臨床研究等提出・公開システム

Scientific Title	Exploratory clinical study to evaluate the safety of Platelet rich plasma transplantation for wound healing at the extracted socket. (Platelet rich plasma transplantation for wound healing of the extracted socket)
Public Title	Platelet rich plasma transplantation for wound healing of the extracted socket (Platelet rich plasma transplantation for wound healing of the extracted socket)
Manager (representative manager when conducting as a multicenter joint research)	Takahashi Kazuhisa

Completion date	Aug. 26, 2021
Result actual enrolment	2
Baseline Characteristics	Patient diagnosed with periodontitis of the wisdom tooth and tooth extraction is appropriate.
Participant flow	Two patients underwent PRP treatment and were evaluated for safety.
Adverse events	No serious adverese events or diseases related to regenerative medicine were observed during the observation period.
Outcome measures	The safety of transplantation of platelet-rich plasma into the extraction socket was confirmed.
Brief summary	The safety of transplantation of platelet-rich plasma into the extraction socket after extraction of a wisdom tooth was evaluated,and a certain validity was confirmed.
Date of posting of results summaries	Dec. 01, 2022
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTc030190273

Contact for Scientific Queries	Name	Tobita Morikuni
	Affiliation	Juntendo Hospital, Juntendo university school of medicine
	Address	3-1-3 Hongo Bunkyou-ku Tokyo
	Telephone	+81-3-3813-3111
	E-mail	mtobita@juntendo.ac.jp
Contact for Public Queries	Name	Masubuchi Yosuke
	Affiliation	Juntendo university
	Address	2-1-1, Hongo Bunkyou-ku Tokyo
	Telephone	+81-3-3813-3111
	E-mail	y-masubuchi@juntendo.ac.jp

Target sample size		2
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	A patient MUST: 1) Have wisdom teeth that it is believed appropriate to carry out tooth extraction. 2) Have good systemic condition. 3) Number of platelet is over 1x10E5 /microliter. 4) 20 years and older. 5) Other,the investigator believes makes him/her suitable for participation in this clinical study.
	Exclusion Criteria	Patient MUST NOT 1) Have a history of Complicate malignant tumor. 2) Have an abnormal gingival proliferation or having a history of abnormal gingival proliferation. 3) Suspected of oral malignant tumor or precancerous lesion. 4) Under 20 years of old. 5) Have anti-coagulant or anti-platelet medications, or have a bleeding disorders. 6) Pregnancy, during breastfeeding, or possibility of pregnancy. 7) Other,the investigator believes makes him/her unsuitable for participation in the clinical study.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pericoronitis of wisdom tooth
Intervention(s) Code
Intervention(s) Keyword
Intervention(s)		administration of cell processing products.
Health Condition(s) Code
Health Condition(s) Keyword
Primary Outcome(s)		Safety
Secondary Outcome(s)		Efficacy

Anticipated date of first enrollment	Mar. 15, 2019
Actual date of first enrollment
Recruitment status	Complete

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Tokyo Medical and Dental University Specially Certified Committee for Regenerative Medicine
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
Telephone	+81-3-5803-4162
E-Mail	kenkyo.adm@cmn.tmd.ac.jp
Approval Status	Approval
Date of approval	Mar. 14, 2019

Secondary ID(s)	UMIN000036233
Issuing Authority	University hospital Medical Information Network (UMIN) Center

History of Changes

List of change history