Dr.Saurabh Gupta BDS MDS
Oral and Maxillofacial Surgeon,
Ambassador, Clean implant Foundation, Germany.
According to a recent revelation by FDA (Food and Drug Administration), out of 2.1 million bad dental implant reports, only 114,200 cases were reported in the year 2018-2019. The number of bad dental implant reports are likely to grow in coming years. This is mainly because the last two decades saw an increase in the number of companies launching their new Implant systems in the market and these devices are commonly used by clinicians.
The initial phase of the biological response to an inserted implant are determined by dental implant surfaces. The implant surfaces also affect its ability of integrating into the surrounding tissue. Most of the dental practitioners only receive limited information and nonbiased details about the surface quality of implants used in their daily practice. Impurities like organic particles on sterile packaged implants which are generated from packaging or production process are suspected for being responsible for a dental implant’s incomplete osseointegration. This incorporates foreign body reaction resulting in loss of bone or early periimplantitis during the initial healing stage.
There are four prominent consecutive studies conducted over more than a decade in collaboration with the University of Cologne and the Charité University Medicine, Berlin, in Germany. These Studies clearly state that neither the CE (French: Conformité Européenne) marking nor U.S. Food and Drug Administration clearance can provide a reliable indication of the cleanliness of zirconia or titanium implants. Also, an astonishing increase in number of dental implants with impurities are revealed by Scanning electron microscopy (SEM) imaging and elemental analysis (EDS).
Today, choosing a safe Implant system for practice has become a challenging task for the dentist. Well, I can say it’s not just Implantology but far beyond that. The primary goal of CleanImplant Foundation is to provide precisely this information worldwide. CleanImplant is a non-profit organization known for periodical quality assessment. It is supported by scientific advisory board. An accredited testing procedure established by this foundation is used for the implant study 2018–2019, and builds the basis for a new, globally accepted quality seal & trusted quality mark for dental implants. All implants must be thoroughly analysed and unpacked carefully by SEM under cleanroom conditions as per ISO Class 5 (DIN EN ISO 146441). The testing laboratory is accredited for this analysis as per DIN EN ISO/IEC 17025 and regularly audited by independent accreditation and external bodies.
Around 600 single SEM images of each implant are digitally composed to one large image with an extremely high resolution to avoid any possible cherry picking. This provides a perfect overview of implant cleanliness. To make a conscientious decision on dental implant system, dentists should not just rely on given marketing information. A Dentist should thoroughly study the company which manufacturers the Implants.
All in all, when it comes to implant production quality, it is very important to act vigilantly. Make a “Clean” choice when it comes to placing implants.
For more information on the organisation log on to www.cleanimplant.com