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

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

Dr Dirk U. Duddeck, managing director and head of research at the CleanImplant Foundation. (Image: CleanImplant Foundation)

Fri. 30. September 2022

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The CleanImplant Foundation seeks to promote global awareness of contaminated implant surfaces caused by poor quality control during production and ill-conceived packaging design. These deficiencies have been noted in the foundation’s scientific research framework and reported in numerous publications in Europe and abroad.1, 2 At the EAO congress, Dr Dirk U. Duddeck, managing director and head of research at the CleanImplant Foundation, is currently collecting implant samples from manufacturers to complete the cohort of the current 2021–2022 CleanImplant Quality Assessment Study.

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

1) A recent quality assessment study revealed that approximately one-third of sterile-packaged implants show factory-related pollutants. This contamination, such as the organic, carbon-containing, contaminants shown, is clinically relevant, having been found to be linked to bone loss and peri-implantitis (full-size, high-resolution SEM image mapping using back-scattered electron imaging, 500×). (Image: CleanImplant Foundation)

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.

Editorial note:

More information about the CleanImplant Foundation can be found at www.cleanimplant.com. EAO congress participants can learn more at Booth F50.

References

  1. Duddeck DU, Albrektsson T, Wennerberg A, Larsson C, Beuer F. On the cleanliness of different oral implant systems: a pilot study. J Clin Med. 2019 Aug 22;8(9):1280. doi: 10.3390/jcm8091280.
  2. Duddeck DU, Albrektsson T, Wennerberg A, Larsson C, Mouhyi J, Beuer F. Quality assessment of five randomly chosen ceramic oral implant systems: cleanliness, Surface topography, and clinical documentation. Int J Oral Maxillofac Implants. 2021 Sep–Oct;36(5):863–74. doi: 10.11607/jomi.8837.
  3. Mouhyi J, Dohan Ehrenfest DM, Albrektsson T. The peri-implantitis: implant surfaces, microstructure, and physicochemical aspects. Clin Implant Dent Relat Res. 2012 Apr;14(2):170–83. doi: 10.1111/j.1708-8208.2009.00244.x. Epub 2009 Oct 16.
  4. Matthews JB, Besong AA, Green TR, Stone MH, Wroblewski BM, Fisher J, Ingham E. Evaluation of the response of primary human peripheral blood mononuclear phagocytes to challenge with in vitro generated clinically relevant UHMWPE particles of known size and dose. J Biomed Mater Res. 2000 Nov;52(2):296–307. doi: 10.1002/1097-4636(200011)52:2<296::aid-jbm8>3.0.co;2-9.
  5. Rader CP, Sterner T, Jakob F, Schütze N, Eulert J. Cytokine response of human macrophage-like cells after contact with polyethylene and pure titanium particles. J Arthroplasty. 1999 Oct;14(7):840–8. doi: 10.1016/s0883-5403(99)90035-9.
  6. Trindade R, Albrektsson T, Tengvall P, Wennerberg A. Foreign body reaction to biomaterials: on mechanisms for buildup and breakdown of osseointegration. Clin Implant Dent Relat Res. 2016 Feb;18(1):192–203. doi: 10.1111/cid.12274. Epub 2014 Sep 25.

Contamination Dental implant EAO congress Implantology Quality management

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