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

Last updated: February 24, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Heart Defect

Congestive Heart Failure

Treatment

Periodontal treatment

Clinical Study ID

NCT04046237
P 171104
  • Ages 30-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients hospitalized for an acute myocardial infarction and included in theFrenchie 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

Exclusion Criteria:

  • Patients with diseases,other than cardiovascular and diabetes, known to change theperiodontal 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

Study Design

Total Participants: 210
Treatment Group(s): 1
Primary Treatment: Periodontal treatment
Phase:
Study Start date:
August 02, 2019
Estimated Completion Date:
August 31, 2028

Study 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 (+12 months) : All patients (intervention group and control group) will have the same tests as M0

Connect with a study center

  • Hôpital Bichat, AP-HP

    Paris,
    France

    Active - Recruiting

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