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Exploratory clinical study to evaluate the safety of Platelet rich plasma transplantation with artificial bone graft material for sinus floor augmentation (Platelet rich plasma transplantation with artificial bone graft material for sinus floor augmentation)

Platelet rich plasma transplantation with artificial bone graft material for sinus floor augmentation (Platelet rich plasma transplantation with artificial bone graft material for sinus floor augmentation)

Takahashi Kazuhisa

Oct. 20, 2021

2

Patients with missing teeth in the maxillary molars for whom dental implants are considered appropriate treatment and who require elevation of the maxillary sinus floor.

No dropout cases occurred from patient screening to the end of observation.

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

The safety of transplantation of platelet-rich plasma during maxillary sinus floor elevation was confirmed.

The safety of transplantation of a mixture of platelet-rich plasma and artifical bone replacement material during maxillary sinus floor elevation was evaluated,and a certain validity was confirmed.

Dec. 01, 2022

https://jrct.mhlw.go.jp/latest-detail/jRCTc030190274

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 missing tooth in the maxillary posterior region.
2) Require dental implant treatment at missing tooth site.
3) Require sinus floor augmentation (socket lift) at the dental implant placement.
4) Have good systemic condition.
5) Number of platelet is over 1x10E5 /microliter.
6) 20 years and older.
7) Other,the investigator believes makes him/her suitable for participation in this clinical study.

1) Have a history of Complicate malignant tumor.
2) Have an abnormal gingival proliferation or having a history of abnormal gingival proliferation.
3) Suspected of oral malignant tumor or precancerous lesion.
4) Under 20 years of old.
5) Have anti-coagulant or anti-platelet medications, or have a bleeding disorders.
6) Pregnancy, breastfeeding, or possibility of pregnancy.
7) Other,the investigator believes makes him/her unsuitable for participation in the clinical study.

Both

Atrophic maxillary alveolar bone

administration of cell processing products.

Safety

Efficacy

Complete

+81-3-5803-4162

Mar. 14, 2019