Aortic Valve StenosisNCT06587971
Intensive Treatment on Periodontitis in Aortic Stenosis
A study testing Standard periodontal treatment protocol and Oral hygiene education in people with Aortic Valve Stenosis and Periodontitis, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Periodontitis
- What is being tested?
- Standard periodontal treatment protocol and Oral hygiene education
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 920 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
Erli Zhang, MD, PhD, 86-18500853301, aricho1985@163.com
About this study
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
- Being tested
- Standard periodontal treatment protocol, Oral hygiene education
- Medical subject headings
- Aortic Valve Stenosis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard periodontal treatment protocolProcedure or surgery
Administering standard treatments for chronic periodontitis according to the current guidelines, including supragingival scaling, subgingival scaling, root planing, and periodontal flap surgery.
Oral hygiene educationBehavioural
Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Oral hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Major Cardiovascular Events (MACE) Endpoint
Composite Major Cardiovascular Events (MACE), including:
- Hospitalization or emergency/outpatient visits due to heart failure.
- Hospitalization or emergency/outpatient visits due to angina.
- Hospitalization or emergency/outpatient visits due to syncope.
- Cardiovascular death.
- Undergoing interventional or surgical valve replacement.
- Non-fatal myocardial infarction.
- Undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
- Ischemic stroke.
Measured: From enrollment to the follow-up periods at 12, 24, and 36 months.
Secondary outcomes (3)
Aortic Valve Peak Velocity Change Endpoint
The difference in the mean change of aortic valve peak velocity before and after the intervention within the control group and the treatment group.
Measured: From enrollment to the follow-up periods at 12, 24, and 36 months.
Serum Biomarker Endpoint
The difference in common serum biomarkers, such as C-reactive protein and interleukin-6, between the control group and the treatment group.
Measured: From enrollment to the follow-up periods at 12, 24, and 36 months.
Periodontal Bacterial Biomarker Endpoint
The difference in the concentration of periodontal bacterial biomarkers between the control group and the treatment group.
Measured: From enrollment to the follow-up periods at 12, 24, and 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 920 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Erli Zhang, MD, PhD, Study chair, China National Center for Cardiovascular DiseasesErli Zhang, MD, PhD, Principal investigator, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587971
- Sponsor's protocol ID
- 2022-GSP-QZ-6
- Status last verified
- Jun 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Treatment on Periodontitis in Aortic Stenosis
- ClinicalTrials.gov ID
- NCT06587971
- Acronym / sponsor ID
- 2022-GSP-QZ-6
- Conditions
- Aortic Valve Stenosis, Periodontitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 920 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 10 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Periodontal Intervention Group | Experimental | Procedure: Standard periodontal treatment protocol, Behavioral: Oral hygiene educationAdministering 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 | Placebo comparator | Behavioral: Oral hygiene educationAdministering Oral Hygiene Education to Participants. Providing guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard periodontal treatment protocolAdministering standard treatments for chronic periodontitis according to the current guidelines, including supragingival scaling, subgingival scaling, root planing, and periodontal flap surgery. | Procedure or surgery | Comprehensive Periodontal Intervention Group |
| Oral hygiene educationProviding guidance on proper brushing techniques, smoking cessation, dietary control, and blood sugar management. | Behavioural | Comprehensive Periodontal Intervention Group, Oral hygiene education group |
Primary outcome
Composite Major Cardiovascular Events (MACE) Endpoint
Time frame: 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.
3 secondary outcomes
Aortic Valve Peak Velocity Change Endpoint
Time frame: From enrollment to the follow-up periods at 12, 24, and 36 months.
Serum Biomarker Endpoint
Time frame: From enrollment to the follow-up periods at 12, 24, and 36 months.
Periodontal Bacterial Biomarker Endpoint
Time frame: From enrollment to the follow-up periods at 12, 24, and 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erli Zhang, MD, PhD study chair
China National Center for Cardiovascular Diseases
Erli Zhang, MD, PhD principal investigator
China National Center for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard periodontal treatment protocol and Oral hygiene education in people with Aortic Valve Stenosis and Periodontitis, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erli Zhang, MD, PhD (+86-18500853301, aricho1985@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Major Cardiovascular Events (MACE) Endpoint (time frame: From enrollment to the follow-up periods at 12, 24, and 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.