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Smart Implants from Safe CERAmics

Periodic Reporting for period 3 - SISCERA (Smart Implants from Safe CERAmics)

Periodo di rendicontazione: 2019-04-01 al 2019-12-31

Great advances were made by SISCERA consortium partners in the development of the world’s first ceramic showing plasticity. This material was based on a novel, highly biocompatible bioceramic composite coupled with a specific surface modification, procuring enhanced osseointegration to implants. The core objective of SISCERA (Smart Innovations from Safe CERAmics) was to prepare market penetration of the first commercial applications of this revolutionary plastic ceramic.
Starting from this material available at project start, the SISCERA consortium finally demonstrated its ability to prepare a range of materials, which properties are balanced progressively from optimal toughness to optimal strength.
This range of materials kept the key features from its initial formulation:
› TOUGHNESS, largely exceeding that of the reference implant material Y-TZP for all compositions, procuring flaw tolerance ability and limited slow crack growth
› STRENGTH, enabling the production of dental implants within the bio-mechanical requirements with a relevant design
› PERFECT LONG-TERM STABILITY against Low-Temperature Degradation, here again procuring a significant added-value compared to existing dental implant materials.
This know-how, industrially installed at Anthogyr and DMC, will allow both partners to apply a MATERIAL by APPLICATION approach, with new application opportunities inside and outside the dental field. These materials can indeed serve as an enabling technology allowing enhanced innovation capacity in many fields such as biomedical (implants, bone saws, dental prosthesis, etc.), automotive, space, fuel cell, cutting tool, ball bearing and chemical industries. The most strategic initial application was the dental implant. This market is indeed expected to grow annually by 6-8% during the next years, to a total of 5.4 Billion € by 2020. In addition, ceramics are gaining popularity on the market as implant materials, but their use is still limited by inadequate toughness and osseointegration properties. The SISCERA consortium has the ideal material and expertise to provide the first dental implant fully meeting patient needs. The current project allowed partners to obtain biocompatibility validation of the implant, confirmation of an improved osseointegration performance, while getting prepared for market introduction.
A very deep understanding of the various material properties featured by the range of materials developed during the project has been gained and shared through publication in 6 international peer-reviewed high-impact journal articles.
Production of implants was started for advanced biocompatibility testing and implantation studies. In this context process capability measurements were performed and new non-contact control means installed. Machining strategies influence was assessed in terms of phase stability, roughness, and visual appearance. Some of them have been considered as an interesting way to add beneficial stresses inside the material. Design improvements were made to propose the most competitive solutions at market launch and prepare the future generations of dental implants. Prototypes were tested and presented in front of clinicians who confirmed its relevance and proposed improvements.
The safety and effectiveness assessment of a new dental implant relies mostly on its biological and mechanical performance evaluation, capped by clinical evaluation. The partners gathered most of these important data. Five material batches were deeply investigated in terms of strength, toughness, microstructure, fatigue and spontaneous transformation temperature. The sum of tests required for a complete biological risk assessment (more than 10 types of tests from cytotoxicity to implantation) have been launched and the results did confirm the biocompatibility of the new solution. Master documents in view of the CE marking were drafted and the clinical evaluation process started by a systematic review of the literature.
The desired surface morphology developed previously has been reproduced on ceramic implants made of the optimized material. The equipment developed for the surface modification was transferred to the industrial production site and firstly used for the preparation of test implants for a specific performance implantation study. This study confirmed biomechanically and histomorphometrically the superiority of the surface treatment compared to state-of-the-art procedures. Based on these results and on the outstanding mechanical properties, key building blocks are available to launch the game-changing implant that was expected. Anthogyr being now part of the world-leading Straumann group, this will help to freeze the implant design and conclude market introduction in the coming years.
Compared to the state of the art material titanium, all ceramic solutions provide a better aesthetics and improved biocompatibility. The total resistance against low temperature degradation and the complete freedom of surface finish of ceramic solutions provide a cutting edge advantage against the ceramic materials Yttria stablilized zirconia (YTZP) and Alumina toughened Zirconia (ATZ). These features are material-inherent and cannot be overcome by design alternatives. The SISCERA consortium is on its way to deliver for the first time, zirconia based ceramic implants exhibiting both high toughness and strength, full stability in vivo and enhanced osseointegration versus titanium. Since the material is uniquely predictable in terms of its properties as a function of microstructure, it enables faster development and commercial take-up of innovative products. In addition, the material is industrially available today and can be produced at industrial scale.
In terms of sustainability, our material has a lower friction coefficient and longer lifetime than metals and, therefore, undergoes less wear in mechanical applications. This means that parts don’t need to be replaced as often, resulting in less waste.
An implant made of our material will be the only non-metal implant for most applications made of a material other than Yttria-doped zirconia. This innovation will enable the implant to last longer while having optimized surface features. It will help tackle such societal challenges as allergies (via reduction of use of allergenic metals in implants) while creating jobs in Europe.
The various applications targeted by the consortium will offer new opportunities and competitive advantages to partners to help them grow. In total, the industrial partners aim to create 20 jobs thanks to SISCERA commercialisation within 3 years after the project.
The producers of the final material and implant, respectively have distributers or sales force across Europe. Markets addressed by SISCERA are global. The dental implant will first penetrate the European market, which is the largest market worldwide. The initial focus will be on the countries offering the highest sales potential: Germany, Switzerland, Italy, France, and Benelux. Later on, the very high potential of the North American market will be targeted following preparatory work concerning regulation, product registration and sales organization.
Prototypes implants were placed in animals as part of safety and performance demonstration in WP3.