Intensive Treatment on Periodontitis in Aortic Stenosis
NCT ID: NCT06587971
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
920 participants
INTERVENTIONAL
2023-05-10
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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
Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management.
Oral hygiene education group
Administering Oral Hygiene Education to Participants. Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management.
Oral hygiene education
Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management.
Interventions
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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
Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Erli Zhang, MD, PhD
Role: STUDY_CHAIR
China National Center for Cardiovascular Diseases
Erli Zhang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
China National Center for Cardiovascular Diseases
Locations
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China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-GSP-QZ-6
Identifier Type: -
Identifier Source: org_study_id
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