China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037, China
Location status: Recruiting
NCT Number: NCT06587971
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100037, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administering standard treatments for chronic periodontitis according to the current guidelines, including supragingival scaling, subgingival scaling, root planing, and periodontal flap surgery.
Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management.
Time frame: From enrollment to the follow-up periods at 12, 24, and 36 months.
Composite Major Cardiovascular Events (MACE), including:
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.
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.
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.
Contact information is provided by the study sponsor or research team.
China National Center for Cardiovascular Diseases
Other Gov
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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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