Public Assistance - Paris Hospitals
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.
Acute Myocardial Infarction
Severe Periodontitis
Carotid Atherosclerosis
Periodontal treatment
NA
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. At M12 (+12 months) : All patients (intervention group and control group) will have the same tests as M0
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 210 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI) |
| Actual Study Start Date : | 2019-08-02 |
| Estimated Primary Completion Date : | 2028-08 |
| Estimated Study Completion Date : | 2028-08 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 30 Years to 70 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Bichat Hospital, AP-HP
Paris, France,