Myocardial Infarction and Periodontitis: Periodontal Health Intervention.
Oral Health Intervention Study in Patients with Myocardial Infarction and Periodontal Disease: a Simulated RCT Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jiawen Wu
- Phone Number: 86+17717070557
- Email: chloewuu@foxmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200092
- Recruiting
- Shanghai Tenth People's Hospital
-
Contact:
- Jiawen Wu
- Phone Number: 17717070557
- Email: chloewuu@foxmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1)Patients diagnosed with ST-segment elevation myocardial infarction (STEMI). 2)Patients with severe periodontal disease, defined as:
5 teeth with clinical attachment loss (CAL) ≥ 4 mm.
- Subgingival probing depth (PD) ≥ 6 mm. ③≥ 8 teeth with gingival bleeding on probing (BOP). 3）Age ≥30 years. 4）Written informed consent provided.
Exclusion Criteria:
- 1) under 30 years old; 2) HIV positive, chronic inflammation, tumor disease, drug dependence, use of anticonvulsants, use of immunosuppressive agents, pregnancy, and lactation; 3) significant tooth loss (number of remaining teeth < 8); 4) long hospital stay (>10 days), new myocardial infarction before randomization, and stent thrombosis; 5) Refusal to sign informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Periodontal Health Intervention Group
Participants in this arm will receive comprehensive periodontal health interventions, including:
|
In the intervention group, patients underwent a comprehensive periodontal evaluation conducted by periodontists at a dental clinic. All permanent teeth, except for third molars, were assessed using dental mirrors and periodontal probes. Each tooth was examined at four sites (vestibular, distal, lingual, and mesial) to evaluate visible plaque, probing depth, probing bleeding, and attachment loss. During the first treatment session, patients were provided with information about periodontal disease, emphasizing the importance of controlling supragingival bacterial biofilms for successful treatment. Plaque-retentive factors (calculus) were removed. Temporary materials were used to restore carious lesions, root remnants were extracted, and maladaptive restorations were adjusted. Supragingival calculus was removed using periodontal scalers, followed by cleaning with a rubber cup, prophylaxis paste, dental floss, and/or interdental brushes. No prophylactic antibiotics were used prior to the |
|
No Intervention: Standard Care Group
Participants in this arm will receive standard care without specific periodontal interventions.
This includes routine medical management for myocardial infarction, as per standard clinical guidelines, without structured periodontal treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in ejection fraction
Time Frame: From enrollment to the end of treatment at 6 months
|
The ejection fraction (EF) changed by 10% half a year after surgery
|
From enrollment to the end of treatment at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiovascular death and MACE events were recorded
Time Frame: From enrollment to the end of treatment at 6 months, a maximum of 12 months.
|
From enrollment to the end of treatment at 6 months, a maximum of 12 months.
|
|
|
level of proBNP
Time Frame: From enrollment to the end of treatment at 6 months
|
The outcome will be assessed by measuring the level of plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP), a biomarker reflecting cardiac stress and heart failure.
|
From enrollment to the end of treatment at 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCS-MIP-PHI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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