Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation
Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation: Prospective, Blinded, Randomized Controlled Trial
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：陈 莉丽, Master
- 电话号码：+86 13606507966
- 邮箱：chenlili_1030@163.com
学习地点
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Zhejiang
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Hangzhou、Zhejiang、中国、310000
- 招聘中
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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接触：
- 陈 莉丽, Master
- 电话号码：+86 13606507966
- 邮箱：chenlili_1030@163.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18-80 years old;
- single tooth in the maxillary posterior area cannot be retained (third degree loosening / alveolar bone resorption to the periapical area), implantation is needed after extraction, and CBCT shows vertical bone defect ≥ 3mm;
- 4 weeks after extraction or missing teeth within 3-5 weeks;
- adjacent teeth exist and loosening is less than Ⅰ degree;
- periodontal disease in inactive stage, whole mouth bleeding index (FMBS) is less than 20%;
- thick gingival biological type.
- CBCT shows that the bone of the edentulous site meets the requirements of tent screw implantation (bone height ≥ 3mm and bone mineral density is sufficient);
- the patients and their families have informed consent and signed the informed consent form.
Exclusion Criteria:
- pregnant and lactating women;
- smoking (> 10 cigarettes per day) and alcoholism;
- taking anticoagulants within 3 months before operation;
- suffering from autoimmune diseases, diabetes, liver disease, blood system diseases and infectious diseases;
- patients taking any drugs that affect platelet function or whose platelet count is less than 200000/mm3 3 months before blood collection;
- patients who have been treated with bisphosphate / steroids for a long time;
- have received alveolar ridge bone augmentation surgery;
- previous history of radiotherapy in the head and neck;
- acute inflammation in edentulous sites;
- inability to maintain good oral hygiene or follow-up visits as required.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Control group
Vertical alveolar bone augmentation was performed by GBR technique before implantation. BIO-OSS+ BIO-GIDE barrier membrane |
guided bone generation: GBR is a procedure that uses barrier membranes with or without particulate bone grafts or/and bone substitutes. tenting screws: Screws are implanted in the surgical area to prevent the barrier membrane from collapsing. A-PRF/I-PRF: Obtained by autologous blood centrifugation.
其他名称：
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实验性的：Treatment group 1
Vertical alveolar bone augmentation was performed by GBR technique and tenting screws before implantation. BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws |
guided bone generation: GBR is a procedure that uses barrier membranes with or without particulate bone grafts or/and bone substitutes. tenting screws: Screws are implanted in the surgical area to prevent the barrier membrane from collapsing. A-PRF/I-PRF: Obtained by autologous blood centrifugation.
其他名称：
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实验性的：Treatment group 2
Vertical alveolar bone augmentation was performed by GBR technique in combination with tenting screws and A-PRF, I-PRF before implantation. BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws+A-PRF, I-PRF |
guided bone generation: GBR is a procedure that uses barrier membranes with or without particulate bone grafts or/and bone substitutes. tenting screws: Screws are implanted in the surgical area to prevent the barrier membrane from collapsing. A-PRF/I-PRF: Obtained by autologous blood centrifugation.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Buccal bone augmentation, BBA(bone height changes between T0 and T2)
大体时间：T0(before surgery), T2(6 months after GBR)
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The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline.
The investigaters will measure the bone height changes by CBCT(three-dimensional CT) and Related measurement software.
The unit of measurement is millimeter.
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T0(before surgery), T2(6 months after GBR)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Lingual bone augmentation, LBA(bone height changes between T0 and T2)
大体时间：T0(before surgery), T2(6 months after GBR)
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The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline. The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline.The investigaters will measure the bone height changes by CBCT(three-dimensional CT) and Related measurement software. The unit of measurement is millimeter. |
T0(before surgery), T2(6 months after GBR)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Bone density, BD
大体时间：T2(6 months after GBR)
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in the area of bone regeneration, ranging 2mm × 2mm
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T2(6 months after GBR)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2021-0050
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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研究美国 FDA 监管的设备产品
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