Comparison of off-the-shelf β-tricalcium phosphate implants with novel resorbable 3D printed implants in mandible ramus of pigs.

Facial reconstructive surgery has already implemented the use of 3D printed Patient Specific Implants derived from CAD/CAM-based technologies as an alternative to preformed bone graft substitutes. 3D-printed patient-specific implants derived from CAD/CAM-based technologies are used in facial reconstructive surgery as an alternative to preformed bone graft substitutes. However, to minimize the invasiveness and long-term adverse effects of surgical interventions, the implant needs to exhibit exact fitting, porosity, density, and volume and be made from resorbable materials that allow ingrowth and formation of new bone tissue. Therefore, we present this pilot study using 3D-printed implants consisting of pure β-TCP, produced using a novel technique that assures these properties. Eight pigs received 3D-printed truncated porous cone bone implants paired with either an off-the-shelve a chronOS (DePuy Synthes chronOS Vivify Preforms) preformed block (n = 4) or a no-implant void (n = 4) in a surgically created defect on each side of the angle of the mandible. After 6 months, CT data showed that all 3D-printed implants performed as well as did the off-the-shelve implants, with predicted osteointegration medially and laterally and with minimal gapping between the implants and native bone. The CT findings were confirmed by histological analysis that revealed that the 3D-printed implants together with the off-the-shelve implants were almost complete resorbed. Much of the resorbed volume had been replaced by vascularized compact bone, and fusion between newly formed bone and native bone was observed in all implants, further indicating that the 3D-printed implants and off-the-shelve implants performed equally well. Only soft tissue developed in the void control sites. Further studies are needed to confirm these initial findings.