VIENNA, Austria: Residues on sterile packaged implants, in particular, organic particles from the production or packaging process, are strongly suspected of being responsible for incomplete osseointegration of dental implants or even loss of bone during the early healing period. Therefore, the CleanImplant Foundation established a new quality seal in order to provide increased safety for patients and practitioners. An implant from dental provider Bredent has been awarded the foundation’s “Trusted Quality” mark during the EAO congress.
Michael Norton, past President of the Academy of Osseointegration, summed up a problem in the implant market, “Dentists have to rely on the word of manufacturers and the FDA or CE marks to feel sure that the implants they are using are being manufactured to a standard one would expect of an implantable dental device. Sadly, this is often not the case.”
Four consecutive studies revealed alarming remnants and contaminants in the SEM-based quality assessment. Areal pollution and particles with iron, copper, chromium, nickel, tungsten, sulphur and large quantities of stainless-steel particles, as well as remnants of polytetrafluoroethylene and other significant organic contaminations gave cause for concern.
At the EAO Congress 2018 the CleanImplant Foundation awarded the Bredent group with the Trusted Quality Certificate. (Photograph: Timo Krause, OEMUS MEDIA)
Dr Dirk Duddeck hands over the CleanImplant Award to Peter Brehm, CEO of the Bredent group. (Photograph: Timo Krause, OEMUS MEDIA)
(Photograph: Timo Krause, OEMUS MEDIA)
(Photograph: Timo Krause, OEMUS MEDIA)
The Bredent group at EAO 2018 in Vienna. (Photograph: Timo Krause, OEMUS MEDIA)
(Photograph: Timo Krause, OEMUS MEDIA)
With the variety of implant systems offered on the market, it has become increasingly difficult for the dentist to choose a safe system for the practice. Based on a consensus paper signed by renowned scientists, the independent non-profit CleanImplant Foundation established a new global quality seal providing exactly this information. Implant companies with their systems already carrying the “Trusted Quality” mark, such as MIS V3, MegaGen AnyRidge, BTI UnicCa, NucleOSS T6 and NDI Replicate are presenting their tested products at the EAO 2018. In addition, other implant systems are currently in the process of examination. The most recent implant manufacturer that has been awarded is Bredent, based in Senden in Germany, for their implant system blueSKY at the EAO. The scientific advisory board proved compliance with the criteria required for issuing the quality mark. The official handover of the certificate took place at the Bredent booth.
From implant sample acquisition to environmental requirements necessary for unpacking and the subsequent analysis process, the CleanImplant Foundation guarantees unbiased research at a high scientific level.
Practitioners interested in a personalised certificate for their specific implant system, and implant manufacturers who want to apply for the new quality mark can find more information and a correspondent newsletter on the project's homepage at www.cleanimplant.com.
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