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临床试验/NCT05860686
NCT05860686尚未招募不适用

Does Post-operative Rinsing With a Monoject Syringe Result in as Much Post-operative Pain After Surgical Removal of Lower Impact Third Molars as no Post-operative Rinsing: a Randomized Controlled Equivalence Trial

Isala0 个研究点目标入组 150 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
Isala
入组人数
150
主要终点
NRS pain

研究概览

简要总结

Many authors have advocated different methods of treating alveolar osteitis. Despite many years of research, however, little progress has been made and so a study with large enough sample and standard outcome measures is warranted.

Goal of this study is assess the effect of postoperative use of a monoject syringe on postoperative complaints after surgical removal of a lower third molar.

详细描述

One of the most common postoperative complications after the removal of a third molar is a condition known as dry socket. This term has been in use since 1896. Since then several other terms have been used, including alveolar osteitis, postoperative alveolitis, alveolitis, sicca dolorosa and fibriniolytic alveolitis. Bim labelled the complication fibrinolytic alveolitis which is the most accurate of the terms, but also the least used. The condition has generally been characterised by delayed healing associated with degradadtion of clot, and is usually accompanied by persistent, radiating, pain postoperativively in and around the extraction site that is not easily relieved by analgesics. Because of the pain, swelling and trismus, patients also tend to have a greater need for painkillers. If it is possible to reduce the amount and severity of postoperative pain felt by patients the postoperative period would be more endurable, the quality of life will be less affected, and in addition to this it is possible that the amount of analgesics taken by patients after surgery could be lowered7. It can be a burden for both patients an surgeons and my result in a loss of productivity because at least 45% of patients require multiple visits to the surgeon.

Objective of the study:

Many authors have advocated different methods of treating alveolar osteitis. Despite many years of research, however, little progress has been made and so a study with large enough sample and standard outcome measures is warranted.

Goal of this study is assess the effect of postoperative use of a monoject syringe on postoperative complaints after surgical removal of a lower third molar

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria: patients over 18 years of age (non-smoking) referred for removal of a wisdom tooth in the mandible. Patient has ASA I.

排除标准

  • Patient is younger than 18 years
  • Patient has an ASA of II,III en IV
  • Patient has only one maxillary third molar that needs to be extracted/removed
  • Patient has an active pericoronitis
  • In case of planned coronectomy
  • Patient has trismus
  • Patient has chronic pain
  • Patient is pregnant
  • Patient has a known allergy for ibuprofen of other NSAID's
  • Patient has a known allergy for articaine of epinefrine
  • Intra-operative compilations for example excessive bleeding

结局指标

主要结局

NRS pain

时间窗: 7 days after treatment

pain score

次要结局

未报告次要终点

研究者

发起方
Isala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeroen van der Sleen

Oral an Maxillo facial surgeon

Isala

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