Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorAssistance Publique - Hôpitaux de Paris

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Periodontal treatment

    Other intervention

    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 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

210 Participants
are divided into 2 treatment groups
Group A: Usual treatment - Control groupNo intervention 0 interventions
Group B: Periodontal treatment - Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 months (+12months) after randomization

Secondary outcomes

1

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

Time frame
12 months (+12months) after randomization
2

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

Time frame
12 months (+12months) after randomization
3

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

Time frame
12 months (+12months) after randomization
4

Dysbiosis

Changes in the dysbiosis index

Time frame
12 months (+12months) after randomization

Other outcomes

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