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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 188
- 主要终点
- Changes in alveolar ridge height from baseline to 24 weeks postoperative.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Changes in alveolar ridge height from baseline to 24 weeks postoperative.
时间窗: 24 weeks
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.
次要结局
- Changes in alveolar ridge width from baseline to 24 weeks postoperative(24 weeks)
- Bone graft density in alveolar socket 24 weeks postoperative(24 weeks)
- Device performance evaluation(24weeks)
- Wound healing(10 days postoperative and 4 weeks postoperative)
- Rejection reaction(12 weeks)