Episode 2 – Dr. Dirk Duddeck talks about Implant Contamination

The "Trusted Quality Mark"

What made a dentist acquire a scanning electron microscope, and—a few years later— establish one of the world’s most recognized “Trusted Quality Marks” for dental implants, whilst continuously running many research projects? In the second episode, Coco Volz will be talking to Dr. Dirk Duddeck, CleanImplant Foundation’s Executive Director and Head of Research.

Dr. Dirk Duddeck will be explaining what type of contaminants are found on implants (titanium and ceramics), describing their clinical relevance and providing implant manufacturers with quality management solutions.

He will also be telling us about the enormous benefit the CleanImplant Certificate for dentists, as it boosts patient confidence and guarantees better implant healing and osseointegration.

Today‘s Guest

Dr. Dirk Duddeck - Clean implant Foundation, Verunreinigung von Implantaten

Dr. Dirk Duddeck

Executive Director of the Clean Implant Foundation

A dentist and biologist who has been researching the consequences and clinical relevance of avoidable contamination and quality defects in dental implants for more than ten years. He wants to equip colleagues with the necessary expertise, and to protect all patients from avoidable risks that often have serious consequences.

Presentation of the Clean Implant Certificate

Awarding of the CleanImplant certificate to SDS SWISS DENTAL SOLUTIONS in October 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 CleanImplant 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.

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 spark for the project?

Dr. Duddeck
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. 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, this highly sophisticated electron-microscope. I saw something that I didn’t understand. To that date sterile meant clean to me. If you buy a 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. Bit I 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, by doing the unpacking.”
This was the beginning. Um, more questions than answers to me. And at that time, the, um, I remember quite well, the European Association of Dental Implantology, EADI, um, was supporting this project. And, um, we made some publications that caused a lot of rumors, the data from some companies. They were angry and, wrote us emails through the association saying, oh, “how can you dare to publish this kind of 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 asking 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 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 well, this was the decision: to invest one hundred, even 120,000 euros in this scanning electron microscope.
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 best idea ever had, because 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: driven by curiosity, 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 showed some interesting particles that were not supposed to be on a sterile, clean dental implant. So this was the beginning of everything.

Okay. Wow. This is very interesting. So, um, let’s talk about the CleanImplant Foundation. What is the goal of the CleanImplant 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.

Dr. Dirk Duddeck
Yeah, the Foundation of the CleanImplant Foundation was the logical consequence of all data we achieved, in the years before. As we needed a space, something like, like a, like a project. The idea to develop this as a nonprofit organization, is important because no one can buy a good result. If you do some research in a university environment, it is not okay if companies give you some money, awaiting good results. So we always try to, to produce non-biased data and. So this was the initial goal of the foundation: to give it a framework for this, let’s say the delicate topic of inferior quality dental implants. This is a huge market. A multi-billion dollar market. And if someone comes around from Germany, looking through the eyes of a scanning electron microscope, and see something that is not okay. And no one expected this kind of contaminants on a factory side reason.
So, wedecided, it was in San Diego, actually, I just tried to remember. I gave a lecture, 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 sterile table, when they start the operation. I showed these images at this conference. And I could see that some people took out their mobile phones. They say “European implants who care for Europe?” 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. But give me one more minute and I’ll show you some more images. And the next images were the SEM images from US-made implants.
And that’s the moment – I can still recall it – It was total silence in these huge room. You could hear a needle fall. And from far, far back, you could see people shocked, just kicking their buddies sitting to them and saying “look at this”. And I said, sorry guys, they are not safe under US law. 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 A-B-C? 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 implants. 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 my lecture.
10:36 min Spotify
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. People like Tomas Albrektsson and Vanderburgh from Sweden, what does our grand scheme university, uh, even Michael Norton, the former president of the American Academy of Osseointegration, the AAO. 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 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 on www.clean-implant.org.
There’s a paper 20 pages long that shows bad and good examples. In the last two pages, we found a consensus about what is clean implant and how many particles can still be accepted. So this was the thing, the question was the goal. And as a nonprofit, we do have to do something that benefits the 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 is this promise of a manufacturer always fulfilled with something real, a real clean implant. So – 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 matters?

Dr. Drik Duddeck
Yeah, this is the shocking experience I made over the years. Um, it’s not getting better. We informed always the manufacturers about the results, every company that sends us an implant, uh, receives an answer, at least a short information. And total it’s more than 300 different implants from, 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. That is a very specific technical detail. You see when something is not made of the core material, if it’s either titanium or zirconia. So we can see quite well if there’s something that is not declared on the, on the paperwork for the implant. So is there a foreign material? And we find very easily organic materials, it’s hard to differentiate what it is. Sometimes we see from the shape of the particles and the elemental signals in the EDS, and out of this we see that there’s a certain combination of elements.
If we want to go deeper and we now have an additional tool. It’s the time of flight, secondary EMS spectrometry, tough SEMS, 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 a plastic material. And what kind of plastic it is. So good example we found Polyacetal, um, Polyoxymethylen “POM” is the technical class of material. We found Polysiloxans. We found 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 Dolyphon Benozo Sulfonic Acid “DBSA”. This 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 toxic hazardous substance remaining on a sterile package implant. While we pay for this implant between 60 and 400 Dollars or Euro. Um, in addition, you ask about foreign metals. Yeah. Interesting. We find particles and not only one, on one implant, we found more than a hundred particles with elements of iron, nickel, chromium. We found 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 Phagocytosis containing corporate tin, and God knows what tin bronze does to the body. I don’t think it’s good for osseointegration, to say it a little bit sarcastic. So we found many different metals, from an either contaminated blasting material or from touching the implant during the process, even the tungsten remnants of, from the blasting nozzle, this, tin bronze 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 implants, 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 are produced on a very high level. I have to speak about this later… The general quality of a dental implant nowadays, it varies from I won’t give my cat to 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 particles usually? Does the size of the particle play a role in the possible foreign body reaction?

D. Dirk Duddeck
Of course, of course, as fast as I remember from my basic study, and you can read this in many, in many publications, the size of a bit of a, of a particle that is okay for phagocytosis. So macrophages come to. No, let us start it another way around. If, if a body 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 reaction. Osseointegration is nothing else than a controlled foreign body reaction. We see some smaller particles with more or less. They are not so bio-inert like implant materials are. The body is reacting by getting rid of these materials. It’s a foreign body. So we have a foreign body reaction, we see the foreign body giant cells. We can detect and see macrophages. And in macrophages, uh, have a, have a nice appetite for these particles and the size of the limitation is about eight to 10 micron. So if people tell me “these particles you find, are so small, the biologic reaction is not worth to mention because they are so small.” My answer is 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 phagocytosis.
The follow-up leads to an increase of osteoclast and osteocluster 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 drill, if you take an implant inside the bone with forces up to 17 Newton centimeters, um, there might some particles detache from the surface and they might all accumulate in the shoulder. And this is the place where you want to have a, uh, from a clinical point of view, see a lack of, uh, osseointegration.
But you are forcing the contaminated, implant is forcing the body to, um, increase there, the osteoclast cells. And not only take away these particles by macrophages and phagocytosis, but also by taking away the bone as well. So this is the start of, some cases, I guess, a lot of cases of peri-implantitis induced by an avoidable 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 particles play any role at all in the healing phase? Meaning do they have any clinical relevance?

Dr. Dirk Duddek
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 most recent FDA numbers of failed implants. There are some statistics that see an incline and in failed implants, 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 Prof. Jack Ng. I don’t know how to pronounce this. However, he’s on the board of American toxicology and I asked him the same question.
We see a very local area, 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 in 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 a 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% osseointegration less good than it could be with a clean implant.
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 contamination be. How big is the particle? Um, do we have a specific amount of specific toxicity of these particles? It is not, um, uh, the particle amount. 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, peri-implantitis parabola. Again, induced most likely by, uh, these avoidable particles. And no patient is the same. And this is why there’s a very nice publication entering the same question.
The answer is 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 osseointegration, even with a contaminated implant. No doubt about it, could happen. It might even take a rusty nail. I don’t know if it’s sterile.
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. Patients with 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 threshold should be always as we are a medical person, we should always take care of the weakest patients. This is what he confirmed, the toxicologist.

In environmental medicine, there is the concept of “precautionary principle”. One assumes a burden on health in this case of contamination until the polluter proves otherwise. Does this also apply to dentistry or implants?

Dr. Dirk Duddeck
The precautionary principle is a German invention, by the way. In the environmental medicine and this was something, that was brought up by Prof. Ng in Brisbane. And he said, um, if this the same rule as in the, environmental topic. If we don’t know how a specific material is good or not good for the bone or the health of our patient. We should always see this as a toxic or let’s say, not having positive effects on health or osseointegration. Unless we have proved that they are healthy and there are 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 a lack of quality management. This is the only reason why we can see these implants even as a CE mark. They say, well, Dr. Duddeck, please send us any information that the things you find have a negative, um, effect on osseointegration. I said, no, you have to show me if you can’t avoid Dolyphon Benozo Sulfonic 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 admit 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?

Dr. Dirk Duddeck
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 20-30 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. So, is there a tendency towards improvement? Um, we have very, very positive and we have very, very negative experiences with dealing with the information.
If we give this information to manufacturers. Um, not all companies start to improve their 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 some diseases or 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-three ratio of significantly contaminated implants, there should be some reaction. I would love to see. We are now starting the fifth study, following the same protocol. We do have a very good database, we can compare data from even from 2011, 2012, a study in 2015 a study in 2017.
And now we do study the years 21/22, collecting more than a hundred implants. So we have a huge database. And the problem is, um, two examples I’ve met a CEO in the, in the most recent IDS at the International Dental Show in Cologne. And he told me, well I know your work, Dr. Duddeck. I know what a CleanImplant is doing, 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 face. I said, I said, and this is the story behind the story is that I addressed a problem to him, where I found an implant from his factory site, contaminated with hundreds and hundreds of stainless steel particles, mixed with aluminium oxide as blasting material. Iron, chromium and nickel metal are’nt good for osseointegration. 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 the 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 osseointegration. I, for sure I have respect for his success, for his 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 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 standard form, I received nearly the same mail, the same information from the company. But in addition, he warned 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 CleanImplant gives 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 to sleep better.
We want to sell a good implant, please help us in 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 really show a huge improvement in the quality of the dental implants. And I’m very proud that these companies, um, are now better on the market.

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 CleanImplant foundation? It has become something like the “Stiftung Warentest” for implants. I hope this word also exists in English.

Dr. Dirk Duddeck
I think that’s a comparable institution, and doing the same as the Stiftung Warentest in Germany. It’s the “UL” in the United States, there is an underwriter’s laboratory. They check everything from a toaster to a washing machine. They check every technical issue. So the same as the Germans’ Stiftung Warentest 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 those, who really improved their 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 – that we give them a stage. I have no fun in dealing with legal threats and some guys told me “Oh 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. Duddeck, 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 at your back!”
So this was the first time I have received this kind of threat. I have this on tape. This was the first time I ever received, a personal 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 with significant contaminants on implants from major manufacturers. And I mean, number one to number five. This is not that they have sometimes, they don’t want to recognize that they maybe even they know that some implants have a lack of quality.
However, the reaction from some major companies differ a lot from the smaller companies. Because they think they are too big to fail. And it’s kind of- the German word is “Majestätsbeleidigung” – 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 or price of the implant we have even. Costs implants with significant contaminants.
So there is no safety in the market, and this is why I think the complete, the project the CleanImplant project is so important for the market.

Absolutely. Yes. So I understand that there is encouragement and at the same time resistance 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 impurities? Shouldn’t the zirconium oxide implants be cleaner since the manufacturing process is fundamentally different from implants made of titanium or titanium allies.

Dr. Dirk Duddeck
True. Um, the process of manufacturing is different. However, um, you can, um, contaminate an implant, even after it’s leaving the oven. The ceramic implants are produced with a high-temperature process and, 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 touching the implant. But the surface, as you 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 performed with the, not only with the Charité University here in Berlin, but also with the University in Gothenburg and the Malmö University in Sweden. Where we collected 25 implants, ceramic implants, to answer your question, from five ceramic implant manufacturers and we, uh, all of these five samples had to follow-up the same protocol of analysis. We measured the roughness. We checked the literature of the implant system. Uh, is there clinical proof of success?
And, um, my job was to check these implants, um, for cleanliness and this scan electron microscope again, using backscattered electron imaging. And what we found unfortunately is the same ratio from these five types. Two types, um, just played significant contaminants, the one with the packaging process problem, having massive milligrams of polyacetal, POM polyoxyethylene on the implant.
So there’s no proof, that simply because they are white, they are not clean. You have to do the same quality management as a titanium 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 practice.

Dr. Dirk Duddeck
Let me just add some additional information.
The publication from the JOMI journal, the Journal of Oral Maxillofacial Implants, can be downloaded, 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. 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 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 are suing their dentist and not only their dentists, even the medical clinics for any kind of mistreatment or misbehavior. 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 process that leads to a, um, the trusted quality mark. The trusted quality mark is awarded to 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 a kind of backyard SEM it’s an accredited laboratory where they produce data on a very high standard of science.
And I would love to have this quality seal on a dental implant, the trusted 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 CleanImplant and sign up as a certified dentist. And aside from supporting a good cause, what is the benefit, for the dentists?

Dr. Dirk Duddeck
Um, supporting us is 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 supporting the CleanImplant as a clean implant certified dentist, they will be shown on a website that is a “CleanImplant4you” with a four, a numeric four “cleanimplants4 you.com”, uh, German it’s “saubere-implantate.de”, people should check this. They will be mentioned, they will be shown in the map. A certified dentist for himself, he has a safety that he’s on the safe side. And his implants are not contaminated. And he can show it to his patients and we support the practices with marketing material. 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 good 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 or FDA mark. They have additional tests, uh, and they underwent additional tests in the CleanImplant foundation and a very high level of scientific evidence. So we can see that these implants are finally clean. So it’s a mixture of marketing and material for the practice. They can convince patients that they are using only good implants. And I can see more and more patients are aware of the problem.
Any patient to date knows the difference between a, uh, vaccination, of the vaccines. They want to have either this, uh, standard vaccine or they want to have the MRA. 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 CleanImplant Foundation has more subscribers on Facebook than, 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?

Dr. Dirk Duddeck
Yeah, we are on social media since 2018. I mean, this is not, this is 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, want to be informed by our emails, by our newsletter. So, um, I think, to kind of put it short: If there wouldn’t be a problem of avoidable contaminants on sterile dental implants, there would be no CleanImplant Foundation. Then I wouldn’t have bought a scanning electron microscope. Maybe I haven’t fancied Cano instead. And, um, we wouldn’t have this discussion for the last 40 minutes. So, um, I think it’s momentum what we see. People, my colleagues, and even patients, although we address only professional colleagues on 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: Where do you see yourself in five or 10 years? What would you like to have achieved with your initiative by then?
Dr. Dirk Duddeck
Oh, good question. I would love to see 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 are, we’re at the beginning of a very, very interesting and a success story here. CleanImplant 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.

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 users appreciate this episode and all the information you gave us today. So thank you for this.

Dr. Dirk Duddeck
It was my pleasure. Thank you for having me now.

Thank you for participating. Bye Mr. Duddeck

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Coco Volz is the younger one of two daughters of the SDS founder and CEO Dr. Ulrich Volz. After completing her studies in media design and multimedia arts with top grades, she has been strengthening the SDS team in the field of marketing since 2021, making effective use of her personal interests and strengths.