两种夹板治疗牙脱位损伤的比较
2023年9月7日 更新者：Arshad Hasan、Dow University of Health Sciences
散装填充可流动和可压缩复合材料在脱位损伤夹板中的比较：随机对照试验
这项随机临床试验 (RCT) 的目的是：
- 比较两种复合材料在材料保留方面的夹板效率
- 比较两组之间的粘合点尺寸
- 比较放置和移除夹板所需的时间
- 评估 bulkfill flowable 在降低脱臼牙齿活动度方面的功效。
研究概览
详细说明
进行了为期 6 个月的随机对照试验。 年龄在 16-50 岁之间的脱位损伤患者在获得知情同意后被要求参与该研究。 然后通过抽签方式将他们分配到任一组（第 1 组：可压缩复合材料 (PC)，第 2 组：Bulkfill Flowable）。 在放置夹板之前使用Periotest检查牙齿的移动度。 根据组别分配采用复合材料进行夹板固定。 记录放置夹板所花费的时间。 使用 DSLR 拍摄夹板牙齿的正面图像，并将其传输到适用于 Windows 的 Adobe Photoshop 版本 22.4.1，以测量修复材料的表面积占牙齿总表面积的百分比。 给出了术后指导。 2 周后，在移除夹板后立即记录 Periotest 读数。 在两次访问中，每颗牙齿记录了 3 个读数。 还记录了移除夹板所花费的时间。 此外，还观察到夹板的保留。
统计分析：
使用 SPSS 版本 26 for windows，使用配对样本 T 检验比较了应用和移除材料所需的平均时间以及移除夹板前后的移动性。 Mann-Whitney 测试比较了材料占用的面积百分比。 交叉表评估了夹板材料的保留。 显着性水平保持在 p ≤ 0.05。
研究类型
介入性
注册 (实际的)
88
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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Sindh
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Karachi、Sindh、巴基斯坦
- Dow University of Health Sciences
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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
16年 至 50年 (孩子、成人)
接受健康志愿者
是的
描述
纳入标准：
- 16-50岁恒牙患者
- 无论性别
- 侧向和挤压性脱位损伤
排除标准：
- 排除具有以下情况的患者
- 侵入伤害
- 根折
- 牙槽骨骨折。
- 全身性疾病患者。
- 牙周炎患者
- 副功能习惯
- 不同意的患者
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：可打包复合材料
脱臼牙夹板选用可压缩复合材料
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脱臼的牙齿用可压缩的复合材料固定
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有源比较器：散装复合材料
Bulkfill 复合材料被选为脱臼牙的夹板
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脱臼的牙齿用散装填充的可流动复合材料固定
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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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夹板的保留
大体时间：2周
|
留存率将按如下方式衡量： 完全粘合：复合材料上没有丝线暴露，丝线仍然粘合在牙齿上。 部分脱粘：复合材料的规格保留在金属丝上，金属丝仍与牙齿粘合。 Unbonded：金属丝暴露在口腔内，上面没有复合材料，金属丝从牙齿上脱离并可以自由移动。 结果将以每组中报告的具有相关条件的案例的百分比来衡量。 |
2周
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胶点尺寸
大体时间：2周
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与牙齿相比，材料所占面积的百分比将记为粘合点尺寸。 结果将以夹板材料占牙齿总面积的百分比来衡量，因为它是从前面可见的。 在我们的案例中，钢丝夹板由 Bulkfill 复合材料或 Packable 复合材料保留。 因此，夹板材料占据的面积百分比是感兴趣的结果。 |
2周
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牙齿活动度
大体时间：2周
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“由于施加的力导致牙齿在牙槽中的移动，通常以 1-3 的递增比例测量，或通过以毫米为单位的水平和/或垂直移动量来测量” Periotest 在评估牙齿活动度方面的价值是基于给出的尺度： 0级：-0.8-+09 I级：+10-+19 II级：+20-+29 III级：+30-+50 结果将测量为在应用夹板之前和移除夹板之后呈现牙齿移动等级的患者的百分比 |
2周
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应用和移除夹板所花费的时间
大体时间：2周
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应用时间：从夹板开始使用蚀刻剂到最后一块复合材料固化所用的时间量（以分钟为单位）。 移除时间：移除夹板材料所花费的时间（以分钟为单位） 结果将以 mm:ss 为单位的时间量来衡量，即在任一组中应用和移除夹板的分钟:秒。 |
2周
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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。
调查人员
- 研究主任：Arshad Hasan, BDS, FCPS、Dow University of Health Sciences
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。
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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7月9日
初级完成 (实际的)
2020年4月20日
研究完成 (实际的)
2020年5月4日
研究注册日期
首次提交
2022年3月4日
首先提交符合 QC 标准的
2022年3月28日
首次发布 (实际的)
2022年3月31日
研究记录更新
最后更新发布 (实际的)
2023年9月11日
上次提交的符合 QC 标准的更新
2023年9月7日
最后验证
2023年9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.