Higher security in implantology and a stage for high quality producers


The CleanImplant Basis seeks to advertise international consciousness of contaminated implant surfaces brought on by poor high quality management throughout manufacturing and ill-conceived packaging design. These deficiencies have been famous within the basis’s scientific analysis framework and reported in quite a few publications in Europe and overseas.1, 2 On the EAO congress, Dr Dirk U. Duddeck, managing director and head of analysis on the CleanImplant Basis, is at present amassing implant samples from producers to finish the cohort of the present 2021–2022 CleanImplant High quality Evaluation Examine.

Dr Duddeck, you will have already carried out a number of high quality evaluation research. Have you ever seen a pattern in the direction of more and more improved implant manufacturing and thus better security for sufferers?
In recent times, we now have analysed properly over 300 implant techniques from many main producers utilizing a Thermo Fisher Scientific scanning electron microscope and had the chance to guage qualitative manufacturing outcomes over an prolonged interval. Within the earlier high quality evaluation research, roughly one-third of implant samples have been discovered to be contaminated with residue from the manufacturing course of or contaminants attributable to the packaging course of.

What contaminants have you ever discovered on the implant surfaces?
Essentially the most ceaselessly detected implant floor particles is a carbonaceous compound recognized as polysiloxane (artificial polymers and thermoplastic supplies), which is thought to exhibit poisonous results. As well as, residues of erucamide (a fatty amide typically used as a lubricant additive within the plastics processing business) and dodecylbenzenesulfonic acid (an aggressive and surface-active chemical that’s labeled as dangerous to the well being by the US Environmental Safety Company) have been discovered on surfaces of sterile-packaged implants. These impurities may be averted by high quality management of the manufacturing processes and applicable packaging methods.

Do these factory-made impurities on implant surfaces have any scientific relevance?
Sure! The scientific relevance has been proved by many peer-reviewed research, which have concluded that residues on implant surfaces current a big concern for therapy success. Natural, that’s, carbonaceous, pollution are related to preliminary bone loss and peri-implantitis.3 International particles of 0.2–7.2 µm are thought of to be extremely pro-inflammatory, and when these particles detach from the floor throughout implant insertion, they will create an increasing zone of soft-tissue degradation. The secretion of inflammatory mediators equivalent to tumour necrosis factor-α, interleukin-1β, interleukin-6 and prostaglandin E2 from the irritation zone can then stimulate the differentiation of osteoclast precursors into mature osteoclasts.4, 5 Contaminants have been proven to disturb the patient-specific foreign-body equilibrium, a significant explanation for peri-implant bone loss, as said by Prof. Tomas Albrektsson.6

1) A latest high quality evaluation research revealed that roughly one-third of sterile-packaged implants present factory-related pollution. This contamination, such because the natural, carbon-containing, contaminants proven, is clinically related, having been discovered to be linked to bone loss and peri-implantitis (full-size, high-resolution SEM picture mapping utilizing back-scattered electron imaging, 500×). (Picture: CleanImplant Basis)

Dentists depend on the truth that implants which have acquired US Meals and Drug Administration (FDA) clearance or the CE mark have a residue-free floor—rightly so?
No, sadly not. All of the implant techniques that we now have examined had both a CE mark or FDA clearance. As customers of permitted medical units, dentists ought to be capable of belief that every one techniques meet optimum high quality requirements. To determine a perfect business normal, the CleanImplant Basis developed the “Trusted High quality” seal in 2017. Solely implant techniques with cross-batch cleanliness and excessive scientific success charges—independently analysed and peer-reviewed—can obtain this high quality seal. Our web site is a stage for high quality producers and offers clinicians with research outcomes on the cleanliness of the implants they use.

How has the non-profit mission continued to develop? How efficient is the attention marketing campaign in reaching dentists?
An rising variety of main implant producers are making use of for the “Trusted High quality” seal. This yr, the CleanImplant Basis has expanded its actions to South Korea and the US, opening an workplace, CleanImplant North America, in New York. Globally, the CleanImplant initiative has seen its membership improve dramatically, properly past our expectations. Presently, the inspiration has greater than 120,000 Fb subscribers and the quantity is rising every day. All of them need extra security, for themselves and their sufferers, as a result of they perceive that there’s authentic trigger for concern.

Editorial observe:

Extra details about the CleanImplant Basis may be discovered at www.cleanimplant.com. EAO congress members can be taught extra at Sales space F50.


  1. Duddeck DU, Albrektsson T, Wennerberg A, Larsson C, Beuer F. On the cleanliness of various oral implant techniques: a pilot research. 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. High quality evaluation of 5 randomly chosen ceramic oral implant techniques: cleanliness, Floor topography, and scientific 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 elements. 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, Inexperienced TR, Stone MH, Wroblewski BM, Fisher J, Ingham E. Analysis of the response of main human peripheral blood mononuclear phagocytes to problem with in vitro generated clinically related UHMWPE particles of recognized measurement 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. International physique response 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.

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