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

A

Assistance Publique - Hôpitaux de Paris

Status

Not yet enrolling

Conditions

Ischemic Stroke
Severe Periodontitis

Treatments

Procedure: periodontal treatment strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT06484036
APHP230861

Details and patient eligibility

About

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.

Enrollment

157 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

157 participants in 2 patient groups

Group with periodontal treatment strategy
Experimental group
Description:
Group with periodontal treatment strategy, in addition to routine care and secondary prevention of ischemic stroke
Treatment:
Procedure: periodontal treatment strategy
Group without periodontal treatment
No Intervention group
Description:
Group without periodontal treatment, with routine care and secondary prevention of ischemic stroke

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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