Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - INPERIO (Non-invasive solution for periodontal and peri-implant diseases)

Teaser

In 2011, NANOKER identified a potential business in developing a solution specifically addressed to patients with periodontal or peri-implant disease. This disease is the most prevalent form of bone pathology in humans, affecting 50% of the entire adult population. It is...

Summary

In 2011, NANOKER identified a potential business in developing a solution specifically addressed to patients with periodontal or peri-implant disease. This disease is the most prevalent form of bone pathology in humans, affecting 50% of the entire adult population.

It is possible to avoid the tremendous effects of periodontitis and peri-implantitis if we prevent the formation of plaque/biofilm. There is a crucial need to supplement conventional invasive mechanical treatment strategies like scaling, root planning and surgery. Different options are being proposed to fight the menace of biofilms. However, all these alternatives have serious drawbacks, mainly antimicrobial resistance (AMR), an increasingly serious threat to global health that requires action across all government sectors and society.

To this end, INPERIO is a revolutionary solution based on patented technology: it combines an advanced bioceramic nanocomposite and an eco-friendly and resistance-free bioglass of outstanding functionality. The bioglass can be sleekly located, as the filler of a polymeric coating, over nanocomposite-based implants, abutments and aesthetic structures and even over natural teeth. This combination of novel and functional biomaterials not only avoids the devastating effects of periodontal and/or peri-implant disease but also accelerates and improves implant primary stability and aesthetics, in cases where natural tooth preservation was not possible, and prevents (or at least restricts) the adhesion of bacteria.

INPERIO is thus very important for society, since it provides a solution demanded by patients: a solution to periodontitis (Pyorrhoea) and peri-implantitis, problems aggravated by the aging population and the burden of antibiotic resistance, and, in doing so, it addresses the EU/global challenge of “health, demographic change and wellbeing”.

INPERIO represents a high-value solution that will greatly improve the quality of life of many people, by reducing disease occurrence and treatment invasiveness.

The project’s main objectives are: a) the successful industrial-scale development of a set of dental prosthetic components made from a coated and highly resistant ceramic nanocomposite; b) performing a clinical validation to obtain the necessary data (reducing bone loss by over 70%, obtaining bone to implant contact values of more than 80% and reaching a close and firm implant to soft tissue attachment without inflammation) to support the potential of INPERIO and help raise awareness among KOL and stakeholders; c) business growth, through two different distribution approaches: an own firm and implant manufacturers with presence in the main markets; and d) the product’s worldwide launch, reaching distribution agreements to put Nanoker at the forefront of the market and industry innovation.

The overall or final aim is to reach commercialisation stage, having demonstrated the capability of the market-ready INPERIO solution to meet and cover the identified business needs, challenges and opportunities.

Work performed

After he completion of the first year of the project Nanoker has up-scaled the manufacturing process in a pilot scale production plant where pre-serial components have been produced for clinical validation. After two months of in vivo preclinical tests, 100% of the implanted systems show perfect viability and osseointegration.

The mechanical tests performed on both monolithic and two-part implant systems have shown impressive results, never seen before for any ceramic implant system in the market. The INPERIO’s 3.3 mm in diameter monotype system shows a higher fatigue limit than the 4.2 mm in diameter monotype sold by the market leader.

The Quality Control of semi-finished products revealed some dimensional aspects that have to be slightly modified. Surface roughness after green machining and sintering showed slightly lower Ra values (1.1 microns) after undergoing the upscaled processes when compared with the 1.5 microns reached in laboratory production conditions. In any case, the high rate (100%) of completely osseointegrated implants after two months of surgery indicates that the surface state achieved after sintering is highly bioactive.

The Ethics Committee has already approved our Clinical Trial, which will start before the end of May 2019. All of the implant systems to be used in the Clinical Trial have been produced following the new upscaled manufacturing process and have undergone a complete quality control process followed by packaging and sterilization.

After the signature of several NDAs with some of the main players in the market, we have initiated several meeting contacts in Spain, France, Sweden, Israel and USA. With some of them, conversations have started towardsthe possible future distribution of our implant system. Other stakeholders have been approached in important key events (IDS) to evaluate the degree of acceptance of this new solution.

As a general result, all workpackages have been developed following the timing proposed, including all the tasks related to general coordination and management.

Final results

At present, the dental market’s state of the art technology does not include an effective solution directed at preventing or solving periodontitis and peri-implantitis. Currently available solutions include a variety of implantable products/components, mainly metal-based, and a range of invasive (painful), repetitive and purely retardant strategies such as scaling, root planning, surgery and aggressive antibiotic treatments that do not solve the problem.

Beyond the State of the Art – INPERIO:
• All-ceramic dental prosthetic set: perfect aesthetics, no ion release, no intolerances/allergies, no complications with diagnostic tools such as MRI.
• Pain-free antimicrobial coating applied to prevent and/or treat periodontal and peri-implant diseases.
• Eco-friendly resistance-free antimicrobial coating.
• Longer lasting material (NK2®): as long as the patient’s life.

INPERIO is expected to become the first non-invasive solution to prevent and treat periodontitis and peri-implantitis. Nanoker’s INPERIO solution is unique and based on patented technology: it combines an advanced bioceramic nanocomposite (NK2®) and a bioglass (G3®) coating of outstanding functionality. The incursion of INPERIO will completely revolutionize dental implantology: the bioceramic nanocomposite provided with optimized surface features accelerates and improves surgical integration, while the eco-friendly antimicrobial bioglass coating prevents (or at least restricts) the adhesion of bacteria.

The use of this revolutionary product at a wide range of disease stages, mouth tissue levels and dental prosthesis parts – including crowns, abutments and/or implants – will change current clinical practice and outcomes for patients suffering from the aforementioned diseases and their associated pain. Undoubtedly, INPERIO’s added value makes it extremely appealing to potential customers.

INPERIO is thus very important for society, since it provides a solution demanded by patients: a solution to periodontitis (Pyorrhoea) and peri-implantitis, problems aggravated by the aging population and the burden of antibiotic resistance. It will greatly improve the quality of life of many people, by reducing disease occurrence and treatment invasiveness.

Website & more info

More info: http://www.inperio.es/.