EVALUAREA CALITĂȚII IMPLANTURILOR DENTARE SUB ASPECTE ALE ANALIZEI SEM SI EDX – O COMPARAȚIE A CINCI IMPLANTURI DINTR-O SINGURA PIESA

Implanturile dentare ar trebui să fie curate atunci când sunt livrate într - un ambalaj steril. Poluarea suprafata implantului cu particule organice și / sau reziduuri anorganice majore care provin din procesul de producție sunt suspectate de a cauza insuficienta sau lipsa osteointegrari implanturilor dentare. Particulele neprevăzute, la scară micrometrica, pot induce o reacție de corp străin , cu o pierdere de os în primele stadii ale osteointegrării

QUALITY ASSESSMENT OF DENTAL IMPLANTS UNDER ASPECTS OF SEM AND EDX ANALYSIS – A COMPARISON OF FIVE ONE-PIECE IMPLANTS

Dental implants are supposed to be clean, when delivered in a sterile packaging. Implant surface pollution with organic particles and/or major inorganic residues originating from the production process are suspected to cause insufficient or missing osseointegration of dental implants. Unintended micrometer-scale particles may induce a foreign body reaction with a loss of bone in the early stages of osseointegration. In cooperation with the University of Cologne and the Charité University Medicine Berlin the Medical Materials Research Institute Berlin analyzed the quality of dental implants in three consecutive studies since 2008 [1, 2]. In 2015 extensive material contrast images were obtained and qualitative and quantitative elemental analyses were performed on 135 dental implants using the same study protocol. Results of the recent study and comparison with previous analyses showed an increasing spread of quality in the market. Dental implants are an integral part of the therapeutic armamentarium of contemporary dental practices. With their excellent success rates, they have become the globally established treatment alternative to purely prosthetic solutions for tooth loss. And with the variety of implant systems offered, it has become ever more difficult for the dentist to choose just the right system for his or her practice and patients. Specific surface topographies, material properties that promote osseointegration or surface treatments are often emphasized in advertising as significant advantages to distinguish a given system from its many competitor

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

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