Intensive Treatment on Periodontitis in Aortic Stenosis
Recruiting now · Not applicable
Conditions studied: Aortic Valve Stenosis, Periodontitis
In brief
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.
Key facts
- Study ID
- NCT06587971
- Run by
- China National Center for Cardiovascular Diseases
- People needed
- 920
- Starts
- 2023-05-10
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- China National Center for Cardiovascular Diseases — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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