Selective laser-melted fully biodegradable scaffold composed of poly(D,L-lactide) and b-tricalcium phosphate with potential as a biodegradable implant for complex maxillofacial reconstruction: In vitro and in vivo results Ralf Smeets, 1 * Mike Barbeck, 2 * Henning Hanken, 1 Horst Fischer, 3 Markus Lindner, 3 Max Heiland, 1 Michael W€ oltje, 4 Shahram Ghanaati, 2 * Andreas Kolk 5 * 1 Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany 2 Frankfurt Orofacial Regenerative Medicine (FORM) Lab, Department for Oral, Cranio-Maxillofacial and Facial Plastic Surgery, Medical Center of the Goethe University Frankfurt, Frankfurt, Germany 3 Department of Dental Materials and Biomaterials Research, University Hospital RWTH Aachen, Aachen, Germany 4 Institute of Textile Machinery and High Performance Material Technology, TU Dresden, Dresden, Germany 5 Department of Oral- and Maxillofacial Surgery, Klinikum rechts der Isar der Technischen Universit€ at M€ unchen, 81675, Munich, Germany Received 9 January 2016; accepted 12 February 2016 Published online 00 Month 2016 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/jbm.b.33660 Abstract: Objectives: Scaffolds (SC) composed of poly(D,L-lac- tide) and b-tricalcium phosphate of variable pore structures were manufactured by selective laser melting (SLM), which allowed the production of porous interconnected structures promoting cellular adhesion and vascular proliferation. Bio- compatibility, rate of osseointegration and new bone forma- tion (NB) were analyzed. Material and methods: Powder based on the material composition was selective melted by a laser beam allowing layer-by-layer production. Pore size and biocompatibility were tested with mesenchymal stem cells (rMSC) and Saos 2 cells that were cultivated on SCs showing better proliferation, without toxicity, than controls. SCs with a 600- to 700-mm pore diameter proved ideal for fast and reli- able cellular and vascular supply throughout the intercon- necting pore system. Jaw and calvarial critical-size defects (CSD) with diameters of 5 or 16 mm were drilled in rats and either SLM test SCs (pore diameter 600 mm) or the previously removed autologs bone as controls were (re-) implanted. Results: The SC in vivo led to complete bone ingrowth with minimal inflammatory reaction adjacent to and within the CSD as compared with controls. The SC promoted the differ- entiation of rMSC into osteoblasts, revealing osteoinductive properties. Promising NB ingrowth of the material was also obtained in the animal study. Conclusion: The SC showed complete bony replacement within 30 days in all rats; this ingrowth was significantly superior to that of controls and revealed no signs of significant foreign body reaction. Because of continuous replacement by bone this material composition is ideal for SCs fitting 3D bone defects. V C 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 00B: 000–000, 2016. Key Words: selective laser melting, pore size, bone defects, bone regeneration, scaffold, bioceramic, biopolymer, biodegradable How to cite this article: Smeets R, Barbeck M, Hanken H, Fischer H, Lindner M, Heiland M, W€ oltje M, Ghanaati S, Kolk A. 2016. Selective laser-melted fully biodegradable scaffold composed of poly(D,L-lactide) and b-tricalcium phosphate with potential as a biodegradable implant for complex maxillofacial reconstruction: In vitro and in vivo results. J Biomed Mater Res Part B 2016:00B:000–000. These authors contributed equally to this work. Ethical Approval: All applicable international, national and institutional guidelines for the care and use of animals were followed. The animal experiment was performed in accordance with the local animal research committee, in accordance with German legislative requirements, and were performed at the Institute of Experimental Oncology and Therapy Research, Centre for Preclinical Research at the Technical University of Munich and the Military Medical Academy of Belgrade, Serbia. Authors’ Roles: Study design: RS, HF, and AK. Study conduct: RS, MB, and AK. Data collection: MB, HH, and AK. Data analysis: HH, MB, SG, and AK. Data interpretation: HH, MB, and AK. Drafting manuscript: AK Revising manuscript content: RS, HH, and AK. Approving final version of manuscript: RS, MB, HH, MW, HF, ML, MH, SG, and AK. RS and AK take responsibility for the integrity of the data analysis. Conflict of interest: The authors have no conflicts of interest to report. Correspondence to: A. Kolk, e-mail: andreas.kolk@gmx.de Contract grant sponsor: German Federal Ministry of Education and Research (BMBF); contract grant number: 16IN0443 V C 2016 WILEY PERIODICALS, INC. 1