A clinical long-term study conducted for the first time has examined patient-specific implants made from bioceramic material over a five-year period. The implants are composed of tricalcium phosphate (TCP), specifically the LithaBone TCP 300 type, processed using a Lithoz CeraFab system based on Lithography-based Ceramic Manufacturing (LCM) technology. The results show a success rate of over 92 percent in applications involving the human jaw.
The study included 14 patients between the ages of 17 and 57 who were affected by dysgnathia. The goal was to prevent the development of antegonial notching following bilateral sagittal split osteotomy (BSSO) using additively manufactured, patient-specific implants. These implants were precisely placed into the bone gaps created during surgery.
A key feature of the beta-TCP material used is its high porosity with interconnected channels, offering both osteoconductive and osteoinductive properties. This structure supports the ingrowth of new bone tissue and enhances post-operative healing. The study confirms that these implants not only perform well in the short term but also deliver stable results over an extended period.
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.”
Given that Lithoz’s production processes are ISO 13485 certified, their technology may play an increasingly important role in surgical applications—especially in complex reconstructions where traditional implants reach their limitations.
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