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

Takamitsu Koga,Kazuhiro Nagai,Masahito Hara,Yoshinori Sumita,Yuya Nakatani,Seigo Ohba,Izumi Asahina

doi:10.3390/jcm10081678

Takamitsu Koga, Kazuhiro Nagai + Show 5 more

Open Access

https://doi.org/10.3390/jcm10081678

Copy DOI

Abstract

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.

Highlights

(4- to 9-fold) in a small plasma volume [1] obtained from autologous peripheral blood (PB)
We focused on the technique of freeze-drying Platelet-rich plasma (PRP) (FD-PRP), which was first reported by Pietramaggiori et al [5] to overcome this problem
The number of white blood cells (WBC) and platelets in PRP were of the PB vertical by a statistically significant

Summary

Introduction

Platelet-rich plasma (PRP) is defined as platelets concentrated over the basal number (4- to 9-fold) in a small plasma volume [1] obtained from autologous peripheral blood (PB). PRP includes various growth factors, such as platelet-derived growth factor (PDGF), transforming growth factor (TGF-β), vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), epithelial growth factor (EGF), and adhesion molecules (i.e., fibrin, fibronectin, and vitronectin). Such growth factors and molecules have been shown to promote cell recruitment, proliferation, and angiogenesis which may be implicated in tissue regeneration and healing [1,2]. It has been used for anagenesis treatment in the multi-field. Many clinical studies have shown that PRP is effective in alveolar bone regeneration [3,4]

Methods

Results

Conclusion