Clean Implant
/

the global quality campaign

 

How clean is your implant?

It should be a matter of course that all dental implants are clean when delivered in sterile packaging. Surface pollution with organic particles or significant inorganic residues, originating from the production process are suspected to cause insufficient or missing osseointegration of dental implants.

Unintended micrometer-scale particles - particually organic materials such as polyethylene - induce a foreign body reaction with multinucleated giant cells and an osteoclastogenesis that can result in a loss of bone in the early stages of osseointegration. 

For more than 10 years we have carried out four consecutive studies in close cooperation with the University of Cologne (Germany) and the Charité University Medicine Berlin (Germany).  SEM imaging as well as elemental analyses (EDS) of more than 250 dental implants from over 200 brands were used to establish one of the largest, most comprehensive databases in implant dentistry. Recent analysis in 2018 shows more implants with severe pollution, compared with previous reports.

 How many impurities can a patient tolerate? 

Alarming remnants and contaminants were found in the SEM-based quality assessment. Areal pollution and particles with iron, copper, chromium, nickel, tungsten, sulfur and large quantities of stainless-steel particles, as well as remnants of polytetrafluoroethylene and other signigficant organic contaminations give cause for concern. However, we also revealed implants with clean surfaces.   Read more


Facts matter.

 

CleanImplant analyzes dental implants on a regular and neutral basis in a cleanroom environment according to Class 100 US Fed. 209 and ISO class 5 (DIN EN ISO 14644-1) - externally audited according to international standards such as DIN EN ISO 9001:2015 and DIN EN ISO/IEC 17025. To further ensure the safety and reliability of our reports, all results are peer-reviewed by a renowned Scientific Advisory Board prior to publication.

One manufacturer of an implant whose analysis showed severe organic contamination and embedded bronze-particles wrote to us that they could "refute the results". They "kindly invited" us "to avoid spreading information that could put a negative image on the company´s reputation".

Another manufacturer claimed that we are "melting the titanium with the energy of the scanning electron microscope" as an explantaion for the implant pollution (ironically, he had no idea how we can reach up to 1.665° C in the SEM). Another accused us of "using different sources of light (!) in the SEM" to produce unfavorable images (ignoring the fact that an SEM needs no light at all). When confronted with poor SEM analysis results, the most disturbing answer was, : "Dentists do not pay attention (for external quality assessments) or even don´t know how to interpret the results that they see." Moreover, as expected: they claimed our "research is biased". 

Well, this project is our answer to an "unhealthy state of thingsand why there is a need for this global quality assessment of dental implants. 


 

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In the video: Dr. Dirk U. Duddeck, Implantologist and Managing Director of the CleanImplant Foundation speaks about possible failings of the European device regulation as studies - years after the PIP scandal - revealed masses of contaminants on many sterile packaged dental implants.



Show the quality of your implant system.

If you want to know and not just believe that your implant system is clean, we have the right answer:

STEP 1: We check our database for your favorite dental implant system. If we do not have recent data about this implant on file, you can send us a sterile packaged implant (only after prior consultation), and we will perform the analysis according to DIN EN ISO/IEC 17025.  

STEP 2: If the result of analysis meets the criteria of a clean implant - according to the CleanImplant consensus paper - you can apply for a personalized certificate for your practice. Show your patients or referral practices this certificate about your implant of choice. Let your patients know even in the waiting room that they can trust that you will provide a high-quality medical device. Demonstrate the cleanliness of your implant system avoiding a possible dental negligence claim. 

How can you apply for such a powerful certificate based on thorough implant analysis? Join the CleanImplant Community and support our project! The personalized certificate will be available exclusively for registered CleanImplant members. This new service will be available soon.

Send us a mailand you will be the first to know all the details. We are looking forward to your feedback.


Monthly CleanImplant Update

In this section we present new information monthly: Interviews with scientists, videos from our testing laboratories, webinars, reviews about dental implants, relevant publications  and videoclips from our project partners. 

This month

Interview with Prof. Hugo de Bruyn, Radboud University Nijmegen and Genth University, 

We speak about impurities on dental implants and discuss the need for a non-biased, independent and global quality assessment. 

We are honored and encouraged to welcome Professor de Bruyn as a new member of the CleanImplant Scientific Advisory Board.

 

 

 

News


 



EUROPERIO 9, 2018, POSTERPRESENTATION

Impurities on Sterile Packaged Implants:
Is the Rise of Cheap Copy-Cat Products
a Danger for our Patients?

30 years after the first SEM research into contaminations on
dental implants by Wahl et al., we can still find major impurities
on many sterile implants today. Not only clinical1,2 but also legal
implications may occur in the future if practitioners continue to use
implants of inferior quality. The quality of a dental implant is
always the result of appropriate quality management. Results of
SEM/EDS analyses in 2017 give cause for concern.


1) Trindade R, Albrektsson T, Tengvall P, Wennerberg A. Foreign Body Reaction to Biomaterials: On Mechanisms for Buildup and Breakdown of Osseointegration. Clin Implant Dent Relat Res 2016; 18: 192-203.
2) Albrektsson T, Dahlin C, Jemt T, Sennerby L, Turri A, Wennerberg A., Is marginal bone loss around oral implants the result of a provoked foreign body reaction? Clin Implant Dent Relat Res 2014; 16(2): 155–65. doi: 10.1111/cid.12142.

Download the complete PDF and read more. 


2018-3-02, Los Angeles, California

"Trusted Quality 2017-2018" Award for MIS at the AO´s Annual Meeting in L.A.

Motti Weisman, CEO of MIS in the United States, is proud to receive the "Trustest Quality 2017-2018" award for the MIS V3 implant at the congress exhibition of the Academy of Ossoeintegration. 

The peer-reviewed process of analysis revealed an outstanding cleanliness of MIS implants. See the corresponding data and SEM images here.




2017-12-01, Duessedorf, Germany

 "Trusted Quality" Award for the custom-made Replicate System of NDI

Smiling faces with Rüdger Rubbert, Lea Ellermeier and Ingo Fritz at the ImplantExpo 2017 in Düsseldorf, Germany: 

The REPLICATE system from NDI was awarded the "CleanImplant Trusted Quality Mark". So proud to welcome this system to the clean Implants family who have passed our in-depth quality assessment and SEM/EDS analysis. Congratulations!

 See more details here.


2017-10-14, Tokyo, Japan

"Trusted Quality" Award for MegaGen

On October 14, 2017 the third "Trusted Quality 2017-2018" award was celebrated in Tokyo, Japan for MegaGen and their AnyRidge implant. CEO of MegaGen Dr. Kwang Bum Park received the certificate from Prof. Jaafar Mouhyi on behalf of the CleanImplant Scientific Advisory Board. 

Correspondent data and SEM images here.


2017-10-06, Madrid, Spain

"Trusted Quality" Award for BTI and NucleOSS

After successfully passing the comprehensive analysis of 5 implants from the same type and a subsequent peer-review process the first companies were awarded the "Trusted Quality 2017-2018" at the EAO meeting in Madrid. Eduardo Anitua, CEO of BTI, Spain, was proud to receive this award for the UniCA implant. The second award was handed over to NucleOSS from Turkey for their implant T6. Congratulations!  


2017-03-21, Cologne, Germany

Great start for the new global quality campaign in implant dentistry! 

CleanImplant Kick-off event at the IDS Cologne 2017 with members of the Scientific Advisory Board, funding partners and interested implant manufacturers. 

We are so proud to have great scientists and friends like Ann Wennerberg, Tomas Albrektsson, Michael Norton, Jaafar Mouhyi, Luigi Canullo and Florian Beuer as members of the board. Thank you for your great support!

Participants of the meeting: Prof. Tomas Albrektsson, Prof. Ann Wennerberg, Luigi Canullo, Prof. Jaafar Mouhyi (Scientific Advisory Board), Dr. Dirk Duddeck (Managing Director CleanImplant Foundation), Sergey Shulezhko (Trate), Vladlena Shulezhko (Trate), Marcellus große Holthaus (Bego), Jonas Ehinger (Osstell), Shelly Akazany (MIS), Dr. Christian Rähle (Camlog), Dr. Markus Kraft (Camlog), Salva Gregori (BTI), Dr. Kwang Bum Park (MegaGen), Sian Matthews (MegaGen), Young Choi (MegaGen), Rüdger Rubbert (Natural Dental Implants), Prof. Sergio Bernades (Neodent), Armin Vollmer (Straumann) and Dr. Michael Hotze (Straumann). A big THANK YOU for your valuable contribution!

 Consensus Paper on "Clean Implants"

The CleanImplant "Trusted Quality" Mark

A global label, the CleanImplant "Trusted Quality Mark" is the expression of a high  quality level in the cleanliness of dental implants. It will raise the awareness of considerable differences in quality and, even more importantly, give orientation for clean implants which not only practitioners but also patients may trust. 

Consensus paper

In September 2017, objective evaluation criteria for the "Trusted Quality 2017-2018" award were summarized in a consensus paper by the CleanImplant Scientific Advisory Board. The document also contains a process description of the required methods of analysis and gives proof of the CleanImplant project´s transparency.

Click on the image to download the correspondent 4 MByte PDF-file.

 

Objective Analysis of Dental Implants - The Five-Step Approach 

From implant sample acquisition to environmental requirements necessary for unpacking and the subsequent analysis process, the CleanImplant Foundation guarantees unbiased research at the highest scientific level

STEP 1: SAMPLE ACQUISITION 

For the new Trusted Quality Mark five samples of each implant (surface-)type will be selected from every company, using a mixture of mystery shopping (two samples) and direct factory order (three samples) to ensure that samples are selected randomly. 

STEP 2: ISO CLASS 5 CLEANROOM ENVIRONMENT - DIN EN ISO 14644-1

In order to avoid artifacts on the unpacked implant samples during their transfer into the SEM, all implants have to be unpacked and analyzed in the scanning electron microscope under cleanroom conditions according to Class 100 US Fed. 209 and ISO class 5 (DIN EN ISO 14644-1). 

STEP 3: SEM ANALYSIS PROCESS ACCREDITATION - DIN EN ISO/IEC 17025 

All collected samples are subjected to the same quality analysis protocol. All independent laboratories have to prove a Quality Management System according to DIN EN ISO/IEC 17025 (general requirements for the competence of testing and calibration laboratories). These laboratories have to implement a quality system aimed at improving their ability to consistently produce valid results. This includes the quality standard according to DIN EN ISO 9001:2015. The laboratories undergo regular audits and multi-annual reassessments by external, independent accreditation bodies (e.g. DAkkS).


STEP 4: FSHR - FULL-SIZE HIGH-RESOLUTION SEM IMAGING

In order to achieve a complete overview of the sample as well as comprehensive surface quality information in high resolution, implants are scanned at a magnification of 500x in “Automated Image-Mapping” mode. 

This technique produces more than 360 single high-resolution SEM images that are digitally composed to one large image with an extremely high resolution. Thus, the complete implant surface will always be assessed at a 120° angle - in other words: 

No chance to "cherry-pick" nice-looking implant areas and ignore areas with impurities. The composed FSHR-image makes it possible to count the particles in the visible field and to identify areas of interest for the subsequent spot-analyses. For a full protocol and extensive quality assessment of one single implant, up to 500 SEM images and numerous additional elemental analyses will be generated.


STEP 5: PEER-REVIEW PROCESS

The analytical reports are screened by the Scientific Advisory Board in a peer-review process. Based on this data the analyzed implant type can be issued with the CleanImplant Trusted Quality Mark. The final report will be available on this website.

 Project Partner

This project is open to manufacturers and suppliers of dental implants as well as companies related to the implant market who share the aims of the CleanImplant quality campaign. In fact, we do need the support of all stakeholders in our quest for quality. Every manufacturer of dental implants is therefore invited to apply for the CleanImplant "Trusted Quality" mark. 

Please contact us to find out how you can support the CleanImplant mission. 

Feedback from Colleagues

"I am a dentist in private practice in Johannesburg , South Africa. I recently attended your lecture at the SAOO congress in Durban. 

I must both thank you and compliment you on the lecture which was delivered with much humour and academic excellence, and I must commend you on your research on such a difficult and sensitive topic! Prior to your lecture I had, probably like most of my colleagues, assumed that all implants on the market were of the highest standard of cleanliness. How wrong I have been!"

Mike Holmes, South Africa


"I attended your lecture in Skopje today and I was very positively surprised by all the information you shared with us. This is a game changer in the implant business. I hope you get your work published. I think we (dentists) do not pay enough attention in the surface quality since we blindly trust the manufacturers once they gain the CE stamp."

Gorazd Danilovski, Slovenia

Read more from other colleagues here...