Actively Recruiting

Phase Not Applicable
Age: 30Years - 70Years
All Genders
ID04046237

Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-08

210

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

N

National Research Agency, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)

Who Can Participate

Age: 30Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients hospitalized for an acute myocardial infarction and included in the Frenchie registry
  • Score 25 5 on the screening questionnaire for periodontitis
  • At least six teeth present (excluding wisdom teeth)
  • Signed consent to participate
  • Affiliated with French medical insurance (S�e9curit�e9 Sociale)
Not Eligible

You will not qualify if you...

  • Diseases other than cardiovascular and diabetes known to affect periodontal health such as AIDS, rheumatoid arthritis, Chediak-Higashi syndrome, or Papillon-Lef�e8vre syndrome
  • Systemic antibiotic therapy longer than 48 hours within 3 months before inclusion
  • Acute heart failure
  • Uncontrolled ventricular rhythm disorders
  • Unable to attend follow-up visits
  • Unable to maintain extended position for 20 minutes
  • Immunosuppressive therapy longer than 1 month within 6 months before inclusion
  • Pregnancy or breastfeeding
  • Known allergy to chlorhexidine, povidone, or 18-fluoro-deoxyglucose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

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

Follow-up

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

Final Evaluation

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

Trial Site Locations

Total: 1 location

1

Hôpital Bichat, AP-HP

Paris, France

Actively Recruiting

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Research Team

P

Philippe Gabriel STEG

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Periodontal disease and atherosclerotic vascular disease: does the evidence support an independent association?: a scientific statement from the American Heart Association.

Peter B Lockhart, Ann F Bolger, Panos N Papapanou...

https://pubmed.ncbi.nlm.nih.gov/22514251

Periodontitis and atherosclerotic cardiovascular disease: consensus report of the Joint EFP/AAP Workshop on Periodontitis and Systemic Diseases.

Maurizio S Tonetti, Thomas E Van Dyke, working group 1 of the joint EFP/AAP workshop

https://pubmed.ncbi.nlm.nih.gov/23631582

History of Periodontitis Diagnosis and Edentulism as Predictors of Cardiovascular Disease, Stroke, and Mortality in Postmenopausal Women.

Michael J LaMonte, Robert J Genco, Kathleen M Hovey...

https://pubmed.ncbi.nlm.nih.gov/28356279

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