Single tooth gaps in premolar region, first molar and second molar.
Conditions
Interventions
None listed
Sponsors
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects with an indication for dental implant treatment in a single tooth gaps in premolar region, first molar and second molar including last molar, who consent to the operation (both maxilla and mandible can be included). 2) Subjects with a first-person voluntary consent to participate in this clinical study, which can be obtained in writing (inpatients, outpatients, or both gender can be included). 3) Subjects aged from 20 to 70 years, at the time of a written consent.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Marginal bone loss | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival rate Success rate Bone fixation(Implant stability quotient) Inflammation of the gums Plaque Radiographic assessment Adverse events and device deficiencies | — |
Countries
Japan
Contacts
Public ContactEriko Marukawa
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University Department of Regenerative and Reconstructive Dental Medicine
Outcome results
None listed