Comparison Between M-Pro and ProTaper Next
赞助:
Cairo University
合作者:
信息的提供 (责任方):
Mohammed Essam Othman Ibrahim，Cairo University
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 29, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | October 2018 | ||
| 预计主要完成日期 | October 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Post operative pain assessed with numerical rating scale[ Time Frame: Up to 72 hours post-operatively ] 0 (none) to 10 (severe) Numerical Pain Rating Scale up to 72 hours post-operatively |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Comparison Between M-Pro and ProTaper Next | ||
| 正式标题 ICMJE | Comparison of Postoperative Pain After Root Canal Instrumentation Using M-Pro and ProTaper Next in Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial | ||
| 简要概况 | Comparing the postoperative pain resulting after mechanical instrumentation using M-pro files versus that resulting after using ProTaper Next rotary files in lower molar with symptomatic Irreversible pulpitis molars. |
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| 详细说明 | Lower molars with symptomatic Irreversible pulpitis molars are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using M-pro Files or ProTaper Next files. Postoperative pain is then assessed using the Numerical Rating scale 6, 12, 24, 48 and 72 hours post-operatively . After completing the treatment, patients will instructed to take placebo if they feel pain and will be asked to provide the quantity of placebo intake until 72 hrs. In case of pain not relieved by placebo, after recording the amount of pain, the patient will be instructed to take an alternative line of pain control (Ibuprofen 400mg tablets every 6 hours). The amount and frequency of Ibuprofen intake will be recorded. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Blocks of 4 are generated on a Microsoft Excel sheet where the intervention and control are denoted A & B and randomly distributed. The table is kept with the assistant supervisor. 盲法: Interventional 盲法描述:After the operator find an eligible participant, a phone call is made to the assistant supervisor to confirm the patient eligibility then to assign the participant to either group according to the generated random sequence. 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
50 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | October 2019 | ||
| 预计主要完成日期 | October 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Age between 15-55 years old. - 2- Males or Females. - 3- Mandibular molar teeth with: - Pre-operative sharp pain. - Vital response of pulp tissue to cold pulp tester (ethyl chloride spray). - Normal periapical radiographic appearance or slight widening in lamina dura using periapical index (PAI) score 1 as normal periapical structures or 2 as small changes in bone structures. Exclusion Criteria: - Patients having significant systemic disorders. - Patients who are allergic to non-steroidal anti-inflammatory drugs. - Patients with two or more adjacent teeth requiring root canal therapy. - Teeth that have: - Necrotic pulp tissues. - Association with swelling or fistulous tract. - Acute or chronic peri-apical abscess. - Greater than grade I mobility. - Pocket depth greater than 5mm. - No possible restorability. - Previous endodontic treatment. | ||
| 性别 |
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| 年龄 | 最小年龄：15 Years ，最大年龄：55 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Egypt | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Mohammed Essam Othman Ibrahim，Cairo University | ||
| 研究赞助商 ICMJE | Cairo University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Cairo University | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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