Intensive Treatment on Periodontitis in Aortic Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard periodontal treatment protocol, Oral hygiene education.
- Who it may be relevant to
- Registry conditions: Aortic Valve Stenosis, Periodontitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Standard periodontal treatment protocol
Administering standard treatments for chronic periodontitis according to the current guidelines, including supragingival scaling, subgingival scaling, root planing, and periodontal flap surgery. - Behavioral Oral hygiene education
Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management.
Primary outcome measures
- Composite Major Cardiovascular Events (MACE) Endpoint [Time frame: From enrollment to the follow-up periods at 12, 24, and 36 months.]
Secondary outcome measures (3)
- Aortic Valve Peak Velocity Change Endpoint [Time frame: From enrollment to the follow-up periods at 12, 24, and 36 months.]
- Serum Biomarker Endpoint [Time frame: From enrollment to the follow-up periods at 12, 24, and 36 months.]
- Periodontal Bacterial Biomarker Endpoint [Time frame: From enrollment to the follow-up periods at 12, 24, and 36 months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- China National Center for Cardiovascular Diseases — Beijing
Identifiers
NCT: NCT06587971 · 2022-GSP-QZ-6