BIOCOMPATIBILITY TESTS


The chemical-physical properties of the implants and the surface topography lead to fast osseointegration. The analyses below have been conducted according to EN ISO 10993-5:1999 with osteoblastic cells from a human osteosarcoma (SAOS-2 line) with protocols contained in international bibliography.

ADHESION AND CELL GROWTH

"Result after 6 hours "... The chemical-physical-morphological properties of the surface do not hinder the adhesion of osteoblastic cells ... already featuring a flattened shape.” Results after 72 hours "… the chemical and morphological parameters of the surface promote considerable cell proliferation... the surface is consistently covered with very flat cell bodies..." Nobil Bio Ricerche - Dr. C. Cassinelli - Dr. M. Morra

CYTOTOXICITY

"... the cellular layer in contact with the implant screws has shown no effects that may adversely affect the cells... not only have dead cells never been observed, neither have multinucleated giant cells, with abnormal morphology or with reduced density."

OSTEOINTEGRATION TESTS

Following explant from the patient, the degree of integration of the Evolution2000 implant was evaluated with a SEM analysis: "...presence of bone around the whole implant and in close contact..." "The dental implant analysed was covered by well-calcified bone tissue that grew in close contact on most of the surface. This material therefore showed excellent biocompatibility and osseointegration."
University of Modena and Reggio Emilia - Biomaterials Laboratory - Dr. A. M. Gatti, Dr. E. Monari.