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临床试验/NCT00805298
NCT00805298已完成不适用

Assessment of the Operative Course in Connection With Removal of Lower Third Molars With Particular Consideration to the Occurence of Pain and Swelling

University of Aarhus1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2008年8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
入组人数
154
试验地点
1
主要终点
postoperative pain

研究概览

简要总结

The aim of this study is to compare postoperative complications after removal of lower third molars using two different types of anaesthetics and two different treatments against swelling and inflammation (methylprednisolone and placebo). The hypothesis is that a combination of a long-duration anaesthetic combined methylprednisolone will result in significantly less postoperative pain and inflammation.

Patients will have both lower third molars removed on two separate occasions. Each patient is randomly assigned to receive one type of local anaesthetic the first time and the other type the second time. Furthermore patients are randomised to receive either methylprednisolone or placebo the first time and the opposite treatment the second time.

During the week after surgery patients fill out a questionnaire with questions about level of pain and swelling at different times as well as the patients' perception of other postoperative complications. The patient is examined by a dentist on the 2nd and 7th day after surgery, where postoperative complications are recorded and thermographic images of the patient's face are taken to assess the degree of inflammation.

详细描述

Background: After removal of lower third molars complications can occur, including pain, swelling, infection and sensory disturbances. As pain intensity has been shown to be worst during the first 4-8 hours post surgery, it might be relevant to use a local anaesthetic with long duration, e.g. bupivacaine, instead of the traditionally used lidocaine. Several studies have focussed on the effect of non-steroid anti-inflammatory drugs (such as glucocorticoids, e.g. methylprednisolone) to reduce postoperative swelling. However, no studies comparing the effect of bupivacaine combined with methylprednisolone and lidocaine combined with methylprednisolone have been conducted.

Aim: To compare postoperative complications after removal of lower third molars using 1) lidocaine, 2) lidocaine combined with methylprednisolone, 3) bupivacaine and 4) bupivacaine combined with methylprednisolone.

Methods: The study compares type end extension of postoperative complications after removal of lower third molars using four different combinations of local anaesthetics and anti-inflammatory treatment. The study is conducted as a double blinded, split mouth crossover trial, where each patient has both lower third molars removed at two different occasions.

Patients are randomised to receive one type of local anaesthetic the first time and the other type the second time. Furthermore patients are randomised to receive either methylprednisolone or placebo the first time and the opposite treatment the second time.

An objective assessment of postoperative swelling and inflammation is made by means of thermographic imaging of the operated side compared to the opposite side after the operation and at 2 and 7 days post surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
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

  • age ≥ 18 years
  • two impacted or semi-impacted lower third molars with indication for removal
  • signed informed consent

排除标准

  • allergy to study drugs or ingredients
  • need for sedation
  • pregnancy
  • systemic disease besides asthma/hay fever

研究组 & 干预措施

methylprednisolone

Active Comparator

干预措施: methylprednisolone (Drug)

placebo

Placebo Comparator

干预措施: placebo (Drug)

lidocaine

Active Comparator

干预措施: xyloplyin adrenalin (Drug)

bupivacaine

Active Comparator

干预措施: marcain adrenalin (Drug)

结局指标

主要结局

postoperative pain

时间窗: within the first week after surgery

postoperative inflammation

时间窗: within the first week after surgery

次要结局

  • use of analgesics(within one week after surgery)
  • absence from work(within one week after surgery)
  • trismus(within one week after surgery)
  • alveolitis (dry socket)(within one week after surgery)
  • sensory disturbance(within one week after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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