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临床试验/NCT06268912
NCT06268912已完成不适用

Cryoanalgesia: Temperature Modulation for Pain Management in Irreversible Pulpitis a Randomized Clinical Trial

Universitat Internacional de Catalunya2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年9月7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
20
试验地点
2
主要终点
Assessment of Pain and Anxiety

研究概览

简要总结

The aim of the present study was to evaluate the effectiveness of pulpal anesthesia in pain control during endodontic treatment by lowering the temperature of the injected plain 3% cold Mepivacaine (5ºC) compared to 3% Mepivacaine at room temperature in teeth with irreversible pulpitis.

详细描述

Mepivacaine has some advantages over other anesthetics. The investigators wanted to compare whether changing temperature could improve its effectiveness in cases of irreversible 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
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All Patients within the age group of 18-100 years old,
  • Patients diagnosed of irreversible pulpitis.

排除标准

  • Moderate to pulp necrosis,
  • Previous initiated treatment.
  • Pregnancy or lactation.
  • Allergy or problems to any substances used in the study,
  • Acute apical abscess.
  • Chronic apical abscess.
  • Unrestorable teeth.
  • Unsuccessful anesthesia technique (no lip numbness for lower molars or positive response to cold test).

结局指标

主要结局

Assessment of Pain and Anxiety

时间窗: 1 visit of 1 hour

Pain during injection, caries removal, access cavity, and instrumentation were recorded. The patients received a full description of the procedure, and patients were asked to rate their current pain and their anxiety with a descriptive scale (Heft-Parker Visual Analog Scale (VAS) before starting the treatment. A visual analog scale of 170 mm that the start points on the left side means "no pain" and the endpoint on the right side means "severe pain". The participants indicated their pain level by marking a point on the scale that best represented their experience. For data interpretation, the Visual Analog Scale (VAS) was segmented into four categories: no pain corresponded to 0 mm on the scale, mild pain as greater than 0 and ≤54mm, moderate pain defined as greater than 54 mm and less than 114 mm and severe pain defined as 114 mm or more.

次要结局

未报告次要终点

研究者

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

Gonzalo Gómez Val

Clinical Professor

Universitat Internacional de Catalunya

研究点 (2)

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