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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT04046237

Collaborator

National Research Agency, France (Other)

135

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction Severe Periodontitis Carotid Atherosclerosis	Other: Periodontal treatment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

135 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 2, 2019

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Effect of treatment of severe periodontitis in patients with an AMI [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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