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临床试验/NCT00006175
NCT00006175已完成不适用

Cytokine Responses to Acute Inflammation in the Oral Surgery Model

National Institute of Dental and Craniofacial Research (NIDCR)1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2000年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
1

研究概览

简要总结

This study will measure levels of an enzyme called cyclooxygenase in gum tissue following third molar (wisdom tooth) extraction. Cyclooxygenase is thought to contribute to pain that normally follows tissue injury or surgery.

Healthy volunteers between 16 and 35 years of age who require removal of their third molars may be eligible for this study. Participants will receive an injection of a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein before surgery. Before the tooth is removed, a small tissue sample (biopsy) will be collected from the gum tissue covering one of the lower third molars to be extracted. After surgery, a second biopsy will be taken at some point between just after surgery to the time when pain from the extraction starts to develop. These tissue samples will be analyzed for cyclooxygenase levels.

Patients will stay in the clinic for up to 4 hours after surgery while the anesthetic wears off. During this time, they will complete pain questionnaires. If needed, patients may receive additional medicine for pain relief at any time during the surgery or the 4-hour observation period. They will also be given standard pain medication to take home at the end of the study.

详细描述

Prostanoids are inflammatory mediators that have been implicated in all stages of acute and chronic inflammation. The inhibition of prostanoid synthesis by NSAIDs forms the basis of their therapeutic as well as side effects. NSAIDs directly inhibit cyclooxygenase [COX], which leads to reduction of prostaglandin synthesis but also to gastric erosions, inhibition of platelet aggregation and nephrotoxicity. The identification of the two isoforms of COX lead to the hypothesis that COX-2 is responsible for the production of prostaglandins following tissue injury, while COX-1 is involved in normal homeostasis. This hypothesis is primarily based on the results of animal studies and chronic inflammatory conditions such as arthritis. Recent results in the oral surgery model of acute inflammation suggest that COX-2 is present in the oral mucosa and may contribute to prostanoid production during acute inflammation rather than require induction in response to the injury. The proposed study aims to evaluate the time course of COX-1 and COX-2 in acute inflammation by evaluating levels of mRNA at baseline prior to surgery, at the completion of surgery, and at one, two and three hours following surgery.

研究设计

研究类型
Observational

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

发起方
National Institute of Dental and Craniofacial Research (NIDCR)
申办方类型
Nih

研究点 (1)

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