UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005027 |
|---|---|
| Receipt number | R000005979 |
| Scientific Title | Periodontal regeneration with autologous periodontal ligament cell sheets. |
| Date of disclosure of the study information | 2011/02/04 |
| Last modified on | 2018/09/26 16:52:01 |
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Basic information
Public title
Periodontal regeneration with autologous periodontal ligament cell sheets.
Acronym
Periodontal regeneration with autologous periodontal ligament cell sheets.
Scientific Title
Periodontal regeneration with autologous periodontal ligament cell sheets.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tomohiro Ando |
Organization
Tokyo Women's Medical University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
tando@oms.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanori Iwata |
Organization
Tokyo Women's Medical University
Division name
Department of Oral and Maxillofacial Surgery
Zip code
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
iwata@abms.twmu.ac.jp
Sponsor or person
Institute
Institute of Advanced Biomedical Engineering and Science, Tokyo Women's Medical University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
http://www.twmu.ac.jp/ABMES/ja/shikonmaku_boshu
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2352320418300282
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 13 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005979
