跳至主要内容
临床试验/NCT04700995
NCT04700995已完成不适用

Postoperative Pain After Endodontic Retreatment Using Different Rotary or Reciprocating Instruments: A Randomized, Controlled Clinical Trial

Trakya University2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
2
主要终点
Postoperative pain after removal of gutta-percha using four different NiTi systems.

研究概览

简要总结

The aim of this randomized clinical trial was to compare the incidence, intensity and duration of postoperative pain following the removal of root canal obturation materials canals using rotary (ProTaper Universal or Hyflex EDM) or reciprocating file (Reciproc Blue or WaveOne Gold) systems. The null hypothesis tested was that there is no difference in postoperative pain following the retreatment procedure between the four systems used.

详细描述

Postoperative pain (PP) is not a certain reason for the long term success of root canal treatment. However, PP control is important for patient comfort and satisfaction. Apical extrusion of debris containing dentin, necrotic pulp tissue, microorganisms, and/or irrigation solutions may occur during retreatment procedures which may result in the induction of periapical inflammation, postoperative pain, and delayed periapical healing. All available techniques and instruments are associated with apical extrusion of debris to some degree during the root canal preparation or removal of the obturation materials. The aim of this randomized clinical trial was to compare the incidence, intensity and duration of postoperative pain following the removal of root canal obturation materials canals using rotary or reciprocating file systems.

Patients referred for non-surgical endodontic retreatment were included. Hundred and eighty cases were selected on the basis of the determined inclusion criteria and randomly allocated to four groups (n = 45).

ProTaper Universal group D1, D2 and D3 files were used respectively with a full rotational motion with a endodontic motor until working was reached as recommended by the manufacturer.

Hylex EDM group Hylex EDM files were used with a full rotational motion with a endodontic motor until the working was reached.

Reciproc Blue group R25 files were used with a reciprocating motion using with the "RECIPROC ALL" mode with a slow in-and-out pecking motion, and the amplitude of pecking movements did not exceed 3 mm until the working lenght was reached.

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
Double (Participant, Outcomes Assessor)

盲法说明

double-blind

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy patient who has a failed root canal treatment.
  • Asymptomatic single rooted teeth that had an initial root canal filling diagnosed with chronic apical periodontitis.
  • Patients agreed to parcitipate in the study

排除标准

  • Overfilled teeth,
  • teeth with intraradicular posts,
  • existence of a sinus tract,
  • consumption of antibiotics or analgesics within one month,
  • pregnancy,
  • history of trauma,
  • traumatic occlusion

结局指标

主要结局

Postoperative pain after removal of gutta-percha using four different NiTi systems.

时间窗: 24 hours postoperatively

Pain intensity was evaluated at 24 hours after retreatment procedures. An 11 item numerical rating scale (NSR) was used to assess the pain. The NSR is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The number 0 represents "no pain" wheres number 10 represents "pain as bad as someone can imagine". All patients were requested to mark a number corresponding to their average pain.

次要结局

  • Postoperative pain after removal of gutta-percha using four different NiTi systems.(24 to 48 hours postoperatively)

研究者

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

Burhan Can Çanakçi

Assistant Professor

Trakya University

研究点 (2)

Loading locations...

相似试验