Clinical Safety Assessment of Autologous Freeze-Drying Platelet-Rich Plasma for Bone Regeneration in Maxillary Sinus Floor Augmentation: A Pilot Study

The purpose of this clinical study is to evaluate the safety and preliminary efficacy of autologous freeze-drying platelet-rich plasma (FD-PRP) on bone regeneration in maxillary sinus floor augmentation as a preliminary pilot study. Five patients that required sinus floor augmentation to facilitate the placement of dental implants participated in this clinical study. The PRP was prepared from the autologous peripheral blood and was lyophilized and stored at −20 °C for 4 weeks before surgery. At surgery, triple-concentrated FD-PRP (x3FD-PRP) mixed with synthetic bone grafting materials was rehydrated following the transplantation into the sinus floor. The primary outcome was a safety verification of x3FD-PRP, evaluated in terms of the clinical course and consecutive blood tests. The secondary outcome was clinical efficacy focused on bone regeneration in sinus floor augmentation evaluated by radiographic examination and implant stability. There were no adverse events, such as systemic complications, excessive inflammatory reactions, severe infection, or local site healing complications, besides those on the usual course associated with surgery. Vertical augmented height was maintained, and the initial stability of implants was achieved post-operatively in 6 months. The results obtained in this study suggest that x3FD-PRP can be used safely for bone engineering in clinical practice. Further studies are required to draw a conclusion concerning the efficacy of x3FD-PRP since this was a pilot study with a single arm and a small sample size.

[1]  N. Maffulli,et al.  Freeze-Drying of Platelet-Rich Plasma: The Quest for Standardization , 2020, International journal of molecular sciences.

[2]  S. Ohtori,et al.  Freeze-Dried Platelet-Rich Plasma Induces Osteoblast Proliferation via Platelet-Derived Growth Factor Receptor-Mediated Signal Transduction , 2019, Asian spine journal.

[3]  Jiang Chen,et al.  Effectiveness of Platelet-Rich Fibrin as an Adjunctive Material to Bone Graft in Maxillary Sinus Augmentation: A Meta-Analysis of Randomized Controlled Trails , 2019, BioMed research international.

[4]  M. Güngörmüş,et al.  Histologic and histomorphometric assessment of sinus‐floor augmentation with beta‐tricalcium phosphate alone or in combination with pure‐platelet‐rich plasma or platelet‐rich fibrin: A randomized clinical trial , 2017, Clinical implant dentistry and related research.

[5]  Jinming Wang,et al.  Evaluation of 3D-Printed Polycaprolactone Scaffolds Coated with Freeze-Dried Platelet-Rich Plasma for Bone Regeneration , 2017, Materials.

[6]  Ting Li,et al.  Clinical and immunohistochemical performance of lyophilized platelet‐rich fibrin (Ly‐PRF) on tissue regeneration , 2017, Clinical implant dentistry and related research.

[7]  S. Ohtori,et al.  Freeze-Dried Human Platelet-Rich Plasma Retains Activation and Growth Factor Expression after an Eight-Week Preservation Period , 2017, Asian spine journal.

[8]  T. Koga,et al.  Efficacy of freeze-dried platelet-rich plasma in bone engineering. , 2017, Archives of oral biology.

[9]  S. Ohtori,et al.  Freeze-Dried Platelet-Rich Plasma Accelerates Bone Union with Adequate Rigidity in Posterolateral Lumbar Fusion Surgery Model in Rats , 2016, Scientific Reports.

[10]  Y. Tabata,et al.  Easy-to-Use Preservation and Application of Platelet-Rich Plasma in Combination Wound Therapy With a Gelatin Sheet and Freeze-Dried Platelet-Rich Plasma: A Case Report , 2016, Eplasty.

[11]  C. Martínez,et al.  The influence of platelet-derived products on angiogenesis and tissue repair: a concise update , 2015, Front. Physiol..

[12]  M. Nagata,et al.  An improved freeze-dried PRP-coated biodegradable material suitable for connective tissue regenerative therapy. , 2013, Cryobiology.

[13]  T. Kawase,et al.  Bioactivity of freeze-dried platelet-rich plasma in an adsorbed form on a biodegradable polymer material , 2012, Platelets.

[14]  P. Coulthard,et al.  Effectiveness of sinus lift procedures for dental implant rehabilitation: a Cochrane systematic review. , 2010, European journal of oral implantology.

[15]  C. T. Wagner,et al.  Freeze‐dried platelet‐rich plasma shows beneficial healing properties in chronic wounds , 2006, Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society.

[16]  F. Graziani,et al.  In vitro effects of different concentration of PRP on primary bone and gingival cell lines. Preliminary results. , 2005, Minerva stomatologica.

[17]  R. Marx Platelet-rich plasma: evidence to support its use. , 2004, Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons.

[18]  D. Buchbinder,et al.  Maxillary sinus augmentation with deproteinated bovine bone and platelet rich plasma with simultaneous insertion of endosseous implants. , 2003, Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons.

[19]  R. Shanaman,et al.  Localized ridge augmentation using GBR and platelet-rich plasma: case reports. , 2001, The International journal of periodontics & restorative dentistry.