Intensive Treatment on Periodontitis in Aortic Stenosis

Not Applicable

Recruiting

• Conditions: Aortic Valve Stenosis; Periodontitis
• Interventions: Procedure: Standard periodontal treatment protocol; Behavioral: Oral hygiene education

• Registration Number: NCT06587971
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-10
• Status Verified: 2024-06
• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-05
• Last Update Submitted: 2024-09-05
• Study First Posted: 2024-09-09
• Last Update Posted: 2024-09-09
• Primary Completion: 2025-12-31
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 920

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comprehensive Periodontal Intervention Group	Standard periodontal treatment protocol	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.
Comprehensive Periodontal Intervention Group	Oral hygiene education	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	Oral hygiene education	Administering Oral Hygiene Education to Participants. Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management.

Primary Outcome Measures

Name	Time	Method
Composite Major Cardiovascular Events (MACE) Endpoint	From enrollment to the follow-up periods at 12, 24, and 36 months.	Composite Major Cardiovascular Events (MACE), including: 1. Hospitalization or emergency/outpatient visits due to heart failure.; 2. Hospitalization or emergency/outpatient visits due to angina.; 3. Hospitalization or emergency/outpatient visits due to syncope.; 4. Cardiovascular death.; 5. Undergoing interventional or surgical valve replacement.; 6. Non-fatal myocardial infarction.; 7. Undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).; 8. Ischemic stroke.

Secondary Outcome Measures

Name	Time	Method
Aortic Valve Peak Velocity Change Endpoint	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.
Serum Biomarker Endpoint	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.
Periodontal Bacterial Biomarker Endpoint	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.

Trial Locations

Locations (1)

China National Center for Cardiovascular Diseases; 🇨🇳 Beijing, Beijing, China