Intensive Treatment on Periodontitis in Aortic Stenosis

National Center for Cardiovascular Diseases

Status: Enrolling

Conditions: Periodontitis; Aortic Valve Stenosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06587971

2022-GSP-QZ-6

Details and patient eligibility

About

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.

Enrollment: 920 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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920 participants in 2 patient groups, including a placebo group

Comprehensive Periodontal Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Oral hygiene education

Procedure: Standard periodontal treatment protocol

Oral hygiene education group

Placebo Comparator group

Description:

Administering Oral Hygiene Education to Participants. Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management.

Treatment:

Behavioral: Oral hygiene education