Myocardial Infarction and Periodontitis: Periodontal Health Intervention.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Periodontal surgery.
- Who it may be relevant to
- Registry conditions: Acute Myocardial Infarction (AMI), Periodontal Disease. Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Oral Health Intervention Study in Patients with Myocardial Infarction and Periodontal Disease: a Simulated RCT Trial
Overview
The aim of this study is to establish a shared database of acute myocardial infarction patients with periodontitis, to clarify the clinical benefits of periodontitis intervention on acute myocardial infarction patients through simulated RCT study, and to establish a high-level database of acute myocardial infarction patients with periodontitis, so as to promote the application of oral health intervention in clinical practice.
Interventions
- Procedure Periodontal surgery
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 diseas
Primary outcome measures
- Changes in ejection fraction [Time frame: From enrollment to the end of treatment at 6 months]
Secondary outcome measures (2)
- Cardiovascular death and MACE events were recorded [Time frame: 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Shanghai Tenth People's Hospital — Shanghai
Identifiers
NCT: NCT06745141 · CCS-MIP-PHI