Inplant
Conditions
Interventions
For patients undergoing maxillary sinus floor elevation, an amount of dental collagen-based bone regeneration material (RED-188) is placed to fill the maxillary sinus as a bone replacement material, a
Sponsors
Nkajima Takehiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be included in the study: 1. Age 20 years or older and younger than 80 years at the time of obtaining informed consent 2. Patients requiring bone augmentation with bone prosthesis during maxillary sinus floor elevation for implant body placement in the maxillary molar region 3. Patients whose general condition is stable and who can be operated on 4. Patients who are able to obtain written informed consent by themselves
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria should not be eligible for the study: 1. Patients with the following general conditions - Severe liver / kidney disorders and heart disease - Malignant tumor (combined or with a history within 5 years) - Severe blood disease -Severe diabetes (diabetes with poor control even after drug therapy *) * Fasting blood glucose: 140 mg / dL excess, ketone bodies (+), HbA1c: 6.9% (NGSP value) or higher - Requires dialysis therapy - Calcium metabolism disorder - Bone target hormone metabolism disorder - Immunodeficiency 2. Patients with a history of allergy to each component of the investigational device (collagen, hydroxyapatite) 3. Patients with drug allergy 4. Patients receiving drugs for osteoporosis (e.g., bisphosphonates) 5. Patients receiving antithrombotic drugs (e.g., Warfarin) 6. Patients receiving immunosuppressive therapy (patients receiving immunosuppressive drugs after organ transplantation, patients with severe collagen disease, etc.) 7. Smoker 8. Pregnant women or women who wish to become pregnant or breastfeeding during the study period. 9. Patients who have participated in other clinical trials within 1 year before the replacement of the investigational device 10. Other patients who are judged by the principal investigator or the subinvestigator to be ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success Rate Based on Implant Treatment Success Criteria at 4 Weeks After Superstructure Placement. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Success rate based on Implant Treatment Success Evaluation Criteria before superstructure placement (at 24 weeks after investigational device replacement) 2) Trends in CT values immediately after surgery, 12 weeks after surgery, and 24 weeks after surgery for investigational device replacement (maxillary sinus floor elevation). 3) Improvement rate of bone regeneration based on the criteria for improvement in bone regeneration at 24 weeks after the replacement of the investigational device (Hounsfield unit: HU). 4) Changes in the amount of vertically residual bone before surgery, immediately after surgery, 12 weeks after surgery, and 24 weeks after surgery for the replacement of the investigational device (floor elevation of the maxillary sinus) 5) Percentage change in vertical residual bone volume before surgery and at 24 weeks after investigational device replacement 6) Implant stability rate based on the acceptance criteria for implant stability according to the ISQs (Implant stability quotient: implant stability index) immediately after implant placement and before superstructure placement (at 24 weeks after investigational device replacement) 7) Improvement rate based on evaluation criteria for improvement in bone regeneration by maximum torque value before superstructure placement (at 24 weeks after investigational device replacement) 8) Improvement rate based on evaluation criteria for improvement in bone regeneration by biopsy diagnosis before superstructure placement (at 24 weeks after investigational device replacement) [Evaluation of waitlist implantation only] Safety Evaluation 1) Adverse events (including confirmation of abnormal laboratory changes) 2) Failure | — |
Contacts
Public ContactTakehiko Nakajima
HOYA Technosurgical Corpolation
Outcome results
None listed