BASEL, Switzerland and Boston, Massachusetts--At the 2009 annual meeting of the American Academy of Periodontology in Boston, Straumann announced the full market launch in North America of Roxolid.
Roxolid is the company's new high-performance dental implant material.
Straumann Ø3.3-mm Bone and Tissue Level implants are now available in the new material in the U.S. and Canada. The implants offer customers small-diameter implants. Currently, Ø3.3-mm implants generate approximately 15% of the company's global implant sales.
Higher tensile and fatigue strengths combined with the osseointegration of SLActive
Roxolid is an alloy of titanium and zirconium and has been designed specifically for dental implants. Its name conveys the concept of natural physical strength combined with solidity (osseointegration).
Tests in Straumann laboratories have shown that the new material has higher fatigue and tensile strength than pure titanium (grade 4 annealed and cold worked), the current material of choice for dental implants.
In addition, preclinical study results have indicated that bone integrated with Roxolid better than with pure titanium (grade 4).
The combination of enhanced strength and osseointegration opens the door for small diameter implants. They may be particularly advantageous in situations in which there is limited space between teeth, and when preserving existing bone and vascular supply is important. A further potential advantage could be the use in thin alveolar bone.
Straumann's largest prelaunch clinical program to date
Engineered and developed by Straumann, Roxolid has been undergoing a broad program of clinical trials in nine countries, the first of which began almost two years ago. Involving 60 centers and more than 300 patients, this is one of the largest clinical research programs ever undertaken by a dental implant company prior to market launch.
Based on reports to date, the implant survival rate exceeds 99%. In addition, Roxolid has been made available to 450 selected specialists in a controlled release program, in which more than 6,300 implants have now been distributed.
Initial clinical reports have already been presented by lead investigators at recent major congresses, including a review of the scientific evidence and clinical application by Professor Hans-Peter Weber (Chair of the Department of Restorative Dentistry and Biomaterials Sciences at Harvard School of Dental Medicine) at the AAP.
Although Straumann obtained regulatory clearance several months ago, the company chose not to launch Roxolid until the available data from preclinical and clinical trials, including 12-month results from completed studies, had been reviewed by a Clinical Advisory Board of independent experts.
On the basis of the Board's unanimous recommendation, Straumann is proceeding with launch, beginning in North America, the world's largest market for dental implants. Roxolid will also become available to doctors and patients in Europe in the coming weeks.
The need 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 orthopedic surgery and subsequently in implant dentistry, where its physical properties were also important in order to bear the very strong forces of chewing.
But the mechanical properties are limited in the case of small-diameter implants or parts, which are needed for narrow spaces. This prompted the use of alternative materials, such as titanium alloys (e.g., Ti-6Al-4V, 'TAV'), but additional strength came at the price of impaired osseointegration due to inferior biocompatibility and surface characteristics.
According to published research, 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 contrast, the alloy of titanium and vanadium has been shown to compromise osseointegration.
Furthermore, TAV cannot accommodate the microstructuring processes required for Straumann's third generation SLActive surface technology, which enhances osseointegration.
Osseointegration with the SLActive surface
Surface texture, purity, and hydrophilicity are important contributors to optimal osseointegration and successful implant outcomes. In 2005, Straumann introduced its third generation implant surface technology SLActive, which cut implant osseointegration times in half from six to eight weeks to three to four weeks. This was the benchmark established by SLA.
Since its launch, more than a million SLActive implants have been sold.
Initial results from large clinical program
In a prospective pilot clinical trial, which is still ongoing, Ø3.3-mm Roxolid implants were placed in 22 patients. One-year data were presented at the Europerio Congress in Stockholm, including bone level measurements, which showed bone gain in 50% of the patients.
A multicenter double-blind randomized study also is underway in eight European centers with more than 90 patients. The one-year follow-up data, which are currently being evaluated, will be presented at forthcoming scientific meetings.
A noninterventional clinical study is also underway with more than 400 implants placed in 230 patients in Europe and North America. More than 50% of the patients in this study have been followed for six months or more.
The potential of smaller implants
In the future, high strength, small-diameter implants with enhanced osseointegration properties are expected to offer a number of advantages to dental professionals and patients, including enhanced esthetics, broader treatment options, shorter treatment times and reduced costs.
This is important as patients often fear implant treatment because of the associated pain, time, and cost. Straumann believes that Roxolid will therefore increase the general acceptance of implant dentistry and will contribute to further enhancing confidence among practitioners placing implants.
Additions to regenerative portfolio
The company also used the AAP as a platform for the U.S. introduction of Straumann Allograft, the oral bone augmentation material supplied through Straumann's partnership with LifeNet Health.
Allograft materials make up more than 50% of the dental bone augmentation market in the U.S., which was estimated to be worth $97 million in 2008. Straumann Allograft complements the company's fully synthetic BoneCeramic, which was launched in the U.S. in 2005.
Additionally, Straumann announced that it has received FDA approval for a new indication of Emdogain, the company's flagship regenerative product. Emdogain can now be used in the U.S. with a number of bone graft materials, in wide defects where additional soft tissue support is needed.
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