On the Cleanliness of Different Oral Implant Systems : A Pilot Study.

(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