UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027144 |
|---|---|
| Receipt number | R000031099 |
| Scientific Title | Efficacy of freeze-dried platelet-rich plasma (FD-PRP) in bone engineering: Pilot study |
| Date of disclosure of the study information | 2017/04/26 |
| Last modified on | 2023/05/01 09:36:42 |
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Basic information
Public title
Efficacy of freeze-dried platelet-rich plasma (FD-PRP) in bone engineering: Pilot study
Acronym
FD-PRP for bone engineering
Scientific Title
Efficacy of freeze-dried platelet-rich plasma (FD-PRP) in bone engineering: Pilot study
Scientific Title:Acronym
FD-PRP for bone engineering
Region
| Japan |
Condition
Condition
alveolar bone atrophy
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Platelet-rich plasma (PRP) is typically isolated and applied immediately after preparation, making it both a time- and labor-intnesive addition to the operative procedure. Thus, it would be convenient if PRP could be preserved. We evaluate the safety and efficacy of freeze-deried PRP (FD-PRP) for bone engineering. The safety, including adverse event, is assessed after FD-PRP transplantation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety (including the adverse events)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention period: 4weeks
Intervention volume: maximum 90ml of peripheral blood for providing FD-PRP
Number of times of Intervention: 1 time
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key 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
Key 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.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Asahina |
Organization
Nagasaki University Graduate School of Biomediacal Sciences
Division name
Department of Regenerative Oral Surgely
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, 852-8588, Japan
TEL
095-819-7704
asahina@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Sumita |
Organization
Faculty of Dentistry, Nagasaki University
Division name
Basic and Translational Research Center for Hard Tissue Disease
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki, 852-8588, Japan
TEL
095-819-7706
Homepage URL
y-sumita@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Regenerative Oral Surgely, Nagasaki University Graduate School of Biomediacal Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Regenerative Oral Surgely, Nagasaki University Graduate School of Biomediacal Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Clinical Research Review Board in Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-Ken
Tel
095-819-7905
gaibushikin@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
長崎大学病院（長崎市）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/re/reports/detail/22773
Publication of results
Published
Result
URL related to results and publications
https://jrct.niph.go.jp/re/reports/detail/22773
Number of participants that the trial has enrolled
5
Results
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.
Results date posted
| 2023 | Year | 05 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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.
Participant flow
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).
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.
Outcome measures
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
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 26 | Day |
Last modified on
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031099
