NCT05371535

A Clinical Trial to Evaluate the Safety and Effectiveness of MatrixOssTM Bone Graft

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Collagen Matrix · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Dental Diseases

Interventions

Type	Name	Description
DEVICE	MatrixOssTM Bone Graft plus Bio-Gide membrane	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.

Timeline

• Start date: 2022-05-30
• Primary completion: 2022-11-30
• Completion: 2023-06-30
• First posted: 2022-05-12
• Last updated: 2022-05-12

Regulatory

• FDA-regulated device study