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

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.