Roxolid® has brought a new level of confidence to implant dentistry that enables Straumann to offer an industry leading guarantee. Frank Hemm, Executive Vice President and Head of Customer Solutions & Education at Straumann, explains in this interview why Straumann has taken this decision and what it means for surgeons and patients.

Roxolid® – the dental implant material for superior strength and more indications

Roxolid® from Straumann (introduced 2009) has been specifically designed for use in dental implantology. It is a unique implant material – a metal alloy composed of ~15 % zirconium and ~ 85 % titanium – combining excellent osseointegrative properties with high mechanical strength. Roxolid® leads to increased mechanical resistance [R1] and up to 21 % higher fatigue strength compared to titanium implants [R2]. This allows dental professionals to use reduced diameter implants to preserve bone and reduce the number of invasive grafting procedures [R3]. In combination with Straumann’s unique SLActive® surface, Roxolid® implants offer increased predictability even in challenging protocols [R4-10], broader treatment possibilities even for patients with compromised health [R11-17] as well as safer and reduced treatment times (from 6 – 8 weeks down to 3 – 4 weeks) in all indications [R18].

Straumann already offers a lifetime guarantee on its titanium implants; what does the Roxolid® Lifetime Plus guarantee offer in addition?
Our ‘standard’ lifetime guarantee covers the replacement of the implant in the rare event of breakage and is valid for the patient’s lifetime. Few manufacturers offer this level of guarantee. For our Roxolid® implants, we are extending the lifetime guarantee in some countries to include a monetary contribution to the follow-up treatment costs.

How much is the monetary contribution?
It varies from country to country. The average amount is CHF 1000, which is paid to the surgeon and is intended to cover part of the cost resulting from additional treatment planning, chair time and follow-up treatment to replace the fractured implant.

Where is it available?
Unfortunately we are not able to offer the Lifetime Plus in every country yet – for administrative and other reasons. However, it is available in all major markets and we are working on making it as widely available as possible.

What is the benefit?
We have invested years of expertise, scientific research and clinical experience in perfecting the design and material properties of our implants and abutments. In addition, we conduct numerous quality checks – all in order to minimize the possibility of implant fracture. As a result, fractures are very rare with Straumann implants. Implant breakages are unpleasant for the patient and the surgeon. Until now, the treatment costs for replacing an implant in the event of breakage had to be borne by the dentist and/or the patient. Straumann is the first leading dental implant manufacturer to offer a lifetime guarantee covering both the product and a contribution to the treatment costs.

Frank Hemm, Executive Vice President and Head of Customer Solutions & Education

“We have invested years of expertise, scientific research and clinical experience in perfecting the design and material properties of our implants and abutments. In addition, we conduct numerous quality checks – all in order to minimize the possibility of implant fracture.”

Frank Hemm, Executive Vice President and Head of Customer Solutions & Education


What has prompted Straumann to take this bold step?
Science and clinical evidence. Roxolid® is stronger than pure titanium [1] and has excellent osseointegration capabilities. Implant fractures are very rare and success rates are very high [2]. We already had extensive data from mechanical strength and durability tests before we introduced Roxolid. Then it was tested in the largest clinical research program initiated by a dental implant company prior to commercial launch. Publications arising from the program currently cover 922 implants, 607 patients and 57 clinical centers3 with up to three years of follow-up [2] (see Tab. 1). One of the most recent publications, a scientific review, reported survival and success rates of 98.4% and 97.8% respectively.[2] Another recent publication reported five-year results from a randomized controlled clinical trial showing that survival and success of Roxolid® implants are maintained over time [4]. To add to this body of scientific evidence, Straumann’s Quality Compliance statistics show that the cumulative fracture rate of all 3.3 mm Roxolid® implants sold to date is just 0.04% [1], which is significantly lower than the rate for our titanium equivalents.  This is why surgeons can be confident with Roxolid. The Lifetime Plus Guarantee adds a further level of confidence for them and their patients.

APPENDIX

roxolid 5 years of validated clinical performance

Fig. 1: Five years of validated clinical performance. First launched in 2009, Roxolid® is available in Straumann’s entire implant portfolio throughout the world, depending on registration processes. Some major markets have shown a major switch from titanium to Roxolid.

Relevant clinical studies with Roxolid® implants (Altuna P, et al. 2016)

Tab. 1: Relevant clinical studies with Roxolid® implants (Altuna P, et al. 2016)

The standard guarantee on all Straumann implants applies worldwide for the lifetime of the patient and covers the implant in case of breakage – irrespective of whether it is made of titanium, ceramic or Roxolid. The Lifetime Plus guarantee is available, for Roxolid® only, in Europe and North America with other regions to follow depending on legal and organizational constraints. For both the Straumann guarantee and the Lifetime Plus guarantee, adherence to the clinical protocol and the approved indications is a precondition.

SCIENTIFIC REFERENCES

1 Data on file 2 Altuna P, et al. Clinical evidence on titanium–zirconium dental implants: a systematic review and meta-analysis, Int J Oral Maxillofac Surg (2016), dx.doi.org/10.1016/j.ijom.2016.01.004 3 www.straumann.com/science-roxolid.html 4 Müller F, et al. Small-diameter titanium grade IV and titanium-zirconium implants in edentulous mandibles: five-year results from a double-blind, randomized controlled trial. BMC Oral Health. 2015 Oct 12;15(1)

R1 Kobayashi E, Matsumoto S, Doi H, Yoneyama T, Hamanaka H. Mechanical properties of the binary titanium-zirconium alloys and their potential for biomedical materials. J Biomed Mater Res. 1995 Aug;29(8):943-50. R2 Bernhard N, Berner S, de Wild M, Wieland M: The binary TiZr Alloy – a newly developed Ti alloy for use in dental implants, Forum Implantol., 2009, 5, 30 -39. R3 Data on file R4 Benic G.I., Gallucci G.O., Mokti M., Hämmerle C.H., Weber H.P., Jung R.E., Titanium-zirconium narrow-diameter versus titanium regular diameter implants for anterior and premolar single crowns: one-year results of a randomized controlled clinical study. Journal of Clinical Periodontology 2013; [Epub ahead of print] R5Schwarz F., et al., Bone regeneration in dehiscence-type defects at chemically modified (SLActive®) and conventional SLA® titanium implants: a pilot study in dogs. J Clin. Periodontol. 34.1 (2007): 78–86 12 Lai H.C., Zhuang L.F., Zhang Z.Y., Wieland M., Liu X., Bone apposition around two different sandblasted, large-grit and acid-etched implant surfaces at sites with coronal circumferential defects: An experimental study in dogs. Clin. Oral Impl. Res. 2009; 20(3): 247–53. R6 Buser D., Wittneben J., Bornstein M.M., Grütter L., Chappuis V., Belser U.C., Stability of contour augmentation and esthetic outcomes of implant-supported single crowns in the esthetic zone: 3-year result of a prospective study with early implant placement post extraction. J. Periodontol. 2011 March; 82(3): 342–9. 7 Buser D., Chappuis V., Kuchler U., Bornstein M.M., Wittneben J.G., Buser R., Cavusoglu Y., Belser U.C., Long-term stability of early implant placement with contour augmentation. J. Dent Res. 2013 Dec; 92 (12 Suppl.): 176S-82S. R8 Nicolau P., Reis R., Guerra F., Rocha S., Tondela J., Brägger U., Immediate and early loading of Straumann® SLActive implants: A Five-Year Follow-up. Presented at the 19th Annual Scientific Meeting of the European Association of Osseointegration – 9 October 2010, Glasgow 10 International Diabetes Federation. http://www.idf.org/diabetesatlas/ R11 6 Bo Wen et al. The osseointegration behavior of titanium-zirconium implants in ovariectomized rabbits. Clin Oral Implants Res. 2013 Feb 21. R12 Schlegel K.A., Prechtl C., Möst T., Seidl C., Lutz R., von Wilmowsky C., Osseointegration of SLActive® implants in diabetic pigs Clin. Oral Implants Res. 2013 Feb; 24 (2): 128–34. 13 Reginster J.Y., Burlet N., Osteoporosis: a still increasing prevalence. Bone. 2006 Feb; 38 (2 Suppl. 1): S4-9. R14 Mardas N., Schwarz F., Petrie A., Hakimi A.R., Donos N., The effect of SLActive® surface in guided bone formation in osteoporotic-like conditions Clin. Oral Implants Res. 2011 Apr; 22 (4): 406-15. 15 WHO:www.who.int/ageing/about/facts/en/index.html R16 iData Report, Dental Implants and Final Abutments, Europe 2012 17iData Report, Dental Implants and Final Abutments, USA 2012 R18 Rupp F., Scheideler L., Olshanska N., de Wild M., Wieland M., Geis-Gerstorfer J., Enhancing surface free energy and hydrophilicity through chemical modification of microstructured titanium implant surfaces. Journal of Biomedical Materials Research A, 76(2): 323–334, 2006. R19 De Wild M., Superhydrophilic SLActive® implants. Straumann document 151.52, 2005 20 Katharina Maniura, Laboratory for Materials – Biology Interactions Empa, St. Gallen, Switzerland, Protein and blood adsorption on Ti and TiZr implants as a model for osseointegration, EAO 22nd Annual Scientific Meeting, October 17–19 2013, Dublin R21 Schwarz F., et al., Bone regeneration in dehiscence-type defects at non-submerged and submerged chemically modified (SLActive®) and conventional SLA® titanium implants: an immunohistochemical study in dogs. J. Clin. Periodontol. 35.1 (2008): 64–75.R22 Rausch-fan X., Qu Z., Wieland M., Matejka M., Schedle A., Differentiation and cytokine synthesis of human alveolar osteoblasts compared to osteoblast-like cells (MG63) in response to titanium surfaces, Dental Materials 2008 Jan.; 24(1): 102-10. Epub 2007 Apr. 27. R23 Schwarz F., Herten M., Sager M., Wieland M., Dard M., Becker J., Histological and immunohistochemical analysis of initial and early osseous integration at chemically modified and conventional SLA®titanium implants: Preliminary results of a pilot study in dogs. Clinical Oral Implants Research, 11(4): 481–488, 2007. 24Lang, N.P., et al., Early osseointegration to hydrophilic and hydrophobic implant surfaces in humans, Clin. Oral Implants. Res 22.4 (2011): 349–56. R25 Raghavendra S., Wood M.C., Taylor T.D.. Int. J. Oral Maxillofac. Implants. 2005 May–Jun; 20(3): 425–31. R26 Oates T.W., Valderrama P., Bischof M., Nedir R., Jones A., Simpson J., Toutenburg H., Cochran D.L., Enhanced implant stability with a chemically modified SLA® surface: a randomized pilot study. Int. J. Oral Maxillofac. Implants. 2007; 22(5): 755–760.