Treatment of periodontal disease results in improvements in endothelial dysfunction and reduction of the carotid intima-media thickness.
Stefania Piconi, Daria Trabattoni, Cristina Luraghi...
https://pubmed.ncbi.nlm.nih.gov/19074511/Actively Recruiting
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-08
210
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the impact of treating severe periodontitis on inflammation in atherosclerotic plaques among adults aged 30 to 70 who have been hospitalized for an acute myocardial infarction AMI. This multicenter randomized clinical trial compares specialized periodontal therapy performed by periodontists against usual dental care by dental surgeons. The study is nested within the Frenchie registry and aims to understand how periodontal treatment affects vascular inflammation and heart-related outcomes. Participants who have severe periodontitis will be randomly assigned to one of two groups the intervention group receives periodontal treatment lasting up to 6 months with follow-up care including a maintenance visit at month 9, while the control group continues with usual dental care provided by their own dentist. Both groups will undergo FDG-PET scans at the start and after 12 months to assess inflammation in carotid atherosclerotic plaques. Additional clinical periodontal assessments and blood samples will also be taken during the study. Throughout the trial, participants will have detailed oral examinations, blood draws, and imaging at baseline and 12 months. The study measures include the effect of periodontal treatment on inflammatory activity, vascular inflammation, and related biomarkers. Follow-up visits help monitor oral health and treatment adherence. The total participation time spans about 12 months, including treatment and observation periods, with safety and inflammation outcomes carefully evaluated.
CONDITIONS
Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)
P
Philippe Gabriel STEG
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Assistance Publique - Hôpitaux de Paris
Lead Sponsor
National Research Agency, France
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 6 months
Participants with severe periodontitis receive periodontal treatment lasting up to 6 months, which includes initial therapy with oral hygiene instruction, scaling and root planing, and possibly periodontal surgeries depending on improvement. This is followed by a maintenance period of repeated simple scaling sessions.
Initial therapy visit, follow-up visit at 6 weeks, and additional treatment or maintenance visits as needed during 6 months
Duration - At least 6 months
After completing periodontal treatment, participants are followed for at least 6 months with maintenance visits, including a visit at Month 9, to monitor periodontal health and inflammatory activity.
Follow-up visits including a maintenance visit at Month 9
Duration - 1 day
All participants, including those in the control group referred for usual dental care, undergo the same tests as at the start of the trial to assess the impact of periodontal treatment on inflammatory activity 12 months after randomization.
1 visit (in-person) at Month 12
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/25688694/Assistance Publique - Hôpitaux de Paris
Lead Sponsor
National Research Agency, France
Collaborating Sponsor