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临床试验/NCT00921479
NCT00921479招募中不适用

Postoperative Course and Quality of Life Following Surgical Removal of the Mandibular 3. Molar

Ullevaal University Hospital2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2005年6月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
2
主要终点
Oral Health Impact Profile (OHIP-14)

研究概览

简要总结

The purpose of this study is to determine how quality of life changes after surgical removal of wisdom teeth

详细描述

A significant percentage of patients are subjected to surgical removal of 3. molars every year. The surgical mucosal and osseous procedure may lead to postoperative discomfort including pain, for the patient. Information with respect to how patients regard the impact of this surgical treatment on oral health including pain and swelling is of great interest. More precise information about the postoperative course following this surgery will be beneficial in improving clinical treatment procedures with respect to alleviating the patients' postoperative period.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of either sex of Caucasian origin, between the age of 18 and 45, who are candidates for surgical removal of one mandibular

排除标准

  • Chronic drug treatment (except birth control medication) with analgesics, anti-inflammatory treatment (both steroidal (SAIDs) and non-steroidal anti-inflammatory drugs (NSAIDs)) apart from standard postoperative analgesic treatment administered by the operator.
  • The necessity for anti-microbial drugs.
  • Pregnant or lactating women.
  • Patients with diabetes.
  • Patients who due to age or communication skills are considered unable to complete patient forms.
  • Professional evaluation suggests an alteration of the planned surgical area or treatment form.
  • Surgery exceeding 45 minutes, from time of first incision to completed suturing.
  • Known or assumed intolerance or hypersensibility to ibuprofen (standard postoperative analgesic treatment).
  • Known or assumed intolerance or hypersensibility to the standard local anaesthetic Xylocain-adrenalin (lidocaine-adrenalin).
  • Consumption of alcohol in the period from 2 days before or until the end of the primary observation period (postoperative days 0-7.

结局指标

主要结局

Oral Health Impact Profile (OHIP-14)

时间窗: 7 days

Measure functional status of the oral cavity

次要结局

  • Norwegian Translated Short-Form McGill Pain Questionnaire (NTSF-MPQ)(7 days)
  • Corahs Dental Anxiety Scale (CDAS)(1 day)
  • Pain Intensity (0-10 Numerical Rating Scale)(7 days)
  • Norwegian McGill Pain Questionnaire (NMPQ)(7 days)
  • Subjective Swelling Assessment (0-10 Numerical rating Scale)(7 Days)

研究者

发起方
Ullevaal University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lasse Ansgar Skoglund

Professor

Oslo University Hospital

研究点 (2)

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