Universal Hydrogel Carrier Enhances Bone Graft Success: Preclinical and Clinical Evaluation

TX hydrogel improves the delivery of different types of particulate bone grafts, maintaining them at the implantation sites, and resulting in favorable bone regenerative outcomes.

Abstract

Orthopedic, maxillofacial, and complex dentoalveolar bone grafting procedures that require donor-site bone harvesting can be associated with post-surgical complications. There has been widespread adoption of exogenously sourced particulate bone graft materials (BGM) for bone regenerative procedures; however, the particulate nature of these materials may lead to compromised healing outcomes, mainly attributed to structural collapse of the BGM, prolonged tissue healing. In this study, a fully synthetic thermoresponsive hydrogel-based universal carrier matrix (TX) that forms flowable and shapable putties with different BGMs while spatially preserving the particles in a 3D scaffold at the implantation site is introduced. The potential synergistic effect of the carrier is investigated in combination with particulate demineralized bone matrix (DBM) in a standard muscle pouch nude mice model (n = 24) as well as in a rabbit femoral critical-sized cortico-cancellous bone defect model (n = 9). Finally, the clinical usability, safety, and efficacy of the carrier for the delivery of deproteinized bovine bone mineral (DBBM) are evaluated in a controlled clinical trial for extraction socket alveolar ridge preservation (ARP) (n = 11 participants). Overall, the TX carrier improved the delivery of different types of BGMs, maintaining these spatially at the implantation site with minimal inflammatory responses, resulting in favorable bone regenerative outcomes.