Myocardial Infarction and Periodontitis: Periodontal Health Intervention.

NCT ID: NCT06745141

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Periodontal Health Intervention Group

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.

Group Type: EXPERIMENTAL

Periodontal surgery

Intervention Type: 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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ya-Wei Xu

professor of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiawen Wu

Role: CONTACT

Phone: 86+17717070557

Email: chloewuu@foxmail.com

Facility Contacts

Jiawen Wu

Role: primary

Other Identifiers

CCS-MIP-PHI

Identifier Type: -

Identifier Source: org_study_id