we have a specific amount of specific toxicity of these parties? It is not, um, uh, the particle amount.
It is. We always see the reaction in the body. And even if it’s a local reaction, um, we, we, we have to deal with, um, para implants parabola. Again, induced most likely by, uh, these avoidable, um, particles and no patient is the same. And this is why there’s a very nice publication entering the same question.
The answer is a, there is an individual foreign body equilibrium. That means a 20-year-old basketball player. Um, super healthy and just losing a tooth, a central incisor by an accident might have a wonderful loss integration, even with a kind of mini implant. No doubt about it could happen. It might even take a rusty nail.
I don’t know if it’s an asteroid. We have to deal always an hour threshold is the weakest patients we can, can, uh, that is visiting our practice. I have to, I, I was working about 14 years in a university. I have to deal with compromised patients and I speak about pre-radiated, um, um, patients inpatients with, uh, Um, heart diseases, and so on.
So we, we went to the, to the limit, to the limits of, of, of indication for implant therapy and the last thing you want to have if you have these weak and, and suffering patients are extra contamination on the implant. If it’s technically avoidable. So the far about equilibrium, it gives us the answer that, um, the one patient can deal with it.
The other one, not. And our bar or the special should be always as we are a medical person, we should always take care of the weakest patients. This is what. Yeah. Talk to the cottages in environmental medicine, there is a concept of precaution. Every principle here, one assumes a burden on health in this case of contamination until the polluter proves otherwise.
Does this also apply to dentistry or implants? The precautions are printed by this, um, It’s a German invention, by the way, um, in the, in the, uh, environmental medicine and, and, um, the, this was something that was brought up by, by a professor in, uh, in Brisbane. And he said, um, if this the same rule as in the, um, environmental, um, uh, topic.
We don’t know how a specific material is, um, is good or not good for the bone or the, for the health of our patient. We should always see this as a, uh, toxic or let’s say, um, not having, not, uh, no positive effects on health or as integration, unless we have proved that they are healthy and they are there, uh, no reason for concerns.
The reverse of the burden of proof is something I have to deal with. People always sell. Some manufacturers would try to reduce the cost, of production by, um, by a lack of quality management. This is the only reason why we can see these implants even as a CE mark. Um, they, they say, well, give Dr. Dudeck.
Please send. Any information that the things you find have a negative, um, effect on our integration. I said, no, you have to show me if you can’t avoid your daughter. So the benzos with chronic acid, if you cannot avoid massive milligrams of plastic from the packaging remaining on the implant surface, if you can’t avoid this, you have to give me as a dentist proof that these materials are safe.
So this is. I think we have to, uh, admit that, uh, that even dentistry is playing by the same rules and it should be for the sake of our patients, that the precautionary principle is something we follow, even in dentistry. Okay. So you have been observing the problem for several years now. And when you report in your lectures and write in articles that one in three implants examined is significantly contaminated, which by the way, as a patient, I find hard to believe.
Is there a tendency over the years towards improvement? Don’t all companies improve their quality management when they learn about contamination in their medical devices? Oh, good question. I hope we have some time to answer this. This would be quite a long podcast here. Yeah, one in three that is still the remaining, um, proportion of, uh, contaminated, significantly contaminated implants.
And when I speak significantly, I mean more than 2030 particles, obviously avoidable on the implant, mainly organic particles, but even some we spoke about before this, even some foreign metals, not by the core material. Um, isn’t there a tendency towards improvement? Um, we have very, very positive and we have very, very negative experiences with dealing with the information.
Uh, we skipped this donation to auto manufacturers. Um, not all companies start to improve theirs. They’re manufacturing, unfortunately, maybe because they don’t feel the pressure. They don’t see any reaction from their customers at all. And the complaints, um, of failing implants is always easy, to address this to a patient with, um, Um, uh, some, some diseases are with a lack of hygiene or at least even a lack of education from the dentist.
I think it’s too easy. Uh, as long as we see this one in. Um, a ratio of significantly coordinated implants. There should be some, some a reaction I would love to see. Uh, we are now starting the fifth study, following the same protocol. Do we have? Database, we can compare data from even from 2011, 2012, a study 2015 study 2017.
And now we do study 2122 collecting more than a hundred implants. So we have a huge database. And the problem is, um, two examples I’ve met, uh, met a CEO in the, in the most recent IDs at the international dental show. And. And he told me, um, well I know your work, Dr. Dudek. I know what a clean implant is doing.
Uh, giving a lot of pressure on the market, but you know what? I sell a million implants. I don’t care what you do. As long as I sell a million implants, we don’t even stop the research on implant services. That is what a CEO of, one of the major companies told me right into my office. I said, I said, and this is the story behind the story is that I addressed a problem to them where I found an implant from his, um, and if, um, from his factory site contaminated with hundreds and hundreds of stainless steel particles, Mixed with aluminum oxide as blasting material.
If, if, if Iran chromium. Uh, nickel metal. Isn’t good for our integration. I would love to see this, um, this study. Um, he couldn’t give it to me because it’s just a contaminated plastic material. So I found this one example and it was two implants from the same batch. Um, but, um, I don’t want to see. 1 million implants, maybe, as far as I know, he has a lot of sales in India and not in Europe, but, um, I doubt that all these implants, uh, lead to our integration, I, for sure I have respect for his.
Um, success from Ms. Business success, but it’s not all about money. It’s not about 1 million sold implants in about 1 million treated patients with inferior quality implants. Another company told me. Um, in 2014, I showed them the results of, uh, two implants that they offered for the study. Um, they have a lot of room for improvement and the answer was very politely asking me, uh, to avoid, publishing any negative data on the company or the implant type.
I checked the same implant three years later. And I found the same or even more contamination, organic material, uh, on the implant. And I received a, like a, a standard form, a received nearly the same mail, the same information from the company. But in addition, he wanted me and he threatened me with legal actions in case of any publication of this.
So this is, let’s say, the dark side of the moon. Uh, on the other hand, we have a lot of positive reactions, and some companies trying to get better. It’s not because of the pressure that clean implants. To the market. Um, control is a very good thing. As long as we have this amount of contaminations, avoidable contaminants on implants, and, um, most likely clinically effects on this contamination, someone has to look at them and there are some companies taking care and asking us, how can we get rid of the problem we want?
Better. We want to sell a good implant, please help us and get better. And this is what we do as well. So even companies that see the room for improvement, we give them a helping hand and whatever we know about this topic, we, uh, we give them a stage and we have candidates in our group of supporting companies who are.
Have I had an inquiry let’s say, and a huge improvement in the quality of the dental implants. And I’m very proud that these companies, um, and are better on the.
No. It was very interesting. Yeah, it’s good that there are, um, companies who want to improve their quality. Um, so what would also interest me is how do manufacturers react to this initiative and the claim in the foundation, which has become something like the ban test for implants. I hope this word also exists in India.
I think there’s a comparable, uh, institution in and doing the same as the shift that has in Germany. It’s the, uh, UL listed. And you asked this in the United States, there is an underwriter’s laboratory. They check every from a toaster to a, uh, to a washing machine. They check every technical issue. So the same at the Germans drift on van test is doing.
Yeah. Um, how do they react? I told you some already spoke about two, two examples. Um, again, we have friends and foes in the market, and, uh, I would like to emphasize that our glass is half full. I would love to give them. Who improve their, their, um, quality. I show from the first moment on an implant with cleanliness that is promised by, by the packaging that is promised by the name of the company, um, that, that, um, we give them a stage.
We, we, we, uh, we have, no, I have no fun and dealing with legal threats and. Sound guys taught me how you are the Robin hood of dentistry implantology. I’m not sure if this is a right, um, a precise description of what we do, however. Sometimes I feel like this, I received a call from a, from a manufacturer I remember quite well, two years ago, he was so angry about the results and about, um, the way we publish this data that he told me.
He was driving his car back home from his factory. And he was so angry, shouting into the microphone, saying, Dr. Dudeck, I know that you live in Berlin the next time you will walk in the evening in the streets of Berlin. We have many, many friends there. Take a look and you’re back. So this was the first time I read this.
I have this on tape. This was the first time I ever received, a person, a threat. Again, on the other hand, we are so proud and we are so happy that we have, uh, companies that help us. I would love to mention one more thing. It’s not a question, but it’s important to understand. Implants are not good, just because the company is a big one.
We still find implants where significant contaminants are on implants from major manufacturers. And I mean, number one to number four. Um, so this is not that they, they have sometimes, um, implants that, um, They don’t want to recognize that they may be even they know that some implants have a lack of quality.
However, the reaction from some major companies differs a lot from the smaller companies because they think they are too big to fail. And it’s kind of UN Germanist. The German boat is my state’s politely gong. It’s uh, if you accused the king that he’s doing something wrong, then you, again, you go into jail.
So, um, It’s kind of, um, uh, we, it is what it is. We open an implant. We don’t care about the size or the name or the reputation of a company. We see the implant as it is. And unfortunately, there is no pattern of, uh, let’s say, market share our price of the implant we have even. Costs implants with significant contaminants.
So there is no safety and the market, and this is why I think the complete, the project that clean entrance project is so important for the market. Absolutely. Yes. So I understand that there is encouragement and at the same time recently, Coming from the industry, but, um, let’s move to the topic of ceramic implants.
I’m sure you’ve seen a variety of ceramic implant systems. What about clinically relevant Imperial? I shouldn’t say corneum oxide implants be cleaner since the manufacturing process is fundamentally different from implants made of titanium or titanium allies. True. Um, the process of manufacturing is different.
However, um, you can, um, Contaminate an implant, even after it’s leaving the the the OVN, uh, the ceramic, uh, implants are produced with, uh, with a high-temperature process and, um, Usually you have a clean implant after this. So at least the organic particles are gone, but if you then take an implant and squeeze it in plastic packaging by using the first the shoulder and the first threat of an implant where the implant packaging is is, is, uh, touching the implant.
But the refs. Uh, as you’d take the implant out of the packaging, you see, the remnants of the packaging itself. So this is something we found in a, uh, um, major research project, um, um, performed with the, uh, uh, not only with the show to university here in Berlin, but also with, as our grand scheme university in Gothenburg, uh, and the Miami University in Sweden, where we collect.
25 implants, ceramic implants, to answer your question from five ceramic implement effectors and we, uh, all of these five samples had to show the same, uh, Hadoop. Follow-up the same. Protocol of analysis. We measured the roughness. We checked the literature on the implant system. Uh, is there clinical proof of success?
And, um, my job was to check these implants, um, for cleanliness and this can electro-microscope again, using backscattered electron imaging. And what we found unfortunately is the same ratio from these five times. Two types, um, just played significant contaminants, the one with the packaging, uh, process problem, um, having massive milligrams of, um, of, uh, polyester, Tod, POM polyoxyethylene on the implant.
So there’s no. Simply because they are white, they are not clean. You have to do the same, um, quality management at H a Tanium implant. This is very important. Okay. As an experienced implantologist, what would you look for when selecting an implant system for your patients or your. Let me just add some, some to the some enter to the, um, um, some additional information.
The publication from the yummy journal, the journal of oral maxillofacial implants, uh, can be downloaded. So it’s on our website. Uh, if you want, uh, they can, people can send me an email and I will send them, uh, a, a print of this publication. It’s important to, to understand, um, um, um, What would I look for when selecting implant for my patients in my practice, when at least I would, for sure don’t buy this in the gray market, I would love to have an, an improvement from a CE mark on FDA clearance, the minimum, but.
As I know, and maybe I know too much about this topic. I would love to see additional information about this implant. I want to be on the safe side. I don’t want to have the problem of, uh, legal threats or, um, seeing that. Uh, the patient can, can Sue me for four and have claims of damages. If they get the information I use, an implant showed in a publication, um, S uh, significant contamination.
So this is a huge problem in the United States, by the way, where it’s kind of standard that so many patients. Uh, our, um, um, uh, suing their dentist and their dentist, even the medical clinics for any kind of mistreatment or misbehavior. So, so there, I would love to have safety and the safety of that, uh, I know from my microscope is then when we give.
There’s a, there’s a process that leads to a, um, the trusted quality mark. The traffic quality mark is, is, um, um, awarded two implants that give proof not based on one implant that on five implants. Um, and they show in the microscope in accredited laboratories, by the way, that’s not. Kind of backyard as the M it’s an accredited laboratory where they produce data on a very high standard of science.
And I would love to have. Quality seal on a dental implant, the traffic quality mark. I think this is where at least the surface is clean. There are more reasons for a good implant, but I would love to have safety on this topic. So as a dentist, you can become a member of clean implant and sign up as a certified dentist and a site from supporting a good cause.
What is the benefit? Um, supporting us as well. One good thing is that we need support from dentists worldwide, and we get them by the way, this is one reason why we have to date. I think, uh, there is a number is 110,000 followers on the internet. It’s even more than the Nobel Biocare by the way. So there’s an impact on the market and people who are.
Um, supporting the clean implant as a clean implant certified dentist, they will be shown on a, an, a website that is a clean implant for you. It’s a, with a four with a, with a numeric, for clean implants for you.com, uh, German it’s Sobel, uh, implant hearted, D E uh, people should check this. They will be mentioned.
They will be shown in the. Uh, a certified dentist for himself. He has a safety that he’s on the safe side and just implanted. Contaminated and he can show it to his patients and we give, uh, we support the practices with, uh, um, marketing material, uh, for the waiting room, um, and for the referral practices. So some dentists don’t do implants on their own, but they have, they, uh, our surgeons, our maxillofacial surgeons doing the, uh, the surgical part of, of implantology.
And this information is even. For these people who can support their practices, showing them that, uh, implants in use are double-checked. They don’t only have the official CE R uh, FDA, uh, mark. Um, they have additional tests, uh, and they underwent additional tests in the clean implant foundation and a very high level.
Uh, scientific evidence. So we can see that these implants are finally clean. So it’s a, it’s a, let’s say it’s, um, it’s a mixture of marketing and, um, material for the practice. They can convince patients that they are using an only good implants. And I, I, I can see. More and more patients are aware of the problem.
Any patient to date knows the difference between a, uh, vaccination, um, uh, of the, of the, of the vaccines. Um, they want to have either this, uh, standard vaccine or they want to have the Mr. M R so, so this is, um, Um, patients are informed and if they take care of so much of explanation, why don’t they, I think they will, sooner or later they will take care for their implants as well.
I can promise this for sure. Yes. So I did some research on the internet before our conversation. And if I see it correctly, the clean implant foundation has more sucks. Subscribers on Facebook. Then, for example, a global market leader like Nobel Biocare, which you just mentioned. But how would you explain the high number of followers in such a short time on social media?
Yeah, we are on social media since 2018. I mean, this is not, this is, not, not, not full four years. And we reached more than a hundred thousand followers. We were surprised by the feedback from colleagues. This topic is something. People, my colleagues don’t want to have in their practice. If they are aware of the problem, they might have a solution.
And, uh, this is why they, um, what left to be informed by our emails, by our newsletter. So, um, To kind of lost our shot. If there wouldn’t be a problem of avoidable contaminants on steroid dental implants, there would be no clean implant foundation that I wouldn’t have bought a scanning electron microscope.
Maybe I haven’t fancied Cano instead. And, um, we wouldn’t have this. For the last 40 minutes. So, um, I think it’s more mental and what we see people, my colleagues, and even patients, although we address only professional, um, uh, colleagues on, on the, on the, um, on the social media, um, I think there’s a small percentage of patients as well.
However, it is something my colleagues are concerned about. So, um, this was very interesting and sadly, we have already reached the end, but I have one final question for you and it is where do you see yourself in five or 10 years? What would you like to have achieved with your initiative by then? Oh, good question.
Um, yeah, that’s good. Um, I would love to see it. A higher percentage of implants with no reason to be concerned of. So I would love to see in a, uh, average less than two out of 10 implants, um, being, being contaminated, um, or being, uh, showing something. Giving fulfilling the promise that they, that the companies do with their advertisement.
And I see myself in five or 10 years. Well, I think we just opened the first box of Pandora. I think we should have a look at us your orthopedic screws as well. We would take care of for, um, bone substitution, bone substitutes for, um, we will take care of, for. Um, other medical devices. I think we S we just, we’re at the beginning of a very, very interesting and a success story here.
The clean implant is something. Although some companies don’t like us, I think it’s hard to ignore that there is power. Of users of customers that we support. And I think in five or 10 years, we will have, um, and even better standing in the market, then this is a very good outlook for the future. And it was, for me, it was a very interesting lecture.
So thank you very much. And I’m sure that our. Appreciate this episode and all the information you gave us today. So thank you for this. It was my pleasure. Thank you for having me now. Thank you for participating. I miss the due date.