Please activate JavaScript!
Please install Adobe Flash Player, click here for download
ePaper created 2017-05-12, 09:42:21 | version 1.38.0
| special How safe is your implant? Global initiative for clean dental implants Author: Dr Dirk U. Duddeck, Germany Residues on sterile packaged implants, in particular organic particles from the production or packaging process, are highly suspected of being responsible for an incomplete osseointegration of dental implants or even a loss of bone in the early healing period. Studies from recent years have shown that neither the CE mark nor the FDA clearance can provide a reliable indication of the cleanliness of dental implants. In March 2017, a new initiative was presented at the IDS in Cologne, which is focusing on this topic for the protection of both the users and the patients. In three consecutive SEM studies, scientists of the University of Cologne and the Charité-University Berlin have analysed more than 200 sterile packaged implants since 2007. Results from the most recent study and comparisons with previous years showed an alarming increase in implants with conspicuous residues. The question we must ask is: How can the clinician know which implants are not affected by these impurities? Due to the variety of implant systems offered on the market, it has become quite difficult for the individual dentist to find a safe system for their practice. Fig. 1: CleanImplant Kick-off meeting at IDS 2017 with renowned manufacturers and scientists: Prof. Tomas Albrektsson, Prof. Ann Wennerberg, Luigi Canullo, Prof. Jaafar Mouhyi (Scientific Advisory Board), Dr Dirk Duddeck (Managing Director CleanImplant Foundation), Jonas Ehinger (Osstell), Shelly Akazany (MIS), Sergey Shulezhko, Vladlena Shulezhko (Trate), Marcellus große Holthaus (BEGO), Dr Christian Rähle, Dr Markus Kraft (CAMLOG), Salva Gregori (BTI), Dr Kwang Bum Park, Sian Matthews, Young Choi (MegaGen), Rüdger Rubbert (Natural Dental Implants), Prof. Sergio Bernades (Neodent), Armin Vollmer and Dr Michael Hotze (Straumann). Fig. 1 38 implants 2 2017 The CleanImplant Foundation was established in 2016 and has set itself the goal of providing exactly this information worldwide. This independent non- profit organisation is supported by a Scientific Advisory Board, which is chaired by renowned sci- entists and practitioners such as Professor Tomas Albrektsson (University of Gothenburg, Sweden), Professor Ann Wennerberg (Malmö University, Sweden), Professor Florian Beuer (Charité-Univer- sity Medicine Berlin, Germany), Professor Jaafar Mouhyi (University of Agadir, Morocco), Luigi Can- ullo (Rome, Italy) and Michael Norton (London, UK), the recently elected President of the US Academy of Osseointegration. Technically it is possible to produce residue-free implants, as many of the implants have shown in the recent quality assessment studies. If, on the other hand, quality control steps are reduced for production and economic reasons, medical devices of inferior quality are the result despite the exis- tence of a CE certification. However, implants with worrying impurities can only be found in the market if there are uninformed dentists who buy these implants. If one follows the discussions on professional internet forums it is surprising to discover that apparently little attention is paid to clean medical products by some medical professionals and implantologists: “Do not make a big deal out of it… Can you convince me that super clean implants have significantly better outcome…? Dental im- plants have been dirty in the last 40 years and they still keep working.” If it is the maxim of these colleagues to rely on the immune defense of the patients entrusted to them, then we can also take off our sterile gloves in the operating room again in order to ensure a better tactility during the implan- tation, commented Dr Dirk Duddeck, head of the CleanImplant project. In order to offer no further room for this kind of misunderstanding, there is a need for a sustained information campaign, which will raise the importance for the awareness of clean dental implants.