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临床试验/NCT03708081
NCT03708081已完成不适用

Comparative Evaluation of Different File Systems in Postoperative Pain: Randomize Clinical Study

Bulent Ecevit University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Post operative pain

研究概览

简要总结

Postoperative pain is a frequent complication associated with root canal treatment. The apical extrusion of irrigant and debris, including bacteria and necrotic tissue, may lead to postoperative pain, periapical inflammation, and flare-ups. The instrumentation technique and the file design may affect the amount of debris extrusion.

The aim of this study was to evaluate the influence of instrumentation techniques on the incidence and intensity of postoperative pain after single-visit root canal treatment.

详细描述

Sixty patients having root canal treatment indication and a single root canal were included in the study. The patients were randomly assigned into 2 groups according to root canal instrumentation technique used. In group 1; ProTaper Next (Dentsply Maillefer, Ballaigues, Switzerland) instruments with rotational motion, in group 2 TF Adaptive (SybronEndo, Orange, CA) instruments with adaptive motion were used for root canal treatments. Root canal treatment was carried out in a single visit and the severity of postoperative pain was assessed via a four-point pain intensity scale. All the participants were called through the phone at 12, 24 and 48h to obtain the pain scores. Data were analyzed using the Mann Whitney-U, Friedman and Wilcoxon tests.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • having root canal treatment indication
  • single root canal

排除标准

  • previously treated tooth

结局指标

主要结局

Post operative pain

时间窗: 2 days

Postoperative pain which occurs after root canal instrumentation and measured with a commonly used scale named 'four-point pain intensity scale' for pain intensity. Patients were instructed postoperatively to express their pain according to the staed scale ranging between no pain and severe pain. The scale consists of 4 scores ranging between 1-4. The pain categories were as follows; 1. no pain; 2. mild pain (slight discomfort, no need for treatment); 3. moderate pain (pain relieved by medication); 4. severe pain (pain and/or swelling not relieved by simple analgesic medication and unscheduled visit required). For patients having no pain score 1, for patients having slight pain in case of no medication score 2 , and score 3 in case of any requirement of medication due to moderate pain, and score 4 for patients having severe pain with the requirement of an unscheduled visit were accepted. The higher values represent more pain intensity.

次要结局

未报告次要终点

研究者

发起方
Bulent Ecevit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa Murat Koçak

Associate professor

Bulent Ecevit University

研究点 (1)

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