Smart multifunctional biomaterials for regenerating the alveolar ridge REGAL

The main objective of the REGAL consortium is to develop a suite of smart multifunctional biomaterial systems (-Frame, -Hydrogel, -Membrane) that will be combined to form the REGAL Device, an advanced patient specific single-stage surgical intervention for successful VRA of ~8mm bone height, decreased complications due to a significantly reduced treatment time of 12 months and reduced DALY by 500,000 in 10 years after project completion. The individual biomaterials and combined Device will be at TRL5, ready for clinical trials at the conclusion of this project. The following specific sub-objectives are expected to be achieved in a large animal (goat) model: 1. Prevent microbial infection at the implant site with absence of infection in at least 80% of the tested devices 2. Regenerate bone with at least 85% of initial thickness (mature bone) after 6 months. 3. Regenerated bone can withstand insertion of endosseous implant while maintaining structural integrity 4. Resorption of at least 50% of the frame in compatibility with objective c) in 6 months. 5. Obtain a bioactive nano-fibrous film enabling gas exchange (porosity >40%), limiting bacterial infiltration (pore size diameter <1000nm), and sustaining soft tissue migration on the upper surface (3 weeks) while preventing soft tissue infiltration across the barrier membrane into the bone tissue 6. Complete wound closure in at least 90% of the animals 7. Establish a standard manufacturing process amenable to industrial scale-up File at least four patents to protect the core technology and initiate licensing negotiation with the realities involved in the project follow-up.