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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)

Platelet rich plasma transplantation for the periodontal tissue defects (Platelet rich plasma transplantation for the periodontal tissue defects)

Kuwatsuru Ryohei

Oct. 21, 2023

2

Patients with more than moderate chronic periodontitis with vertical bone defect (68-year-old man and 66-year-old woman)

Transplantation of PRP into periodontal tissue defects caused by moderate or severe periodontitis. Transplantation was completed to a target number of 2 patients.

No serious adverse events or diseases related to this regenerative medicine were observed during the observation period.

Primary endpoint: no serious adverse events were observed during the observation period. Secondary endpoint: postoperative radiographic evaluation showed accelerated alveolar bone regeneration at the transplanted site.

The safety of transplanting PRP into vertical bone defects caused by chronic periodontitis of moderate or higher severity was assessed and confirmed with a certain degree of validity.

Mar. 31, 2025

https://jrct.mhlw.go.jp/latest-detail/jRCTc030190277

Tobita Morikuni

Juntendo Hospital, Juntendo university school of medicine

3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan

mtobita@juntendo.ac.jp

Masubuchi Yosuke

Juntendo university

2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan

+81-3-3813-3111

y-masubuchi@juntendo.ac.jp

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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.

Both

Chronic Periodontitis

administration of cell processing products.

Safety

Efficacy

Complete

+81-3-5803-4162

Mar. 14, 2019