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Efficacy of freeze-dried platelet-rich plasma (FD-PRP) in bone engineering: Pilot study (Efficacy of freeze-dried platelet-rich plasma (FD-PRP) in bone engineering)

Freeze-deried (FD) PRP for bone engineering (FD-PRP for bone engineering)

5

Patients who are partially or fully edentulous, and were required to treat by dental implants for prosthetic rehabilitation. Furthermore, patients who were being treated at the Nagasaki University Hospital and had insufficient bone height and/or width to place the dental implant. A total of five patients, including 1 man and 4 females (age range, 39 to 64 years; mean age, 52 years) were enrolled in this study.

A maximum of 90 mL of autologous peripheral blood was collected for preparing the FD-PRP. FD-PRP was stored at minus twenty degrees centigrade for 1 month in order to prevent contamination and transformation. Then, x3 FD-PRP was mixed with artificial bone substitute and rehydrated with sterile purified water. The complex of x3 FD-PRP and the artificial bone substitute was transplanted to the maxillary sinus floor for bone augmentation (Left sinus: 3 patients, Right sinus: 2 patients).

The following findings were obtained by the clinical evaluations: 1) there were no local-site infections with drainage; 2) there were no severe pains that could not be controlled using an anti-inflammatory analgesic in more than a day; 3) there were no local site bleeds that required hemostasis treatment; 4) there was no severe swelling with dysfunction; 5) there were no fevers over 38 degrees centigrade after more than a day; 6) there were no wound -healing complications; 7) there were no sensory disturbances; 8) there were no adverse reactions associated with the treatment. In the blood tests, no serious liver dysfunction, renal dysfunction, or electrolyte imbalances were recognized without transient, slight deviations, from the normal range at 4 weeks post-operatively.

Primary endpoint (Safety including adverse events): The following findings were obtained by the clinical evaluations: (1) there were no local-site infections with drainage; (2) there were no severe pains that could not be controlled using an anti-inflammatory analgesic in more than a day; (3) there were no local site bleeds that required hemostasis treatment; (4) there was no severe swelling with dysfunction; (5) there were no fevers over 38 degrees centigrade after more than a day; (6) there were no wound -healing complications; (7) there were no sensory disturbances; (8) there were no adverse reactions associated with the treatment. In the blood tests, no serious liver dysfunction, renal dysfunction, or electrolyte imbalances were recognized without transient, slight deviations, from the normal range at 4 weeks post-operatively. Secondary endpoint: none

The purpose of this study is to evaluate the safety and preliminary efficacy of autologous freeze-drying platelet-rich plasma (FD-PRP) on maxillary sinus floor bone augmentation as a preliminary pilot study. 5 patients that required sinus floor augmentation to facilitate the placement of dental implants participated in this study. The primary outcome was a safety verification of triple-concentrated FD-PRP (x3 FD-PRP) and there were no adverse events related to the transplantation of FD-PRP.

June. 30, 2022

April. 14, 2021

https://www.mdpi.com/2077-0383/10/8/1678

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs072180076

Asahina Izumi

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasaki

asahina@nagasaki-u.ac.jp

Sumita Yoshinori

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasaki

+81-95-819-7706

y-sumita@nagasaki-u.ac.jp

Complete

May. 08, 2017

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

supportive care

1. Patients who are partially or fully edentulous, and are required to treat by dental implants for prosthetic rehabilitation.
2. Patients who have insufficient bone height and/or width to place the dental implant
3. Patients who received the oral health care and maintain the good condition of Plaque Control.
4. The age of the patients: 20- to 75-years old

1. All patients are required to be nonsmokers.
2. Patients who have systemic disease, malignances, chronic infections, immune system abnormalities, septicemia, syphilis, HBV, HCV, HTLV-1, HIV, pregnancy, dementia.
3. Patients who have disorder of blood coagulation.
4. Patients who have hepatitis function disorders, metabolic bone disease or skeletal dysplasia.
5. Patients who needs the legal representative.

Both

alveolar bone atrophy

Intervention period: 4weeks
Intervention volume: maximum 90ml of peripheral blood for providing FD-PRP
Number of times of Intervention: 1 time

-

-

-

-

Safety (including the adverse events)

None

+81-95-819-7229

Mar. 14, 2019

none