Tooth Loss/Alveolar Bone Loss Alveolar Bone Loss
Conditions
Interventions
Guided bone regeneration
Sponsors
Marukawa Eriko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who need GBR prior to dental implant placement. 2. Patients for whom the clinical research director (registered dentist) determines that simultaneous placement of implants with bone augmentation (simultaneous placement) is difficult. 3. Patients aged 20 years old or more and below 80. 4. Patients who have been fully informed of the study and who have given written consent of their own free will after full understanding of the study.
Exclusion criteria
Exclusion criteria: The following patients are excluded from this study. 1. Patients with severe blood disorder or bone target hormone metabolic disorders. 2. Patients who suspected collagenosis and the abnormalities of calcium metabolism organs such as kidney and gastrointestinal tract 3.Patients under dialysis treatment 4. Patients using steroids 5. Uncontrolled diabetes mellitus patients who have had not adequate glycemic control (HbA1c less than 6.9%). 6. Patients with uncontrollable complications that are restricted from observing the requirements of this clinical research, such as severe disease (infection, immunodeficiency, heart disease, etc) or psychiatric disorder. 7. Patients with or with a history of malignant tumors. 8. Patients receiving treatment with bisphosphonates or bone resorption inhibitors such as denosumab 9. Patient with alcohol/drug addiction. 10. Smokers 11. Patients who are restricted from observing the requirements of clinical research for social or domestic environments. 12. Patients who participated in clinical studies with interventions for other medical devices or drugs within the past 3 months. 13. Patients who fall into any of the following categories : pregnant, possibly pregnant, within 28 days postpartum, or lactating. 14. Patients who are considered inappropriate as subjects for this clinical study by the clinical research director or registered dentist for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Adverse events and failures 2) Presence of subjective symptoms (Spontaneous pain, contact pain, paresthesias) 3) Presence of objective symptoms (Redness, swelling, wound opening, pus, exposure/leakage of material) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Implant stability (measurement of ISQ value using Ostell ISQ Analyzer) 2) Sufficient regenerated bone to allow implant placement 3) Presence of new bone at the implantation site of the device under study (evaluation in tissue specimen) 4) Presence of residuals of the device under test (evaluation in tissue specimen) | — |
Contacts
Public ContactMasaki Shibasaki
Tokyo Medical and Dental University
Outcome results
None listed