CleanImplant Foundation: Greater safety in implantology and a stage for quality manufacturers

Dr Duddeck, you have already conducted several quality assessment studies. Have you seen a trend towards increasingly improved implant manufacturing and thus greater safety for patients?
In recent years, we have analysed well over 300 implant systems from many leading manufacturers using a Thermo Fisher Scientific scanning electron microscope and had the opportunity to evaluate qualitative manufacturing results over an extended period. In the previous quality assessment study, approximately one-third of implant samples have been found to be contaminated with residue from the manufacturing process or contaminants attributable to the packaging process.

What contaminants have you found on the implant surfaces?
The most frequently detected implant surface debris is a carbonaceous compound identified as polysiloxane (synthetic polymers and thermoplastic materials), which is known to exhibit toxic effects. In addition, residues of erucamide (a fatty amide often used as a lubricant additive in the plastics processing industry) and dodecylbenzenesulfonic acid (an aggressive and surface-active chemical that is classified as harmful to the health by the US Environmental Protection Agency) have been found on surfaces of sterile-packaged implants. These impurities can be avoided through quality control of the production processes and appropriate packaging techniques.

Do these factory-made impurities on implant surfaces have any clinical relevance?
Yes! The clinical relevance has been proved by many peer-reviewed studies, which have concluded that residues on implant surfaces present a significant concern for treatment success. Organic, that is, carbonaceous, pollutants are associated with initial bone loss and peri-implantitis.³ Foreign particles of 0.2–7.2 µm are considered to be highly pro-inflammatory, and when these particles detach from the surface during implant insertion, they can create an expanding zone of soft-tissue degradation. The secretion of inflammatory mediators such as tumour necrosis factor-α, interleukin-1β, interleukin-6 and prostaglandin E₂ from the inflammation zone can then stimulate the differentiation of osteoclast precursors into mature osteoclasts.^4, 5 Contaminants have been shown to disturb the patient-specific foreign-body equilibrium, a major cause of peri-implant bone loss, as stated by Prof. Tomas Albrektsson.⁶

Dentists rely on the fact that implants which have received US Food and Drug Administration (FDA) clearance or the CE mark have a residue-free surface—rightly so?
No, unfortunately not. All the implant systems that we have examined had either a CE mark or FDA clearance. As users of approved medical devices, dentists should be able to trust that all systems meet optimal quality standards. To establish an ideal industry standard, the CleanImplant Foundation developed the “Trusted Quality” seal in 2017. Only implant systems with cross-batch cleanliness and high clinical success rates—independently analysed and peer-reviewed—can receive this quality seal. Our website is a stage for quality manufacturers and provides clinicians with study results on the cleanliness of the implants they use.

How has the non-profit project continued to develop? How effective is the awareness campaign in reaching dentists?
An increasing number of leading implant manufacturers are applying for the “Trusted Quality” seal. This year, the CleanImplant Foundation has expanded its activities to South Korea and the US, opening an office, CleanImplant North America, in New York. Globally, the CleanImplant initiative has seen its membership increase dramatically, well beyond our expectations. Currently, the foundation has more than 120,000 Facebook subscribers and the number is increasing each day. They all want more safety, for themselves and their patients, because they understand that there is legitimate cause for concern.

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