Is your dental implant system truly safe and clean?

Dr Michael Norton, past President of the Academy of Osseointegration, summed up the problem in the implant market: “Dentists have to rely on the word of manufacturers and the FDA [US Food and Drug Administration] 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.”

Impurities on sterile-packaged implants, in particular organic particles from the production or packaging process, are highly suspected of being responsible for incomplete osseointegration of dental implants or even loss of bone in the early healing period. And even worse, this has already given patients’ lawyers opportunity for negligence claims.

A recent study, initiated by the non-profit CleanImplant Foundation in close collaboration with the Charité—Universitätsmedizin Berlin in Germany, revealed a continually growing number of implants with severe contamination, compared with preceding analyses. Areal organic contaminants, plastic particles from handling and packaging, and particles of tungsten, tin bronze and PTFE, and even large quantities of stainless-steel particles on the sterile implant surface are cause for concern.

How can the clinician know which implants are not affected by impurities?

It has become increasingly difficult for the dentist to choose a safe system for his or her practice. The CleanImplant Foundation has set the goal of providing precisely this information worldwide. This independent organisation is supported and managed by a scientific advisory board, which is chaired by renowned scientists and practitioners. In 2017, the board set the criteria for a new global quality seal, the CleanImplant Trusted Quality Mark. Through a thorough protocol, implants are analysed in accredited testing laboratories according to DIN EN ISO/IEC 17025. This procedure guarantees objective results and reliable information for the new global quality seal.

Implant systems to date that meet the high standards of the Trusted Quality Mark are NobelActive (Nobel Biocare), V3 (MIS Implants Technologies), AnyRidge (MegaGen), UnicCa (BTI), SLA (Straumann), T6 (NucleOSS), blueSKY (bredent) and REPLICATE (NDI). Other implant systems are currently in the process of being analysed.

Practitioners interested in an appropriate answer to patients’ questions can join the CleanImplant Community and ask for a personalised certificate, which informs patients already in the practice waiting room. Implant manufacturers who want to apply for the quality mark can find more information on the project’s website, www.cleanimplant.com.

At IDS in Cologne in Germany, the CleanImplant Foundation will be demonstrating full transparency and showing whether implants are as clean as promised by the respective manufacturers with a scanning electron microscope (SEM) installation on-site. On Wednesday, 13 March, at 5 p.m., the organisation will be holding a lecture at the IDS Speakers’ Corner explaining why “sterile” does not necessarily mean “clean” and why there is a need for a global quality mark in implant dentistry.

Visitors to IDS can learn more about this in Hall 11.1 at Booth B020–C021.