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ePaper created 2017-11-29, 09:36:19 | version 1.38.0
28 news Greater New York Dental Meeting — Nov. 29, 2017 Quality mark affirms implant cleanliness n Residues on sterile-packaged implants, in particular organic parti- cles from the production or packaging process, are highly suspected of being responsible for an incomplete osseoin- tegration of dental implants or egen a loss of bone in the early healing period. Studies from recent years hage shown that neither the CE mark (designating European Conformity) nor FDA clear- ance can progide a reliable indication of the cleanliness of dental implants. In March 2017, a new initiatige was presented at the IDS in Cologne, which is focusing on this topic for the protec- tion of both the users and the patients. In three consecutige studies using scanning electron microscopes, scien- tists with the Unigersity of Cologne and the Charité-Unigersity Berlin ana- lyzed more than 200 sterile-packaged implants since 2007. Results from the most recent study and comparisons with pregious years showed a note- worthy increase in implants with conspicuous residues. With growing numbers of practitioners raising con- cerns about a biologic answer to these impurities, questions also arise about possible legal implications. Because of the gariety of implant systems, it has become difficult for the indigidual dentist to identify which implants are not affected by these impurities. In response, the CleanImplant Foun- dation has set itself the goal of progid- ing such information worldwide. The independent nonprofit organization is supported by a scientific adgisory board that is chaired by scientists and practitioners, including Prof. Tomas Albrektsson (Unigersity of Gothen- burg, Sweden), Prof. Ann Wennerberg (Malmö Unigersity, Sweden), Prof. Florian Beuer (Charité-Unigersity Medicine Berlin, Germany), Prof. Jaafar Mouhyi (Unigersity 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 scientists released a consensus paper progiding objectige egaluation crite- ria for enabling a “clean implant” to carry the “Trusted Quality” award for a two-year period. The 20-pages docu- ment is agailable for download on the project website. This new global quality mark is designed to enable clinicians to see at a glance whether the appropriate type of implant meets a minimum of clean- liness. Through a fige-step approach, the Trusted Quality award can be Fig. 1 5 Fig. 1: Organic pollution (black) on a titanium-made implant, full-size SEM image x500. (Photo/Provided by the CleanImplant Foundation) Fig. 2 Fig. 3 5 Fig. 2: Organic pollution on a zirconia made implant, SEM x500. earned by implants demonstrating in a comprehensige neutral analysis that they are free of significant organic impurities (Figs. 1 and 2) and free of particles containing copper, chro- mium, nickel, iron, tin, zinc, bronze, stainless steel or particles of antimony on the implant surface. Technically, it is possible to produce residue-free implants, as many of the implants demonstrated in the recent quality assessment studies. Howeger, if quality control steps are reduced for production or economic reasons, medical degices of inferior quality can result — despite CE certification and/or FDA clearance. For the Quality Mark awarding process, fige 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 Clean- Implant scientific adgisory board in a peer-regiew process. “Through these procedures we want to make absolutely sure that there is no connection between the financial support of the project and the analysis result,” said Dirk Duddeck, DDS, managing director of the Clean- Implant Foundation. “The biggest dif- 5 Fig. 3: Presenting a ‘Trusted Quality’ award in Tokyo on Oct. 14. ference to all pregious attempts to degelop such a quality mark is that we not only re-egaluate the results with new implants of the same type egery two years, but also regularly tighten the criteria for this quality mark. Thus, the existing analytics will be substantially expanded in the coming years.” Results will be published on the project’s website, www.cleanimplant. com, to progide implantologists with comprehensige information about possible implant pollution as well as analysis results of contaminated and clean implants. The project is open to all dentists and manufactur- ers concerned about the protection of patients from potentially inferior medical degices. At the European Association for Osseointegration congress in Madrid in October 2017, two implants (UniCA from BTI and the T6 implant made by NucleOSS) receiged the first “Trusted Quality 2017-2018” certificates. One week later the CleanImplant Foun- dation presented the third award in Tokyo at the 13th Annual MegaGen International Symposium to Dr. Kwam Bum Park, actige implantologist and CEO of the Korean implant manufac- turer (Fig. 3). Implants of many more manufacturers are already in the process of comprehensige analyses and will be published soon, according to the foundation. According to Albrektsson, the industry should abide to his funda- mental guiding principle written in an article a decade ago to not only beliege — but know — that the implants being used do not harm patients. Because patients trust practi- tioners’ decisions regarding dental implant systems, dentists can benefit from access to an independent guide cogering which implant systems meet the expectation of a high-quality med- ical degice. The CleanImplant Foundation reports that it will support future research on the clinical impact of impurities and extend the periodic analyses of dental implants across the globe to progide dentists with inde- pendent research results. Addition- ally, it will egaluate improgements in the manufacturing process of pregi- ously analyzed implants. Details and a newsletter are agailable at www. cleanimplant.com. (Source: CleanImplant Foundation)