Ministerio de Desarrollo Social
MINISTERIO DE AMBIENTE Y ESPACIO PÚBLICO Circular Sin Consulta Nº 2 - Concurso Público Nº 1/10
Improving the patient treatment experience by optimizing the treatment path leading to integrated solutions, thus mak- ing the treatment process more efficient and limiting inva- sive approaches.
Assuring and demonstrating the safety and efficacy of our solutions by maintaining state-of-the-art design control pro- cesses, conducting comprehensive pre-clinical testing and developing clinical follow-up documentation.
The ultimate goal is to maintain crestal bone, improve es- thetics, restore speech and eating ability, and improve com- fort before, during, and following treatment. These goals can be achieved by less invasive treatment procedures and treatment planning that together reduce chair-time and in- crease predictability.
Priorities in 2009
Nobel Biocare applies the highest scientific standards and principles to all its solutions. Prior to market launch, products must undergo thorough pre-clinical testing and validation. Following approval and clearance in accordance with ap- plicable laws and regulations, Nobel Biocare solutions enter a pre-launch, or restricted use, period for clinical study. In 2009, we initiated a number of research projects aimed at expanding restorative options and allowing for safer, more effective treatment. Key research initiatives focus on ad- vancing implant materials and surfaces in order to further increase predictability for patients with severely impaired bone conditions.
Another area of focus is the prevention of early peri-implant infection. The goal here is to further reduce potential implant loss due to post-operative infections, for example through antibiotic prophylaxis.
Further research topics are summarized in the table above. Highlights in clinical research
Nobel Biocare solutions are launched to the general dental market only after satisfactory clinical results have been achieved. In the case of dental implants, this is often de- monstrated by one-year cumulative survival rates (CSRs) in the mid to high ninetieth percentiles. After market introduc- tion, product efficacy is closely monitored through obser- vational studies as part of post-market surveillance. Clinical studies involving implants are typically performed using demanding protocols, such as immediate loading in extraction sites, including prospective randomized con- trolled trials (RCTs) performed at multiple centers, using a large sampling of products and a select group of patients. Regulatory Affairs
Our Regulatory Affairs (RA) department takes care of secur- ing regulatory clearance for the distribution of Nobel Biocare’s product portfolio in all our markets. In 2009, RA obtained numerous clearances including seven 510K sub- mittals in the US, eleven licenses in Canada, nine approvals and two license amendments in Japan, seven licences in Russia and three in the Ukraine. Furthermore, BSI, Nobel Biocare’s notifying body, granted an EC license renewal in November 2009. In 2010, RA will initiate additional license
Ongoing research activities in 2009
Research area Topic Potential
Engineering Flaps and mini-flaps with NobelGuide Guided implant surgical support for flapped and mini-flap procedures
Engineering Short and narrow diameter implants Reduce need for guided bone regeneration (GBR), and improve implant therapy success, in narrow bone ridges and insufficient bone height
Life sciences Soft tissue integration Understand the interaction of soft tissue with implant surfaces, in order to create optimized surface structures, which promote gingival growth and health Life sciences Early implant placement Understand the biological response during the early healing phase
Materials Dental ceramics Stronger, safer and more reliable materials for patient esthetics and clinical success
Materials Surface morphologies Understand the effect of surface roughness on osseointegration and wound healing to enhance predictability in compromised bone situations
31 Research and development
submissions worldwide according to business needs and in order to meet the growing demand for our NobelProcera product portfolio.
First P-I Brånemark Scientific Symposium
A scientific highlight of 2009 was the first P-I Brånemark Scientific Symposium in Gothenburg, which brought to- gether over 200 world-leading healthcare and dental experts to exchange knowledge and experience. The program focused on science, economics, quality of life, and future developments of osseointegration for use in intra- and extra- oral implant-based rehabilitations. Professor Per-Ingvar Brånemark personally delivered the opening speech and attended the meeting. The next symposium is scheduled for 2011.
Outlook
Nobel Biocare remains dedicated to R&D strategies for im- proving patient quality of life. We will thus continue to focus on less invasive approaches like in- and onlays, flapless or mini-flap solutions and short or narrow implants with the goal to reduce patient discomfort and treatment time, thereby producing faster recovery and preserving more natural tissue. Another goal is to broaden our offering in the area of overdenture bar solutions, including the develop-
ment of a dedicated implant design. The research accom- plished and initiated in 2009 will continue to provide the foundation for solutions that enhance the safety and ef- fectiveness of implant-based as well as tooth-retained den- tal restorations.
References
Albrektsson T, Johansson C, Lundgren AK, Sul Y, Gottlow J. Experimental studies on oxidized implants. A histomorphometrical and biomechanical analysis. Appl Osseointegration Res 2000;1:21-24.
Gottlow J, Johansson C, Albrektsson T, Lundgren AK. Biomechanical and histologic evaluation of the TiUnite and Osseotite implant surfaces in rabbits after 6 weeks of healing. Appl Osseointegration Res 2000;1:25-27.
Kurze P, Krysmann W, Marx G, Knöfler W, Graf HL Hampel H. Beschichtetes Implantat. DD 210 607, 20.6.84, Patentschrift WP A61F/2439385.
Neupert G, Knöfler W. Untersuchungen zur Zytotoxizität verschiedener Metalle mit Oxidbeschichtung in vitro. II. Verhalten von Zellen direkt auf den Oxidschichten. Stomatol. DDR 1986; 36: 33-36.
Selected publications on clinical trials in 2009
Product(s) Follow-up Researchers CSR* (%) Publication status
Brånemark TiUnite 7 years Glauser et al 97.1 In preparation
TiUnite implants 5 years Friberg & Jemt 98.4 Clin Implant Dent Relat Res 2009; epub ahead of print
Brånemark System 5 years Caladriello & Tomatis 95.0 Clin Implant Dent Relat Res 2009; epub ahead of print
Zygoma 5 years Davó 97.4 Eur J Oral Implantol 2009;2:115-124
Brånemark System, NobelSpeedy Groovy, All-on-4 up to 5-year Agliardi et al 99.7 mandible 98.4 maxilla
Clin Oral Implants Res; Accepted for publication Brånemark System & Zygoma up to 3 years Duarté 100.0 Zygoma
97.2 BS
J O Implantol; Accepted for publication Replace TiUnite up to 3 years Bahat 99.3 Int J Oral Maxillofac Implants
2009;25(2):325-334
All-on-4 min 2 years Pomares 96.9 Eur J Oral Implantol 2009;2:55-60
NobelActive 1 year Kielbassa et al 96.5 J Prosthet Dent 2009;101:293-305