SMILE: A Randomized Trial of Preoperative Dental Screening for the Prevention of Endocarditis, Reoperation or Death in Patients Undergoing Surgical or Transcatheter Cardiac Valve Intervention.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 1,300
- 试验地点
- 5
- 主要终点
- Composite outcome of death, redo-intervention, or infective endocarditis
研究概览
简要总结
This randomized, multicenter, open-label trial evaluates whether preoperative dental screening improves outcomes in patients undergoing surgical or transcatheter cardiac valve intervention. Participants are randomized 1:1 to preoperative dental screening or no screening. The primary outcome is time to first occurrence of all-cause death, redo-intervention of the index valve, or definite infective endocarditis within 2 years. The study uses registry-based follow-up to ensure complete outcome ascertainment.
详细描述
Infective endocarditis is associated with high morbidity and mortality in patients with prosthetic heart valves. Current recommendations for preoperative dental screening are based on observational data, and randomized evidence is lacking.
This is a pragmatic, multicenter, randomized controlled trial conducted in Sweden. Patients accepted for surgical or transcatheter valve intervention are randomized 1:1 to:
- Preoperative dental screening
- No preoperative dental screening
Dental treatment in the intervention group is performed according to clinical practice. No routine dental screening is performed in the control group.
The primary endpoint is a composite of all-cause death, redo-intervention of the index valve, and definite infective endocarditis within 2 years.
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
- Single (Outcomes Assessor)
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
- •Age ≥18 years
- •Accepted for cardiac valve intervention
- •Able to provide informed consent
排除标准
- •Previous or ongoing infective endocarditis
- •Urgent surgery
- •Pain from loose tooth/teeth
- •Immunosuppressive therapy (excluding corticosteroids)
- •Inability to provide informed consent
- •Expected loss to follow-up
研究组 & 干预措施
Preoperative dental screening
Preoperative dental examination with treatment if clinically indicated.
干预措施: Preoperative dental screening (Other)
No preoperative dental screening
No routine dental screening prior to valve intervention.
干预措施: No preoperative dental screening (Other)
结局指标
主要结局
Composite outcome of death, redo-intervention, or infective endocarditis
时间窗: 2 years
Time to first occurrence of all-cause death, redo-intervention of the index valve, or definite infective endocarditis.
次要结局
- Redo-intervention of index valve(2 years)
- Definite infective endocarditis(2 years)
- CIED extraction(2 years)
- Quality of life (EQ-5D-5L score)(3 months)
- All-cause mortality(2 years)
- Oral health (GOHAI score)(3 months)
- Quality of life (EQ-5D-5L index and VAS score)(3 months)
研究者
Patrik Gilje
Principal Investigator
Region Skane