Comprehensive Oral Intervention in Patients With AMI

Study Overview
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Brief Summary
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The investigators performed a randomized controlled trial with investigator-masked design enrolling subjects with acute myocardial infarction. The purpose of this study is to find a treatment strategy to reduce the risk of recurrence of myocardial infarction through oral hygiene improvement.

Detailed Description
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Subjects were divided into a treatment group and a control group. Both sides receive basic periodontal examinations, but the treatment group receives active dental procedure such as scaling and root planing. Both groups also receive post-myocardial infarction management. As part of a pilot study, this study used the primary outcome measure for changes in surrogate markers rather than clinical outcomes.

Official Title
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A Randomized Control Trial of Comprehensive Oral Intervention in Patients With Acute Myocardial Infarction: a Pilot Study

Conditions
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Acute Myocardial Infarction, Dental Diseases

Intervention / Treatment
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* Procedure: active dental procedure
* Drug: post-myocardial infarction management
* Radiation: basic periodontal examinations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults over 18 Patients diagnosed with type 1 or 2 MI according to the Fourth Universal Definition of Myocardial Infarction (2018) criteria Patients with baseline hsCRP (high-sensitivity C-reactive protein) elevated above 1.0 mg / dL Exclusion Criteria: clinical exclusion criteria Inability to provide informed consent Patients who are predicted to have low compliance Those whose life expectancy is less than 3 months due to cardiovascular disease or other reasons Those who are considered to be too poor condition to perform dental treatment or have a high risk of bleeding Those who need active dental treatment such as extraction Patients suspected of having active infection Those who are taking long-term systemic antibiotics or receiving immunosuppressive treatment periodontal exclusion criteria Fully edentulous (Except for fixed implant restorations) If more than 15 teeth and implants do not exist If the last dental visit experience is less than 6 months If periodontal treatment is not possible by the researcher

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is randomized controlled trial. Patients who agreed to the study were randomly assigned to the intervention group and control group at a 1: 1 ratio.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>post-myocardial infarction management basic periodontal examinations active dental procedure | Procedure: active dental procedure<br>* scaling and root planing<br>Drug: post-myocardial infarction management<br>* aspirin, clopidogrel, ticagrelor<br>* Other names: dual antiplatelet drug;Radiation: basic periodontal examinations<br>* panorama radiograph : full mouth periapical radiograph<br>|
| Active Comparator: control group<br>post-myocardial infarction management basic periodontal examinations | Drug: post-myocardial infarction management<br>* aspirin, clopidogrel, ticagrelor<br>* Other names: dual antiplatelet drug;Radiation: basic periodontal examinations<br>* panorama radiograph : full mouth periapical radiograph<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hsCRP | hsCRP(high sensitivity C-reactive protein), mg/dL | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surrogate blood markers | FBS & Total cholesterol & LDL-cholesterol & HDL-cholesterol & Triglyceride & Apolipoprotein A & Apolipoprotein B, mg/dL | at 3 months | 
| patient symptom | NYHA functional class | at 3 months & 12 months | 
| Systolic & diastolic blood pressure | automated blood pressure, mmHg | at 3 months & 12 months | 
| Exercise performance | Treadmill test | at 3 months | 
| Death | number of cardiovascular death | at 12 months | 
| unscheduled coronary revascularization | number of unscheduled coronary revascularization | at 12 months | 
| stroke | number of stroke | at 12 months | 
| HF admission | number of HF admission | at 12 months | 
| unstable angina | number of unstable angina | at 12 months | 
| recurrent MI | number of recent MI | at 12 months |