Collagen Matrix
The objective of this clinical trial is to evaluate the efficacy and safety of MatrixOssTM Bone Graft in bone defect repair caused by tooth extraction.
Dental Diseases
MatrixOssTM Bone Graft plus Bio-Gide membrane
Not Applicable
This is a prospective, randomized, multi-center and parallel controlled clinical trial. It is planned to be carried out in more than 3 (including 3) hospitals with qualifications as a national-level clinical trial institution. Subjects included will be randomly assigned into the experimental group and the control group at a ratio of 1:1. Those in the experimental group will receive MatrixOssTM Bone Graft plus Bio-Gide membrane, and those in the control group will receive Bio-Oss Bone Graft plus Bio-Gide membrane. To evaluate whether the changes in alveolar ridge height from baseline to 24 weeks postoperative in the experimental group is non-inferior to that in the control group, so as to verify the efficacy and safety of MatrixOssTM Bone Graft developed and manufactured by Collagen Matrix, Inc. for bone defect repair caused by tooth extraction.}}
Study Type : | Interventional |
Estimated Enrollment : | 188 participants |
Masking : | Single |
Primary Purpose : | Treatment |
Official Title : | A Prospective, Randomized, Multi-center, Parallel Controlled Trial Evaluating the Efficacy and Safety of MatrixOssTM Bone Graft in Bone Defect Repair Caused by Tooth Extraction |
Actual Study Start Date : | May 30, 2022 |
Estimated Primary Completion Date : | November 30, 2022 |
Estimated Study Completion Date : | June 30, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Experimental group Those in the experimental group will receive MatrixOssTM Bone Graft plus Bio-Gide membrane. |
Device: MatrixOssTM Bone Graft plus Bio-Gide membrane |
Active Comparator: Control group Those in the control group will receive Bio-Oss Bone Graft plus Bio-Gide membrane |
Device: MatrixOssTM Bone Graft plus Bio-Gide membrane |
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.