UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036232 |
|---|---|
| Receipt number | R000040615 |
| Scientific Title | A clinical study for validity and provision method of periodontal tissue regeneration with autologous adipose derived stem cells and platelet rich plasma |
| Date of disclosure of the study information | 2019/03/17 |
| Last modified on | 2019/03/19 09:15:53 |
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Basic information
Public title
A clinical study for validity and provision method of periodontal tissue regeneration with autologous adipose
derived stem cells and platelet rich plasma
Acronym
Periodontal tissue regeneration using adipose derived stem cells and platelet rich plasma
Scientific Title
A clinical study for validity and provision method of periodontal tissue regeneration with autologous adipose
derived stem cells and platelet rich plasma
Scientific Title:Acronym
Periodontal tissue regeneration using adipose derived stem cells and platelet rich plasma
Region
| Japan |
Condition
Condition
periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and efficacy of transplantation of the mixture of autologous adipose-derived stem cells and platelet-rich plasma for periodontal tissue regeneration
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validity and efficacy
Key secondary outcomes
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Transplantation of the processed cells
Interventions/Control_2
Administration of Enamel matrix derivative
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
A patient MUST:
1)Have a Periodontal pocket more than 5 mm at baseline examination.
2) Intrabony defect is 5 mm and more depth, and 2 mm and more width at interproximal site of the experimental tooth by X-ray examination.
3)Already have received initial preparation at the screening.
4)Mobility of experimental tooth is 0, 1, or 2, and exist keratinized gingiva.
5)Good oral health.
6)Subcutaneous fat tissue can be harvest normally and safely
7)20 years and older.
8)Signed informed consent.
Key exclusion criteria
Patient MUST NOT:
1)Can not be measured clinical attachment level of experimental tooth.
2)Have a history of Complicate malignant tumor.
3)Suspected of oral malignant tumor or precancerous lesion.
4)Have a history of usage bisphosphonate, or necessary.
5)Need to undergo the treatment, such as surgical treatment, restorative treatment or root canal treatment, at the experimental tooth within 36 weeks after transplant.
6)Pregnancy, during breastfeeding, or possibility of pregnancy.
7)Have disease of kidney, liver and/or blood.
8)Hemoglobin A1c is more than 6.8% at the screening.
9)Have active infectious diseases.
10)Alcoholism or Drug dependence.
11)Mental or consciousness disorder.
12)HCV antibody, HBs antigen, ATLA virus antibody or HIV antibody positive person.
13)Smoke more than 10 pieces per day.
14)Other,the investigator believes makes him/her unsuitable for participation in the clinical study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Morikuni |
| Middle name | |
| Last name | Tobita |
Organization
Juntendo University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL
03-3813-3111
mtobita@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Morikuni |
| Middle name | |
| Last name | Tobita |
Organization
Juntendo University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL
03-3813-3111
Homepage URL
mtobita@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japan agency of medical research and development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo clinical research and trial ceter, Juntendo hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Juntendo University Faculty of Medicine
Address
2-1-1,Hongo,Bunkyo-ku,Tokyo
Tel
03-3813-3111
rinri@juntendo.ac.jp
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
順天堂大学医学部附属順天堂医院、日本大学松戸歯学部付属病院、愛知学院大学歯学部附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040615
