Cryotherapy to Improve Outcomes in Lower Third Molar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Post-operative pain
研究概览
简要总结
This study is looking to see whether cooling the face using a special cooling device (Hilotherm®) before and during the removal of wisdom teeth will reduce the pain and discomfort patients feel after the procedure. The surgical removal of lower third molars (wisdom teeth) is arguably the most commonly performed surgical procedure worldwide. If this study shows that application of cold before and throughout the procedure is a simple way to reduce post-operative symptoms, it could benefit thousands of patients every year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18+ years requiring surgical removal of a single (unilateral) mandibular wisdom tooth
- •Tooth requiring full mucoperiosteal flap and bone removal for removal of tooth
- •Written informed consent
排除标准
- •Patients refusing to give written informed consent
- •Clinically significant or unstable physical or mental disability rendering the participants incapable of complying with the study protocol as judged by the investigator
- •Pregnant women
- •Patients taking long-term anti-microbial or anti-inflammatory drugs
- •Patients requiring pre-operative antibiotics for surgery
- •Patients requiring concomitant extractions or contralateral lower 3rd molar removal
研究组 & 干预措施
Hilotherm® Device
Patients undergo removal of lower third molar with Hilotherm® cooling device applied.
干预措施: Hilotherm® cooling device and face mask (Device)
Control
Patients undergo removal of lower third molar without the Hilotherm® cooling device applied.
结局指标
主要结局
Post-operative pain
时间窗: 7 days
Post operative pain 7 days after operation as measured in mm from VAS scale
次要结局
未报告次要终点