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临床试验/NCT01603498
NCT01603498已完成不适用

Preemptive Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery: a Split-mouth Randomized Triple-blind Clinical Trial

Federal University of the Valleys of Jequitinhonha and Mucuri1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
Postoperative sequelae following thir molar extraction

研究概览

简要总结

The main aim of the present study was to investigate the effect of preemptive dexamethasone and methylprednisolone to prevent pain, swelling and limitation in mouth opening following third molar extraction.

详细描述

Third molar surgery is often associated with significant post-surgical sequelae. The trauma caused to soft and bony tissue can result in considerable pain, swelling and trismus. Symptoms begin gradually having a peak 2 days after extraction. The use of corticosteroids such as dexamethasone and methylprednisolone can be a valuable tool when performing moderate to moderately severe oral surgical procedures. No clear consensus have emerged yet regarding patient selection, dosage, timing and type of administration of steroid. In this light, this clinical trial aim to compare the effect of preemptive dexamethasone and methylprednisolone to prevent pain, swelling and limitation in mouth opening following third molar extraction.

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
Quadruple (Participant, Care Provider, 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 8mg

Experimental

干预措施: Dexamethasone (Drug)

Methylprednisolone

Experimental

Methylprednisolone 40mg

干预措施: Methylprednisolone (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

  • Analgesic consumption; duration of surgery(up to 7 days)

研究者

发起方
Federal University of the Valleys of Jequitinhonha and Mucuri
申办方类型
Other
责任方
Sponsor

研究点 (1)

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