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Clinical Trial Summary

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.


Clinical Trial Description

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 : All patients (intervention group and control group) will have the same tests as M0 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04046237
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Philippe Gabriel STEG
Phone 01 40 25 80 80
Email gabriel.steg@aphp.fr
Status Recruiting
Phase N/A
Start date August 2, 2019
Completion date December 2024

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