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临床试验/NCT03005522
NCT03005522已完成不适用

The Effects of Dexamethasone on the Time to Pain Resolution in Dental Periapical Abscess

University of Arizona1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2017年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
1
主要终点
Decrease Time of Oral Pain

研究概览

简要总结

An individual's quality of life can be seriously affected by the severity of dental pain. The emergency department is a common place to find those seeking relief from their dental pain- often times seeking removal of the affected tooth, dental anesthetic injections or oral pain medications. There are a number of dental infections that cause this type of debilitating pain. One such dental infection is termed periapical abscess. This infection involves the tooth pulp. These infections can arise in three ways: introduction through a defect in the enamel and dentin; from a periodontal pocket or an adjacent tooth; or hematogenous seeding of the pulp from mechanical irritation. As this disease process continues there are a number of complications including chronic pain and, more seriously, the spread of infection into deep spaces which can be a life threatening condition.

The Emergency Department treatment of this infection includes pain control, antibiotics and dental referral for ultimate management of the infection.

The purpose of our study is to investigate whether the addition of oral steroids will alter the time until patient experiences improvement in their dental pain. Steroids are a commonly used anti-inflammatory that is used in the Emergency Departmentfor the purpose of pain relief from throat pain. As the pain from periapical infection is thought to be largely from the pressure we speculate that the anti-inflammatory effects of steroids may decrease the inflammation thus the pressure and may ultimately lead to a decrease in time until the patient experiences some relief from their pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Patients included if they had clinical diagnosis of pulpitis/dental apical abscess and physical exam revealed pain with percussion of the affected tooth/teeth plus or minus evidence of periapical abscess (gingival erythema, swelling, draining pus). Written informed consent was obtained from each patient prior to enrollment in the study.-

排除标准

  • Younger than 18 years old
  • Immunosuppression : HIV patient, transplant patient, chemotherapy
  • History of diabetes
  • Recent (<1 month) or chronic steroid use
  • Hospitalization required due to intractable vomiting/pain
  • Pregnancy, self report

研究组 & 干预措施

placebo

Placebo Comparator

dosed with placebo

干预措施: Placebo Oral Capsule (Drug)

intervention

Active Comparator

10mg oral dexamethasone

干预措施: oral dexamethasone (Drug)

结局指标

主要结局

Decrease Time of Oral Pain

时间窗: 72 hours

The purpose of this study is to investigate whether the addition of oral steroids will alter the time until patient experiences improvement in their dental pain from an acute dental periapical abscess. The patients will be randomized to receive either dexamethasone or placebo. The patients will be contacted over a period 72 hours to assess their level of pain resolution. Pain was reported using a verbal numeric scale in which 10=maximum pain and 0=no pain

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

Noah Tolby

Principle Investigator

University of Arizona

研究点 (1)

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