Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patie… (NCT04046237) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)
France210 participantsStarted 2019-08-02
Plain-language summary
Multicenter randomized clinical trial with two arms in patients hospitalized for an AMI nested in the Frenchie registry. Periodontal therapy is performed by periodontists in the intervention group versus treatment by dental surgeons as part of their usual practice in the control group.
For the intervention group, periodontal management will be carried out for a maximum of 6 months after randomisation, prolonged by a follow-up of 6 months including a maintenance visit at M9.
All patients will have an FDG-PET at M0 and M12 for evaluation of inflammation on carotid atherosclerotic plaques.
Who can participate
Age range
30 Years – 70 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:
* Patients hospitalized for an acute myocardial infarction and included in the Frenchie registry
* Score ≥ 5 on the screening questionnaire for periodontitis
* Six teeth at least (excluding wisdom teeth)
* Consent signature
* Affiliation to a French medical insurance (Sécurité Sociale)
Exclusion Criteria:
* Patients with diseases,other than cardiovascular and diabetes, known to change the periodontal state such as AIDS, rheumatoid arthritis, Chediak-Higashi syndrome, Papillon-Lefèvre
* Systemic antibiotic therapy\> 48 hours in the 3 months prior to inclusion
* Acute heart failure
* Uncontrolled ventricular rhythm disorders
* Impossibility for the patient to attend follow-up visits
* Impossibility to maintain the extended position for 20 minutes
* Immunosuppressive therapy\> 1 month in the 6 months prior to inclusion
* Pregnancy, breastfeeding
* Known hypersensitivity to chlorhexidine, povidone, 18-fluoro-deoxyglucose
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
Effect of treatment of severe periodontitis in patients with an AMI
Timeframe: 12 months (+12months) after randomization