Dienstag, 19. September 2017

  • Pressemitteilung BoxID 66912

Straumann presents "Roxolid™" a new material designed to enhance the strength and healing properties of dental implants

Warsaw/Basel, (lifePR) - .
- Impressive preclinical and preliminary clinical data presented at EAO by independent researchers and clinicians
- 50% stronger than pure titanium, the most widely used material for dental implants
- The combination of strength and osseointegration could make Roxolid ideal for reduced diameter implants
- International clinical program underway in 10 centers; implants already placed in more than 100 patients
- Company foresees launch in initial markets in 2009, pending favourable clinical results and regulatory clearances

At the17th Annual Scientific Meeting of the European Association for Osseointegration (EAO) in Warsaw, Poland, Straumann presented a new material that could make dental implants smaller and stronger. The new material, which is called Roxolid™, is an alloy of titanium and zirconium and is the first material to be designed specifically for dental implants.

Roxolid™ is 50% stronger than pure titanium(1), the current material of choice for implants. Exciting preclinical study results presented in Warsaw showed that Roxolid integrated with bone better than pure titanium(2). The combination of enhanced strength and osseointegration could open the door for a new generation of smaller, safer implants, which would be particularly advantageous in situations where there is limited space between teeth. A further potential advantage could be the use in thin bone (narrow bone ridge), where wider implants would necessitate bone augmentation/grafting procedures.

Engineered and developed by Straumann, Roxolid is currently undergoing clinical trials in 6 countries. Preliminary (6-12 month) observations from the first clinical trial were also presented at the EAO(3) showing very promising survival rates. Pending regulatory approvals and further positive findings from the broad clinical program, Roxolid implants are expected to become available in initial markets in the course of 2009.

The quest for high performance materials

Pure titanium is well known for its biological compatibility with the human body and its resistance to corrosion. The discovery that bone integrates with titanium (osseointegration) opened the way for its use in orthopaedic surgery and subsequently in implant dentistry, where its physical properties were also important in order to bear the very strong forces of chewing. However, the mechanical properties are limited in the case of small diameter implants or parts, which are needed for narrow spaces (e.g. to replace the lower front teeth). This prompted the use of alternative materials, such as titanium alloys (e.g. Ti-6Al-4V, 'TAV'). However, additional strength came at the price of osseointegration due to inferior biocompatibility and surface characteristics(4,5).

According to published research(4), titanium and zirconium are the only two metals commonly used in implantology that do not inhibit the growth of osteoblasts, the bone forming cells that are essential for osseointegration. In addition to this attribute, Roxolid can be combined with Straumann's third-generation SLActive surface technology, unlike other alloys such as TAV, which cannot accommodate the sophisticated mircostructuring processes required.

SLActive outperforms main competitor

In addition to material, surface is a key factor in successful implant therapy. In 2005, Straumann introduced its third generation implant surface technology SLActive, which cut implant healing times in half from 6-8 to 3-4 weeks(6).

In a preclinical head-to-head study presented at the EAO, the osseointegration of titanium- SLActive was compared to a leading competitor surface (TiUnite®(7)) at three time points (10 days, 3 and 6 weeks) after implant placement(2). At each time, SLActive demonstrated higher mean shear strength values (indicative of surface osseointegration), which were statistically significant at both 3 and 6 weeks. The investigators concluded that SLActive was more effective in enhancing interfacial shear strength. This adds to the large body of data and experience supporting SLActive on titanium implants as the benchmark.

A new level of osseointegration indicated

One of the most remarkable findings presented at the EAO was the observation that Roxolid enhanced osseointegration beyond the current SLActive gold standard. In a preclinical study, titanium-SLActive implants were compared with Roxolid-SLActive equivalents at 4 weeks after placement. Histomorphometry revealed significantly more bone growth around the Roxolid implant. The removal torque values for the new material were significantly higher, leading to the conclusion that Roxolid improved osseointegration performance(2).

Initial results from large clinical program

In a prospective pilot clinical trial, which is still ongoing, small diameter (3.3mm) Roxolid implants were placed in 22 patients. Preliminary data (6-12 months) were presented at the EAO showing very promising survival rates. This is the first of a number of clinical studies evaluating the new material. A multicenter double-blind randomized study is underway in 8 European centers with 88 patients and the planning phase of a non-interventional study involving more than 300 patients in Europe and North America has been completed.

In the future, safe, high strength, small diameter implants with enhanced osseointegration properties are expected to offer a number of advantages to dental professionals and patients. These include: enhanced esthetics, shorter healing times and the possibility of avoiding bone graft/augmentation procedures in patients with narrow bone ridges, which in turn will translate into simpler and less traumatic treatments and reduced chair time.

Virtual press kit

The abstracts of the presentations at the EAO and further information are published in a virtual press kit on www.straumann.com/press-kit.

(1) Based on internal specifications and ASTM F67
(2) Gottlow J et al. Preclinical data presented at the 23rd Annual meeting of the Academy of Osseointegration (AO), Boston, February 2008, and at the 17th Annual Scientific Meeting of the European Association for Osseointegration (EAO), Warsaw, September 2008
(3) Barter S et al. Clinical data presented at the 17th Annual Scientific Meeting of the European Association for Osseointegration (EAO), Warsaw, September 2008
(4) Steinemann S. Peridontol 2000 1998;17:7-21
(5) Wong M. et al. J. Biomed Mater Res 1995;29:1567-1575
(6) Oates TW et al. Int J Oral Maxillofax Implants 2007;22:755-760
(7) Registered trademark of Nobel Biocare

Concerning forward looking statements

This release contains certain "forward-looking statements", which can be identified by the use of terminology such as "could", "would", "indicate", "expected", "pending",
"will", "planning", or similar wording. Such forward-looking statements reflect the current views of management and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of the Group to differ materially from those expressed or implied. These include risks related to the success of and demand for the Group's products, the potential for the Group's products to become obsolete, the Group's ability to defend its intellectual property, the Group's ability to develop and commercialize new products in a timely manner, the dynamic and competitive environment in which the Group operates, the regulatory environment, changes in currency exchange rates, the Group's ability to generate revenues and profitability, and the Group's ability to realize its expansion projects in a timely manner. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this report. Straumann is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in it as a result of new information, future events or otherwise.

A webcast on Roxolid can be viewed for a limited period on www.straumann.com/webcast.

Further information about Straumann and our products is also available at www.straumann.com.

Further key reporting dates

30 October 2008 Q3 and 9M sales
12 February 2009 Q4 and Full year results

Details of Straumann roadshows and other events for investors are published on www.straumann.com.

Institut Straumann AG

Headquartered in Basel, Switzerland, the Straumann Group (SWX: STMN) is a global leader in implant and restorative dentistry and oral tissue regeneration. In collaboration with leading clinics, research institutes and universities, Straumann researches, develops and manufactures dental implants, instruments, prosthetics and tissue regeneration products for use in tooth replacement and restoration solutions or to prevent tooth loss. The Group manufactures implant system components and instruments in Switzerland and the US, CAD/CAM prosthetics in Germany, and dental tissue regeneration products in Sweden. Straumann also offers comprehensive training and services to the dental profession worldwide, including training and education, which is provided in collaboration with the International Team for Implantology (ITI). Altogether, Straumann employs approximately 2150 people worldwide and its products and services are available in more than 60 countries through the Group's 21 distribution subsidiaries and broad network of distribution partners.

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