A Comparison of Long-Term Effectiveness of Two Desensitizing Products
2019年10月2日 更新者：Leyla Kerimova、Baskent University
A Comparison of Long-Term Effectiveness of Two Desensitizing Products: A Randomized Clinical Placebo-Controlled Study
This randomized, controlled, clinical trial aimed to compare the 6- month clinical performance of a desensitizer that contains calcium phosphate TM with a two-step self-etch adhesive SE and placebo (distilled water).
At least 150 teeth wil be treated with desensitizing products and placebo randomly one third usig TM, one third using SE and one third using placebo.
The efficiency of the materials will be evaluated at baseline, 1 week, 1 month, 3 months and 6 months after treatment.
研究概览
详细说明
The aim of this randomized, controlled, clinical trial is to compare the clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period (6 months).
At least fifty patients with a sensitivity score of 6 or higher, according to the Visual Analog Scale (VAS), with at least three teeth will participate in this study.
Teethmate Desensitizer (TM), Clearfil SE Bond 2 (SE) and placebo (distilled water) will be applied randomly to three teeth of each patient.
Recalls will be done at baseline, 1 week, 1 month, 3 months and 6 months after treatment by applying air-blast and the sensitivity scores will be determined according to VAS.
The efficiency of the materials will be determined according to the VAS scores.
Data will be analyzed using Paired t test and repeated measures of ANOVA.
研究类型
介入性
注册 (实际的)
50
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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Ankara、火鸡
- Hacettepe University
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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 至 70年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subjects with 3 or more hypersensitive teeth with a VAS (Visual Analog Scale) score
- Willingness to participate in the study
Exclusion Criteria:
- Subjects are unwilling to participate voluntarily
- Patients under 18 years old
- Those that were taking analgesic medicaments
- Pregnant and breastfeeding females
- The presence of a systemic disease that affects the participation
- Teeth with cervical loss of hard tissue that need restoration absolutely
- Large/defective restoration, caries or enamel cracks in sensitive teeth
- Teeth with vulnerability to hypersensitivity after root scaling
- Pulpitis presence.
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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实验性的：Teethmate Desensitizer (TM)
Calcium phosphate biomimetic material that forms hydroxyapatite from tetracalcium phosphate and dicalcium phosphate anhydrous and plug the dentin tubules causing remineralization and dentin hypersensitivity relief.
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Desensitizing agent will be applied to sensitive teeth.
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有源比较器：Clearfil SE Bond 2 (SE)
Two-step self etch adhesive resin treating dentin hypersensitivity b covering a film layer after light-curing.
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Desensitizing agent will be applied to sensitive teeth.
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安慰剂比较：Distilled water
Distilled water with no desensitizing components.
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Placebo will be applied to sensitive teeth as a negative control.
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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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The effectiveness of desensitizers through long-term period
大体时间：6 months
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The clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period.
Evaluation will be performed usig the Visual Analog Scale(VAS).
VAS values will be according to the following parameters: 0 - no discomfort;1 to 3 - light discomfort;4 to 6 - mild discomfort;7 to 9 - severe discomfort;10 - Unbearable discomfort.
After each stimulus to the suspected site the degree of hypersensitivity will be determined from 6 to 10 as the preop VAS score for each individual painful tooth.
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6 months
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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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Subjective satisfaction of patients
大体时间：6 months
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Because of the patient-centered aspect of the study patients' subjective satisfaction will be prior. Patients will be asked to define their sensitivity according to Visual Analog Scale (VAS) scale. VAS values will be according to the following parameters: 0 - no discomfort;1 to 3 - light discomfort;4 to 6 - mild discomfort;7 to 9 - severe discomfort;10 - Unbearable discomfort. In case of persistant or recurrent sensitivity reported by the participants after application of desensitizing agents or placebo, even if the Visual Analog Scale score was decreased, it was accepted as failure, so alternative hypersensitivity treatments applied and current teeth will be excluded. |
6 months
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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。
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2月1日
初级完成 (实际的)
2019年10月1日
研究完成 (实际的)
2019年10月1日
研究注册日期
首次提交
2019年2月21日
首先提交符合 QC 标准的
2019年2月21日
首次发布 (实际的)
2019年2月22日
研究记录更新
最后更新发布 (实际的)
2019年10月3日
上次提交的符合 QC 标准的更新
2019年10月2日
最后验证
2019年10月1日
更多信息
与本研究相关的术语
其他研究编号
- Hacettepe 2017/06-26 KA-16009
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
Teethmate Desensitizer (TM)的临床试验
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University of BirminghamTikoMed AB; University Hospital Birmingham; Neuregenix完全的
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Zimmer Biomet主动，不招人骨关节炎 | 类风湿关节炎 | 缺血性坏死 | 创伤后关节炎 | 翻修全肩关节置换术 | 不愈合的肱骨头骨折 | 不可复性的三部分和四部分肱骨近端骨折 | 总肩袖缺陷美国, 英国
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University of UtahEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)主动，不招人
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Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH); Atrium Medical Corporation完全的
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University Hospital Inselspital, BerneEdwards Lifesciences完全的
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University of CalgaryCanadian Diabetes Association; Becton, Dickinson and Company; LifeScan Canada完全的