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

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.

Freeze‐Dried Mesenchymal Stem Cells: From Bench to Bedside. Review

“…[ 142 ] The use of autologous freeze‐drying platelet‐rich plasma (FD‐PRP) on bone regeneration in maxillary sinus floor augmentation has been mentioned in a preliminary pilot study. [ 143 ] The authors have noted that the results generated in this study suggest that autologous freeze‐drying platelet‐rich plasma can be used safely for bone engineering in clinical practice. It is also noted that FD‐PRP preserves platelet function, cytokine concentration, and functionality.…”

Socratic Lectures 8

“…The benefits of freeze-dried preparations are besides the prolonged viability of products, the possible storage in the refrigerator or at room temperature in its powder form which is optimal for mixing with other materials, such as the artificial bone. In a study by Koga et al (2021) the researchers evaluated the lyophilized form of PRP stored at -20°C for 4 weeks and discovered that the preparation remained safe to use in bone engineering up to 4 weeks after freeze-dried storage, with no side effects reported. Roffi et al (2014) reported that immediate and 7-day release of growth factors of frozen PRP was lower compared to the fresh preparation, but the cold stored preparation effectively preserved the ability to induce proliferation and extracellular matrix production, as shown in chondrocyte and synoviocyte culture.…”

“…Moreover, Li et al (2017) used 3D-printed biomaterial scaffolds for bone tissue engineering coated with freeze-dried PRP and showed significantly greater osteogenic differentiation induction compared to traditionally prepared PRP. Koga et al (2021) conducted a study with freeze-dried PRP stored at -20°C for 1 month, which was rehydrated and applied in five patients for sinus surgery mixed with bone grafting materials. The results were assessed 4 weeks after the surgery of maxillary sinus floor augmentation showing that the vertical augmented height was maintained and that the preparation remained safe to use in bone engineering up to 4 weeks after freeze-dried storage, with no side effects reported.…”

Maxillary sinus surgery with autologous or allogenic graft with platelet-rich plasma/fibrin for dental implants: a systematic review

“…The maxillary sinus drains through its ostium into the nasal cavity, which usually takes place in the middle meatus. In around 25% of all maxillary sinuses, there is an accessory bone that is located lower than the main ostium, and all the mucus produced and the particles trapped in this mucus are directed through the ciliary beat to the ostium [3].…”