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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periodontal Health Intervention Group | Experimental | Participants in this arm will receive comprehensive periodontal health interventions, including:
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| Standard Care Group | No Intervention | Participants in this arm will receive standard care without specific periodontal interventions. This includes routine medical management for myocardial infarction, as per standard clinical guidelines, without structured periodontal treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periodontal surgery | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in ejection fraction | The ejection fraction (EF) changed by 10% half a year after surgery | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiawen Wu | Contact | 86+17717070557 | chloewuu@foxmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tenth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200092 | China |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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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.
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| From enrollment to the end of treatment at 6 months |