About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Periodontal treatment
Other interventionPeriodontal 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 to M9. Briefly, the intervention group includes initial therapy in 48 hours maximum which includes information on oral hygiene techniques (verbal + brochure), scaling and surfacing of dental roots with antiseptic irrigation and non-tooth extraction. retainable. 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.
Treatment groups
Trial outcomes
Primary outcomes
Effect of treatment of severe periodontitis in patients with an AMI
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
Secondary outcomes
Effect of treatment of severe periodontitis in patients with an AMI
Relative difference of the most-diseased segment (MDS) Tissue to Background ratio (TBR) ((M12-M0)/M0) of the Most-Diseased Segment (MDS) -Target to Background Ratio (TBR) measured at the segment with the highest activity
Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the alveolar bone
Relative ((M12-M0)/M0) and absolute (M12-M0) differences of TBR in the alveolar bone
Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the thoracic aorta
Relative ((M12-M0)/M0) and absolute (M12-M0) differences of mean TBR in the thoracic aorta
Dysbiosis
Changes in the dysbiosis index
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
National Research Agency, France
Collaborator