Myocardial Infarction and Periodontitis: Periodontal Health Intervention.

NCT06745141 | Recruiting

• 1 other identifier: CCS-MIP-PHI
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myocardial Infarction (AMI); Periodontal Disease

Outcome Measures

Primary Outcomes (1)

• Changes in ejection fraction

  The ejection fraction (EF) changed by 10% half a year after surgery

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (2)

• Cardiovascular death and MACE events were recorded

  From enrollment to the end of treatment at 6 months, a maximum of 12 months.

• level of proBNP

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Periodontal Health Intervention Group

EXPERIMENTAL

Participants in this arm will receive comprehensive periodontal health interventions, including: 1. Full periodontal evaluation using dental mirrors and probes (assessing visible plaque, probing depth, bleeding on probing, and attachment loss). 2. Supragingival scaling, root planing, and professional plaque removal. 3. Temporary restoration of carious lesions and extraction of root remnants, as needed. 4. Personalized oral hygiene instruction, including the use of multi-tufted brushes, toothpaste, floss, and interdental brushes.

Procedure: Periodontal surgery

Standard Care Group

NO INTERVENTION

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.

Interventions

Periodontal surgery PROCEDURE

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

Periodontal Health Intervention Group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• )Patients diagnosed with ST-segment elevation myocardial infarction (STEMI). 2)Patients with severe periodontal disease, defined as:
• 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Jiawen Wu

CONTACT

86+17717070557; chloewuu@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of medicine

Model Details: This study employs a simulated randomized controlled trial (RCT) design to evaluate the effects of periodontal health interventions on patients with myocardial infarction (MI) complicated by periodontitis. The study mimics the framework of a traditional randomized controlled trial but does not involve formal randomization of participants. Participants are allocated into intervention and control groups in a structured manner to minimize bias, ensuring comparability.

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 20, 2024
• Study Start: December 1, 2020
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

CN (1)