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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Dental Diseases

Intervention / Treatment
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* Device: MatrixOssTM Bone Graft plus Bio-Gide membrane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged 18-65 years (including 18 years and 65 years); Bone loss caused by singe tooth extraction requiring bone grafting; At least one natural tooth adjacent to the targeted tooth; The subjects could understand the purpose of this trial, voluntarily participate in this trial and willing to sign an Informed Consent Form (ICF). Exclusion Criteria: Bone defect caused by invasive or malignant bone tumors； Subjects with uncontrolled periodontitis, acute periapical inflammation; Subjects who are receiving or had received any drug in last 3 months that may influence or promote bone metabolism; Active infectious disease, various bone defects during the active phase of metabolic bone disease; Subjects with acute or chronic infection (osteomyelitis) at the surgical site; Subjects with osteoporosis or osteomalacia; Alanine Aminotransferase，ALT）Aspartate Aminotransferase，AST） Subjects with abnormal liver or kidney functions (ALT or AST or creatinine exceeds 1.5 times the upper limit of normal range); Subjects who has a history of or is undergoing cervico-facial radiotherapy or chemotherapy; Subjects with serious blood system diseases, such as leukemia or other hemorrhagic diseases; Subjects with abnormal coagulation function; Subjects with severe cardiovascular and cerebrovascular diseases; Subjects with systemic diseases may affect postoperative healing and/or osseointegration, such as diabetes, uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), hyperparathyroidism, etc. Subjects with mental disorder and lack of behavioral autonomy; Known allergy or hypersensitivity to animal-derived implantable materials; Subjects who refuse to use porcine-derived implantable materials; Pregnant and lactating women, or those who plan to conceive within 6 months; Subjects with implants adjacent to the targeted teeth that can cause oral imaging artifacts, such as metal dentures, porcelain teeth, etc. that may cause oral imaging artifacts; Subjects who smoking more than 5 cigarettes per day; Subjects who are alcoholism, drug abuse, or drug dependence; Subjects who have participated or are participating in a drug clinical trials in last 3 months, or have participated in other medical device clinical trials in last 30 days; Other circumstances which are considered by the investigator not suitable for enrollment in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Those in the experimental group will receive MatrixOssTM Bone Graft plus Bio-Gide membrane. | Device: MatrixOssTM Bone Graft plus Bio-Gide membrane<br>* 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.<br>|
| Active Comparator: Control group<br>Those in the control group will receive Bio-Oss Bone Graft plus Bio-Gide membrane | Device: MatrixOssTM Bone Graft plus Bio-Gide membrane<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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: Lower than surrounding alveolar bone density; Same as surrounding alveolar bone density; Higher than surrounding alveolar bone density. | 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? Convenient Common Inconvenient （2）Is the product easy to fuse with blood? Easy to fuse Common Not easy to fuse | 24weeks |