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Implant Tribune Asia Pacific Edition

20 SCIENCE & PRACTICE Implant Tribune Asia Pacific Edition | 11/2017 Hidden danger: Contamination of sterile-packaged implants Why we need a global initiative for clean dental implants 1 2 3 Fig. 1: Organic residue (black) on a titanium implant; full-size SEM image at x500 magniication.—Fig. 2: Organic residue on a zirconia implant; SEM image at x500 magniication.—Fig. 3: Well-known manufacturers and scientists at the CleanImplant kick-off meeting at the 2017 International Dental Show. By Dr Dirk U. Duddeck, Germany Residues on sterile-packaged im- plants, particularly organic parti- cles from the production or packag- ing process, are highly suspected of being responsible for incomplete osseointegration of dental im- plants or even a loss of bone in the early healing period. Studies in re- cent years have shown that nei- ther the CE marking nor U.S. Food and Drug Administration (FDA) clearance provide a reliable indica- tion of the cleanliness of dental im- plants. In March 2017, a new initia- tive was presented at the Interna- tional Dental Show in Germany that focuses on this topic for the safety of both dentists and pa- tients. In three consecutive scan- ning electron microscopy (SEM) studies, scientists of the Univer- sity of Cologne and the Charité— Universitätsmedizin Berlin in Germany analysed more than 200 sterile-packaged implants since 2007. Results from the most recent study and compari- sons with previous years showed an alarming increase in implants with conspicuous residues. An increasing number of practition- ers have concerns about the bio- logical response to these impuri- ties, and the possibility of legal implications has arisen. The question we must ask is: how can the clinician know which im- plants are not affected by these impurities? Owing to the variety of implant systems offered on the market, it has become quite dificult for the individual den- tist to ind a safe system for his or her practice. “This new global quality mark is intended to ena ble clinicians to see at a glance whether the specific implant meets a minimum standard of cleanliness.” The CleanImplant Founda- tion has set itself the goal of pro- viding exactly this information worldwide. This independent non-proit organisation is sup- ported by a scientiic advisory board made up of well-known sci- entists and practitioners, such as Prof. Tomas Albrektsson (Univer- sity of Gothenburg, Sweden), Prof. Ann Wennerberg (Malmö University, Sweden), Prof. Florian Beuer (Charité, Germany), Prof. Jaafar Mouhyi (Universiapolis— International University of Aga- dir, Morocco), Dr Luigi Canullo (private practice, Italy) and Dr Mi- chael Norton (private practice, UK), President of the US Academy of Osseointegration. In Septem- ber 2017, this group of scientists released a consensus paper pro- viding objective evaluation crite- ria for a clean implant, awarding

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