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临床试验/NCT02481700
NCT02481700已完成不适用

Epidemiological Study on the Surgical Removal of Third Molars

Universitaire Ziekenhuizen KU Leuven0 个研究点目标入组 6,010 人开始时间: 2015年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6,010
主要终点
Morbidity

研究概览

简要总结

The aim of this study is to get a clear view on current practice of surgical third molar removal in Belgium and the association with morbidity and complications.

For this prospective cohort study, patients who visit the outpatient department of Oral and Maxillofacial Surgery of the University Hospitals Leuven or hospitals affiliated with the Flemish Hospital Network will be participating. All included patients are referred from primary dental providers for the surgical removal of one or more third molars. Before participating, written informed consent will be recorded from all eligible subjects.

Patients consult one of the oral and maxillofacial surgeons or residents working on the department of the University Hospitals Leuven for the removal of third molars. In the standard procedure, patients are not routinely clinically monitored after one week at the department.

Pre-operative, operative and postoperative data will be collected through a questionnaire, extracted data from the patient's medical file and panoramic radiography. The surgeon's individual operation technique will be registered through a one-off questionnaire. The questionnaires are taken at the same time of consultation and includes a maximum of 8 questions per time and are considered as non-invasive and a minimal burden for the patient. Postoperatively, patients record their recovery status and ability to resume daily- and work activities at day 3 and 10 by using a dairy system and, if necessary, revisit the outpatient department of oral and maxillofacial surgery.

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
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • referred for the removal of one or more third molars

排除标准

  • other concomitant oral procedures in the same surgical session

结局指标

主要结局

Morbidity

时间窗: 10 days

Assessing pain, trismus, swelling and neurosensory disturbances

次要结局

  • Resuming daily activities(10 days)

研究者

申办方类型
Other
责任方
Sponsor

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