3D Printed Beta-TCP Ceramic Bone Replacement Manufactured by Lithography-Based Ceramic Manufacturing: A Short-Term Pilot Study.

Clinical application of beta-tricalcium phosphate (β-TCP) has been limited by a lack of bone infiltration within its bulk form. Lithography-based ceramic manufacturing (LCM), a novel additive manufacturing (AM) technique, leverages photopolymerization to create β-TCP structures with higher feature resolution and surface quality than traditional techniques. This modality allows for a more efficient and precise means to control implant microarchitecture and macroarchitecture, enabling the production of novel implant configurations. This pilot study explores the bone regenerative capacity of lithography-based ceramic-manufactured 100% β-TCP scaffolds for the repair of critically sized mandibular defects in a skeletally mature rabbit model. Quantitative and qualitative analyses of regenerated bone were performed using micro-computer tomography (micro-CT) and two-dimensional histologic analysis, respectively. Three-dimensional volumetric reconstruction revealed bridging bone in sites treated with β-TCP implants, yielding ~8.6±3.5% of regenerated bone within the construct and ~33±3.2% remaining scaffold volume. Bone regeneration and remaining scaffold quantification were corroborated using traditional two-dimensional histologic micrographs and three-dimensional volumetric analysis (P<0.05). Qualitative histologic analysis revealed vascularized woven and lamellar bone, with no evidence of ectopic bone, excess inflammation, or fracture. Bone regeneration in this short-term rabbit model following a critical-sized mandibular defect repaired with LCM β-TCP scaffolds demonstrated analogous radiographic and histologic properties to native bone.