Multicenter study to evaluate efficacy and safety of FINESIA system in dental implant treatment. - FINESIA Study

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University0 sites40 target enrollmentJanuary 24, 2017

Overview

No summary available.

Registry

who.int

Start Date

January 24, 2017

End Date

March 10, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

•1\) The exclusion criteria for study device. (1\) Patients with hemorrhagic diathesis. (2\) Patients with metabolic or endocrine diseases that may significantly affect postoperative bone formation (severe osteoporosis and others). (3\) Patients taking steroids that may affect the postoperative healing of tissues. (4\) Patients with uncontrolled diabetes. (5\) Patients with strong bruxism or in overloading condition. (6\) Patients known to be allergic to the metal (titanium alloy) used in this product. (7\) Patients with a history of radiotherapy at the site of implantation. (8\) Patients for whom postoperative care cannot be controlled such as the following: \- Patients with dementia or other mental disabilities \- Patients with drug addiction \- Patients with alcoholism (9\) Patients with excessive expectation for implant functions. (10\) Patients with insufficient width and height of bone (bone mass) around the implant (patients who need combination therapy of bone prosthetic materials). (11\) Patients with a history of impaired healing. (12\) Patients with insufficient width of alveolar mucosa around the penetration site of the implant. (13\) Patients with unstable adjacent abutment teeth. (14\) Patients with serious cardiovascular disease such as myocardial infarction. (15\) Pregnant or breast\-feeding patients. (16\) Other patients who are not adequate to participate this study. \*Additionally, the exclusion criteria for clinical study.