UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Periodontal regeneration with autologous periodontal ligament cell sheets.
Title of the study (Brief title)	Periodontal regeneration with autologous periodontal ligament cell sheets.
Region	Japan

Condition
Condition	Periodontitis (intrabony defect with probing depths more than 4 mm)
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to confirm the safety and efficacy of autologous transplantation of periodontal ligament cell sheets for the treatment of periodontitis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcome of this study is to evaluate the safety of autologous transplantation of periodontal ligament cell sheets.
Key secondary outcomes	We also evaluate the clinical efficacy of autologous transplantation of periodontal ligament cell sheets.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Autologous periodontal ligament cell sheets is transplanted to the denuded root surface during the modified Widman flap procedure.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Patients having intrabony defects with probing depths more than 4 mm after initial therapy. Radiographic evidence of intrabony defects had to exist. (2)All patients gave written informed consent. (3)Patients having a redundant tooth which contains healthy periodontal tissues.
Key exclusion criteria	1) relevant medical conditions contraindicating surgical interventions (e.g., diabetes mellitus, cardiovascular, kidney, liver, or lung disease, or compromised immune system. 2) pregnancy or lactation. 3) tobacco smoking (more than 11 cigarettes a day)
Target sample size	10

Research contact person
Name of lead principal investigator	Tomohiro Ando
Organization	Tokyo Women's Medical University
Division name	Department of Oral and Maxillofacial Surgery
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL	03-3353-8111
Email	tando@oms.twmu.ac.jp

Public contact
Name of contact person	Takanori Iwata
Organization	Tokyo Women's Medical University
Division name	Department of Oral and Maxillofacial Surgery
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL	03-5367-9945-6225
Homepage URL	http://www.twmu.ac.jp/ABMES/ja/shikonmaku_boshu
Email	iwata@abms.twmu.ac.jp

Sponsor
Institute	Institute of Advanced Biomedical Engineering and Science, Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	The Ministry of Education, Culture, Sports, Science and Technology (MEXT) of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東京女子医科大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2011 Year 02 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 13 Day
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date	2014 Year 11 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://www.twmu.ac.jp/ABMES/ja/shikonmaku_boshu
Publication of results	Published
URL releasing results	https://www.sciencedirect.com/science/article/pii/S2352320418300282
Results
Other related information

Management information
Registered date	2011 Year 02 Month 04 Day
Last modified on	2018 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005979