Unique ID issued by UMIN | UMIN000036237 |
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Receipt number | R000041001 |
Scientific Title | Exploratory clinical study to evaluate the safety of Platelet rich plasma transplantation for the periodontal tissue defects |
Date of disclosure of the study information | 2019/03/17 |
Last modified on | 2019/03/19 09:17:27 |
Exploratory clinical study to evaluate the safety of Platelet rich plasma transplantation for the periodontal tissue defects
Platelet rich plasma transplantation for the periodontal tissue defects
Exploratory clinical study to evaluate the safety of Platelet rich plasma transplantation for the periodontal tissue defects
Platelet rich plasma transplantation for the periodontal tissue defects
Japan |
Chronic Periodontitis
Oral surgery | Dental medicine |
Others
NO
To examine the safety of Platelet rich plasma transplantation for the periodontal tissue defects of moderate periodontitis
Safety
Safety
Scientific validity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
Platelet rich plasma transplantation
20 | years-old | <= |
Not applicable |
Male and Female
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) Persons whose oral hygiene is established Good oral hygiene.
6) 20 years and older.
7) Signed informed consent.
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) Need to undergo the treatment, such as surgical treatment, restorative treatment or root canal treatment, at the experimental tooth within 36 weeks after transplant.
5) Pregnancy, during breastfeeding, or possibility of pregnancy.
6) Persons who suffer from disorders of kidney, liver or blood
7) Have disease of kidney, liver and/or blood.
8) Have active infectious diseases.
9) Alcoholism or Drug dependence.
10) Mental or consciousness disorder.
11) HCV antibody, HBs antigen, ATLA virus antibody or HIV antibody positive person.
12) Smoke more than 10 pieces per day.
13) Have anti-coagulant or anti-platelet medications, or have a bleeding disorders.
14) Other,the investigator believes makes him/her unsuitable for participation in the clinical study.
2
1st name | Morikuni |
Middle name | |
Last name | Tobita |
Juntendo Hospital, Juntendo university school of medicine
Department of Oral and Maxillofacial Surgery
113-8431
3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
03-3813-3111
mtobita@juntendo.ac.jp
1st name | Morikuni |
Middle name | |
Last name | Tobita |
Juntendo Hospital, Juntendo university school of medicine
Department of Oral and Maxillofacial Surgery
113-8431
3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
03-3813-3111
mtobita@juntendo.ac.jp
Juntendo University
None
Self funding
Ethical Review Board of Juntendo University Faculty of Medicine
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
03-3813-3111
rinri@juntendo.ac.jp
NO
順天堂大学附属順天堂医院(東京都)
2019 | Year | 03 | Month | 17 | Day |
Unpublished
Open public recruiting
2019 | Year | 03 | Month | 14 | Day |
2019 | Year | 03 | Month | 18 | Day |
2019 | Year | 03 | Month | 18 | Day |
2021 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 17 | Day |
2019 | Year | 03 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041001
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