The first ever scientific long-term study on 3D-printed bioceramic patient specific implants (PSI) shows impressive results of over 92% total success rate achieved with Lithoz's LithaBone TCP 300 tricalcium phosphate material.
Processed on a Lithoz CeraFab printer, these implants display the high medical standards of Lithoz technology which since recently is produced under an ISO 13485 certified quality management system. This pioneering study, that evaluates the healing success of LCM-manufactured ceramic implants in human bodies over a follow-up period of 5 years, will significantly support the distribution of ceramic 3D printing in surgery.
In a minimally invasive approach, 14 patients between 17 and 57 years of age suffering from dysgnathia were treated with patient specific implants (PSI) produced on a Lithoz CeraFab printer to prevent antegonial notching.
Delivering ideal osteoconductivity and osteoinductivity, the study clearly confirmed the implants' potential to reconstruct and bridge healing gaps occurring after surgical bone cutting intervention ("osteotomy gap") due to its interconnected pores.
The study also found that the rapid growth of new bone tissue in the beta-TCP implant is promoted. Prior to this study, surgeons had yet to find an ideal solution to the postoperative development of mandibular lower border defects and irregularities following bilateral sagittal split osteotomy (BSSO).
Dr. Johannes Homa, Lithoz CEO, emphasized the study's pioneering character and fundamental importance for the entire 3D printing industry: "This first ever long-term clinical follow-up study marks an historic moment for the entire additive manufacturing industry! These results are not only about celebrating a great achievement for our Lithoz LCM technology. By clinically proving a success rate of over 92%, we've set a game-changing milestone in the history of surgery to establish the 3D printing of patient-specific bioceramic implants as a fully-fledged alternative alongside traditional surgical interventions."
The clinical paper's conclusion shows "the feasibility and potential of the β-TCP gap PSI concept as an innovative and promising approach to prevent antegonial notching after BSSO at primary surgery and in the long term."