Clinical Trial of RED-188 Supplementation Treatment for Maxillary Sinus Floor Lifting

HOYA Technosurgical Corporation0 个研究点目标入组 24 人开始时间: 待定最近更新: 2025年5月1日

试验速览

暂无简介。

•Patients who meet all of the following criteria will be included in the study:
•Age 20 years or older and younger than 80 years at the time of obtaining informed consent
•Patients requiring bone augmentation with bone prosthesis during maxillary sinus floor elevation for implant body placement in the maxillary molar region
•Patients whose general condition is stable and who can be operated on
•Patients who are able to obtain written informed consent by themselves

•Patients who meet any of the following criteria should not be eligible for the study:
•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
•Patients with a history of allergy to each component of the investigational device (collagen, hydroxyapatite)
•Patients with drug allergy
•Patients receiving drugs for osteoporosis (e.g., bisphosphonates)
•Patients receiving antithrombotic drugs (e.g., Warfarin)
•Patients receiving immunosuppressive therapy (patients receiving immunosuppressive drugs after organ transplantation, patients with severe collagen disease, etc.)
•Pregnant women or women who wish to become pregnant or breastfeeding during the study period.
•Patients who have participated in other clinical trials within 1 year before the replacement of the investigational device
•Other patients who are judged by the principal investigator or the subinvestigator to be ineligible for the study.

Success Rate Based on Implant Treatment Success Criteria at 4 Weeks After Superstructure Placement.

Success rate based on Implant Treatment Success Evaluation Criteria(at 24 weeks after investigational device replacement)
Trends in CT values(immediately after surgery, 12 weeks after surgery, and 24 weeks after surgery)
Improvement rate of bone regeneration(at 24 weeks after the replacement of the investigational device)
Changes in the amount of vertically residual bone(before surgery, immediately after surgery, 12 weeks after surgery, and 24 weeks after surgery)
Percentage change in vertical residual bone volume(before surgery and at 24 weeks after investigational device replacement)
Implant stability rate(immediately after implant placement and before superstructure placement (at 24 weeks after investigational device replacement))
Improvement rate based on evaluation criteria for improvement in bone regeneration by maximum torque value(at 24 weeks after investigational device replacement)
Improvement rate based on evaluation criteria for improvement in bone regeneration by biopsy diagnosis(at 24 weeks after investigational device replacement)
Adverse events
Failure

发起方

HOYA Technosurgical Corporation