Myocardial Infarction and Periodontitis: Periodontal Health Intervention.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorShanghai 10th People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Periodontal surgery
Procedure/SurgeryIn 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
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Periodontal Health Intervention GroupExperimental treatment 1 intervention
Group B: Standard Care GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Changes in ejection fraction
The ejection fraction (EF) changed by 10% half a year after surgery
Time frame
From enrollment to the end of treatment at 6 monthsSecondary outcomes
1
Cardiovascular death and MACE events were recorded
Time frame
From enrollment to the end of treatment at 6 months, a maximum of 12 months.2
level of proBNP
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.
Time frame
From enrollment to the end of treatment at 6 monthsSponsors and contacts
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Source ClinicalTrials.gov