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NCT Number: NCT04046237

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

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.

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Key information

Conditions

Acute Myocardial Infarction Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Atherosclerosis Central Nervous System Diseases Cerebrovascular Disorders Mouth Diseases Nervous System Diseases Periodontal Diseases Periodontitis Severe Periodontitis Stomatognathic Diseases Vascular Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periodontal treatment

Other

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.

Primary outcomes

  1. Effect of treatment of severe periodontitis in patients with an AMI

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

    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

  1. Effect of treatment of severe periodontitis in patients with an AMI

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

    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

  2. Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the alveolar bone

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

    Relative ((M12-M0)/M0) and absolute (M12-M0) differences of TBR in the alveolar bone

  3. Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the thoracic aorta

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

    Relative ((M12-M0)/M0) and absolute (M12-M0) differences of mean TBR in the thoracic aorta

  4. Dysbiosis

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

    Changes in the dysbiosis index

  5. CD31 in plasma and gingival fluid

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

    Changes in concentrations of soluble CD31 in plasma and the gingival fluid

  6. Inflammatory markers concentrations in the gingival fluid and in the plasma

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

    Changes in the inflammatory markers including IL-1β, IL-6, IL-8, TNFalpha, MMP8, MMP9 concentrations in the gingival fluid and in the plasma

  7. Evaluation of overall inflammation in vascular arteries

    Time frame: At randomization

    Correlation between soluble CD31 / cleaved CD31 ratio and TBR

  8. Evaluation of TBR measurments according to glycemia values

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

    Evaluation of TBR measurments according to glycemia values measured prior to FDG-PET

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe Gabriel STEG

CONTACT

[email protected]

01 40 25 80 80

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • National Research Agency, France

Registry information

Acronym: PAROCARD

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Aug 6, 2019
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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