Clean Implant
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the global quality campaign

 

Watch this 6 min video. It may open your eyes as a dental professional! 

Interview with Prof. Jack C. Ng, PhD, Diplomate of the American Board of Toxicology, University of Queensland, Brisbane, Australia

Inorganic and organic impurities on sterile packaged dental implants can lead to a foreign body reaction with activation of osteoclasts and a loss of bone in the follow​-up. However, this is not the only concern as some of the particles that were found on implants using ToF-SIMS analysis may even have toxic potential. As these particles and impurities are technically avoidable, we should follow the Precautionary Principle, which says: "When an activity raises threats of harm to human health, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically."

 

In other words: It´s not our job to prove, that particles shown in this video are a problem for your patients. If an implant manufacturer cannot deliver his medical devices without impurities, it is the job of the manufacturer to give proof, that these impurities cause no harm. CleanImpant provides a stage for implants, that were tested "clean" and particle-free according to the guideline and established consensus.


We tested implants that showed no impurities and others that were contaminated. Send us a mail, if you want to know more.

We have a data base of more than 250 dental implants tested from an accredited testing laboratory by SEM/EDS analysis. Please understand that we cannot publish names and brands of implants with massive contminations on the Internet, as we already received threats of legal action from manufacturers concerned. You find clean implants that met the consensus criteria and established guideline listed in the DATA section here.  

If you do not find your implant system in the data section, send us an email by using the reply form here.  

 

More than ever before, we need your help and financial support. 

 The CleanImplant work relies on active members of the CleanImplant Community to continue independent research and quality assessments. A click on the Facebook "LIKE" button is not enough. This does not alter the facts, that there is a lack of control in implant manufacturing and that you may unknowingly use implants causing potential harm to your patients. 

If you beleive our campaign can help bring about positive change, join the CleanImplant Community today - for your safety and for the sake of your patients.  Read more ...

  

Prof. Tomas Albrektsson: "We have to study about impurities on implant surfaces!" 

 

Prof. Ann Wennerberg and Prof. Tomas Albrektsson, Members of our Scientific Advisory Board, about their motivation to support the CleanImplant project. 


 

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 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 things" and why there is a need for this global quality assessment of dental implants. 


Can dentists trust in the CE label ?

CE label and FDA clearance are supposed to be seen as quality marks. However, impurities on sterile packaged medical devices give cause for concern.
 

 

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 sterile packaged dental implants.

 

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.


It took years to build up your reputation as an implantogist. Yet, it can be destroyed by one negligent choice of an implant. Stay on the safe side. Choose a proven implant that carries the Trusted Quality Mark. Ask us about the cleanliness of your implant system if it does not carry the mark.  Read more


Objective Analysis of Dental Implants - The Five-Step Approach 


 STEP 1

Neutral sampling of 5 implants 

3 implants are ordered ex factory + 2 implants of the same type are provided via mystery shopping from practices. 

STEP 2

Unpacking and scanning under clean room conditions 

All 5 collected samples are carefully unpacked, mounted and scanned in a clean room environment according Class 100 US Fed. 209, Class 5 DIN EN ISO 14644-1.

STEP 3

Externally audited process of analysis 

SEM imaging and elemental analysis (EDS) are performed according to DIN EN ISO/IEC 17025 accreditation process (competence of testing and calibration laboratories) with external audits and multi-annual re-assessments.

STEP 4

Full-size and high-resolution SEM images

A special FSHR SEM image - digitally composed of more than 360 single SEM images in a magnification of 500x - shows always the complete surface; i.e. no “cherry-picking” of  clean looking areas.

STEP 5

Peer-review process

Two members of the Scientific Advisory Board independently review the comprehensive report of analysis and sufficient clinical documentation or multi-annual PMCF studies (Post-Marketing Clinical Follow-Up) of the analyzed implant type showing survival rates of more than 95% for the device or device family.



 Consensus Paper on "Clean Implants"

 

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.

 

 


News

IDS 2019 - Impressions of a succesful week in Cologne

With members of the CleanImplant Scientific Advisory Board, Ambassadors, partners, members of the CleanImplant Community and hundreds of concerned colleagues - who want to know more about inferior quality implants, implant pollution and the clinical impact for their patients.

Thank you all for your feedback, support and valuable contribution that made this week a special one for CleanImplant.



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...