Vital Pulp Therapy to Treat Irreversible Pulpitis (VPT)
Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.
研究概览
详细说明
In one visit RCT (Arm 1): The teeth were anesthetized, isolated and endodontic access and instrumentation of all canals was done. Canal preparation was conducted using a step-back technique. The working lengths were determined and confirmed by radiography. Sterile normal saline solution was used for intra-canal irrigation. Root canals were obturated with gutta-percha and sealer using lateral condensation technique. After placing a cotton pellet in the pulp chamber, the access cavity was closed with Cavit.
In pulpotomy treatment with CEM/MTA (Arm 2): The teeth were anesthetized. Pulpotomy procedure of removing inflamed pulp tissue to the stump level was done. Homeostasis was achieved by irrigating the cavity with sterile normal saline and application of small pieces of sterile cotton pellets. The pulpal wound was covered with an approximately 2-mm-thick layer of MTA/CEM cement. Pulp chambers were then covered with a wet cotton pellet and sealed with Cavit.
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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Tehran、伊朗伊斯兰共和国、19839
- Iranian Center for Endodontic research
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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:
Diagnostic criteria:
- Patient reports pain of endodontic origin
- Diagnosis of irreversible pulpitis
Eligibility criteria:
- Molar tooth
- Patient chooses to have tooth extraction for pain relief
- Age 9-65 years
- Both gender
- The patient had read and thoroughly understood the questionnaires; and
- Written informed consent
Exclusion Criteria:
- Moderate or severe periodontitis
- None restorable tooth
- Internal or external root resorption
- Root canal calcification
- No bleeding after access cavity preparation
- Analgesic taken within the last 4 h
- Active systemic disease
- The patient was pregnant or nursing
- History of opioid addiction or abuse
- Temporary residency
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：1
ORCT
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Teeth were isolated, caries was removed and access cavities were prepared.
Canal preparation was conducted using step-back technique.
The working lengths were determined and confirmed by radiographs.
The minimum size file for preparing the working length was size ISO #25 K-file to within 0.5-2 mm of the radiographic apex of the root.
During hand instrumentation, canals were frequently irrigated with adequate amount of sterile normal saline solution.
The root canals were filled with multiple gutta-percha cones and sealer using lateral condensation technique.
Placing a cotton pellet in the pulp chamber, the access cavity was temporarily filled.
The treatments of all samples were performed one-visit.
其他名称：
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实验性的：2
PCEM/PMTA
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Pulpotomy was performed with a large round bur in a high-speed handpiece with copious irrigation; removing inflamed pulp tissue to stump level.
Hemostasis was achieved by irrigation of the cavity with sterile normal saline and application of small pieces of sterile cotton pellets.
The blood clot-free pulpal wound was covered with approximately 2 mm layer of endodontic bio-materials, a sterile wet cotton pellet was then placed over the MTA/CEM cement and the cavity sealed with Cavit.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Clinical and radiographical success of pulpotomy with CEM cement
大体时间：5 year
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5 year
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次要结果测量
结果测量 |
大体时间 |
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Patient Assessment of Pain - Visual Analogue Scale
大体时间：7 day
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7 day
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合作者和调查者
调查人员
- 研究主任：Mohammad Jafar Eghbal, Prof.、Shahid Beheshti University of Medical Sciences
- 首席研究员：Jamileh Ghoddusi, Prof.、Mashhad University Of Medical Sciences
研究记录日期
研究主要日期
学习开始
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 (估计)
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
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