Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06587971

Intensive Treatment on Periodontitis in Aortic Stenosis

Led by China National Center for Cardiovascular Diseases · Updated on 2024-09-19

920

Participants Needed

1

Research Sites

238 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Intensive Treatment on Periodontitis in Aortic Stenosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older.
  • Aortic valve peak velocity (Vmax) between 3.0 and 3.9 m/s.
  • Diagnosis of degenerative aortic valve stenosis.
  • Presence of gingivitis or mild-to-moderate periodontitis confirmed by periodontal probing or panoramic dental radiography.
  • Willingness to participate and signing informed consent.
Not Eligible

You will not qualify if you...

  • End-stage renal disease with eGFR < 15 ml/min/1.73m².
  • Pregnant, breastfeeding, or women of childbearing age without effective contraception.
  • Factors that may affect study follow-up or adherence to periodontal therapy.
  • Unwilling or unable to undergo comprehensive periodontal treatment.
  • Patients who do not consent to participate in the study.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, China, 100037

Actively Recruiting

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Research Team

E

Erli Zhang, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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