评估两种不同牙刷对牙菌斑控制功效的随机试验
2017年3月31日 更新者：Faculty Sao Leopoldo Mandic Campinas
本研究的目的是评估两种不同牙刷（手动和声波）对牙菌斑控制的功效
研究概览
详细说明
在巴西圣保罗州 São Bernardo do Campo 市对 56 名年龄在 15 至 20 岁之间的患者进行了平行随机临床试验，他们都是 CAMP (Centro de Formação e Integração Social) 的学生.
随机化：受试者被随机分配到两个不同的组（A 组使用手动牙刷，B 组使用声波牙刷），方法是从骨灰盒中取出一张纸，上面写着各自的组别。
在基线以及 3 个月和 6 个月后评估了 Silness & Löe 牙龈指数、Quigley Hein 牙菌斑指数的 Turesky 修改版和社区牙周指数。
研究类型
介入性
注册 (实际的)
56
阶段
- 第四阶段
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
15年 至 20年 (成人、孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
纳入标准：
- 受试者必须身体健康，至少拥有 20 颗天然恒牙，不包括第三磨牙。
排除标准：
- 如果受试者有固定的正畸矫治器、晚期牙周病、手部灵巧度有限、活动性龋齿、限制其唾液功能或免疫状况的医疗状况，以及他们是否吸烟，则受试者被排除在外。
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：其他
- 分配：随机化
- 介入模型：平行线
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
ACTIVE_COMPARATOR：手动牙刷用户
使用手动牙刷 Curaprox 5460 Ultra Soft 的团体
|
每天使用 Bass 技术使用手动牙刷两次，每次 2 分钟
|
|
ACTIVE_COMPARATOR：声波牙刷用户
使用声波牙刷 Edel White 的小组
|
声波牙刷每天使用两次，每次 2 分钟
|
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 |
|---|---|---|
|
Silness & Löe 牙龈指数
大体时间：6个月
|
0 = 正常牙龈； 1 = 轻度炎症 - 颜色轻微变化，轻微水肿。
探诊无出血； 2 = 中度炎症 - 发红、水肿和无光泽；探诊出血； 3 = 严重炎症 - 明显发红和水肿。
溃疡。
自发性出血倾向
|
6个月
|
|
Quigley Hein 斑块指数的 Turesky 修改
大体时间：6个月
|
0 = 无菌斑； 1 = 牙齿颈部边缘有单独的斑点； 2 = 在牙齿的颈部边缘有一条薄的连续牙菌斑带（最多 1 毫米）； 3 = 宽度超过 1 毫米但覆盖不到牙冠三分之一的菌斑带； 4 = 菌斑覆盖至少三分之一但少于三分之二的牙冠； 5 = 牙菌斑覆盖牙冠的三分之二或更多
|
6个月
|
|
社区牙周指数
大体时间：6个月
|
0 = 无牙周病； 1 = 探诊出血； 2 = 探诊可见或摸到有牙菌斑的牙结石。
|
6个月
|
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。
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)
2016年12月1日
初级完成 (实际的)
2017年3月1日
研究完成 (预期的)
2017年6月1日
研究注册日期
首次提交
2017年3月28日
首先提交符合 QC 标准的
2017年3月31日
首次发布 (实际的)
2017年4月4日
研究记录更新
最后更新发布 (实际的)
2017年4月4日
上次提交的符合 QC 标准的更新
2017年3月31日
最后验证
2017年3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.