Nanolevel Topographic Modifications on the OsseoSpeed(TM) Fluoride Modified Implant Surface Provide Additional Mode of Action for Documented Bone Response



    MVLNDAL, Sweden, March 9 /CNW/ - When the fluoride modified
OsseoSpeed(TM) implant was launched in 2004 it was based on solid pre-clinical
and clinical documentation and in order to fully understand and utilize the
full potential of OsseoSpeed, Astra Tech has continued to search further.

    (Photo: http://www.newscom.com/cgi-bin/prnh/20070309/248142-a)
    (Photo: http://www.newscom.com/cgi-bin/prnh/20070309/248142-b)
    (Photo: http://www.newscom.com/cgi-bin/prnh/20070309/248142-c)
    (Photo: http://www.newscom.com/cgi-bin/prnh/20070309/248142-d)

    Scientific results from in vitro studies show that human mesenchymal stem
cells (hMSC) grown on the OsseoSpeed(TM) surface differentiate to a larger
extent to osteoblasts. The gene expression further shows that the cells that
grow on OsseoSpeed mineralize. Similarly, significantly higher expression of
bone formation markers have also been identified in the tissue close to
OsseoSpeed implants in vivo, demonstrating that the bone response to this
implant surface is favorable and can be identified.
    "The original idea for fluoride treatment of titanium wasn't conjured out
of the air" says Professor Jan Eirik Ellingsen, University of Oslo, the
inventor of the OsseoSpeed surface. He continues:
    "It was based on established theories on the reaction between fluoride
and titanium and possible biological consequences. Even before we started with
these studies, we tried to figure out what mechanisms might be involved.
Results from numerous research projects in this area ended up with the
OsseoSpeed surface. One important finding is that the fluoride treatment
brings about a topographical change at a nanoscale level. When we examine
surface characteristics at the usual magnifications, we don't see any
difference between the OsseoSpeed surface and the control. But looking at a
higher resolution at nanolevel (500 nm) you can see that the surface has a
modified topography and nanoscale structures are created. This unique
nanoscale topography can only be created through the OsseoSpeed surface
modification."
    "What we have observed is a physical-chemical effect of the OsseoSpeed
surface leading to the improved adsorption of calcium phosphate to the
surface. For patients and doctors this means that OsseoSpeed is demonstrated
to result in more bone formation, stronger bone integration and faster bone
healing" Ellingsen concludes.

    
    OsseoSpeed(TM), short facts
    -   The first-ever fluoride-modified titanium implant surface with a
        unique nanoscale topography
    -   More and earlier bone formation
    -   Increased bone-to-implant contact ratio
    -   Stronger bone-to-implant interface
    -   More than 800 patients enrolled and treated in clinical trials
    -   Superior maintenance of stability during the early healing phase
    -   High survival rates for implants placed in soft bone

    The FOCUS project
    The FOCUS project evaluates the treatment success of OsseoSpeed when used
in a general population under conditions found in daily practice. More than
150 dentists in 14 countries are involved in the project.

    -   Follow-up: 3 years

    Study status
    -   Treated patients: 541
    -   One year follow-up: 187 patients
    -   Last patient out: 2011

    Results
    -   57% poor bone quality (III/IV)
    -   98.7% survival rate with up to one year follow-up
    -   Few complications, mainly associated with prosthetic issues
    -   (greater than)80% of the patients were satisfied or very satisfied
        with the overall result of the treatment (QoL) one year after being
        restored.

    Predictable results using an early loading protocol in the posterior
    maxilla and mandible (YA-OSS-0001)

    Maxilla
    -   Countries: Germany and USA
    -   Follow-up: 5 years
    -   One stage, early loading (6-7 weeks)

    Study status
    -   Treated/planned patients: 47/45
    -   Last patient out: 2011

    Results
    -   80% soft bone quality (III/IV)
    -   52% with osteotome technique
    -   93.9% survival rate with up to one year follow-up

    Mandible
    -   Countries: Germany and USA
    -   Follow-up: 5 years
    -   One-stage, early loading (6-7 weeks)

    Study Status
    -   Treated/planned patients 45/45
    -   Last patient out: 2010

    Results
    -   20% poor bone quality (III/IV)
    -   100% survival rate after two years follow-up
    

    Encl.

    Scientific Review, OsseoSpeed(TM)

    Why accept bone loss? (The Astra Tech BioManagement Complex(TM))

    Astra Tech, a subsidiary of the pharmaceutical company AstraZeneca,
develops and produces dental implants and advanced medical devices. With these
products, Astra Tech aims to improve treatment results, facilitate procedures,
reduce health care costs and enhance the quality of life for patients.
    Astra Tech's headquarters, located in Mvlndal, Sweden, house facilities
for research and development as well as production. The company has 15
subsidiaries in Europe, North America and Asia/Pacific and is represented by
local partners in other selected markets.

    Astra Tech had sales of US$360 million in 2006 and employs approximately
1,800 people.

    www.astratechdental.com

    Photo:
    http://www.newscom.com/cgi-bin/prnh/20070309/248142-a
    http://www.newscom.com/cgi-bin/prnh/20070309/248142-b
    http://www.newscom.com/cgi-bin/prnh/20070309/248142-c
    http://www.newscom.com/cgi-bin/prnh/20070309/248142-d





For further information:

For further information: Kerstin Wettby, Head of Market Communication
Dental, Astra Tech AB, Phone: +46-31-776-30-00/32-02, cell phone
+46-705-16-32-02, E-mail: kerstin.wettby@astratech.com; Janie Shen, Director
Corporate Communications, Astra Tech Inc., USA, Phone: +1-781-890-6800/6605,
E-mail: janie.shen@astratech.com

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