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NCT Number: NCT06587971

Intensive Treatment on Periodontitis in Aortic Stenosis

The goal of this clinical trial is to determine if standardized periodontal therapy can effectively slow the progression of aortic valve stenosis in adult patients diagnosed with moderate aortic valve stenosis and coexisting gingivitis or mild-to-moderate periodontitis.

The main questions it aims to answer are: Can periodontal therapy slow the progression of aortic valve stenosis? Is chronic periodontitis an independent risk factor for the accelerated progression of aortic valve stenosis? Researchers will compare a group of patients receiving standardized periodontal therapy to a control group receiving only oral hygiene education to see if periodontal treatment results in a slower progression of aortic valve stenosis.

Participants will undergo initial screening to confirm eligibility based on aortic valve peak velocity and periodontal status. They will then be randomly assigned to either the treatment group, which will receive comprehensive periodontal therapy, or the control group, which will receive only oral hygiene education. Participants will be followed up regularly over a 36-month period, with assessments including echocardiograms to monitor the progression of aortic valve stenosis, periodontal examinations to assess oral health status, and blood tests to measure relevant serum biomarkers. The study will also track any cardiovascular events and adverse events related to the interventions.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Erli Zhang, MD, PhD

CONTACT

[email protected]

86-18500853301

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older.
  • Aortic valve peak velocity (Vmax) between 3.0 and 3.9 m/s.
  • Diagnosis of aortic valve stenosis identified as degenerative aortic valve stenosis.
  • Presence of gingivitis or mild-to-moderate periodontitis confirmed by periodontal probing or panoramic dental radiography.
  • Willingness to participate in the study and signing of informed consent.

Exclusion criteria

  • End-stage renal disease with eGFR < 15 ml/min/1.73m² (according to the Cockcroft & Gault formula).
  • Pregnant, breastfeeding, and women of childbearing age (except those with effective contraception).
  • Factors that may affect study follow-up or adherence to periodontal therapy.
  • Patients unwilling or unable to undergo comprehensive periodontal treatment.
  • Patients who do not consent to participate in the study.

Treatment and study plan

Standard periodontal treatment protocol

Procedure

Administering standard treatments for chronic periodontitis according to the current guidelines, including supragingival scaling, subgingival scaling, root planing, and periodontal flap surgery.

Oral hygiene education

Behavioral

Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management.

Primary outcomes

  1. Composite Major Cardiovascular Events (MACE) Endpoint

    Time frame: From enrollment to the follow-up periods at 12, 24, and 36 months.

    Composite Major Cardiovascular Events (MACE), including:

    • Hospitalization or emergency/outpatient visits due to heart failure.
    • Hospitalization or emergency/outpatient visits due to angina.
    • Hospitalization or emergency/outpatient visits due to syncope.
    • Cardiovascular death.
    • Undergoing interventional or surgical valve replacement.
    • Non-fatal myocardial infarction.
    • Undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
    • Ischemic stroke.

Secondary outcomes

  1. Aortic Valve Peak Velocity Change Endpoint

    Time frame: From enrollment to the follow-up periods at 12, 24, and 36 months.

    The difference in the mean change of aortic valve peak velocity before and after the intervention within the control group and the treatment group.

  2. Serum Biomarker Endpoint

    Time frame: From enrollment to the follow-up periods at 12, 24, and 36 months.

    The difference in common serum biomarkers, such as C-reactive protein and interleukin-6, between the control group and the treatment group.

  3. Periodontal Bacterial Biomarker Endpoint

    Time frame: From enrollment to the follow-up periods at 12, 24, and 36 months.

    The difference in the concentration of periodontal bacterial biomarkers between the control group and the treatment group.

Study contacts

Contact information is provided by the study sponsor or research team.

Erli Zhang, MD, PhD

CONTACT

[email protected]

+86-18500853301

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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