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DENTAL TRIBUNE DENTAL TRIBUNE The World’s Dental Newspaper · U.S. Edition The World’s Dental Newspaper · U.S. Edition DECEMBER 2017 — Vol. 12, No. 12 www.dental-tribune.com www.dental-tribune.com Quality mark afirms implant cleanliness Residues on sterile-packaged im- steel or particles of antimony on the im- plant surface. plants, in particular organic particles from the production or packaging process, are highly suspected of being responsible for an in- complete osseointegration of dental im- plants or even a loss of bone in the early healing period. Studies from recent years have shown that neither the CE mark (des- ignating European Conformity) nor FDA clearance can provide a reliable indication of the cleanliness of dental implants. In March 2017, a new initiative was present- ed at the IDS in Cologne, which is focusing on this topic for the protection of both the users and the patients. In three consecutive studies using scan- ning electron microscopes, scientists with the University of Cologne and the Charité- University Berlin analyzed more than 200 sterile-packaged implants since 2007. Results from the most recent study and comparisons with previous years showed a noteworthy increase in implants with conspicuous residues. With growing numbers of practitioners raising concerns about a biologic answer to these impuri- ties, questions also arise about possible legal implications. Because of the variety of implant sys- tems, it has become dificult for the indi- vidual dentist to identify which implants are not affected by these impurities. In response, the CleanImplant Founda- tion has set itself the goal of providing such information worldwide. The inde- pendent nonproit organization is sup- ported by a scientiic advisory board that is chaired by scientists and practitioners, including Prof. Tomas Albrektsson (Uni- versity of Gothenburg, Sweden), Prof. Ann Wennerberg (Malmö University, Sweden), Prof. Florian Beuer (Charité-University Medicine Berlin, Germany), Prof. Jaafar Mouhyi (University of Agadir, Morocco), Luigi Canullo (Rome, Italy) and Michael Norton (London, U.K.), who is president of the U.S. Academy of Osseointegration. In September 2017, this group of scien- tists released a consensus paper providing objective evaluation criteria for enabling a “clean implant” to carry the “Trusted Quality” award for a two-year period. The 20-pages document is available for down- load on the project website. This new global quality mark is de- signed to enable clinicians to see at a glance whether the appropriate type of implant meets a minimum of cleanliness. Through a ive-step approach, the Trusted Quality award can be earned by implants demonstrating in a comprehensive neu- tral analysis that they are free of signii- cant organic impurities (Fig. 1) and free of particles containing copper, chromium, nickel, iron, tin, zinc, bronze, stainless Technically, it is possible to produce residue-free implants, as many of the im- plants demonstrated in the recent quality assessment studies. However, if quality control steps are reduced for production or economic reasons, medical devices of inferior quality can result — despite CE certiication and/or FDA clearance. For the Quality Mark awarding process, ive implants per type are examined, with at least two of those bought through blind purchase from practices. The analytical reports are screened and released by the CleanImplant scientiic advisory board in a peer-review process. “Through these procedures we want to make absolutely sure that there is no con- nection between the inancial support of the project and the analysis result,” said Dirk Duddeck, DDS, managing director of the CleanImplant Foundation. “The big- gest difference to all previous attempts to develop such a quality mark is that we not only re-evaluate the results with new im- plants of the same type every two years, but also regularly tighten the criteria for this quality mark. Thus, the existing ana- lytics will be substantially expanded in the coming years.” Results will be published on the proj- ect’s website, www.cleanimplant.com, to Fig. 1: Organdc pollutdon (black) on a tdtandum-made dmplant, full-sdze SEM dmage x500. Photo/Provdded by the CleanImplant Foundatdon provide implantologists with compre- hensive information about possible im- plant pollution as well as analysis results of contaminated and clean implants. The project is open to all dentists and manu- facturers concerned about the protection of patients from potentially inferior med- ical devices. At the European Association for Osseo- integration congress in Madrid in Octo- ber 2017, two implants (UniCA from BTI and the T6 implant made by NucleOSS) ” See CLEANLINESS, page B4 Disposable system mixes two components The time-saving Unit Dose 0.5 ml from Sulzer Mixpac is a single-use hygienic application system for two-component dental materials such as cements and bleaching materials. MIXPACTM T-Mixer mixing technology produces high-quality, reliable mixing results, according to the company. The ergonomic and easy-to-use system has a range of safe- ty features including transport protection and a safety fastener. Clear visual indicators ensure that the user can see at a glance whether the system has been activated and is ready to use. The Unut Dose 0.5 ml from Sulzer Muxpac has clear vusual unducators to ensure that the user can see at a glance (Source: Sulzer Mixpac) whether the system has been actuvated and us ready to use. Photo/Provdded by Sulzer Mdxpac AD