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临床试验/NCT03567369
NCT03567369Unknown不适用

Comparative Study of the Preoperative Efficacy of Traumeel Versus Dexamethasone in Control of Pain, Swelling and Trismus After Mandibular Third Molar Extractions

Federal University of the Valleys of Jequitinhonha and Mucuri1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年4月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
17
试验地点
1
主要终点
Postoperative sequelae following thir molar extraction

研究概览

简要总结

To compare the efficacy of intramuscular injection of two anti-inflammatory drugs, Traumeel and Dexamethasone, used in the control of postoperative complications pain, edema and trismus after third molar extraction mandibular

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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 with indication of asymptomatic bilateral extractions of lower third molars;
  • Aged 18 years or older;
  • Have a good health and no disease.

排除标准

  • Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation

研究组 & 干预措施

Dexamethasone

Experimental

Dexamethasone 4,0 mg / mL

干预措施: Dexamethasone (Drug)

Traumeel S

Experimental

Traumeel 2,2 mg / mL

干预措施: Traumeel S (Drug)

结局指标

主要结局

Postoperative sequelae following thir molar extraction

时间窗: up to seven days postoperative

During the postoperative intervals of 24, 48 and 72 hours and seven days, the swelling was determined using linear measures in the face and trismus by maximum mouth opening. The postoperative pain was self-recorded by the patient using visual analogue scale in 72 hours with an interval of eight hours

次要结局

未报告次要终点

研究者

发起方
Federal University of the Valleys of Jequitinhonha and Mucuri
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcos Luciano Pimenta Pinheiro

Principal Investigator

Federal University of the Valleys of Jequitinhonha and Mucuri

研究点 (1)

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