ACTIGEN®
TREATMENT OF IMPLANT SURFACE

The strength of compatibility

  • ACTIGEN® is the exclusive surface treatment in bovine collagen type I which significantly promotes the osseointegration of dental implants. Dental implants with this surface treatment are class III medical devices available only from a few selected, certified implant manufacturers. UBGEN® has developed the only bioactive surface treatment, with osteoinductive effect, with the ability to:

    • stimulate platelet activity

    • predispose the surface of the implants to be rapidly colonized by the bone

    • increase the bone/implant contact area

    • shorten recovery times

    For our users, this means being able to make a safe choice, with predictable results even in patients defined as high-risk.

Analysis and research of the UBGEN® process

  • Starting from today's implant coating technologies, UBGEN® has invested in research for a biological surface able to accelerate and increase the osseointegration process of implant fixtures. The topography and the chemical composition of the surface are used as a tool to address cellular behaviour and therefore the process of bone regeneration. For some time, we have been talking about the possibility of activating implant surfaces through their functionalization with different biologically active molecules for bone formation: from peptide synthesis, to growth factors and many others.
    In order to make the most performing and bioactive product available, UBGEN® has worked on the development of ACTIGEN®, the exclusive implant surface coating.

ACTIGEN®: the evolution of the implant coating

  • The significant result in terms of osseointegration was obtained by immobilizing type I collagen, extracted from bovine dermis, on etched surfaces. This type of collagen is the main component of the organic portion of the bone, where it acts as a support for vital processes.

    In the regenerative processes, in fact, the osteoblastic cells initially deposit a collagen matrix which is then mineralized. This collagen matrix exerts a series of positive biological effects. This in fact promotes the adhesion of osteoblasts and osteoclasts and acts as a cofactor for numerous growth factors.
    The use of collagen was a decisive choice for UBGEN® in order to create a biological solution that anticipates future needs in the world of dentistry.

In vitro test

To confirm the cell adhesion properties and stimulation of cell differentiation of collagen, some in vitro tests on implants coated with the ACTIGEN® treatment have been published.

Test on the production of the enzyme alkaline phosphatase (ALP) by osteoblasts cultured on titanium bars and titanium bars coated with collagen. The results after 3 and 7 days of culture show that the collagen-coated titanium produced more ALP, the main marker of osteoblastic activity, confirming the role of collagen inducing pro-osteogenic activity.

The collagen coating was applied to titanium screws which were then inserted into rabbit femurs for an in vivo assessment after four weeks. The trabecular bone showed improvements of the bone-implant contact surface compared to the control (non-treated titanium implant) which corresponds to faster regeneration of the bone surrounding the implant site.

A second set of implants was inserted into rabbit femurs and histomorphometric analyses were performed at two and four weeks (Fig. 12). After two weeks, these analyses showed a significant increase in bone-implant contact surface, whereas at four weeks bone healing was complete on both implant surfaces.

These data support the hypothesis that collagen induces faster bone production at the interface with the implant in accordance with the biological role of collagen.

Case report

In a series of case reports made on animals in 2016, 160 implants with ACTIGEN® coating were inserted following a strict surgical and clinical follow-up protocol, in order to demonstrate the effectiveness of the coating with the following guidelines:

• placement in native bone D4p> • uncovering after 10 weeks

• ASA 1 patient

Upon uncovering, two tests were performed to demonstrate the achievement of implant stability: the percussion test and the torque removal test at 20 N∙cm. All surgical steps were documented with x-rays and photographs. After one year, all the implants are correctly osseointegrated and stable, as verified when the implant was uncovered after ten weeks.

ACTIGEN® the difference lies in the result

  • Data analysis from histomorphometric studies on implants treated with ACTIGEN® coating indicate that the localization of collagen molecules on the interface has increased both the percentage of bone-implant contact and bone growth within the loops in a statistically significant manner.

    The results, therefore, demonstrate that ACTIGEN® surface treatment allows for an increase of up to 3 times the BIC (Bone Interface Contact) compared to the traditional surface in just two weeks.

We certify that the entire range of medical devices described above is CE marked and manufactured in accordance with the requirements of Directive 93/42 / EEC implemented in Italy with the DLGS. n. 46 dated 24-02-97 and subsequent amendments. The company operates in compliance with UNI EN ISO 9001 standards.

UBGEN Srl Viale del Lavoro 14, 35010, Vigonza (PD), Italy - Phone: +39 049 628 630

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