About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
< 6 teeth
Without independent oral hygiene
Contraindications to PET scan
Known allergy to fluoro-deoxyglucose and its excipient
Trial design
Parallel
Treatments tested in this trial
periodontal treatment strategy
Procedure/SurgeryPeriodontal treatment sessions (Experimental Group only) (1 to 3 months) after randomization
Treatment groups
Trial outcomes
Primary outcomes
Percentage evolution (relative evolution) of patients with Target-to-Background (TBR) becomes <1.6 (threshold).
The evolution of the metabolic activity of the atherosclerotic plaque measured by the Target-to-Background ratio (TBR) measured by PET scan after injection of 18-FDG at 6 months versus at baseline in percentage evolution (relative evolution) and in number of patients for whom the TBR becomes \<1.6 (threshold).
Number of patients with Target-to-Background (TBR) becomes <1.6 (threshold).
The evolution of the metabolic activity of the atherosclerotic plaque measured by the Target-to-Background ratio (TBR) measured by PET scan after injection of 18-FDG at 6 months versus at baseline in percentage evolution (relative evolution) and in number of patients for whom the TBR becomes \<1.6 (threshold).
Secondary outcomes
Absolute change on Target-to-Background (TBR) ratio
Nominal change in atherosclerotic plaque metabolic activity measured by Target-to-Background (TBR) ratio measured by PET scan after 18-FDG injection at 6 months versus at baseline (absolute change).
Proportion of TBR success becomes <1.6
cardiovascular event
ischemic stroke
Locations
Sponsors and contacts
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