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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name