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

  • End date
    Dec 27, 2024
  • participants needed
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 27 April 2022
myocardial infarction


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.


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

Condition Acute Myocardial Infarction, Severe Periodontitis, Carotid Atherosclerosis
Treatment Periodontal treatment
Clinical Study IdentifierNCT04046237
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on27 April 2022


Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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