Are Implants Safe?
Dr. Dirk Duddeck, Implantologist and Founder of the Cleanimplant Foundation, gives answers to current questions.
CleanImplant Pilot Study published
One surface characteristic of sterile packaged oral implants is their cleanliness. Oral implants may display different surface impurities of an inorganic or organic nature. These impurities may derive from the manufacturing handling and packaging processes and may remain on the commercially available implant. We are presently lacking in knowledge of the precise clinical risks of implant impurities. However, contaminations are technically avoidable and, generally speaking, the authors assume all of us would prefer clean implants to avoid potential problems from surface impurities.
The article describes the problem on the implant market and the need for a global quality assessment. Criteria for "clean" implants, as well as the conditions for the globally established "Trusted Quality Mark" are discussed in detail in this paper.
Read the full article here.
2.1 million reports of bad dental implants
June, 2019: The Food and Drug Administration - FDA - has just released two decades of previously hidden data containing millions of malfunctions by medical devices.
This isn't the time to say "we told you so...". However, we should all be concerned, reconsider and double-check our choice of dental implant systems in the future. The question is: Can I blindly trust the information provided by the manufacturer or supplier?
Is the implant system that I use in my dental practice safe and at least free of major impurities? CleanImplant provides precisely this data and valuable information for all members.
When will you join us? Read the full story here.
(Kaiser Health News (KHN) is a nonprofit news service committed to in-depth coverage of health care policy and politics.)
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, but others, that were highly contaminated. CleanImplant has an impressive data base of more than 250 dental implants tested only in accredited testing laboratories in accordance to DIN EN ISO/IEC 17025 by SEM/EDS analysis.
It is our aim to raise the quest for better quality and to give you information and better orientation. You find clean implants, that meet the consensus criteria and established guideline for clean implants listed in the DATA section here.
Nevertheless, there is an enormous lack of control in implant manufacturing and you may unknowingly use implants causing potentional harm to your patients! Please understand that we cannot publish names and brands of implants with massive contminations here, as we already received threats of legal action from manufacturers. As an active member you will get all the answers you need.
More than ever before, we need your help.
And financial support. CleanImplant’s work relies on you as active members of the CleanImplant Community to ensure the continuous and independent research and quality assessments. A click on our Facebook "LIKE" button is a great motivation. But, if you believe our campaign can bring about positive change, join the CleanImplant Community today - for your safety and for the benefit of all our patients. Read more ...
Sincerely yours, Dr. Dirk Duddeck
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
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 ?
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
Neutral sampling of 5 implants
3 implants are ordered ex factory + 2 implants of the same type are provided via mystery shopping from practices.
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.
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.
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.
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.
Welcome Sweden & Martina !
We took a close look on the implant system PRAMA made by Sweden & Martina, a leading manufacturer in Italy. All five samples, randomly selected, showed a clean surface in the thorough SEM analysis performed by an officially accredited testing laboratory. We are happy to announce that the PRAMA implant system meets the strict criteria of the consensus-based CleanImplant guideline and was awarded with the "Trusted Quality Mark 2020-2021". Congratulations!
Find more information and impressive SEM images of the PRAMA implant system here.
Trusted Qualitiy Mark for In-Kone from Global D
2019, October| During the EAO Meeting in Lisbon, Dr. Dirk Duddeck handed over the Certificate of CleanImplant "Trusted Quality" to the management of Global D, the French manufacturer located in Lyon. After the thorough testing procedure of five implant samples and the evaluation of the clinical documentation, two members of the CleanImplant Scientific Advisory Board confirmed in a peer-review independently to issue the coveted award!
IDS Cologne 2019 - Impressions
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