Effectiveness of Periodontitis Treatment on the Metabolic Activity of Symptomatic Carotid Atherosclerotic Plaque Responsible for Ischemic Stroke

NCT ID: NCT06484036

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2028-09-01

Brief Summary

Cardiovascular disease is the world's leading cause of death. Atherothrombosis is a common cause of ischemic stroke.

A strong epidemiological link has been established between periodontitis and the risk of stroke. It shares common risk factors with atherothrombosis, and its severe form is associated with low-grade systemic inflammation and daily low-intensity bacteremia. Atherothrombosis is a frequent cause of ischemic stroke.

Periodontal bacteria have been found within atheromatous plaques, correlated with a greater risk of rupture.

Thus, periodontitis could be a modifiable risk factor for atherothrombosis and future vascular events: its early diagnosis and treatment could have a major impact on cardiovascular prevention.

Hypothesis: In patients with periodontitis who have had an ischemic stroke, periodontal treatment may reduce atherosclerotic plaque activity.

Conditions

Severe Periodontitis; Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group with periodontal treatment strategy

Group with periodontal treatment strategy, in addition to routine care and secondary prevention of ischemic stroke

Group Type: EXPERIMENTAL

periodontal treatment strategy

Intervention Type: PROCEDURE

Periodontal treatment sessions (Experimental Group only) (1 to 3 months) after randomization

Group without periodontal treatment

Group without periodontal treatment, with routine care and secondary prevention of ischemic stroke

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

periodontal treatment strategy

Periodontal treatment sessions (Experimental Group only) (1 to 3 months) after randomization

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Minor ischemic stroke of the anterior circulation (NIHSS ≤ 5) of atherothrombotic origin according to the TOAST scale <30 days
• Atheroma plaque of the ipsilateral carotid bulb >30% not eligible for intervention (endarterectomy or angioplasty-stenting)
• Severe periodontitis (stage 3 or 4)
• Signed informed consent
• Affiliation to a social security scheme

Exclusion Criteria

• < 6 teeth
• Without independent oral hygiene
• Contraindications to PET scan
• Known allergy to fluoro-deoxyglucose and its excipient
• Immunosuppressive treatment
• Uncontrolled diabetes
• High risk of infective endocarditis
• Organ transplant pending
• Progressive infectious diseases
• Active smoking not stopped
• Patient deprived of liberty by judicial or administrative decision
• Patient under legal protection (guardianship, curatorship)
• Participation in another interventional research involving humans or being in the exclusion period following previous research involving humans
• Pregnant or breastfeeding woman Patient under AME (state medical aid)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

APHP230861

Identifier Type: -

Identifier Source: org_study_id