3D Imaging (Cone Beam Computed Tomography) Versus Orthopantomogram on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis: a Multicenter Randomized Superiority Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 17
- 主要终点
- Superiority of CBCT
研究概览
简要总结
1. Infective Endocarditis (IE) is a rare and serious disease with high morbidity and mortality; 2. Streptoccoci of oral origin are the second more frequent microorganisms responsible for IE; 3. Oral Infectious Foci (OIF) are underdetected using the current recommended clinical examination/Orthopantomogram (OPT) approach; 4. Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF than OPT; 5. To date, no study has been performed to assess the potential benefit of a clinical examination/CBCT approach on the oral health status in IE patients.
Thus, conducting a randomized controlled trial is highly desirable to assess the potential impact of a clinical examination/CBCT approach on the oral health status of patients hospitalized for IE and potentially to reduce IE new episodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized or recently hospitalized for definite IE according to the 2015 ESC classification, naive patients for dental examination and imaging, whatever the IE responsible microorganism;
- •Patients with a stable clinical state, meaning stabilized IE patients out of the critical phase, compatible with the performance of an OPT and a CBCT;
- •Patients whose life expectancy is expected to be longer than 6 months;
- •Patients who agree to visit the dental department of the hospital to carry out OIF eradication or at his/her personal dentist;
- •Patients over 18 years old;
- •Patients affiliated to a Social Security or a health insurance scheme;
- •Patients who have given informed consent to participate to the study.
排除标准
- •OPT or CBCT already performed before the inclusion of the patients in the study and available for the investigator during the patient's hospitalization.
- •Medical contraindications to perform OPT or CBCT imaging;
- •Absence of microbiologic identification of the IE responsible microorganism;
- •Pregnant or breastfeeding women;
- •Patients unable to give informed consent to participate to the study (under trusteeship, guardianship and legal protection).
研究组 & 干预措施
OPT
Orthopantomogram = current recommended clinical examination approach (comparator procedure)
CBCT
Cone Beam Computed Tomography = experimental clinical examination approach (procedure under evaluation)
干预措施: CBCT (Diagnostic Test)
结局指标
主要结局
Superiority of CBCT
时间窗: Month 12
Number of oral infectious foci detected using orthopantomogram versus Cone Beam Computer Tomography
次要结局
- Diagnostic at inclusion(Day 0)
- Incident symptomatic OIF(Month 12)
- Incident asymptomatic OIF(Month 12)
- Oral hygiene(Day 0 and Month 12)
- Oral health quality of life(Day 0 and Month 12)
- Premature end of study(Month 12)
- Impact of dental OIF(Month 12)
- Impact of periodontal OIF(Month 12)
- Impact of mucosal OIF(Month 12)
- Follow-up habits(Day 0 and Month 12)