Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive Periodontal Intervention Group | Experimental | Administering the current guideline-recommended comprehensive periodontal treatment protocol to participants, which includes: Oral hygiene education: Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management. 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. |
|
| Oral hygiene education group | Placebo Comparator | Administering Oral Hygiene Education to Participants. Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard periodontal treatment protocol | Procedure | Administering standard treatments for chronic periodontitis according to the current guidelines, including supragingival scaling, subgingival scaling, root planing, and periodontal flap surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Major Cardiovascular Events (MACE) Endpoint | Composite Major Cardiovascular Events (MACE), including:
| From enrollment to the follow-up periods at 12, 24, and 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic Valve Peak Velocity Change Endpoint | The difference in the mean change of aortic valve peak velocity before and after the intervention within the control group and the treatment group. | From enrollment to the follow-up periods at 12, 24, and 36 months. |
| Serum Biomarker Endpoint |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erli Zhang, MD, PhD | Contact | +86-18500853301 | aricho1985@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Erli Zhang, MD, PhD | China National Center for Cardiovascular Diseases | Study Chair |
| Erli Zhang, MD, PhD | China National Center for Cardiovascular Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China National Center for Cardiovascular Diseases | Recruiting | Beijing | Beijing Municipality | 100037 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oral hygiene education | Behavioral | Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management. |
|
The difference in common serum biomarkers, such as C-reactive protein and interleukin-6, between the control group and the treatment group. |
| From enrollment to the follow-up periods at 12, 24, and 36 months. |
| Periodontal Bacterial Biomarker Endpoint | The difference in the concentration of periodontal bacterial biomarkers between the control group and the treatment group. | From enrollment to the follow-up periods at 12, 24, and 36 months. |
| D014694 |
| Ventricular Outflow Obstruction |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |