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Implant Tribune Asia Pacific Edition

Implant Tribune Asia Pacific Edition | 11/2017 SCIENCE & PRACTICE 21 tentially inferior medical de- vices. The ive-step approach The CleanImplant Trusted Quality Mark Step 1 Unbiased sampling 3 implants from the factory and 2 implants from practices via ghost shopping Step 2 Unpacking and scanning in clean room conditions Samples are unpacked and scanned under clean room conditions according to Class 100 US Fed. 209 and Class 5 DIN EN ISO 14644-1 Step 3 Accredited process of analysis Step 4 Full-size SEM images SEM imaging and elemental analysis (energy-dispersive spectroscopy) according to DIN EN ISO/IEC 17025 accredi- tation process (competence of testing and calibration laboratories) with external audits and multi-annual reassessments Digitally composed SEM images of more than 360 single SEM images at a magniication of x500 always show the complete surface, i.e. no cherry-picking of clean-looking areas Step 5 Peer-reviewed evidence and proof of suficient clinical documentation Two members of the scientiic advisory board inde- pendently sign the comprehensive report of analysis and proof of the corresponding clinical documentation providing valid data on a > 95% survival rate AD The Dental Tribune International Magazines www.dental-tribune.com I would like to subscribe to CAD/CAM Clinical Masters* cosmetic dentistry* implants laser ortho** prevention* roots Journal of Oral Science & Rehabilitation*** EUR 44 per year (4 issues per year; incl. shipping and VAT for customers in Germany) and EUR 46 per year (4 issues per year; incl. shipping for customers outside Germany). * EUR 12 per year (1 issue per year; incl. shipping and VAT for customers in Germany) and EUR 14 per year (1 issue per year; incl. shipping for customers outside Germany). ** EUR 22 per year (2 issues per year; incl. shipping and VAT for customers in Germany) and EUR 23 per year (2 issues per year; incl. shipping for customers outside Germany). *** EUR 200 per year (4 issues per year; incl. shipping and VAT). Your subscription will be renewed automatically every year until a written cancellation is sent to Dental Tribune International GmbH, Holbeinstr. 29, 04229 Leipzig, Germany, six weeks prior to the renewal date. Shipping Address Name Address Zip Code, City E-mail Date, Signature Country PayPal Credit Card Credit Card Number Expiration Date Security Code SUBSCRIBE NOW! F +49 341 48474 173 subscriptions@dental-tribune.com it the Trusted Quality Mark for a two-year period. The 20-page document is available for down- load on the project website. This new global quality mark is intended to enable clinicians to see at a glance whether the spe- ciic implant meets a minimum standard of cleanliness. Following a ive-step approach (Table 1), the Trusted Quality Mark can be awarded to implants that have been shown in a comprehensive, unbiased analysis to be free of signiicant organic impurities (Figs. 1 & 2) and of particles con- taining, for example, copper, chromium, nickel, iron, tin, zinc, bronze, stainless steel or anti- mony on the implant surface. Technically, it is possible to produce residue-free implants, as many implants have shown in re- cent quality assessment studies. If, however, quality control steps are reduced for production and i- nancial reasons, medical devices of inferior quality are the result despite bearing a CE marking or having FDA clearance. For the Trusted Quality Mark award process, ive implants per type are examined, at least two of which are obtained through blind purchase from practices. The ana- lytical reports are screened and released by the scientiic advisory board in a peer review process. Through these procedures, we want to make absolutely sure that there is no connection between the inancial support of the pro- ject and the analysis result. The greatest difference to all previous attempts to develop such a quality mark is that we not only re-evalu- ate the results with new implants of the same type every two years, but also regularly tighten the cri- teria for this quality mark. Thus, the existing analytics will be sub- stantially expanded in the com- ing years. The results are published on the project’s website, www.clean- implant.com. This grants inter- ested implantologists a quick and easy way to obtain compre- hensive information about the possible kinds of implant pollu- tion, as well as numerous analy- sis results of contaminated and clean implants. The project is open to every dentist and manu- facturer concerned about the protection of patients from po- At the European Association for Osseointegration congress in Spain in October, two implants— UnicCA by BTI Biotechnology In- stitute and the T6 implant made by NucleOSS—received the irst Trusted Quality Mark 2017–2018 certiicates. Only a week later, the CleanImplant Foundation handed over the third award in Japan at the 13th Annual Mega- Gen International Symposium to Dr Kwang Bum Park, active implantologist and CEO of Korean implant manufacturer MegaGen. Implants of many more manufacturers are already in the process of comprehensive analyses and the results will be published soon. According to Albrektsson, we should abide by his fundamental guiding principle, stated in an ar- ticle a decade ago, that we cannot only believe, but rather have to know that the implants we are using do not harm our patients.1 Patients trust in our decisions on the right dental implant systems. Dentists should have an inde- pendent guide to ind out which implant system meets the re- quirements of a high-quality medical device. The CleanImplant Foundation will support future research on the clinical impact of impurities and expand the peri- odic analysis of dental implants all over the globe in order to pro- vide dentists with independent re- search results and evaluate im- provements in the manufactur- ing process of previously analysed implants. More information and an in- formative newsletter are available on the project’s homepage: www. cleanimplant.com. Editorial note: The reference can be obtained from the publisher. Dr Dirk U. Duddeck is the Managing Director of the C l e a n I m p l a n t Foundation. In addition, he is a guest researcher at Charité. He can be contacted at duddeck@cleanimplant.com. The CleanImplant Foundation was established in 2016 with the aim of providing information on possible contamination of sterile-pack- aged implants sold throughout the world and the consequent po- tential clinical signiicance. Jointly developed with the implant in- dustry to address the issue of dental implant purity, the initiative was irst introduced in March at the 2017 International Dental Show ( F i g . 3 ) . Initial funding was provided through the support of numerous implant manufacturers and other companies in the ield of oral implantology that are driven by a common vital interest in establishing an objective research and educational platform, thus contributing to greater patient safety. All manufacturers are invited to support the project. However, neither the form nor the extent of any support will have any inluence on the test results or reports.

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