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

Overview

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.

Detailed description

Eligible adults 30 to 70 years old hospitalized for an MI, (cf inclusion and non-inclusion criteria), will be asked to participate in the study. (screening)

At M0 :

* patients will be examined by a periodontist for assessing the severity of periodontitis (standard oral examination including a periodontal screening test). * Patients with severe periodontitis will then receive: Complete periodontal examination of all teeth (6 sites per tooth) including pocket depth measurement, measurement of gingival recession, plaque index, gingival bleeding index, and a gingival fluid sample. Patients will then be informed of their periodontal status and therapeutic options. At this point, the patient may decide not to follow the treatment and will not be randomized. * Patients who agree to continue the study will have a venous blood sample and a PET-FDG examination. Patients in whom the acquisition of FDG-PET is impossible will not be randomized.

At the end of these examinations, if all the conditions are met, the randomization will be carried out :

* Intervention group: Periodontal treatment, for a maximum of 6 months. At the end of the periodontal treatment, a follow-up of at least 6 months, including a maintenance visit to M9, will be performed. * Control group: patients will be referred to their treating dentist for usual care.

At M12 (+12 months) : All patients (intervention group and control group) will have the same tests as M0

Interventions

• Other Periodontal treatment
  Periodontal treatment can last up to 6 months depending on the periodontal state, followed by a follow-up period of at least 6 months including a visit to M9. Briefly, the intervention group includes initial therapy in 48 hours maximum which includes information on oral hygiene techniques (verbal + brochure), scaling and surfacing of dental roots with antiseptic irrigation and non-tooth extraction. retainable. This initial therapy is followed by a resumption of periodontal clinical measures aft

Primary outcome measures

• Effect of treatment of severe periodontitis in patients with an AMI [Time frame: 12 months (+12months) after randomization]

Secondary outcome measures (8)

• Effect of treatment of severe periodontitis in patients with an AMI [Time frame: 12 months (+12months) after randomization]
• Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the alveolar bone [Time frame: 12 months (+12months) after randomization]
• Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the thoracic aorta [Time frame: 12 months (+12months) after randomization]
• Dysbiosis [Time frame: 12 months (+12months) after randomization]
• CD31 in plasma and gingival fluid [Time frame: 12 months (+12months) after randomization]
• Inflammatory markers concentrations in the gingival fluid and in the plasma [Time frame: 12 months (+12months) after randomization]
• Evaluation of overall inflammation in vascular arteries [Time frame: At randomization]
• Evaluation of TBR measurments according to glycemia values [Time frame: 12 months (+12months) after randomization]

Eligibility criteria

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

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

Treatment

Study locations

France · 1 center

• Hôpital Bichat, AP-HP — Paris

Publications

• Lockhart PB, Bolger AF, Papapanou PN, Osinbowale O, Trevisan M, Levison ME, Taubert KA, Newburger JW, Gornik HL, Gewitz MH, Wilson WR, Smith SC Jr, Baddour LM; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young, Council on Epidemiology and Prevention, Council on Peripheral Vascular Disease, and Council on C PMID 22514251
• Tonetti MS, Van Dyke TE; working group 1 of the joint EFP/AAP workshop. Periodontitis and atherosclerotic cardiovascular disease: consensus report of the Joint EFP/AAP Workshop on Periodontitis and Systemic Diseases. J Periodontol. 2013 Apr;84(4 Suppl):S24-9. doi: 10.1902/jop.2013.1340019. PMID 23631582
• LaMonte MJ, Genco RJ, Hovey KM, Wallace RB, Freudenheim JL, Michaud DS, Mai X, Tinker LF, Salazar CR, Andrews CA, Li W, Eaton CB, Martin LW, Wactawski-Wende J. History of Periodontitis Diagnosis and Edentulism as Predictors of Cardiovascular Disease, Stroke, and Mortality in Postmenopausal Women. J Am Heart Assoc. 2017 Mar 29;6(4):e004518. doi: 10.1161/JAHA.116.004518. PMID 28356279
• Adolph M, Darnaud C, Thomas F, Pannier B, Danchin N, Batty GD, Bouchard P. Oral health in relation to all-cause mortality: the IPC cohort study. Sci Rep. 2017 Mar 15;7:44604. doi: 10.1038/srep44604. PMID 28294149
• Schmitt A, Carra MC, Boutouyrie P, Bouchard P. Periodontitis and arterial stiffness: a systematic review and meta-analysis. J Clin Periodontol. 2015 Nov;42(11):977-87. doi: 10.1111/jcpe.12467. Epub 2015 Nov 24. PMID 26465940
• Piconi S, Trabattoni D, Luraghi C, Perilli E, Borelli M, Pacei M, Rizzardini G, Lattuada A, Bray DH, Catalano M, Sparaco A, Clerici M. Treatment of periodontal disease results in improvements in endothelial dysfunction and reduction of the carotid intima-media thickness. FASEB J. 2009 Apr;23(4):1196-204. doi: 10.1096/fj.08-119578. Epub 2008 Dec 12. PMID 19074511
• Tonetti MS, D'Aiuto F, Nibali L, Donald A, Storry C, Parkar M, Suvan J, Hingorani AD, Vallance P, Deanfield J. Treatment of periodontitis and endothelial function. N Engl J Med. 2007 Mar 1;356(9):911-20. doi: 10.1056/NEJMoa063186. PMID 17329698
• Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785. PMID 25534621

Identifiers

NCT: NCT04046237 · P171104

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗