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

Completion date	Sept. 24, 2022
Result actual enrolment	2
Baseline Characteristics	Patient diagnosed with a fractured tooth with vertical root fracture and intentional tooth replantation determined to be a treatment option.
Participant flow	No dropout cases occurred from patient screening to the end of observation.
Adverse events	No serious adverse events or diseases related to this regenerative medicine were observed during the obsevation period.
Outcome measures	The safety of transplantation of platelet-rich plasma during tooth replantation was confirmed.
Brief summary	The safety of transplantation of platelet-rich plasma at the replantation of teeth with fractured roots 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/jRCTc030190275

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 fracture of dental root. 2) Have a tooth which considered to effective by the tooth replantation. 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 separated dental root and have an abscess at the root apical. 2) Have a history of Complicate malignant tumor. 3) Have an abnormal gingival proliferation or having a history of abnormal gingival proliferation. 4) Suspected of oral malignant tumor or precancerous lesion. 5) Under 20 years of old. 6) Have anti-coagulant or anti-platelet medications, or have a bleeding disorders. 7) Pregnancy, breastfeeding, or possibility of pregnancy 8) 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		Fracture of dental root
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 , 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)	UMIN000036235
Issuing Authority	University hospital Medical Information Network (UMIN) Center

History of Changes

List of change history