Treatment for gum disease to slow heart valve narrowing
Intensive Treatment on Periodontitis in Aortic Stenosis
This study is testing if treating gum disease can help slow down the worsening of heart valve narrowing in adults who have both aortic valve stenosis and gum issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 920 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06587971 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine whether standardized periodontal therapy can slow the progression of aortic valve stenosis in adults with moderate aortic valve stenosis and coexisting gingivitis or mild-to-moderate periodontitis. Participants will be screened for eligibility based on their aortic valve peak velocity and periodontal status, and then randomly assigned to either receive comprehensive periodontal therapy or only oral hygiene education. The study seeks to answer if chronic periodontitis is an independent risk factor for the accelerated progression of aortic valve stenosis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years or older with moderate aortic valve stenosis and mild-to-moderate periodontitis.
Not a fit: Patients with end-stage renal disease, those who are pregnant or breastfeeding, or individuals unable to adhere to the treatment protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could potentially slow the progression of aortic valve stenosis in patients with periodontal disease.
How similar studies have performed: There is limited information on similar studies, making this approach relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- China National Center for Cardiovascular Diseases — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Erli Zhang, MD, PhD — China National Center for Cardiovascular Diseases
- Study coordinator: Erli Zhang, MD, PhD
- Email: aricho1985@163.com
- Phone: +86-18500853301
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.