Effectiveness of Bromelain Supplement in Reduction of Facial Swelling Caused by Orthognathic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in Volume of Swelling
研究概览
简要总结
The goal of this clinical trial is to learn if Bromelain Supplement works to decrease the amount of swelling or the amount of time swelling is present following jaw surgery. It will also learn about the safety of Bromelain supplement. The main questions it aims to answer are:
Does Bromelain decrease facial swelling following orthognathic, or jaw, surgery? Does Bromelain supplement decrease the amount of time that patients are swollen following orthognathic, or jaw, surgery?
Participants will:
Take Bromelain supplement once daily for 9 days total. Take 2 days before surgery and 7 days following surgery.
Keep a log of when the bromelain supplement is taken as well as another other medications.
Visit the clinic with pre and post surgical protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing orthognathic surgery
排除标准
- •craniofacial anomalies
- •incomplete patient data
- •systemic disease that could affect healing
- •allergy to latex or pineapple
- •under 18 years of age
- •non english speaking
研究组 & 干预措施
Control
Standard of care
Bromelain Supplement
1000mg bromelain supplement once a day, 2 days prior to and 7 days following surgery
干预措施: Bromelain (Dietary Supplement)
结局指标
主要结局
Change in Volume of Swelling
时间窗: Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6
Images will be obtained with the Vectra 3D imaging system to look at the volume of swelling in patients that undergo orthognathic surgery and measured in Cubic Centimeters. Will also have a heat map to visually show where swelling has increased or decreased since previously obtained imaging. All these images and measurements will be compared between the control and experimental groups.
Duration of Swelling following Orthognathic Surgery
时间窗: Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6
Images will be obtained with the Vectra 3D imaging system to look at the volume of swelling in patients that underwent orthognathic surgery at multiple time periods. With comparisons of these multiple photos the duration of swelling can be assessed and compared to the average amount of time it takes swelling to go down in a patient not taking bromelain supplement.
次要结局
未报告次要终点
研究者
Mohamed Bazina
Assistant Professor
University of Kentucky