“We believe that the problems related to Nobel Direct result both from the design of the implant and an uneven surface against the soft tissue in combination with the method of treatment recommended by the company,” according to Professor Lars Sennerby.
For some time, Nobel Direct was marketed as an implant that was easy to use, and therefore suitable for less experienced dentists. According to the company’s marketing, the implant would also counteract marginal bone loss.
”If the implant is inserted in a more conservative manner, avoiding direct load, the results appear to be better. We believe that there are additional implants with similar design that can also cause problems if they are inserted in the same way as Nobel Direct. However, we are unable to draw any certain conclusions regarding these,” says Professor Tomas Albrektsson, the head of the Department for Biomaterials Science at the Sahlgrenska Academy.
At the request of the Medical Products Agency, Nobel Biocare AB is now working to clarify certain information in the product information material. The company also markets several other titanium implants that have been scientifically proved to be very safe, including a Brånemark implant with the same patented surface as the Nobel Direct implant in dispute.
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FACTS ON DENTAL IMPLANTAT
The implant is a type of artificial dental root made of titanium. The titanium screw is surgically inserted in the jawbone, and must often become well-secured there so that after several months, it can be used as a foundation for crowns, bridges and dentures. The method was invented by Professor Per-Ingvar Brånemark at the Sahlgrenska Academy in the 1960s. There are several types of titanium appliances, but all are based on titanium being a metal with the unique property of being able to be osseointegrated.
The Sahlgrenska Academy is the health science faculty of Göteborg University. Teaching and research is carried out in medicine, odontology and nursing sciences. We have about 4,000 undergraduate and 1,000 postgraduate students. Of our 1,500 employees, 850 are teachers and/or researchers.
For additional information, please contact:
Pär-Olov Östman, Licensed Dentist, telephone: +46 (0)70-247 89 50,
E-mail: po@holmgatan.se
Professor Lars Sennerby, telephone: +46 (0)31-786 29 65,
E-mail: lars.sennerby@biomaterials.gu.se
Professor Tomas Albrektsson, telephone: +46 (0)31-786 29 50,
E-mail: tomas.albrektsson@biomaterials.gu.se
Mats Hellman, Licensed Dentist, orthognathic surgeon, telephone: +46 (0)70-648 94 50,
e-mail: mats.hellman@edentatio.se
Elin Lindström Claessen
Information Officer, Sahlgrenska Academy at Göteborg University
Tel: +46 31 786 3837, +46 70 829 43 03
e-mail: elin.lindstrom@sahlgrenska.gu.se |
