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Status unknownNCT04012541Updated Jul 9, 2019

Comprehensive Oral Intervention in Patients With AMI

An interventional study of active dental procedure and post-myocardial infarction management in Acute Myocardial Infarction and Dental Diseases, sponsored by Seoul National University Bundang Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-09.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Acute Myocardial Infarction
  • Dental Diseases
03

In context

Stomatognathic Diseases

110 studies on the registry are indexed under Stomatognathic Diseases; 26 are open to participants now.

This study's planned enrollment of 68 is above the median of 59 across 86 interventional studies indexed under Stomatognathic Diseases.

Browse Stomatognathic Diseases studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    treatment group

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

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

  • Active comparator
    control group

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

    Drug: post-myocardial infarction management · Radiation: basic periodontal examinations

Interventions

  • Procedureactive dental procedure

    scaling and root planing

  • Drugpost-myocardial infarction management

    aspirin, clopidogrel, ticagrelor

    Also known as: dual antiplatelet drug

  • Radiationbasic periodontal examinations

    panorama radiograph : full mouth periapical radiograph

06

What researchers measure

Primary outcomes

  1. hsCRP

    hsCRP(high sensitivity C-reactive protein), mg/dL

    Time frame: at 3 months

Secondary outcomes

  1. surrogate blood markers

    FBS \& Total cholesterol \& LDL-cholesterol \& HDL-cholesterol \& Triglyceride \& Apolipoprotein A \& Apolipoprotein B, mg/dL

    Time frame: at 3 months

  2. patient symptom

    NYHA functional class

    Time frame: at 3 months & 12 months

  3. Systolic & diastolic blood pressure

    automated blood pressure, mmHg

    Time frame: at 3 months & 12 months

  4. Exercise performance

    Treadmill test

    Time frame: at 3 months

  5. Death

    number of cardiovascular death

    Time frame: at 12 months

  6. unscheduled coronary revascularization

    number of unscheduled coronary revascularization

    Time frame: at 12 months

  7. stroke

    number of stroke

    Time frame: at 12 months

  8. HF admission

    number of HF admission

    Time frame: at 12 months

  9. unstable angina

    number of unstable angina

    Time frame: at 12 months

  10. recurrent MI

    number of recent MI

    Time frame: at 12 months

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Bundang Hospital
    Seongnam, Gyeonggi-do 13620, Korea, Republic of
    Recruiting
08

References and documents

Publications

  • 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. PubMed 36194420 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04012541
Lead sponsor
Seoul National University Bundang Hospital
Collaborators
National Research Foundation of Korea
Responsible party
Si-Hyuck Kang (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Jul 9, 2019
Start date
Jul 5, 2019
Primary completion
Mar 31, 2021 (estimated)
Completion
Mar 31, 2021 (estimated)
Last update
Jul 9, 2019

Study contacts

Si-Hyuck Kang, MD
Contact
eandp303@gmail.com
82317877027
Ji Yeon Yoon
Contact
r1999@snubh.org
82317873974
Si-Hyuck Kang, MD
principal investigator · Seoul National University Bundang Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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