Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Effect of treatment of severe periodontitis in patients with an AMI
研究概览
简要总结
Multicenter randomized clinical trial with two arms in patients hospitalized for an AMI nested in the Frenchie registry. Periodontal therapy is performed by periodontists in the intervention group versus treatment by dental surgeons as part of their usual practice in the control group.
For the intervention group, periodontal management will be carried out for a maximum of 6 months after randomisation, prolonged by a follow-up of 6 months including a maintenance visit at M9.
All patients will have an FDG-PET at M0 and M12 for evaluation of inflammation on carotid atherosclerotic plaques.
详细描述
Eligible adults 30 to 70 years old hospitalized for an MI, (cf inclusion and non-inclusion criteria), will be asked to participate in the study. (screening)
At M0 :
- patients will be examined by a periodontist for assessing the severity of periodontitis (standard oral examination including a periodontal screening test).
- Patients with severe periodontitis will then receive: Complete periodontal examination of all teeth (6 sites per tooth) including pocket depth measurement, measurement of gingival recession, plaque index, gingival bleeding index, and a gingival fluid sample. Patients will then be informed of their periodontal status and therapeutic options. At this point, the patient may decide not to follow the treatment and will not be randomized.
- Patients who agree to continue the study will have a venous blood sample and a PET-FDG examination. Patients in whom the acquisition of FDG-PET is impossible will not be randomized.
At the end of these examinations, if all the conditions are met, the randomization will be carried out :
- Intervention group: Periodontal treatment, for a maximum of 6 months. At the end of the periodontal treatment, a follow-up of at least 6 months, including a maintenance visit to M9, will be performed.
- Control group: patients will be referred to their treating dentist for usual care.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized for an acute myocardial infarction and included in the Frenchie registry
- •Score ≥ 5 on the screening questionnaire for periodontitis
- •Six teeth at least (excluding wisdom teeth)
- •Consent signature
- •Affiliation to a French medical insurance (Sécurité Sociale)
排除标准
- •Patients with diseases,other than cardiovascular and diabetes, known to change the periodontal state such as AIDS, rheumatoid arthritis, Chediak-Higashi syndrome, Papillon-Lefèvre
- •Systemic antibiotic therapy> 48 hours in the 3 months prior to inclusion
- •Acute heart failure
- •Uncontrolled ventricular rhythm disorders
- •Impossibility for the patient to attend follow-up visits
- •Impossibility to maintain the extended position for 20 minutes
- •Immunosuppressive therapy> 1 month in the 6 months prior to inclusion
- •Pregnancy, breastfeeding
- •Known hypersensitivity to chlorhexidine, povidone, 18-fluoro-deoxyglucose
研究组 & 干预措施
Usual treatment - Control group
The patient is referred to his treating dentist with a diagnosis report of his oral state including his periodontal status.
The usual care usually includes the extraction of non-preservable teeth, the dental prosthesis to replace them and at least one descaling session.
Periodontal treatment - Intervention group
Periodontal treatment can last up to 6 months depending on the periodontal state, followed by a follow-up period of at least 6 months including a visit at M9.
Briefly, the intervention group includes initial therapy with information on oral hygiene techniques, scaling and surfacing of dental roots. This initial therapy is followed by a resumption of periodontal clinical measures after 6 weeks. Depending on the degree of improvement of the measurements, the treatment is either completed, or continues with further scaling-surfacing and / or performing one or more periodontal surgeries. Periodontal monitoring period often called "maintenance" includes repeated sessions of simple scaling whose rate does not exceed 4 per year.
干预措施: Periodontal treatment (Other)
结局指标
主要结局
Effect of treatment of severe periodontitis in patients with an AMI
时间窗: 12 months (+12months) after randomization
The primary endpoint will be the absolute difference of the Most-Diseased Segment (MDS) -Target to Background Ratio (TBR) measured at the segment with the highest activity on carotid arteries between the initial PET scan and the PET scan performed at 12 months (+12months) after randomization
次要结局
- Effect of treatment of severe periodontitis in patients with an AMI(12 months (+12months) after randomization)
- Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the thoracic aorta(12 months (+12months) after randomization)
- Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the alveolar bone(12 months (+12months) after randomization)
- Dysbiosis(12 months (+12months) after randomization)
- CD31 in plasma and gingival fluid(12 months (+12months) after randomization)
- Inflammatory markers concentrations in the gingival fluid and in the plasma(12 months (+12months) after randomization)
- Evaluation of TBR measurments according to glycemia values(12 months (+12months) after randomization)
- Evaluation of overall inflammation in vascular arteries(At randomization)