Effectiveness of Periodontitis Treatment on the Metabolic Activity of Symptomatic Carotid Atheros… (NCT06484036) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of Periodontitis Treatment on the Metabolic Activity of Symptomatic Carotid Atherosclerotic Plaque Responsible for Ischemic Stroke
157 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage evolution (relative evolution) of patients with Target-to-Background (TBR) becomes <1.6 (threshold).
Timeframe: At 6 months
2
Number of patients with Target-to-Background (TBR) becomes <1.6 (threshold).