Comprehensive Oral Intervention in Patients With AMI

Seoul National University

Status: Unknown

Conditions: Acute Myocardial Infarction; Dental Diseases

Treatments: Procedure: active dental procedure; Radiation: basic periodontal examinations; Drug: post-myocardial infarction management

Study type: Interventional

Funder types: Other

Identifiers

NCT04012541

AMI oral intervention

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

1. 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

2. 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

treatment group

Experimental group

Description:

1. post-myocardial infarction management 2. basic periodontal examinations 3. active dental procedure

Treatment:

Drug: post-myocardial infarction management

Procedure: active dental procedure

Radiation: basic periodontal examinations

control group

Active Comparator group

Description:

1. post-myocardial infarction management 2. basic periodontal examinations

Treatment:

Drug: post-myocardial infarction management

Radiation: basic periodontal examinations