Clean Implant
/

the global quality campaign

 

"Criticism may not be agreeable, but it is necessary.

It fulfils the same function as pain in the human body:

it calls attention to the development 

of an unhealthy state of things."


Winston Churchill  [New Statesman interview, 7 January 1939]


Manufacturers of implants with severe contaminations wrote us that they can "refute the results". They "kindly invited" us "to avoid spreading information that could put a negative image to the company´s reputation". 

One manufacturer claimed that we are "melting the titanium with the energy of the scanning electron microscope". Another accused us of "using different sources of light (!) in the SEM" to produce bad looking images. Probably the best answer when confronted with poor SEM analysis results: "Dentist do not pay attention or even don´t know how to interpret the results that they see." And  what was to be expected: they claimed our "research is biased".

Well, here is our answer to an "unhealthy state of things" and why we think that there is a need for a global quality seal. 

Get your own picture. 

Dirk U. Duddeck 
DDS. Dr. med. dent., 
Implantologist

Director CleanImplant Foundation


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.


The CleanImplant Project

The CleanImplant Project is internationally promoting the highest quality of dental implants. As a non-profit organization the CleanImplant Foundation CIF GmbH regularly initiates objective analysis of the production quality of dental implants by independent institutes based on a defined protocol. 

CleanImplant will strive to create and protect a quality mark recognized worldwide by clinicians in the quest for a better awareness of clean medical devices and better clinical results. Read more about the CleanImplant Foundation and the Scientific Advisory Board here.


 

"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 on December 1st, 2107: 

The REPLICATE system from NDI was awarded with the "CleanImplant Trusted Quality Mark". So proud to see this system in the family of implants that passed the in-depth quality assessment and SEM/EDS analysis. Congratulation!

 See more details here.

 

 

 

"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.




 

 

 

"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 received the "Trusted Quality 2017-2018" award 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!   

Small antimony particles (bright spots with 5-10 µm), embedded in major organic pollution (400 µm), SEM 500x

How clean is your implant?

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

Unintended micrometre-scale particles may induce a foreign body reaction with a loss of bone in the early stages of osseointegration. In three consecutive studies since 2008 - performed in cooperation with the University of Cologne (Germany) and the Charité University Medicine Berlin (Germany) - scientists analysed the quality of dental implants by means of SEM/EDS.

In 2015 extensive material contrast images were obtained and qualitative and quantitative elemental analyses were performed on 140 dental implants from 100 brands using the same study protocol. Surprising results of the recent study and a comparison with previous analyses showed an increasing spread of quality in the market. 

How many impurities can a patient tolerate? 

Alarming remnants and contaminants were found in the recent analysis e.g. iron, copper, chromium, nickel, tungsten, sulfur and large quantities of stainless-steel particles, as well as remnants of polytetrafluorethylene and other major organic contaminations.    Read more



You want to know more?  Sign in for the Newsletter.

Sign in for the newsletter and we provide you 2-4 times a year with free information about new developments, implant research results and about implants that received the "Trusted Quality 2017-2018" mark. Please use the contact form here.

You have comments or questions ?

You have indications of clinical problems like suspicious higher failure rate if using  specific implants? Send us your comments, questions and hints. Your views and suggestions are of tremendous value to us and we look forward to your feedback. 

 "Trusted Quality Mark" 2017-2018 

Consensus Paper


The CleanImplant "Trusted Quality" Mark

A new 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 for considerable differences in quality and, even more important, gives orientation for clean implants 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 contains also a process description for 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 implants

A 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 from each implant (surface-)type of every company will be selected through a mixture of mystery shopping (two samples) and direct factory order (three samples) to assure that the 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 the transfer into the SEM all implants have to be unpacked and analyzed in the scanning electron microscope under cleanroom conditions according 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 performed by independent laboratories that are in the process for - or completed - 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 multiannual re-assessments 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 and 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 extreme high resolution. Thus, always the complete implant surface in an angle of view of 120° will be assessed - in other words: 

No chance to "cherry-pick" nice looking implant areas and to 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. On the basis of these data the analyzed implant type can be issued with the CleanImplant Trusted Quality Mark. The final report will be available on this website.


Kick-off Event IDS 2017 Cologne

What a 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!   


 Project Partner

This project is open for 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 to support the CleanImplant Foundation. 

 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...