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implants _ international magazine of oral implantology No. 2, 2017

manufacturer news Nobel Biocare Treat more patients better—Genesis of a project At the 2016 Nobel Biocare Global Symposium in New York, Trefoil was introduced to an in- ternational audience. This treatment approach offers the possibility of same-day rehabilitation of the edentulous mandible or a failing dentition in the lower jaw with a definitive implant sup- ported prosthesis. An innovative compensation mechanism incorporated into a prefabricated framework allows adjustment to a precision fit on three implants, making Trefoil unique. Based on a heritage of innovation Over several decades, Prof. Brånemark and Barbro Brånemark travelled the globe in order to provide care to hundreds of patients suffer- ing from acquired or congenital cranio-maxillo- facial defects, something they did without direct financial compensation. Brånemark recognised the high global incidence of edentulism and the universal problem of affordability for implant re- habilitation. In 1999, as a potential solution for this predicament he introduced Novum, which was the forerunner and progenitor of the Trefoil concept. Novum was a pioneering landmark using imme- diate loading of implants combined with ana- logue-guided surgery. Favourable short-term results of implant and prosthesis survival rates were reported by multiple centres; however, a concerning incidence of post-surgical prosthet- ic complications was also documented. These restorative problems, coupled with the unfor- giving nature of surgery, resulted in a deci- sion by Nobel Biocare to discontinue Novum in 2007. Based upon positive clinical results with over 70 patients treated using the Novum proce- dure in private practice and similar experi- ences from other surgeons it became clear 46 implants 2 2017 that the unforgiving surgical requirements of Novum and the high incidence of post-surgical restorative problems being reported were of- ten related to misfit between the prefabricated framework and the three misaligned implants. Trefoil: collaborative innovation Over a four-year period, 2012–2016, the Trefoil team undertook an intense process of collabo- rative innovation, which included multiple engi- neers and clinical specialists. The Trefoil team focused on rectifying the deficiencies of Novum using engineering and clinical technology not available in the mid-1990s. By the early spring of 2015, the present Trefoil framework with three internal com- pensation mechanisms was developed and tested over a period of 70 weeks. This ground-breaking adjustable framework has the capability of correcting meaningful horizontal, vertical and angular misalignment of the three implants placed with guided sur- gery to achieve a precise fit. This collaborative development required three years of bi-weekly meetings during which 25 framework iterations and over 100 component design changes were evaluated. In April 2016, an international 5-year multicentre post market trial was commenced. By the end of December 2016, completed en- rolment of 90 patients in the study was antici- pated. To date, excellent early results have been reported in this prospective long-term study. The Trefoil concept embodies the Nobel Biocare objective, “to treat more patients better,” by offering a reduction in cost using a simplified clinical workflow, a standardised prefabricated framework, and minimised componentry that reduces treatment time. The Trefoil concept was conceived and developed to extend the benefits of osseointegration to a new patient population. It is not intended to replace any of the current edentulous solutions presently available, but of- fers a more affordable premium alternative for an entirely new patient population instead. Author: Dr Kenji W. Higuchi Nobel Biocare Services AG P.O. Box 8058 Zurich-Airport, Switzerland nobelbiocare.com/trefoil

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