聚合物纳米氟化钙护齿剂、二极管激光器及其联合治疗牙本质过敏症
聚合物纳米氟化钙涂料、二极管激光单独及联合治疗牙本质过敏症的疗效。
The aim of the study is to assess the effect of polymeric nano calcium fluoride Varnish (Oli-NANO seal), 976 nm diode laser solely and combination of both therapies in the treatment of dentin hypersensitivity
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Cairo、埃及、4470351
- Faculty of Dental medicine for Girls
-
-
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:
-
Medically free
- Non-smokers
- Co-operative patients who will be interested in participating in the study and willing to sign the informed consent.
- Availability of patients for 1 year
Exclusion Criteria:
-
Patients currently using analgesic, anti-inflammatory medications, sedatives, tranquilizers, anticonvulsants, or any other medications that could potentially alter pain perception.
- Patients undergoing orthodontic treatment.
- Patients using desensitizing toothpaste
- Patients receiving dentin hypersensitivity (DH) treatment
- Pregnant or lactating women
- Patients have high consumption of sour and acidic food
- Patients who had undergone professional desensitizing therapy during the previous 3 months.
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group 1 (OliNano Seal)
OliNano Seal (polymeric nano calcium fluoride containing varnish) |
The OliNANO seal is "varnish-like" shield which is based on nanotechnology that allows an optimum adhesion to enamel and dentin, it could be used as an effective desensitizing agent by forming a protective layer that occludes the dentinal tubules which can be effective for a year as mentioned by the manufacturer. Polymeric nano calcium fluoride varnish consists of four main components, silicone polymer, NANO-fluorapatite, nano-calcium fluoride and amine fluoride (Olaflur) |
|
有源比较器：Group 2 (Diode laser)
Diode laser |
increase in the metabolic activity of odontoblasts. Thus, obliteration of the dentinal tubules and formation of tertiary dentin. |
|
实验性的：Group 3 (OliNano Seal and Diode laser)
OliNano Seal and Diode laser |
Combined methods have been also evaluated in some previous studies. It showed more effect in reducing Dentin hypersensitivity than using every treatment solely |
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 |
|---|---|---|
|
Pain severity
大体时间：Before the treatment (Baseline), after the first session (T1), second session (T2) will be done after a week from the first session, after 3 months (T3), 6 months (T6), 9 months (T9) and 12 months (T12)
|
The pain will be assessed using the (VAS) scale. The VAS is a scale that allows the patient to self-assess the pain felt by means of a line in which the patient marks the pain level "no pain" to the "maximum pain". 0: low pain, 1 - 3: moderate pain: 4 - 6, intense pain: 7 - 9, extremely intense pain: 10 |
Before the treatment (Baseline), after the first session (T1), second session (T2) will be done after a week from the first session, after 3 months (T3), 6 months (T6), 9 months (T9) and 12 months (T12)
|
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 (实际的)
研究完成 (实际的)
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
关键字
其他研究编号
- P-OP-24-08
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 共享时间框架
Start date: After publication, End Date: 10 years
IPD 共享访问标准
After publication through the corresponding author
IPD 共享支持信息类型
- 研究方案
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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