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临床试验/NCT03694743
NCT03694743Unknown不适用

Assessment of Postoperative Pain After Using 2Shape and Protaper Next Rotary Systems in Patients With Symptomatic Pulpitis in Mandibular Molars:A Randomized Clinical Trial

Cairo University0 个研究点目标入组 44 人开始时间: 2018年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
44
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Double (Participant, Outcomes Assessor)

入排标准

年龄范围
22 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • - 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.

排除标准

  • - 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.

研究组 & 干预措施

2Shape rotary system

Experimental

root canal preparation using 2Shape rotary system in mandibular molars with symptomatic pulpitis

干预措施: 2Shape rotary system (Device)

Protaper Next rotary system

Active Comparator

root canal preparation using Protaper Next rotary system comparing to 2Shape rotary system in mandibular molars with symptomatic pulpitis

干预措施: 2Shape rotary system (Device)

结局指标

主要结局

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

时间窗: 3 days

using numerical rating scale ranges between (0-10) where 0 indicates no pain while 10 indicates maximum pain degree

次要结局

  • Need for / and number of analgesic tablets taken.(3 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heba Ibrahim Mohamady

Ass.lecturer of endodotics

Cairo University

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