On the Cleanliness of Different Oral Implant Systems
A Pilot Study
Dirk U. Duddeck 1,2, *, Tomas Albrektsson 3 , Ann Wennerberg 4 , Christel Larsson 5 and Florian Beuer
Journal of Clinical Medicine
Received: 16 July 2019; Accepted: 19 August 2019; Published: 22 August 2019
Abstract: (1) Background: This paper aimed to compare the cleanliness of clinically well-documented implant systems with implants providing very similar designs. The hypothesis was that three well-established implant systems from Dentsply Implants, Straumann, and Nobel Biocare were not only produced with a higher level of surface cleanliness but also provided significantly more comprehensive published clinical documentation than their correspondent look-alike implants from Cumdente, Bioconcept, and Biodenta, which show similar geometry and surface structure. (2) Methods: Implants were analyzed using SEM imaging and energy-dispersive X-ray spectroscopy to determine the elemental composition of potential impurities. A search for clinical trials was carried out in the PubMed database and by reaching out to the corresponding manufacturer. (3) Results: In comparison to their corresponding look-alikes, all implants of the original manufacturers showed—within the scope of this analysis—a surface free of foreign materials and reliable clinical documentation, while the SEM analysis revealed significant impurities on all look-alike implants such as organic residues and unintended metal particles of iron or aluminum. Other than case reports, the look-alike implant manufacturers provided no reports of clinical documentation. (4) Conclusions: In contrast to the original implants of market-leading manufacturers, the analyzed look-alike implants showed significant impurities, underlining the need for periodic reviews of sterile packaged medical devices and their clinical documentation.
Quality Seal for Dental Implants
More safety for patients and practitioners
Article by Dr. Dirk U. Duddeck, published in: implants 4-2018
Dr Michael Norton, former president of the Academy of Osseointegration, summed up a problem of the implant market, stating “Dentists have to rely on the word of manufacturers and the FDA 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 (Figs. 1–3), are highly suspected of being responsible for incomplete osseointegration of dental implants or even loss of bone in the early healing period.
Four consecutive studies over a period of more than ten years conducted in close cooperation with the University of Cologne and the Charité-University MedicineBerlin, both in Germany, have shown that neither CE (French: Conformité Européenne) marking nor U.S. Food and Drug Administration clearance can provide a reliable... (Read the full article as PDF here)
Interview with Prof. Hugo de Bruyn
Radboud University Nijmegen and Genth University
We speak about impurities on dental implants and discuss the need for a non-biased, independent and global quality assessment.
We are honored and encouraged to welcome Professor de Bruyn as a new member of the CleanImplant Scientific Advisory Board.
"All that glitters ain´t gold"
Can ceramic implants meet higher expectations?
Article by Dr. Dirk U. Duddeck, published in: ceramic implants 2-2018
When Prince wrote his song “Gold”, of which the headline of this article quotes the refrain, he tried to explain the problem of having exaggerated expectations in a relationship. Presumably, he was not thinking about an ideal material for dental implants. Zirconium dioxide may have some advantages in comparison with titanium or titanium alloys.
Better aesthetic appearance in case of significant bone loss and low plaque affinity are benefits of this material. As the production process differs from titanium implants, one might expect that the surface cleanlinessof zirconia implants further makes a difference... (Read the full article as PDF here)
Impurities on Sterile Packaged Implants:
Is the Rise of Cheap Copy-Cat Products a Danger for our Patients?
Posterpresentation Europerio 9, Amsterdam; June 20, 2018
30 years after the first SEM research about contaminations on dental implants by Wahl et al., we still can find major impurities on many sterile implants today. Not only clinical1,2 but also legal implications may occur in the future if practitioners are using implants of inferior quality. The quality of a dental implant is always the result of appropriate quality management. Results of SEM/EDS analyses in 2017 give cause for concern.
1) 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; 18: 192-203.
2) Albrektsson T, Dahlin C, Jemt T, Sennerby L, Turri A, Wennerberg A., Is marginal bone loss around oral implants the result of a provoked foreign body reaction? Clin Implant Dent Relat Res 2014; 16(2): 155–65. doi: 10.1111/cid.12142.
Download the complete PDF and read more.
How safe is your implant?
Global initiative for clean dental implants
Article by Dr. Dirk U. Duddeck published in: implants 2-2017
Residues on sterile packaged implants, in particular organic particles from the production or packaging process, are highly suspected of being responsible for an incomplete osseointegration of dental implants or even a loss of bone in the early healing period.
Studies from recent years have shown that neither the CE mark nor the FDA clearance can provide a reliable indication of the cleanliness of dental implants. In March 2017, a new initiative was presented at the IDS in Cologne, which is focusing on this topic for the protection of both the users and the patients.
Cover Story Article (German)
zm berichtet über das CleanImplant Projekt
(CleanImplant project has become a cover story of the official journal of the German Dentists Association)
In der aktuellen Ausgabe der zm werden Aufgaben und Ziele des CleanImplant Projekts im Detail erklärt.
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Interview with Dental Online Channel
Interview in German language
Rückstände am Implantat – trotz steriler Verpackung
Welche Folgen hat es für Patienten, wenn ein Implantat mit Partikeln aus dem Produktions- und Verpackungsprozess belastet ist? Und welche Implantate sind wirklich rückstandsfrei? Das untersucht die CleanImplant Foundation. Im exklusiven Telefoninterview mit dem Dental Online Channel erläutert der Managing Director Dr. Dirk Duddeck die Hintergründe des Projekts.