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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Those in the experimental group will receive MatrixOssTM Bone Graft plus Bio-Gide membrane. |
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| Control group | Active Comparator | Those in the control group will receive Bio-Oss Bone Graft plus Bio-Gide membrane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MatrixOssTM Bone Graft plus Bio-Gide membrane | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in alveolar ridge height from baseline to 24 weeks postoperative. | The alveolar ridge height immediately postoperative and 24 weeks postoperative were measured by CBCT, and changes in alveolar ridge height were calculated. Evaluate whether the changes in alveolar ridge height 24 weeks postoperative in the experimental group was non-inferior to that in the control group. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in alveolar ridge width from baseline to 24 weeks postoperative | The alveolar ridge height immediately postoperative and 24 weeks postoperative were measured by CBCT, and changes in alveolar ridge height were calculated. Compare the changes in alveolar ridge width from baseline to 24 weeks postoperative between the experimental group and control group. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meenakshi Paliwal | Contact | 201-405-1477 | 324 | mpaliwal@collagenmatrix.com |
| Peggy Hansen | Contact | phansen@collagenmatrix.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Jian Pan | West China Stomatological Hospital of Sichuan University | Principal Investigator |
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| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
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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.
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| Bone graft density in alveolar socket 24 weeks postoperative | According to the CBCT results at 24 weeks postoperative, the consistency between the bone graft density in alveolar socket and the surrounding alveolar bone density was evaluated. The evaluation contents include:
| 24 weeks |
| Wound healing | The wound healing conditions of the subjects in the experimental group and control group 10 days postoperative and 4 weeks postoperative were assessed using the Wound Healing Assessment Scale, and the gingival tissue in the implanted area of the material was evaluated as follows: Score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence; Score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence but no suppuration; Score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration. | 10 days postoperative and 4 weeks postoperative |
| Rejection reaction | Observe whether there are redness, suppuration, inflammation, granulation tissue hyperplasia, exposure/overflow of bone graft and other rejection reactions at the operation site of the subjects in the experimental group and the control group from immediately to 12 weeks postoperative. | 12 weeks |
| Device performance evaluation | The device performance of the experimental device/control device was evaluated by the investigator, and the evaluation criteria were as follows: Is the product operation convenient?
| 24weeks |