CBCT 与 OPT 对因感染性心内膜炎住院 12 个月患者口腔健康状况的影响。 (3D STARS)
3D 成像（锥形束计算机断层扫描）与正射断层扫描对感染性心内膜炎住院 12 个月患者口腔健康状况的影响：一项多中心随机优势对照试验。
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Bordeaux、法国
- 招聘中
- CHU Bordeaux - Site Pellegrin
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接触：
- Elise ARRIVE
- 电话号码：+33/5 56 79 56 79
- 邮箱：elise.arrive@u-bordeaux.fr
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Clermont-Ferrand、法国
- 招聘中
- CHU Clermont-Ferrand
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接触：
- Magali VIDAL
- 电话号码：+33473754405
- 邮箱：mvidal@chu-clermontferrand.fr
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Grenoble、法国
- 招聘中
- CHU Grenoble
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接触：
- Cécile CHATEL
- 电话号码：+33/4 76 76 50 26
- 邮箱：cchatel1@chu-grenoble.fr
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Lyon、法国
- 招聘中
- HCL
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接触：
- Sarah MILLOT GUARD
- 电话号码：+33426680250
- 邮箱：sarah.millot-guard@chu-lyon.fr
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Marseille、法国
- 招聘中
- APHM
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接触：
- Jean-Hugues CATHERINE
- 电话号码：+33676320760
- 邮箱：jean-hugues.catherine@ap-hm.fr
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Nancy、法国
- 招聘中
- CHRU Nancy
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接触：
- Vanessa MOBY
- 电话号码：+33/3 83 39 18 00
- 邮箱：vanessa.moby@univ-lorraine.fr
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Nantes、法国
- 招聘中
- CHU Nantes
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接触：
- Astrid GARREAU
- 邮箱：astrid.garreau@chu-nantes.fr
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接触：
- Alexandra CLOITRE
- 电话号码：+33/2.40.41.29.85
- 邮箱：alexandra.cloitre@univ-nantes.fr
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Paris、法国
- 招聘中
- AP-HP - Site Bretonneau
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接触：
- MESSECA Clément
- 电话号码：+33/1 53 11 18 00
- 邮箱：clement.messeca@aphp.fr
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Toulouse、法国
- 招聘中
- CHU Toulouse
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接触：
- Sarah COUSTY
- 电话号码：+33/5.61.32.20.30
- 邮箱：cousty.s@chu-toulouse.fr
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Tours、法国
- 招聘中
- CHRU Tours
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接触：
- Frédéric DENIS
- 电话号码：+33/2 47 47 47 47
- 邮箱：frederic.denis@univ-tours.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：OPT
Orthopantomogram = current recommended clinical examination approach (comparator procedure) |
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实验性的：CBCT
Cone Beam Computed Tomography = experimental clinical examination approach (procedure under evaluation) |
Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Superiority of CBCT
大体时间：Month 12
|
Number of oral infectious foci detected using orthopantomogram versus Cone Beam Computer Tomography |
Month 12
|
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Superiority of CBCT
大体时间：Month 12
|
DFMT index comprising the number of decayed, filled and missing teeth |
Month 12
|
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Superiority of CBCT
大体时间：Month 12
|
Number of severe periodontitis sites |
Month 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Diagnostic at inclusion
大体时间：Day 0
|
Determine the diagnostic impact of clinical examination combined with CBCT at inclusion visit (Number of OIF detected at inclusion visit through clinical examination and CBCT versus clinical examination and OPT). |
Day 0
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Incident symptomatic OIF
大体时间：Month 12
|
Monitor incident symptomatic OIF occuring during the study impacting the initial personalized OIF management (Number of incident symptomatic OIF detected during the study). |
Month 12
|
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Incident asymptomatic OIF
大体时间：Month 12
|
Monitor incident asymptomatic OIF occuring during the study i.e. OIF absent at the initial examination but identified at the ultimate visit without symptomatic episode, in patients subjected to a clinical oral examination coupled with a CBCT (Number of incident asymptomatic OIF occuring during the study i.e. OIF absent at the initial examination but detected at the ultimate visit without symptomatic episode, in patients subjected to a clinical oral examination coupled with a CBCT). |
Month 12
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Oral hygiene
大体时间：Day 0 and Month 12
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Evaluate the oral hygiene of the IE patients included in the study (Oral hygiene using the Oral Hygiene Index- Simplified score (OHI-S) at inclusion visit and at the end-of-study visit). |
Day 0 and Month 12
|
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Follow-up habits
大体时间：Day 0 and Month 12
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Evaluate the follow-up habits of the IE patients included in the study by number of dental visits per year at inclusion visit and at the end-of-study visit). |
Day 0 and Month 12
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Follow-up habits
大体时间：Day 0 and Month 12
|
Evaluate the follow-up habits of the IE patients included in the study by number of dental brushings per day (specific questionnaire already validated in French version) at inclusion visit and at the end-of-study visit). |
Day 0 and Month 12
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Oral health quality of life
大体时间：Day 0 and Month 12
|
Assess the oral health quality of life of the IE patients included in this study (Oral health quality of life using by the short version of the self-administrated Oral Health impact profile-14 questionnaire (OHIP-14), at inclusion visit and at the end-of-study visit). |
Day 0 and Month 12
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Premature end of study
大体时间：Month 12
|
Analyse the patient's premature end of study (Causes of the patient's premature end of study: loss to follow-up, death, patient withdrawing consent). |
Month 12
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Impact of dental OIF
大体时间：Month 12
|
Number of dental OIF detected at the end-of-study visit through clinical examination versus number of periodontal OIF detected at the inclusion visit through clinical examination. |
Month 12
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Impact of periodontal OIF
大体时间：Month 12
|
Number of periodontal OIF detected at the end-of-study visit through clinical examination versus number of periodontal OIF detected at the inclusion visit through clinical examination. |
Month 12
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Impact of mucosal OIF
大体时间：Month 12
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Number of mucosal OIF detected at the end-of-study visit through clinical examination versus number of periodontal OIF detected at the inclusion visit through clinical examination. |
Month 12
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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