#	Pagina
attuale pagina	/open-h2020/projects/206781/results.html

Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - SISCERA (Smart Implants from Safe CERAmics)

Teaser

Summary

Great advances were made by SISCERA consortium partners in the development of the worldâ€™s first ceramic showing plasticity. This material is 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) is to prepare market penetration of the first commercial applications of this revolutionary plastic ceramic.
This new type of material can 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 partners have carefully analysed the different markets and have determined that the most strategic initial application is 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 â‚¬ 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 will allow partners to obtain clinical and biocompatibility validation of the implant while setting-up a broader market penetration strategy for next most promising applications.

Work performed

To ensure the most recent requirements will be met, the material composition was optimized at project start and double-sourced at the same time. Its features as half-finished parts were defined in a technical supply specification developed and agreed between DMC and ANTHOGYR.
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. Alternative machining methods were also evaluated that would enable more complex geometries and lower production costs. Design improvements were made to propose the most competitive solutions at market launch and prepare the future generations of dental implants. This implied to re-challenge the production mode to increase design flexibility and maintain reasonable production cost at the same time. Prototypes were tested and presented in front of clinicians who confirmed its overall relevance and proposed improvements.

The desired surface morphology developed previously has been reproduced on ceramic implants made of the new SISCERA composite material. The equipment developed for the surface modification was designed to use a robot for all movements in the process. The use of a robot increases the flexibility and allow and modifications to be easily made during the development phase as well as during the future operational use. Blasting in combination with acid etching has also been introduced as an additional process for structuring of the implant surface. Prototype implants intended for a performance implantation study were produced in this equipment which is now ready for transfer to the industrial production site.

The safety and effectiveness assessment of a new dental implant relies mostly on its biological and mechanical performance evaluation, capped by clinical evaluation. In this first project period, 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. These laboratory tests led to the choice of a material characterized by a load to failure of 400N for the dental implant product, which are higher requirements than planned initially. The underlying phenomena are thoroughly investigated and disseminated to the scientific community by the academic team.
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. A specific performance implantation study has been designed and launched to demonstrate the new surface assets, and a patent application is being prepared to protect this result. The preparation of a multicentric randomized controlled clinical trial is ongoing.

Final results

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 provide a cutting edge 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 donâ€™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.