Smart, Multifunctional Dental Implants: A Solution for Peri-Implantitis and Bone Loss

Project Information

I-SMarD

Grant agreement ID: 953128

DOI

10.3030/953128

Project closed

EC signature date 16 December 2020

Start date 1 April 2021

End date 30 September 2025

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies

Total cost

€ 5 099 851,25

EU contribution

€ 5 099 851,25

Coordinated by

UNIVERSITY OF LEEDS
United Kingdom

Periodic Reporting for period 2 - I-SMarD (Smart, Multifunctional Dental Implants: A Solution for Peri-Implantitis and Bone Loss)

Reporting period: 2022-10-01 to 2024-03-31

Summary of the context and overall objectives of the project

I-SMarD adopts a holistic approach for the development and delivery of a multifunctional dental implant that will provide a solution for a significant clinical condition in dentistry i.e. peri-implantitis.
Obj1: To deliver “smart” multifunctional titanium implants.
Obj2: To implement and establish 3D printing techniques (e.g. Selective Laser Sintering) for the manufacturing of functional dental implants.
Obj3: To deliver a promising product with the potential to generate revenue in the long term.
Obj4: To develop and use appropriate tools that will improve and simplify the optimisation and evaluation of our medical devices.
Research challenges (secondary objectives):
C1) Design and fabricate porous Ti implants with appropriate biomechanical properties.
C2) Development of appropriate pH sensitive polymers for “smart” delivery of antibacterial agents.
C3) Fabrication of photoactive layers for monitoring soft tissue health via blood oximetry and development of a diagnostic tool.
C4) To identify an ideal combination of nanomaterials that can be loaded to our implant to promote i) new bone formation (e.g. calcium phosphates), ii) the attachment of soft tissue to the implant iii) antibacterial potential (Ce oxide NPs).
C5) Design and fabrication of optofluidic based bioreactors in which we can mimic the dynamic microenvironment around the implant
C6) Develop models for the scale up and mass production of our nanomaterials and medical devices.
C7) Demonstrate the efficacy of the developed implants in animal models.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

WP1- Validation of the finite element (FE) simulation has been developed to predict biomechanical properties of dental implant and fatigue life of 3D printed porous titanium samples. With improve design, implants with different pores configurations have been produced to validate of the FE model (this comprises of the printing parameters found to be considered adequate to produce titanium samples with suitable properties for the current application). Final design, fabrication protocol and verification of the mechanical competence has been completed as well.
WP2- The deposition process parameters and the properties of the bioceramic and photoactive coatings on a flat substrate and implants (complex implant shapes) including on equipment optimisation have been determined. Almost the advanced surface characterisation have been completed with the exception of X-ray Photoelectron Spectroscopy (XPS), which is on-going. Photo-active implant and implants for mechanical testing have been provided to ARI for mechanical testing. In vitro experiments has also been conducted as a diagnostic tool in microfluidics. Based on the results obtained from the diagnostic tool, we developed a diagnostic protocol and instrumentation.
WP3-Focused on Polymers for “smart” drug delivery and nanomaterials, which we aim to incorporate during manufacturing of Ti-implants. The preparation of the pH-sensitive materials and the formulation of functional with zwitterionic molecules chitosan have been completed. Further functionalization of the polymers for their pH-responsive behaviour has been achieved. We completed the synthesis and characterization of Cerium oxide and mesoporous cerium-doped silicate n nanoparticles. The Drug loading and release experiments and pharmacokinetic models have been completed.
WP4-Focused on the experimental and numerical study of the drug release from the polymer taking into account mainly the properties of the material. There is close collaboration with the rest of the partners for the different tasks; a) ATD provides dental implants and samples for testing in bioreactors; b) UNIVLEEDS is conducting spectrometry measurements in wet environment and special bioreactor to host the samples of interest were fabricated; c) ARI provides information regarding the geometrical characteristics of the implant that are critical for the design of the final bioreactor.
WP5-Focussed on the biological evaluation and animal trials. Evaluated all the synthesized materials for their biological properties. Evaluated and proved to be biocompatible with human periodontal ligament cells. Antibacterial properties evaluation properties of synthesized NPs and polymeric materials have been completed. Osteogenic differentiation evaluation in vitro has been achieved. In vivo experiments in beagle dogs is still in progress.
WP6-A detailed cost analysis has been achieved for design and fabrication processes of the implant and nanomaterials. A detailed techno-economic analysis has been done for determination of the economic feasibility of the adopted manufacturing processes.
WP7- Focussed on stakeholder engagement and dissemination.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

This project will deliver a novel implant that will prevent the formation of bacterial biofilm (cause of peri-implantitis) and will have increased regenerative potential for the healing of the surrounding dental tissues.
3D printing techniques (i.e. selective laser sintering) will be used for the manufacturing of our medical devices. The capability to fabricate complex geometries is critical in order to achieve the increased functionality and personalisation of our dental implants.
Cost optimisation of the 3D printing procedure will also be conducted.
WP7 is dedicated to end users’ engagement. We will have an end user committee (manufacturers, clinicians, patients) who will give valuable input both for the design and manufacturing of our implants but also the overall translation strategy.
Various technologies and tools will be developed in I-SMarD that can benefit the development, design and evaluation of medical devices. The most characteristic examples are a) Finite Element models for biomechanical analysis of the dental implants; b) optofluidic bioreactors that will be an intermediate evaluation step between in vitro testing and animal trials.
The developed concept involves the synergy between manufacturers, clinicians, engineers, biologists and materials scientists. New methodologies for the design, manufacturing and evaluation of dental implants will be adopted.
The success of our concept will eliminate the complications arising from bacterial infections and will reduce the time needed for the healing and regeneration of the surrounding dental tissues. The time and the cost of rehabilitation is expected to be reduced to the benefit of the patients and the national healthcare systems.
WP6 is dedicated to the cost analysis and cost optimisation of the materials and the utilised procedures for the development and fabrication of our implants. At the end of I-SMarD we will have a realistic business plan that will identify the appropriate route for commercialisation.
The implants proposed in I-SMarD is an excellent example how advanced manufacturing technologies and nanomaterials can be combined for the development of a functional medical device. The optimisation of manufacturing techniques like 3D printing and PLD, the development of models for mass production of materials and the delivery of new tools for the design and testing of medical devices will benefit the overall nano- and biotechnology industry in Europe.

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