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临床试验/NCT05722704
NCT05722704已完成不适用

Effect of Cryotherapy and Occlusal Reduction on Post-endodontic Pain in Patients With Symptomatic Apical Periodontitis

Gulf Medical University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年9月12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
2
主要终点
The Level of Post-endodontic Pain

研究概览

简要总结

The goal of this clinical trial is to compare Cryotherapy with occlusal reduction in the reduction of post-endodontic pain in molars with symptomatic apical periodontitis. The main question it aims to answer is:

Is there is a difference in post-endodontic pain intensity following cryotherapy or occlusal reduction in patients with symptomatic apical periodontitis on mandibular first molars?

Participants will undergo root canal treatment including cryotherapy or post-operative occlusal reduction.

Researchers will compare [Cryotherapy, occlusal reduction, and no intervention] to see the intensity of post-endodontic pain.

详细描述

The study will be conducted on 60 first mandibular molars; with 20 first mandibular molars in each group (n=20). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 3. The resultant number will determine in which group the participants will be placed. Double blinding will be maintained in this study as the operator and the patients will not be aware of their group/used root canal irrigant.

Group I : normal room temperature saline irrigation protocol without occlusal reduction.

Group II : normal room temperature saline irrigation protocol with occlusal reduction.

Group III : final irrigation with cold saline (2.5 C°- 4 C°) without occlusal reduction.

Procedural steps:

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)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-70 years
  • A patient diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis
  • require endodontic therapy
  • Mandibular first molars that are diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis
  • Healthy patients without systemic disease
  • Permanent mature first mandibular molars

排除标准

  • Medically compromised patients
  • Pregnant patients
  • Teeth with incomplete apex formation
  • Teeth with calcified canals
  • Periapical abscess
  • Patients on antibiotic therapy

结局指标

主要结局

The Level of Post-endodontic Pain

时间窗: 72 hours

Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)

次要结局

未报告次要终点

研究者

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

Rania Zaarour

Assistant Professor of Cell Biology and Researcher

Gulf Medical University

研究点 (2)

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