种植体基台断开/重新连接对种植体周围骨水平的影响
2024年11月12日 更新者：Joseph Kan, DDS、Loma Linda University
种植体基台断开和重新连接对种植体周围骨水平的影响：一项为期 1 年的前瞻性研究
本前瞻性研究的目的是评估种植体植入时确定基台连接对上颌后牙区和下颌骨区域骨水平变化的影响。
研究概览
详细说明
在本研究中，上颌骨和下颌骨至少有 2 颗后牙缺失的 19 名患者共植入 38 颗种植体。
最终预制基台将在种植体植入时连接。
将随机选择两个种植体之一的基台（对照组）在 16- (DR1)、19- (DR2)、22- (DR3) 和 24 处通过手动完全断开和重新连接的一个完整周期- 植入手术后 (DR4) 周。
在整个研究期间，另一个种植体上的基台（测试组）将保持原状。
在研究期间（12 个月）内，所有植入物都将保持未修复状态。
种植体植入后 (T0)、3-(T3)、6-(T6) 和 12-(T12) 个月的随访检查以及每次断开连接期间，将使用标准化的根尖周 X 光片评估种植体周围骨水平变化基台。
研究类型
介入性
注册 (实际的)
19
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Loma Linda、California、美国、92350
- LOMA LINDA UNIVERSITY, School of Dentistry
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
描述
纳入标准：
- 最低 18 岁
- 良好的口腔卫生
- 上颌或下颌后牙区（不包括第三磨牙）有两颗或更多颗牙齿缺失的愈合部位
- 足够的骨骼以在每个部位容纳至少 4.3 毫米直径和 8 毫米长度的植入物
- 具有至少 8mm 的牙合间修复空间
- 愿意参与并参加计划的后续访问。
排除标准：
- 酒精/药物依赖史，或任何可能影响手术或修复程序和后续检查的医学、身体或心理因素
- 头部和颈部放射治疗史
- 吸烟史或目前的吸烟习惯
- 磨牙症的历史或当前习惯
- 无对立咬合牙列或假牙
- 种植体植入期间需要骨增量
- 种植体插入扭矩值 <35 Ncm
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：对照组
分口：手术当天将愈合基台连接到种植体上，在研究期间将多次断开和重新连接
|
|
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实验性的：测试组
分口：手术当天将最终基台连接至种植体。
修复阶段不会断开或重新连接
|
有两个可用的高度选项，根据软组织的厚度选择 On1 Base。
从种植体植入到最终完成，它始终保持原位，使软组织不受干扰以优化愈合，将 Nobel Biocare 锥形连接种植体的修复平台从骨骼水平移动到组织水平，从而简化了修复程序
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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基线（种植体植入）和 1 年随访期间种植体周围边缘骨水平的变化
大体时间：基线（种植体植入）和 1 年随访
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使用长锥平行技术和定制夹具在基线（种植体植入）和 1 年随访时拍摄标准化数字根尖周 X 线照片。
测量种植体周围近中和远端边缘骨水平以评估骨丢失。
通过将 1 年随访时的测量值与基线值进行比较，计算种植体周围边缘骨水平的变化。
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基线（种植体植入）和 1 年随访
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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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角化粘膜宽度的变化
大体时间：基线（种植体植入）和 1 年随访
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使用带有 1.0 mm 标记的牙周探针在基台的颊中部测量角化粘膜的宽度。
一年随访时在同一地点重复测量，并与基线值进行比较。
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基线（种植体植入）和 1 年随访
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舌粘膜厚度的变化
大体时间：基线（种植体植入）和 1 年随访
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使用带有 1.0 mm 标记的牙周探针在种植位点中心从骨嵴测量每个种植位点的舌粘膜厚度。
一年随访时在同一位置重复测量，并与种植手术当天的基线值进行比较。
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基线（种植体植入）和 1 年随访
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根据美国牙周病学会 (AAP) 制定的 2017 年分类标准的种植成功率
大体时间：手术植入后12个月
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成功取决于植入物满足这些临床因素的能力，例如在术后植入 12 个月时评估，没有疼痛、感染、活动能力和超出随访期可接受阈值的放射线骨丢失。
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手术植入后12个月
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Joseph Kan, DDS, MS、Loma Linda University School of Dentistry
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年9月30日
初级完成 (实际的)
2023年9月18日
研究完成 (实际的)
2023年9月18日
研究注册日期
首次提交
2019年7月31日
首先提交符合 QC 标准的
2019年7月31日
首次发布 (实际的)
2019年8月2日
研究记录更新
最后更新发布 (实际的)
2024年12月4日
上次提交的符合 QC 标准的更新
2024年11月12日
最后验证
2024年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.