Intensive Treatment on Periodontitis in Aortic Stenosis

NCT06587971 | Recruiting DMC

• 1 other identifier: 2022-GSP-QZ-6
• Study Type: interventional
• Target: 920
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Composite Major Cardiovascular Events (MACE) Endpoint

  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.

  From enrollment to the follow-up periods at 12, 24, and 36 months.

Secondary Outcomes (3)

• Aortic Valve Peak Velocity Change Endpoint

  From enrollment to the follow-up periods at 12, 24, and 36 months.

• Serum Biomarker Endpoint

  From enrollment to the follow-up periods at 12, 24, and 36 months.

• Periodontal Bacterial Biomarker Endpoint

  From enrollment to the follow-up periods at 12, 24, and 36 months.

Study Arms (2)

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.

Procedure: Standard periodontal treatment protocol; Behavioral: Oral hygiene education

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.

Behavioral: Oral hygiene education

Interventions

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.

Comprehensive Periodontal Intervention Group

Oral hygiene education BEHAVIORAL

Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management.

Comprehensive Periodontal Intervention Group; Oral hygiene education group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Periodontitis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Erli Zhang, MD, PhD

  China National Center for Cardiovascular Diseases

  STUDY CHAIR

• Erli Zhang, MD, PhD

  China National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erli Zhang, MD, PhD

CONTACT

+86-18500853301; aricho1985@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: May 10, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)