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临床试验/NCT05091554
NCT05091554已完成不适用

Effect of Intraoral Cryotherapy Application on Postoperative Pain in Nonsurgical Endodontic Retreatment of Teeth With Apical Periodontitis: A Randomized Clinical Trial

Izmir Katip Celebi University2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2019年4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
118
试验地点
2
主要终点
Levels of postoperative pain

研究概览

简要总结

The aim of this study was to evaluate the effect of intraoral cryotherapy application on postoperative pain in single and multiple visit retreatment of teeth with symptomatic or asymptomatic apical periodontitis. This clinical trial was also investigate the potential of intraoral cryotherapy application to reduce on postoperative analgesic use of patients in line with the results obtained.

A total of 118 patients who met the inclusion criteria were selected for the study. The patients were randomly divided into two groups as single visit and multiple visit (n=59). Then, each group was randomly divided into three subgroups as control (without cryotherapy), 15 minutes of cryotherapy, and 30 minutes of cryotherapy. Twenty two teeth were retreated in each cryotherapy group and 15 teeth in each control group. Visual analogue scale (VAS) was used to evaluate and compare postoperative pain. Postoperative analgesic use of patients was also recorded.

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
None

盲法说明

In this study, double blindness was not possible because of the nature of the ice packs, the patients and the physician were aware of the cryotherapy groups. Therefore, patients were only blinded before the treatment procedures.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 and 65 year-old patients.
  • Patients with pre-treated teeth diagnosed with symptomatic or asymptomatic apical periodontitis.
  • Patients who can tolerate the treatment physically and mentally.

排除标准

  • The presence of any systemic disease,
  • the presence of any allergic reactions or pregnancy,
  • use of any analgesic or antibiotic medication within 7 days,
  • use of corticosteroid within 6 months,
  • severe periodontal disease (periodontal pockets >3 mm) in the pretreated tooth,
  • surgical endodontic treatment,
  • having drainage,
  • periapical index (PAI) score 1 and 2,
  • excessively curved, excessively long or short roots, calcified or resorbed root canals,
  • immature apices,
  • complications like perforation, overfilling, broken files

结局指标

主要结局

Levels of postoperative pain

时间窗: 1 week

The primary endpoint in calculating the sample size was to obtain visual analog scale (VAS) values. The intensity of postoperative pain was evaluated with visual analogue scale, which is a 10 cm line representing a continuum of pain levels between "no pain" on the left side and "most severe pain" on the right side between 0 and 10.

次要结局

  • Rate of analgesic use(1 week)

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

emrah karataslioglu

Assoc. Prof. Dr.

Izmir Katip Celebi University

研究点 (2)

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