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CleanImplant Newsletter 2 | 2019

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Editorial

"A bend in the road is not the end of the road… unless you fail to make the turn."

Dear colleagues, friends and supporters 

I hope you have had a wonderful summer and even managed to catch up on some good books. You maybe found some peace and quiet to delve into informative newspapers or scientific topics that interest you.

I’m sure you must have noticed the main subjects in the news nowadays such as climate change or marine pollution with microplastics. We cannot ignore the constant appeal togovernments, industry and finally to ourselves to support changes to save the world. But, change can only be built together!

And so to our project. One could argue, that the world will not suffer from contaminated implants. However, our patients have to bear the clinical consequences and dentists have to pay the price for it. Colleagues are liable for using implants with impurities and will face charges of negligence. If you are still hesitant, now is the time to join this project. Make the turn. Protect yourself and your patients against the use of implants of inferior quality.

Sincerely yours,
Dr. Dirk U. Duddeck
On behalf of the CleanImplant Foundation 
 

FDA revealed 2.1 million reports of bad dental implants

Let’s start our newsletter with an alarming    piece of information published by the FDA   (US Food and Drug Administration) last month. Here we quote parts of a very worrying article by Kaiser Health News (KHN), a nonprofit news service committed to the in-depth coverage of health care policy and politics: 

"After two decades of keeping the public in the dark about millions of medical device malfunctions and injuries, the FDA has published the once hidden database online, revealing millions of incidents publicly for the first time..."

"...The high number of reports is expected because these are commonly used devices. More and more companies have brought new products to market in the past two decades".

The 2.1 million reports concerning bad implants corroborate what we have repeatedly warned about. And even more. Not only do our studies reveal poor and unreliable production quality from new or small implant manufacturers but also, more worryingly, even implant types from big international well-established companies showed severe findings. 

"What we find, that many of the reports were for problems with connections between the device and the bone... it often can’t be replaced because the underlying bone is so damaged."

And yet too many manufacturers still continue to claim that impurities on dental implants don't matter at all. As we found contaminations on sterile packaged implants and particles with a size between 1 and 100 micron - containing chromium, copper, tungsten, tin or nickel as well as remnants of hazardous dodecylbenzensulfonic acid - we think it´s time to rethink, considering these disturbing FDA numbers. Read the full story here.
 
 

Quality assessment of dental implants  – What are they trying to hide?

A substantial amount of information from our continuously updated database is shared with you as our fellow members. We receive many requests and give satisfying or concerning answers about implant types in use.

What happens in cases where we receive requests about data that we do not have on file yet? There are manufacturers who vehemently try to prevent having their products tested by us. Some of them even boycott our current quality assessment study and do not deliver implants we order on a regular basis.

With your help, we have received many missing, new and/or current implant types to perform the comprehensive analyses according to the standard protocol and CleanImplant guideline. Every result will expand our large database that will serve you and other members in the future.

Among other samples, we wanted to test a specific zirconia implant, that has been on the market for a long time and is currently being used by thousands of dentists. We reached out several times to the correspondent manufacturer in order to receive a sample for our ananlysis. Finally, they informed us that they may send us an implant sample for analysis "in a couple of months", because they are planning to change the packaging. Thus, we had to ask one of our members to send us a sample of very recent production. The following SEM analysis revealed massive organic impurities on the implant shoulder with embedded particles of iron (see image below). Was the manufacturer already aware of the “quality”, aware of a lack of quality control? Did the company simply try to sweep this problem under the carpet for as long as possible?
   
The message for you is plain and simple: A white material like zirconia does not necessarily mean that this type of implant is clean. Find out more about the cleanliness of ceramic implants in an artcile, published in the journal Ceramic Implants 2-2018 here.

New "Trusted Quality Mark" Awards 

The family of implant-companies who join our project and apply for the coveted “CleanImplant Trusted Quality” award is constantly growing. Preconditions are not only “clean” implants, where we randomly collect five implants of the same type for thorough testing, but also proof of clinical success published in peer reviewed scientific journals. Finally, members of the scientific advisory board perform a critical peer-review of all achieved data, before the Quality Mark is given.

In September 2019, the Trusted Quality Mark was awarded to the InKone implant from the French manufacturer Global D and for the ICX Premium implant, produced by the German company medentis medical

Congratulations for an outstanding quality and welcome to the group of trusted implants! 

Further information about the "Five-Steps Approach", the "Trusted Quality Mark" and corresponding SEM images of all award-winning implants can be seen on the website here.

 
 

Key Takeaway #1 from the EAO Congress 2019 in Lisbon 

Ann Wennerberg, member of the CleanImplant Scientific Advisory Board, gave an outstanding  lecture at the EAO Congress in Lisbon, Portugal. She presented results of the pilot study: “On the Cleanliness of Different Oral Implant Systems” and explained the impact of the established "Trusted Quality Mark". The study, which followed the standard protocoll of the CleanImplant testing procedure, was performed as an international collaboration  between the Medical Materials Research Institute (Berlin, Germany) and universities in Gothenburg, Malmö and Berlin. The authors, among them renown scientists such as Tomas Albrektsson, Florian Beuer, Christel Larsson and Ann Wennerberg, made a remarkable statement:

“…Impurities on sterile packaged implants—caused by metal particles and contaminations with organic substances such as thermoplastic materials, synthetic polymers, or polysiloxanes—are technically avoidable, as this paper demonstrated. The academic discussion as to what extent implant pollution is acceptable normally ends quickly when dental professionals know about such contamination of an implant system and the next patient for an implant therapy is their partner or child. We should avoid using sterile packaged implants with verifiable impurities and therewith follow the well-established “precautionary principle” as an evolution of the ancient medical principle of “primum non nocere”.

Click on the image or download the full article here.

Takeaway #2 from the EAO Congress 2019

Safety in implantology was an important topic we heard about in several discussions on the main podium, at industry booths, between experts and colleagues. This safety does not end with the right choice of an implant. 

One of the topics in the next newsletter will be  Guided Surgery as not all templates can enssure a contamination-free process of insertion. An additionaler key factor for clinical success is the important issue of implant stability after insertion. When is the best time to load an implant?

At the 11th Osstell Scientific Symposium at EAO 2019 in Lisbon Dr Barry Levin (USA) talked about the correlation of insertion torque value (ITV) and the implant stability quotient ISQ. Dr. Jeff Ganeles (USA) demonstrated how measuring stability and introducing objective ISQ measurements into clinical decision making give dentists more confidence to restore sooner, and help patients to accept and value treatment more.

Prof. Neil Meredith (Australia) demonstrated how the ISQ is so much more than a simple number and can be used to measure, monitor and enhance clinical success utilizing global data analysis. See the full lecture of Prof. Meredith here.

New collaborations - Extra benefit for members  

We are excited about our partnership with two important groups in the field of dental implantology who introduce themselves as follows:

The International Academy Of Ceramic Implantology is the first professional organization worldwide established around the concept that ceramic dental implants are a viable, safe and predictable option of teeth replacement. The IAOCI seeks to achieve its goals with state of the art education, research and scientific evidence.

The Digital Dentistry Society was established to to connect dentists, students, dental technicians, software developers and engineers, encouraging research, communication and collaboration between them, in order to stimulate opportunities for the advancement, extension and practice of Digital Dentistry worldwide.

Check the websites of our partners and find out more. CleanImplant offers a reduced membership fee for members of these partner associations. Send us a mail and ask for the special rate here. 

Your support and encouragement - Our motivation!

We are really proud to announce that we have reached - in less than one year - more than 55.000 dentists following us on Facebook! 

If all of you pass on your concerns to your distributor, if you reconsider and double-check your choice of dental implant systems in the future, if you consult our database in your decision-making process, than we will be one big step closer to safer implantology.

Let us close by saying how grateful we are to all of our committed colleagues who have registered as fellow members. We are dedicated to helping you make your patients and colleagues understand how much you care!

At the same time, your support helps us to continue our independent initiative and achieve our common aim: clean medical devices for a clean and safe implantology.


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CleanImplant Foundation CIF GmbH
Pariser Platz 4a
10117 Berlin
Deutschland


info@cleanimplant.org
www.cleanimplant.org
Managing Director: Dr. Dirk U. Duddeck
Registered / Handelsregister: HRB 179 652 B

The CleanImplant Foundation CIF GmbH is a non-for-profit Organization.