Ný málmblanda í Straumann tannplöntum
Þann 23. september s.l á „Annual Scientific of the European Association for Osseointegration” (EAO) í Póllandi kynnti Straumann fyrirtækið nýtt efni sem mun geta boðið upp á að tannplantar verði minni og um leið sterkari í náinni framtíð. Nýja efnið sem nefnist ROXOLID er málmblanda af Titanium og Zirconium. Roxolid er 50% sterkari efni en hreint Titanium.
Straumann presents Roxolid™ a new material designed to enhance the strength and healing properties of dental implants
- 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
Warsaw/Basel, 23 September 2008: 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 titanium1, the current material of choice for implants. Exciting preclinical study results presented in Warsaw showed that Roxolid™ integrated with bone better than pure titanium2. 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 EAO3 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 characteristics4,5.
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 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 weeks6.
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 placement2. 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 performance2.
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.