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 the tooth transplantation (Platelet rich plasma transplantation for the tooth transplantation)
Public Title	Platelet rich plasma transplantation for the tooth transplantation (Platelet rich plasma transplantation for the tooth transplantation)
Manager (representative manager when conducting as a multicenter joint research)	Takahashi Kazuhisa

Completion date	Mar. 14, 2022
Result actual enrolment	0
Baseline Characteristics	N/A
Participant flow	N/A
Adverse events	N/A
Outcome measures	N/A
Brief summary	N/A
Date of posting of results summaries
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/jRCTc030190276

Contact for Scientific Queries	Name	Tobita Morikuni
	Affiliation	Juntendo Hospital, Juntendo university school of medicine
	Address	3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
	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, Bunkyo-ku, Tokyo, Japan
	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	1) Have a tooth which need to extraction of tooth at the upper or lower molar. 2) Have a wisdom tooth which can be extracted normally. 3) Have good systemic condition. 4) Number of platelet is over 1x10E5 /microliter. 5) 20 years and older. 6) Other, the investigator believes makes him/her suitable for participation in this clinical study.
	Exclusion Criteria	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, 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		Dental caries (need to tooth extraction)
Intervention(s) Code
Intervention(s) Keyword
Intervention(s)		administration of cell processing products.
Health Condition(s) Code
Health Condition(s) Keyword
Primary Outcome(s)		Safaty
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 , 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)	UMIN000036236
Issuing Authority	University hospital Medical Information Network (UMIN) Center

History of Changes

List of change history