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CleanImplant Newsletter 1 | 2019

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Content:


- Editorial

- Sneak Preview of the latest Quality Assessment Study

- Hazardous substances on dental implant

- Make a clean choice. Become a member

- Trusted Quality Mark prevails

- Overwhelming social media response and dynamics

- IDS Cologne March 2019  - Spectacular Live-check of Implant


Editorial

"Bad news isn't wine. It doesn't improve with age"
 

Colin Powell once said.

Dear colleagues, friends and supporters

We promised to keep you updated about the CleanImplant Project – whether the news is good or bad.
The results we found in our recent quality assessment affect every practitioner. 

So, good news if you use an implant system that has no significant pollutants and bad news if you unknowingly use a system that showed not only remnants of the production process but also hazardous substances.
A newsletter should inform you whenever real news is worth reading. We hope you agree after reading this one. We will not only tell you about the growing number of implant systems that met the guideline for "clean implants" and passed the thorough testing protocol but we will also share our increasing concerns about the quality, quantity, and toxicity of dental implant impurities, found on far too many tested implants in the past year.

Make a "clean" choice. Protect your patients and become a member if you haven't decided to join the CleanImplant Community yet. Support our unbiased and independent  quest for safer implantology.  

Please contact us directly if you have any questions or comments. Let us know if you agree or disagree with our mission, our opinion or conclusion.

On behalf of the CleanImplant Project
Dr. Dirk U. Duddeck

 

Sneak Preview of the latest
Quality Assessment Study

So let´s start with the bad news.

The Implant Study 2017-2019 is coming to an end and scientific publications are already in preparation. We found foreign material on nearly every second implant system in the scanning electron microscope. Not only the sheer amount of impurities such as metal particles of stainless steel, tungsten and elemental aluminum (not the blasting material aluminum oxide) and various organic pollutants give cause for concern.
Rather the surprising fact that a significant number of implant systems, with good results in the preceding quality assessment study of 2015, seem to have a lack of quality control in their manufacturing sites if we compare the recent data of analysis.

Surprisingly, this applies even to implants of market-leading brands. Other companies that we informed of significant organic impurities on their zirconia implant surface four years ago, obviously could not care less as their implants of recent production show the same amount of packaging plastic on the surface in the analysis today (see images on the right).
Members of the Cleanimplant Community will be informed about their implants in use.
 
 

Hazardous substances on implants.
Suprised? Read more...

We wanted to know what the organic particles, found on far too many implants, are made of, i.e. what substances are the relevant pollutants on dental implant surfaces, as the energy dispersive x-ray spectroscopy provides the information only on an elemental scale. So we decided to invest a significant amount of the CleanImplant research budget in finding the answer and analyzed several implants with impurities using a different technique: the Time-of-Flight Secondary Ion Mass Spectroscopy (ToF-SIMS).

Results of these analyses - performed again in an officially accredited testing laboratory – made our blood run cold. ToF-SIMS finally gave a precise answer to the origin of the particles - until then summarized as "organic." We could identify thermoplastic materials, synthetic polymers, polysiloxanes and, even more surprisingly, DBSA, Dodecylbenzene Sulfonic Acid - which is a  laundry detergent and a hazardous aggressive corrosive surfactant (EPA). Let me remind you... found on sterile packaged dental implants.

If anybody still doubts that these substances have no business on the implant surface inserted in our patients' jaws, he or she has to rewrite biology.

Find more information about DBSA at TOXNET provided by U.S. National Library of Medicine here...
 
Time-of-flight Secondary Ion Mass Spectroscopy revealed hazardous materials

 

Make a clean choice.
Become a member.

You can now show your patients and referral practices that they can trust in your decision for an implant system. As a supporting member of the CleanImplant Community, you will not only receive information about the system you have in use. You will also receive a personalized certificate in the language your patients understand (7 languages available). Demonstrate that you care about your patients and their safety.

The certificate gives clear information if your implant system meets the criteria for a "clean" implant. Your membership reflects your commitment to a trustworthy, independent evaluation of the quality of medical devices for the patients’ benefit.  

The non-profit CleanImplant Foundation faces many obstacles in the implant market and is even confronted with threats of legal action by some implant manufacturers.
Only a strong community can protect you and your patients - legally and clinically. Find out more about additional benefits for active supporters. Get your Membership Booklet here.
 
    Yes. I want to know more and join the Community.

Trusted Quality Mark prevails 

Last year, implant systems from

- bredent medical (blueSKY),
- BTI (UnicCa),
- MegaGen (AnyRidge)
- MIS Implants Technologies (V3)
- NDI (REPLICATE)
- NucleOSS (T6)

were awarded the "Trusted Quality Mark" after meeting the criteria of the CleanImplant Guideline/Consenus. All systems successfully passed the strict peer-review process.

In 2019,  following the same comprehensive analysis in a testing laboratory, accredited according to DIN EN ISO/IEC 17025, implants from

- Straumann (SLA Standard) and
- Nobel Biocare (NobelActive)

also met the strict testing criteria of this international quality label with five randomly selected implant samples for each type. Further information about the "Five-Steps Approach", the "Trusted Quality Mark" and corresponding SEM images of the awarded implants can be seen on the website here
WWW.CLEANIMPLANT.ORG/DATA 
More implants are currently in the process of analysis or in the peer-review. We will keep you informed.

Additional implant systems, that showed in an annual test of one implant sample that they are at least technically clean, can be found on the CleanImplant homepage in the section "Data" -> "Listed Implants". 

 
 

Overwhelming response 
and online dynamics

In the past six months, more than 15,000 dental professionals have decided to follow our activities on Facebook and support our strive for a safer and more predictable implantology.

At the same time, we registered more than 13,000 colleagues from more than 130 countries on our website. This is a good sign and shows that dentists appreciate unbiased independent information. We are grateful for your confidence and commitment. It´s a fantastic motivation.

 

IDS Cologne March 2019  -  spectacular live-check of implants 

Dental professionals and 160,000 visitors of this world stage for dentistry were able to check the quality of their implant system using a Scannin Electron Microscope installation on the CleanImplant booth and watch the analysis live. Some colleagues left the booth of CleanImplant with a happy smile. Others were deeply concerned after they saw the result of SEM imaging and elemental analysis.

The first public presentation of all  CleanImplant Foundations' services was supported by Thermo Fisher Scientific, one of the world-leading manufacturers of analysis-instruments and laboratory equipment.

Click on the image and watch the video of the CleanImplant activities during the IDS including the 3rd CleanImplant Group & Experts Meeting.


     Find out more on the CleanImplant website here

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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.