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

April 4, 2022 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 : All patients (intervention group and control group) will have the same tests as M0

Study Type

Interventional

Enrollment (Anticipated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France
        • Recruiting
        • Hôpital Bichat, AP-HP
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual treatment - Control group

The patient is referred to his treating dentist with a diagnosis report of his oral state including his periodontal status.

The usual care usually includes the extraction of non-preservable teeth, the dental prosthesis to replace them and at least one descaling session.
Experimental: Periodontal treatment - Intervention group

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 at M9.

Briefly, the intervention group includes initial therapy with information on oral hygiene techniques, scaling and surfacing of dental roots. 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.
Other: Periodontal treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of treatment of severe periodontitis in patients with an AMI
Time Frame: 12 months 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 after randomization
12 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of treatment of severe periodontitis in patients with an AMI
Time Frame: 12 months 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
12 months after randomization
Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the alveolar bone
Time Frame: 12 months after randomization
Relative ((M12-M0)/M0) and absolute (M12-M0) differences of TBR in the alveolar bone
12 months after randomization
Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the thoracic aorta
Time Frame: 12 months after randomization
Relative ((M12-M0)/M0) and absolute (M12-M0) differences of mean TBR in the thoracic aorta
12 months after randomization
Dysbiosis
Time Frame: 12 months after randomization
Changes in the dysbiosis index
12 months after randomization
CD31 in plasma and gingival fluid
Time Frame: 12 months after randomization
Changes in concentrations of soluble CD31 in plasma and the gingival fluid
12 months after randomization
Inflammatory markers concentrations in the gingival fluid and in the plasma
Time Frame: 12 months 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
12 months after randomization
Evaluation of overall inflammation in vascular arteries
Time Frame: At randomization
Correlation between soluble CD31 / cleaved CD31 ratio and TBR
At randomization
Evaluation of TBR measurments according to glycemia values
Time Frame: 12 months after randomization
Evaluation of TBR measurments according to glycemia values measured prior to FDG-PET
12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

National Research Agency, France

Investigators

  • Principal Investigator: Philippe Gabriel STEG, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2019

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

August 2, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P 171104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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