Comprehensive Oral Intervention in Patients With AMI

NCT ID: NCT04012541

Last Updated: 2019-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-05

Study Completion Date

2021-03-31

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.

Conditions

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Acute Myocardial Infarction Dental Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
Participating patients and dentists are not able to blind information about random allocation. However, in order to reduce the bias, the cardiologist who treats the patient and prescribes the medicines performs an investigator-masked design that masks information about the treatment group.

Study Groups

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treatment group

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

Group Type EXPERIMENTAL

active dental procedure

Intervention Type PROCEDURE

scaling and root planing

post-myocardial infarction management

Intervention Type DRUG

aspirin, clopidogrel, ticagrelor

basic periodontal examinations

Intervention Type RADIATION

panorama radiograph : full mouth periapical radiograph

control group

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

Group Type ACTIVE_COMPARATOR

post-myocardial infarction management

Intervention Type DRUG

aspirin, clopidogrel, ticagrelor

basic periodontal examinations

Intervention Type RADIATION

panorama radiograph : full mouth periapical radiograph

Interventions

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active dental procedure

scaling and root planing

Intervention Type PROCEDURE

post-myocardial infarction management

aspirin, clopidogrel, ticagrelor

Intervention Type DRUG

basic periodontal examinations

panorama radiograph : full mouth periapical radiograph

Intervention Type RADIATION

Other Intervention Names

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dual antiplatelet drug

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

* 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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Foundation of Korea

OTHER

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Si-Hyuck Kang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Si-Hyuck Kang, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Si-Hyuck Kang, MD

Role: CONTACT

82317877027

Ji Yeon Yoon

Role: CONTACT

82317873974

Facility Contacts

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Si-Hyuck Kang, MD

Role: primary

82317877027

Ji Yeon Yoon

Role: backup

82317873974

References

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Ye Z, Cao Y, Miao C, Liu W, Dong L, Lv Z, Iheozor-Ejiofor Z, Li C. Periodontal therapy for primary or secondary prevention of cardiovascular disease in people with periodontitis. Cochrane Database Syst Rev. 2022 Oct 4;10(10):CD009197. doi: 10.1002/14651858.CD009197.pub5.

Reference Type DERIVED
PMID: 36194420 (View on PubMed)

Other Identifiers

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AMI oral intervention

Identifier Type: -

Identifier Source: org_study_id

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