Effectiveness of Periodontitis Treatment on the Metabolic Activity of Symptomatic Carotid Atherosclerotic Plaque Responsible for Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: periodontal treatment strategy.
- Who it may be relevant to
- Registry conditions: Severe Periodontitis, Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Periodontitis Treatment on the Metabolic Activity of Symptomatic Carotid Atherosclerotic Plaque Responsible for Ischemic Stroke: a Multicenter Randomized Controlled Trial: a Multicenter Randomized Controlled Trial
Overview
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.
Interventions
- Procedure periodontal treatment strategy
Periodontal treatment sessions (Experimental Group only) (1 to 3 months) after randomization
Primary outcome measures
- Percentage evolution (relative evolution) of patients with Target-to-Background (TBR) becomes <1.6 (threshold). [Time frame: At 6 months]
- Number of patients with Target-to-Background (TBR) becomes <1.6 (threshold). [Time frame: At 6 months]
Secondary outcome measures (11)
- Absolute change on Target-to-Background (TBR) ratio [Time frame: At 6 months]
- Proportion of TBR success becomes <1.6 [Time frame: At 6 months]
- cardiovascular event [Time frame: At 12 months]
- ischemic stroke [Time frame: At 12 months]
- Atherothrombotic event [Time frame: At 12 months]
- Acute coronary syndrome [Time frame: At 12 months]
- Limb ischemia [Time frame: At 12 months]
- Mortality [Time frame: At 12 months]
- Difference in hs-CRP measurement [Time frame: 6 months and 12 months]
- Difference in Lp-PLA2 measurement [Time frame: 6 months and 12 months]
- Serious and non-serious adverse events [Time frame: up to 12 Months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06484036 · APHP230861