Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)
NCT ID: NCT04046237
Last Updated: 2025-09-08
Study Results
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Basic Information
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RECRUITING
NA
210 participants
INTERVENTIONAL
2019-08-02
2028-08-31
Brief Summary
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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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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
70 Years
ALL
No
Sponsors
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National Research Agency, France
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Philippe Gabriel STEG
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Bichat, AP-HP
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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P171104
Identifier Type: -
Identifier Source: org_study_id
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