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- Duddeck, D. U., et al.
(författare)
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On the Cleanliness of Different Oral Implant Systems: A Pilot Study
- 2019
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Ingår i: Journal of Clinical Medicine. - : MDPI AG. - 2077-0383. ; 8:9
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Tidskriftsartikel (refereegranskat)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.
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| 2. |
- Duddeck, D. U., et al.
(författare)
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Quality Assessment of Five Randomly Chosen Ceramic Oral Implant Systems: Cleanliness, Surface Topography, and Clinical Documentation
- 2021
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Ingår i: International Journal of Oral & Maxillofacial Implants. - : Quintessence Publishing. - 0882-2786 .- 1942-4434. ; 36:5, s. 863-874
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: After some initial setbacks in the 1970s, ceramic implants seem to be a promising alternative to titanium implants. Since the surface of an implant system represents the interface to surrounding biologic structures, the study focuses on cleanliness and surface topography. Clinical documentation of the corresponding systems completes the picture and allows a better evaluation of zirconia implant systems. Materials and Methods: Five different ceramic implant systems were selected randomly and purchased via blind-shopping: Z5s (Z-Systems), ZiBone (COHO), W implant (TAVDental), ceramic. implant (vitaclinical), and BioWinI/Standard Zirkon Implantat (Champions-Implants/ZV3 system). Three samples of each implant system underwent scanning electron microscopy (SEM) imaging and elemental analysis (EDS). Where appropriate, subsequent Time-of-Flight Secondary Ion Mass Spectrometry (ToF-SIMS) was performed to identify the chemical nature of impurities. Surface topography was evaluated, and a search for clinical trials in the PubMed database, on the websites and by written request to each dental implant manufacturer, was performed. Results: Surfaces of Champions implants (ZV3) and Z-Systems implants were relatively clean, whereas the other investigated surfaces of vitaclinical, TAV Dental, and ZiBone implants all displayed organic contaminations on their surfaces. Four of the investigated ceramic implants showed a moderately rough implant surface. Only the vitaclinical ceramic implant had minimal surface roughness. Three ceramic designs-vitaclinical, ZV3, and Z-Systems-had clinical trials documented with up to 3 years of follow-up and results varying between 82.5% and 100% survival. TAV Dental W and ZiBone implant systems lacked properly conducted clinical recording of results. Conclusion: The results of this study showed that it is technically possible to produce zirconia implants that are largely residue-free. On the other hand, the variety of significant residues found in this analysis raises concerns, as contamination may lead to undesirable biologic effects. The lack of clinical studies in peer-reviewed journals does not seem to be relevant for the approval of marketing, nor does the lack of surface cleanliness. In the authors' opinion, a critical analysis of these aspects should be included in a more stringent future analysis prior to the marketing of oral implant systems.
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