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Freeze-deried (FD) PRP for bone engineering

Phase 1
Conditions
alveolar bone atrophy
-
Registration Number
JPRN-jRCTs072180076
Lead Sponsor
Asahina Izumi
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
5
Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Safety (including the adverse events)
Secondary Outcome Measures
NameTimeMethod
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