Yuelian LIU (Maria) is an associate professor in the section oral implantology (2006 up to May 2021;) and Oral Cell Biology (June 2021-now) at ACTA. She worked in Shanghai, China; Leuven, Belgium; Bern, Switzerland and ACTA, Amsterdam, the Netherlands as a clinician (maxillofacial surgeon) and research scientist internationally. She is a research group leader and a supervisor of PhD students and has received more than ten internationally recognized scientific awards. She has applied five patents in the field of biomaterial and bone regeneration and more than 20 international research grants. She is an honorary professor for several Universities internationally. She lectures widely at national and international conferences.

Her research is focused on bone regeneration and osteointegration.

She developed and patented biomimetic calcium phosphate as a bone substitute has recently completed a proof of principle clinical trial with 40 patients. 3D printing biomaterials for clinical application is the ongoing international collaborative project.

Topic title: The efficacy and safety of BioReBone® as a novel bone substitute using the tooth-extraction-socket-healing model in a clinical trial

Abstract:

Aim

This randomized, controlled, proof-of-concept clinical trial aims to prove that BioReBone® is a safe and effective bone substitute for bone regeneration using the tooth-extraction-socket-healing model.

Material and methods

Forty patients with single extraction sockets were enrolled and randomized to receive BioReBone® (the investigational medical device, 15 patients), β-TCP (15 patients) or no bone grafts (patients) at the extraction socket. The sockets with bone grafts or blood clot were covered by collagen membranes and healed for six weeks. For efficacy analyses, the volume density of the new bone in biopsies, the bone width and height change, and the soft tissue sectional area and width changes at the tooth extraction site 6 weeks after surgery were measured by bone histomorphometry, dual CBCT scan, and dual intraoral scan respectively. For safety analyses, the adverse events, the soft tissue healing score, and the rate of rhBMP-2 positive in serum were measured.

Results

All patients completed the trial with none lost to follow-up or discontinued intervention. The histomorphological results demonstrated that the new bone volume density in the biopsies of BioReBone® group was significantly larger than that of the β-TCP filled sockets. Moreover, the BioReBone® also maintained the alveolar ridge contour in both the vertical height and horizontal width and achieved alveolar ridge preservation effectively. Concerning the safety, no investigational device related unanticipated adverse events and severe adverse events occurred. Moreover, the soft tissue healing score at each follow-up visit made no significant differences among the three groups, and no subject exhibited rhBMP-2 positive in serum after the treatment.

Conclusion

This clinical trial demonstrated that BioReBone® could be preliminarily considered as an osteo-promotive and biocompatible bone substitute. This novel bone substitute has potentials to achieve safe and effective treatment for repairing bone defects.