Post-operative Pain in 2Shape Versus Protaper Next Rotary Systems
赞助:
Cairo University
合作者:
信息的提供 (责任方):
Heba Ibrahim Mohamady，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 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | December 2018 | ||
| 预计主要完成日期 | August 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
intensity of postoperative pain assessed by numerical rating scale Immediately after the end of treatment, and at 6, 12, 24, 48, and 72 hours. post-operative pain[ Time Frame: 3 days ] using numerical rating scale ranges between (0-10) where 0 indicates no pain while 10 indicates maximum pain degree |
||
| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
|
||
| 描述性信息 | |||
| 简略标题 ICMJE | Post-operative Pain in 2Shape Versus Protaper Next Rotary Systems | ||
| 正式标题 ICMJE | Assessment of Postoperative Pain After Using 2Shape and Protaper Next Rotary Systems in Patients With Symptomatic Pulpitis in Mandibular Molars:A Randomized Clinical Trial | ||
| 简要概况 | Pain after endodontic treatment is considered the most disturbing problem facing both the patient and the dentist especially in cases of symptomatic pulpitis as the patient is expecting to relief the pain that already exists.Therefore, this study aims to find a solution for the post-operative pain felt by the patient with symptomatic pulpitis in mandibular molars through comparing post-operative pain following use of 2Shape and Protaper Next rotary systems. |
||
| 详细说明 | Root canal preparation is the most important step in endodontic treatment. For successful treatment, pulp tissue, dentin debris and microorganisms should be completely eradicated from the root canal system.However, it has been reported that all the instrumentation techniques (manual or mechanical) cause debris extrusion into the periradicular tissue resulting in periapical inflammation that causes post-operative pain and flare up. Instrumentation technique and instrument design were found to be related to the amount of debris extruded which is the main cause of post-operative pain. It has been reported that rotary NiTi systems cause less debris extrusion than manual instrumentation. Within NiTi systems, instrument design, taper and tip size were found to affect debris extrusion. Therefore, new innovations in the instrument designs are introduced in order to reduce post-operative pain and flare up incidence. Therefore, this study is established to compare the effect of 2 different rotary systems on postoperative pain in patients with symptomatic pulpitis. The aim of the present study is to assess the effect of rotary instrumentation using Protaper Next rotary system versus 2Shape rotary system on postoperative pain and the number of analgesics taken by the patient following single visit root canal treatment in mandibular molars with symptomatic pulpitis. Primary objective: Comparing the intensity of post-operative pain using Numerical Rating Scale (NRS) immediately after root canal treatment and post-appointment at 6, 12, 24, 48 and 72hours. Secondary objectives: - The need for / and number of analgesic tablets taken within 3 days after end of endodontic treatment. - Instrument separation during instrumentation. | ||
| 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: 盲法: Interventional 盲法描述:Double (Participant, Outcomes Assessor) 主要目的: Treatment |
||
| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
|
||
| 研究工具 |
|
||
| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
44 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | October 2020 | ||
| 预计主要完成日期 | August 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - - Medically free patients. - Patients with symptomatic pulpitis in one of their mandibular molars. - Patient's age ranges between 22 to 45 years with no sex predilection. - Patients who can understand Numerical Analogue Scales (NRS). - Patients able to sign informed consent. Exclusion Criteria: - - Patients having a systemic disorder. - Presence of periapical lesion. - Pregnant females. - Patients who had taken analgesics during the last 12 hours preoperatively. - Patients having active pain in more than one tooth. - Non- educated patients. | ||
| 性别 |
|
||
| 年龄 | 最小年龄：22 Years ，最大年龄：45 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | ||
| 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 |
||
| IPD 共享声明 |
|
||
| 责任方 | Heba Ibrahim Mohamady，Cairo University | ||
| 研究赞助商 ICMJE | Cairo University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
|
||
| PRS 账户 | Cairo University | ||
| 验证日期 | September 2018 | ||
|
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 |
|||
请使用微信扫码报名
京公网安备 11010102003638号