Acute Myocardial InfarctionPAROCARDNCT04046237
Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)
A study testing Periodontal treatment in people with Acute Myocardial Infarction and Severe Periodontitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Acute Myocardial Infarction, Severe Periodontitis, Carotid Atherosclerosis
- What is being tested?
- Periodontal treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 2 Aug 2019to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Immunosuppressive therapy> 1 month in the 6 months prior to inclusion
- Pregnancy, breastfeeding
- Known hypersensitivity to chlorhexidine, povidone, 18-fluoro-deoxyglucose
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Bichat, AP-HP
Paris
Philippe Gabriel STEG, 01 40 25 80 80, gabriel.steg@aphp.fr
About this study
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.
Read the 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
- Being tested
- Periodontal treatment
- Keywords
- Acute Myocardial Infarction, Severe Periodontitis, FDG-PET, Carotid Atherosclerosis
- Medical subject headings
- Periodontitis, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal treatmentOther
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 after 6 weeks. Depending on the degree of improvement of the measurements, the treatment is either completed, or continues with further scaling-surfacing and / or performing one or more periodontal surgeries. Periodontal monitoring period often called "maintenance" includes repeated sessions of simple scaling whose rate does not exceed 4 per year.
| Study group | Role | What they receive |
|---|---|---|
| Usual treatment - Control group | No intervention | The patient is referred to his treating dentist with a diagnosis report of his oral state including his periodontal status. The usual care usually includes the extraction of non-preservable teeth, the dental prosthesis to replace them and at least one descaling session. |
| Periodontal treatment - Intervention group | Experimental | 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 at M9.
Briefly, the intervention group includes initial therapy with information on oral hygiene techniques, scaling and surfacing of dental roots. This initial therapy is followed by a resumption of periodontal clinical measures after 6 weeks. Depending on the degree of improvement of the measurements, the treatment is either completed, or continues with further scaling-surfacing and / or performing one or more periodontal surgeries. Periodontal monitoring period often called "maintenance" includes repeated sessions of simple scaling whose rate does not exceed 4 per year. Receives: Other: Periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of treatment of severe periodontitis in patients with an AMI
The primary endpoint will be the absolute difference of the Most-Diseased Segment (MDS) -Target to Background Ratio (TBR) measured at the segment with the highest activity on carotid arteries between the initial PET scan and the PET scan performed at 12 months (+12months) after randomization
Measured: 12 months (+12months) after randomization
Secondary outcomes (8)
Effect of treatment of severe periodontitis in patients with an AMI
Relative difference of the most-diseased segment (MDS) Tissue to Background ratio (TBR) ((M12-M0)/M0) of the Most-Diseased Segment (MDS) -Target to Background Ratio (TBR) measured at the segment with the highest activity
Measured: 12 months (+12months) after randomization
Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the alveolar bone
Relative ((M12-M0)/M0) and absolute (M12-M0) differences of TBR in the alveolar bone
Measured: 12 months (+12months) after randomization
Impact of periodontitis treatment on the intensity of global inflammatory activity measured in the thoracic aorta
Relative ((M12-M0)/M0) and absolute (M12-M0) differences of mean TBR in the thoracic aorta
Measured: 12 months (+12months) after randomization
Dysbiosis
Changes in the dysbiosis index
Measured: 12 months (+12months) after randomization
CD31 in plasma and gingival fluid
Changes in concentrations of soluble CD31 in plasma and the gingival fluid
Measured: 12 months (+12months) after randomization
Inflammatory markers concentrations in the gingival fluid and in the plasma
Changes in the inflammatory markers including IL-1β, IL-6, IL-8, TNFalpha, MMP8, MMP9 concentrations in the gingival fluid and in the plasma
Measured: 12 months (+12months) after randomization
Evaluation of overall inflammation in vascular arteries
Correlation between soluble CD31 / cleaved CD31 ratio and TBR
Measured: At randomization
Evaluation of TBR measurments according to glycemia values
Evaluation of TBR measurments according to glycemia values measured prior to FDG-PET
Measured: 12 months (+12months) after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start2 Aug 2019
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Philippe Gabriel STEG, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046237
- Sponsor's protocol ID
- P171104
- Acronym
- PAROCARD
- Status last verified
- Feb 2025
- First submitted
- 2 Aug 2019
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 Clinical Cardiology. Periodontal disease and atherosclerotic vascular disease: does the evidence support an independent association?: a scientific statement from the American Heart Association. Circulation. 2012 May 22;125(20):2520-44. doi: 10.1161/CIR.0b013e31825719f3. Epub 2012 Apr 18.
PubMed 22514251Tonetti 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.
PubMed 23631582LaMonte 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.
PubMed 28356279Adolph 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.
PubMed 28294149Schmitt 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.
PubMed 26465940Piconi 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.
PubMed 19074511Tonetti 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.
PubMed 17329698Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.
PubMed 25534621Eke PI, Dye BA, Wei L, Slade GD, Thornton-Evans GO, Borgnakke WS, Taylor GW, Page RC, Beck JD, Genco RJ. Update on Prevalence of Periodontitis in Adults in the United States: NHANES 2009 to 2012. J Periodontol. 2015 May;86(5):611-22. doi: 10.1902/jop.2015.140520. Epub 2015 Feb 17.
PubMed 25688694Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.
PubMed 25261053Bahekar AA, Singh S, Saha S, Molnar J, Arora R. The prevalence and incidence of coronary heart disease is significantly increased in periodontitis: a meta-analysis. Am Heart J. 2007 Nov;154(5):830-7. doi: 10.1016/j.ahj.2007.06.037. Epub 2007 Aug 20.
PubMed 17967586Pussinen PJ, Alfthan G, Jousilahti P, Paju S, Tuomilehto J. Systemic exposure to Porphyromonas gingivalis predicts incident stroke. Atherosclerosis. 2007 Jul;193(1):222-8. doi: 10.1016/j.atherosclerosis.2006.06.027. Epub 2006 Jul 26.
PubMed 16872615Reyes L, Herrera D, Kozarov E, Roldan S, Progulske-Fox A. Periodontal bacterial invasion and infection: contribution to atherosclerotic pathology. J Clin Periodontol. 2013 Apr;40 Suppl 14:S30-50. doi: 10.1111/jcpe.12079.
PubMed 23627333Pessi T, Karhunen V, Karjalainen PP, Ylitalo A, Airaksinen JK, Niemi M, Pietila M, Lounatmaa K, Haapaniemi T, Lehtimaki T, Laaksonen R, Karhunen PJ, Mikkelsson J. Bacterial signatures in thrombus aspirates of patients with myocardial infarction. Circulation. 2013 Mar 19;127(11):1219-28, e1-6. doi: 10.1161/CIRCULATIONAHA.112.001254. Epub 2013 Feb 15.
PubMed 23418311Offenbacher S, Beck JD, Moss K, Mendoza L, Paquette DW, Barrow DA, Couper DJ, Stewart DD, Falkner KL, Graham SP, Grossi S, Gunsolley JC, Madden T, Maupome G, Trevisan M, Van Dyke TE, Genco RJ. Results from the Periodontitis and Vascular Events (PAVE) Study: a pilot multicentered, randomized, controlled trial to study effects of periodontal therapy in a secondary prevention model of cardiovascular disease. J Periodontol. 2009 Feb;80(2):190-201. doi: 10.1902/jop.2009.080007.
PubMed 19186958
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)
- ClinicalTrials.gov ID
- NCT04046237
- Acronym / sponsor ID
- PAROCARD / P171104
- Keywords
- Acute Myocardial Infarction, Severe Periodontitis, FDG-PET, Carotid Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual treatment - Control group | No intervention | –The patient is referred to his treating dentist with a diagnosis report of his oral state including his periodontal status. The usual care usually includes the extraction of non-preservable teeth, the dental prosthesis to replace them and at least one descaling session. |
| Periodontal treatment - Intervention group | Experimental | Other: Periodontal treatmentPeriodontal 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 at M9. Briefly, the intervention group includes initial therapy with information on oral hygiene techniques, scaling and surfacing of dental roots. This initial therapy is followed by a resumption of periodontal clinical measures after 6 weeks. Depending on the degree of improvement of the measurements, the treatment is either completed, or continues with further scaling-surfacing and / or performing one or more periodontal surgeries. Periodontal monitoring period often called "maintenance" includes repeated sessions of simple scaling whose rate does not exceed 4 per year. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal treatmentPeriodontal 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 after 6 weeks. Depending on the degree of improvement of the measurements, the treatment is either completed, or continues with further scaling-surfacing and / or performing one or more periodontal surgeries. Periodontal monitoring period often called "maintenance" includes repeated sessions of simple scaling whose rate does not exceed 4 per year. | Other | Periodontal treatment - Intervention group |
Primary outcome
Effect of treatment of severe periodontitis in patients with an AMI
Time frame: 12 months (+12months) after randomization
The primary endpoint will be the absolute difference of the Most-Diseased Segment (MDS) -Target to Background Ratio (TBR) measured at the segment with the highest activity on carotid arteries between the initial PET scan and the PET scan performed at 12 months (+12months) after randomization
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 22514251Lockhart 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 Clinical Cardiology. Periodontal disease and atherosclerotic vascular disease: does the evidence support an independent association?: a scientific statement from the American Heart Association. Circulation. 2012 May 22;125(20):2520-44. doi: 10.1161/CIR.0b013e31825719f3. Epub 2012 Apr 18.
- Background: PubMed 23631582Tonetti 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.
- Background: PubMed 28356279LaMonte 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.
- Background: PubMed 28294149Adolph 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.
- Background: PubMed 26465940Schmitt 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.
- Background: PubMed 19074511Piconi 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.
- Background: PubMed 17329698Tonetti 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.
- Background: PubMed 25534621Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.
- Background: PubMed 25688694Eke PI, Dye BA, Wei L, Slade GD, Thornton-Evans GO, Borgnakke WS, Taylor GW, Page RC, Beck JD, Genco RJ. Update on Prevalence of Periodontitis in Adults in the United States: NHANES 2009 to 2012. J Periodontol. 2015 May;86(5):611-22. doi: 10.1902/jop.2015.140520. Epub 2015 Feb 17.
- Background: PubMed 25261053Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.
- Background: PubMed 17967586Bahekar AA, Singh S, Saha S, Molnar J, Arora R. The prevalence and incidence of coronary heart disease is significantly increased in periodontitis: a meta-analysis. Am Heart J. 2007 Nov;154(5):830-7. doi: 10.1016/j.ahj.2007.06.037. Epub 2007 Aug 20.
- Background: PubMed 16872615Pussinen PJ, Alfthan G, Jousilahti P, Paju S, Tuomilehto J. Systemic exposure to Porphyromonas gingivalis predicts incident stroke. Atherosclerosis. 2007 Jul;193(1):222-8. doi: 10.1016/j.atherosclerosis.2006.06.027. Epub 2006 Jul 26.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philippe Gabriel STEG principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal treatment in people with Acute Myocardial Infarction and Severe Periodontitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Gabriel STEG (01 40 25 80 80, gabriel.steg@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of treatment of severe periodontitis in patients with an AMI (time frame: 12 months (+12months) after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04046237, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.