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临床试验/NCT06432712
NCT06432712尚未招募早期 1 期

Comparison of Post Operative Endodontic Pain in Patients with Irreversible Pulpitis Treated with and Without Dexamethasone.

Shoaib Rahim0 个研究点目标入组 140 人开始时间: 2025年1月10日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
尚未招募
发起方
入组人数
140
主要终点
post operative pain

研究概览

简要总结

Root canal procedure is a common procedure in dentistry. Acute inflammatory response in peri-radicular tissues after root canal treatment is the main cause of post op pain.

Potential Solution: The current study will assess effect of dexamethasone administered as periapical infiltration in reducing post-instrumentation pain.

Research Goal: Pain score of patients treated with dexamethasone infiltration will be less compared to patients treated with NSAIDS alone after canal instrumentation.

详细描述

Acute inflammatory response in peri-radicular tissues after root canal treatment is the main cause of post op pain. The peak inflammatory response occurs after 24 - 48 hours of root canal instrumentation. As management of post-endodontic pain is still a challenge for clinicians several drugs which include NSAIDs, acetaminophen, opioids and steroids are used to reduce the inflammatory response. Corticosteroids possess anti-inflammatory efficacy, and they prevent the production and release of inflammatory mediators at the site of tissue injury thus reducing the signs & symptoms of inflammation such as pain, swelling & loss of function. Dexamethasone is a potent corticosteroid that has the ability to reduce the production of proinflammatory cytokines. Dexamethasone can be administered orally, or as an intraosseous, intra ligament periapical & intracanal injection. Dexamethasone is effective in alleviating pain in first 24 hours post endodontic treatment. Previous research on the effect of dexamethasone injection on post-endodontic treatment pain in patients presenting with necrotic pulp treated with single visit endodontic treatment reported 25% post operative pain occurrence and 9% when treated with dexamethasone.

Study Goal : The current study will assess effect of dexamethasone administered as periapical infiltration in reducing post-instrumentation pain as compared to the prescription of NSAIDs only. If dexamethasone infiltration is effective in pain relief after endodontic treatment, it can be a useful adjunct in managing patients presenting with acute pulpal pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

Interventional or control group will be selected randomly through sealed envelope by an independent researcher not involved in the study.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of age 18-50 years
  • Maxillary molar and premolar teeth
  • Pt diagnosed with irreversible pulpitis with or without apical periodontitis

排除标准

  • Teeth with calcified canals.
  • Teeth with incompletely formed apices.
  • Teeth requiring retreatment.
  • Taking analgesics, anti-inflammatory, or tri-cyclic anti-depressants for their medical conditions.
  • Teeth with grade II or III mobility (more than 2 mm)
  • Pregnant patients
  • Pt who are immunocompromised (uncontrolled diabetes mellitus, renal impairment)

研究组 & 干预措施

Experimental

Experimental

Participants in this arm will receive routine root canal treatment along with 2.5ml of dexamethasone 4mg/ml peri apical infiltration with a prescription of NSAIDs post operatively.

干预措施: Dexamethasone 4mg (Drug)

结局指标

主要结局

post operative pain

时间窗: 12 hours, 24 hours and 1 week

The patient's pain response before treatment will be recorded using visual analogue scale 0-10.Pain score of 3 and less than 3 will be categorized as no postoperative pain and score greater than 3 will be categorized as post operative pain.

次要结局

未报告次要终点

研究者

发起方
Shoaib Rahim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shoaib Rahim

Assistant professor

Foundation University Islamabad

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