A Randomized Control Trial of Comprehensive Oral Intervention in Patients With Acute Myocardial Infarction: a Pilot Study
active dental procedure
+ post-myocardial infarction management
+ basic periodontal examinations
Stomatognathic Diseases
Prevention Study
Summary
Study start date: July 5, 2019
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.68 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Seoul National University Bundang Hospital
Seongnam-si, South KoreaOpen Seoul National University Bundang Hospital in Google Maps