Intensive Treatment on Periodontitis in Aortic Stenosis

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
China National Center for Cardiovascular Diseases
RECRUITING
Beijing
Contact Information
Primary
Erli Zhang, MD, PhD
aricho1985@163.com
+86-18500853301
Time Frame
Start Date: 2023-05-10
Estimated Completion Date: 2027-12
Participants
Target number of participants: 920
Treatments
Experimental: Comprehensive Periodontal Intervention Group
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.
Placebo_comparator: Oral hygiene education group
Administering Oral Hygiene Education to Participants. Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management.
Related Therapeutic Areas
Sponsors
Leads: China National Center for Cardiovascular Diseases

This content was sourced from clinicaltrials.gov