Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Protooth Vs. MTA
Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Novel Fast-setting Calcium Silicate Cement (Protooth) Versus Mineral Trioxide Aggregate (MTA): A Pilot Study
研究概览
地位
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Adel Elbardissy, Professor
- 电话号码：01271289999
- 邮箱：adelbardissy@dentistry.cu.edu.eg
研究联系人备份
- 姓名：Passant Nagy, Doctorat
- 电话号码：0128557107
- 邮箱：passant.nagi@dentistry.cu.edu.eg
学习地点
-
-
El Manial
-
Cairo、El Manial、埃及、11553
- Faculty of Dentsitry , Cairo University
-
接触：
- Adel Elbardissy, Professor
- 电话号码：01271289999
- 邮箱：adelbardissy@dentistry.cu.edu.eg
-
接触：
- Passant Nagy, Doctorat
- 电话号码：01280557107
- 邮箱：passant.nagi@dentistry.cu.edu.eg
-
-
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:
- Complete physical and mental health, with no confounding history of systemic disease and/or use of special local or systemic drugs
- No allergic reactions recorded in patient history
- Having primary molar teeth in one jaw, having deep caries and vital pulp.
- No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule
Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test
- Radiographic criteria:
- No sign of radiolucency in periapical or furcation area
- No widening of PDL space or loss of lamina dura continuity
- No evidence of internal/external pathologic root resorption
Exclusion Criteria:
- Lack of informed consent by the child patient's parent
- Lack of informed consent by the child patient's parent
- Unable to attend follow-up visits.
- Refusal of participation.
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 |
|---|---|
|
有源比较器：Novel fast setting calcium silicate ( Protooth)
In the form of powder and liquid to be mixed together to form paste.
|
In form of power and liquid to be mixed together to form a paste.
其他名称：
|
|
实验性的：MTA
In form of powder to be mixed with saline to form paste.
|
In form of power and liquid to be mixed together to form a paste.
其他名称：
|
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 |
|---|---|---|
|
Clinical evaluation including postoperative pain , pain on percussion or palpation will be measured using VAS
大体时间：12 months
|
Post-operative pain following pulpotomy treatment will be measured. A pain chart using visual analogue scale (VAS) will be used to record the patients' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow: 0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured. |
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Radiographic evaluation following the Pulpotomy treatment will be measured
大体时间：12 months
|
Binary assessment of the radiographs taken after the treatment ( if there is any radiolucent or widening in the lamina sure nor evidence of internal/external pathologic root resorption)
|
12 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
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
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
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