Acute Myocardial Infarction (AMI), Periodontal Disease
Conditions
Brief summary
The aim of this study is to establish a shared database of acute myocardial infarction patients with periodontitis, to clarify the clinical benefits of periodontitis intervention on acute myocardial infarction patients through simulated RCT study, and to establish a high-level database of acute myocardial infarction patients with periodontitis, so as to promote the application of oral health intervention in clinical practice.
Interventions
PROCEDUREPeriodontal surgery
In the intervention group, patients underwent a comprehensive periodontal evaluation conducted by periodontists at a dental clinic. All permanent teeth, except for third molars, were assessed using dental mirrors and periodontal probes. Each tooth was examined at four sites (vestibular, distal, lingual, and mesial) to evaluate visible plaque, probing depth, probing bleeding, and attachment loss. During the first treatment session, patients were provided with information about periodontal disease, emphasizing the importance of controlling supragingival bacterial biofilms for successful treatment. Plaque-retentive factors (calculus) were removed. Temporary materials were used to restore carious lesions, root remnants were extracted, and maladaptive restorations were adjusted. Supragingival calculus was removed using periodontal scalers, followed by cleaning with a rubber cup, prophylaxis paste, dental floss, and/or interdental brushes. No prophylactic antibiotics were used prior to the
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This study employs a simulated randomized controlled trial (RCT) design to evaluate the effects of periodontal health interventions on patients with myocardial infarction (MI) complicated by periodontitis. The study mimics the framework of a traditional randomized controlled trial but does not involve formal randomization of participants. Participants are allocated into intervention and control groups in a structured manner to minimize bias, ensuring comparability.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1)Patients diagnosed with ST-segment elevation myocardial infarction (STEMI). 2)Patients with severe periodontal disease, defined as: * 5 teeth with clinical attachment loss (CAL) ≥ 4 mm. * Subgingival probing depth (PD) ≥ 6 mm. ③≥ 8 teeth with gingival bleeding on probing (BOP). 3）Age ≥30 years. 4）Written informed consent provided.
Exclusion criteria
* 1\) under 30 years old; 2) HIV positive, chronic inflammation, tumor disease, drug dependence, use of anticonvulsants, use of immunosuppressive agents, pregnancy, and lactation; 3) significant tooth loss (number of remaining teeth \< 8); 4) long hospital stay (\>10 days), new myocardial infarction before randomization, and stent thrombosis; 5) Refusal to sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in ejection fraction | From enrollment to the end of treatment at 6 months | The ejection fraction (EF) changed by 10% half a year after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular death and MACE events were recorded | From enrollment to the end of treatment at 6 months, a maximum of 12 months. | — |
| level of proBNP | From enrollment to the end of treatment at 6 months | The outcome will be assessed by measuring the level of plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP), a biomarker reflecting cardiac stress and heart failure. |
Countries
China
Contacts
Primary ContactJiawen Wu
Outcome results
None listed