Straumann launches Roxolid, a new high performance material for dental implants

Straumann launches Roxolid™, a new high performance material for dental implants

·         New material increases the choice of treatment options with small diameter implants

·         Roxolid combines higher tensile and fatigue strengths1 with excellent osseointegration2 and is designed to increase reliability and confidence with small diameter implants

·         Less invasive treatment using smaller implants is expected to increase patient acceptance of implant solutions

·         More than 6,300 Roxolid implants in controlled release program and international clinical trials

·         Roxolid 03.3mm Bone and Tissue Level implants now available in the U.S. and Canada; European launch to follow later this year

Basel/Boston 14 September 2009: At the 2009 Annual Meeting of the American Academy of Periodontology (AAP) currently taking place in Boston, Straumann announced the full market launch in North America of its new high performance dental implant material Roxolid™. Straumann 03.3mm Bone and Tissue Level implants are now available in the new material in the U.S. and Canada, offering customers a new level of confidence with small diameter implants. 03.3mm implants currently generate approximately 15% of Straumann’s global implant sales.

Higher tensile and fatigue strengths combined with the excellent 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).

Rigorous 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)3.

The combination of enhanced strength and osseointegration opens the door for a new generation of smaller diameter implants, which may be particularly advantageous in situations where 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 9 countries, the first of which began almost 2 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 fate, 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 congreses4,5,6,7, 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, currently taking place in Boston.

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 Broup of independent experts. On the basis of their unanimous recommendation, Straumann is preceding with a full market 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. However, 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 characteristics8,9,10,11.

According to published research4, 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 (TAV) has been shown to compromise osseointegration10,11. Furthermore, TAV cannot accommodate the sophisticated microstructuring processes required for Straumann’s third-generation SLActive® surface technology, which enhances osseointegration.

Excellent 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 healing times in half to 3-4 weeks from 6-8 , which was the benchmark established by SLA®12. Since its launch, more than a million SLActive implants have been sold and it has set a benchmark for enhanced osseointegration.

Initial results from large clinical program 

In a prospective pilot clinical trial, which is still ongoing, 03.3mm Roxolid implants were placed in 22 patients. One-year data was presented at the Europerio Congress in Stockholm, including bone level measurements, which showed bone gain in 50% of the patients13.

A multicenter double-blind randomized study also is underway in 8 European centers with more than 90 patients. The one-year follow-up data, which is currently being evaluated, will be presented at forthcoming scientific meetings.

A non-interventional clinical study is also underway with more than more than 400 implants placed in 230 patients in Europe and North America. More than 50% of the patients have been followed for 6 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.

About Straumann

Headquartered in Basel, Switzerland, the Straumann Group (SIX: 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. Straumann currently employs approximately 2,200 people worldwide and its products and services are available in more than 70 countries through its broad network of distribution subsidiaries and partners.