Cardiovascular DiseasesNCT05459727
Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk
A study testing Non-surgical periodontal therapy in people with Cardiovascular Diseases and Periodontitis, run by Nanfang Hospital, Southern Medical University at 2 sites in China.
Trial summary
This study is to evaluate whether non-surgical periodontal therapy can help to control the cardiovascular risk among patients with moderate/severe periodontitis and at risk of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Periodontitis
- What is being tested?
- Non-surgical periodontal therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 376 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2022to 31 Dec 2026
- 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
- Age ≥ 18 years;
- At risk of cardiovascular disease (defined as "Framingham Score" predicted 10-year risk of cardiovascular disease ≥ 20%);
- Moderate//severe periodontitis;
Who cannot join
- Cardiovascular diseases at baseline (coronary heart disease, stroke and peripheral artery disease);
- Received periodontal treatment within the past 6 months;
- Pregnant or lactating females;
- Non residents of Guangzhou and its surrounding cities or expected to leave Guangzhou or its surrounding cities within 1 year;
- Malignant tumors or other end-stage diseases with life expectancy less than 1 year;
- End-stage renal disease;
- Patients with high bleeding risk, high blood pressures or other situations that make them unable to receive interventions;
- Refuse to provide informed consent;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Stomatological Hospital, Southern Medical University
Guangzhou, Guangdong, 510280
Jia Ni, MD, 441569008@qq.com
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk in People at Risk of Cardiovascular Disease
This study is to evaluate whether non-surgical periodontal therapy can help to control the cardiovascular risk among patients with moderate/severe periodontitis and at risk of cardiovascular disease.
Read the detailed description
Previous studies showed that the treatment of periodontitis can partially improve the control of risk factors of cardiovascular disease (e.g. blood pressure, interleukin 6), whereas the evidence is still limited. Moreover, there is currently no study reporting the impact of periodontal treatment on the overall risk of cardiovascular disease. The prevalence of periodontitis in China was 62.4%. In clinical practice, a large number of patients with moderate/severe periodontitis and at risk of cardiovascular disease seek medical advice. However, the existing guidelines lack relevant recommendations. Therefore, this study intends to evaluate whether non-surgical periodontal therapy can help to control cardiovascular risk.
376 patients with moderate/severe periodontitis and at risk of cardiovascular disease will be randomized. Those randomized to the intervention arm will receive non-surgical periodontal therapy which includes full-mouth subgingival scaling and root planing. Those randomized to the control arm will receive supragingival ultrasonic scaling. All patients were given instructions on basic oral hygiene.
- Conditions
- Cardiovascular Diseases, Periodontitis
- Being tested
- Non-surgical periodontal therapy, Control periodontal treatment
- Keywords
- Periodontitis, Non-surgical Periodontal Therapy, Cardiovascular risk
- Medical subject headings
- Cardiovascular Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal therapyProcedure or surgery
Non-surgical periodontal therapy includes basic oral hygiene instructions and full-mouth subgingival scaling and root planing under local anesthesia.
Control periodontal treatmentProcedure or surgery
Control periodontal treatment includes basic oral hygiene instructions and full-mouth supragingival ultrasonic scaling.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 1. Basic oral hygiene instructions.
2. Full-mouth subgingival scaling and root planing under local anesthesia.
3. Additional full-mouth subgingival scaling and root planing under local anesthesia every 3 months during the follow-up period if necessary. Receives: Procedure: Non-surgical periodontal therapy |
| Control arm | Placebo comparator | 1. Basic oral hygiene instructions.
2. Full-mouth supragingival ultrasonic scaling. Receives: Procedure: Control periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Cardiovascular risk (Framingham risk score (FRS)) at 1 year.
Cardiovascular risk is assessed by "Framingham risk score (FRS)". (Circulation, 2008,117(6): 743-753.) Generally, the "Framingham risk score (FRS)" ranges from -4 to 33 for men and -5 to 33 for women. A higher "Framingham risk score (FRS)" means a higher risk of developing cardiovascular disease.
Measured: Baseline; 1 year
Secondary outcomes (16)
Change from baseline systolic blood pressure at 1 year after enrollment.
Measured: Baseline; 1 year
Change from baseline diastolic blood pressure at 1 year after enrollment.
Measured: Baseline; 1 year
Change from baseline fasting blood glucose at 1 year after enrollment.
Measured: Baseline; 1 year
Change from baseline glycosylated hemoglobin at 1 year after enrollment.
Measured: Baseline; 1 year
Change from baseline total cholesterol at 1 year after enrollment.
Measured: Baseline; 1 year
Change from baseline triglyceride at 1 year after enrollment.
Measured: Baseline; 1 year
Change from baseline low-density lipoprotein cholesterol at 1 year after enrollment.
Measured: Baseline; 1 year
Change from baseline high-density lipoprotein cholesterol at 1 year after enrollment.
Measured: Baseline; 1 year
Change from baseline high sensitivity C-reactive protein at 1 year after enrollment.
Measured: Baseline; 1 year
Change from baseline interleukin-6 at 1 year after enrollment.
Measured: Baseline; 1 year
Change from baseline cardiovascular risk (CHINA-PAR) at 1 year after enrollment.
China-PAR is an abbreviation of "Prediction for ASCVD Risk in China". It is a prediction model developed by YANG X. (Circulation, 2016,134(19):1430-1440.) Through China-PAR, the investigators can assess one's cardiovascular risk in 10 years. The result of China-PAR is directly one's predicted cardiovascular risk in 10 years, ranging from 0% - 100%, with a higher probability meaning a higher risk of cardiovascular disease.
Measured: Baseline; 1 year
Change from baseline community periodontal index at 1 year after enrollment.
Community periodontal index will be evaluated according to the guidelines by stomatologists. The community periodontal index ranges from 0 - 4 points for each tooth. Higher points mean more severe periodontitis.
Measured: Baseline; 1 year
Major adverse cardiovascular event
The major adverse cardiovascular event includes acute myocardial infarction, stroke, heart failure, peripheral artery disease, and coronary heart disease.
Measured: Baseline; 3 months; 6 months; 9 months; 1 year; 2 years; 3 years;
All-cause mortality
Defined as any death after enrollment.
Measured: Baseline; 3 months; 6 months; 9 months; 1 year; 2 years; 3 years;
Change from baseline anxiety at 1 year after enrollment.
Anxiety will be assessed through "Self-Rating Anxiety Scale (SAS)". The SAS score range from 20 - 80 points. Higher points mean more serious anxiety.
Measured: Baseline; 1 year
Change from baseline pain at 1 year after enrollment.
The degree of pain will be assessed through "Visual Analogue Scale (VAS)". The VAS score range from 0 - 10 points. Higher points mean more serious pain.
Measured: Baseline; 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Medical University, China
- Responsible party
- Sponsor
- Investigators
- Jiancheng Xiu, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459727
- Sponsor's protocol ID
- NFEC-2022-243
- Status last verified
- May 2022
- First submitted
- 5 Jul 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk in People at Risk of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT05459727
- Acronym / sponsor ID
- NFEC-2022-243
- Conditions
- Cardiovascular Diseases, Periodontitis
- Keywords
- Periodontitis, Non-surgical Periodontal Therapy, Cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Southern Medical University, China
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jul 2022 (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.
This study is to evaluate whether non-surgical periodontal therapy can help to control the cardiovascular risk among patients with moderate/severe periodontitis and at risk of cardiovascular disease.
Detailed description
Previous studies showed that the treatment of periodontitis can partially improve the control of risk factors of cardiovascular disease (e.g. blood pressure, interleukin 6), whereas the evidence is still limited. Moreover, there is currently no study reporting the impact of periodontal treatment on the overall risk of cardiovascular disease. The prevalence of periodontitis in China was 62.4%. In clinical practice, a large number of patients with moderate/severe periodontitis and at risk of cardiovascular disease seek medical advice. However, the existing guidelines lack relevant recommendations. Therefore, this study intends to evaluate whether non-surgical periodontal therapy can help to control cardiovascular risk.
376 patients with moderate/severe periodontitis and at risk of cardiovascular disease will be randomized. Those randomized to the intervention arm will receive non-surgical periodontal therapy which includes full-mouth subgingival scaling and root planing. Those randomized to the control arm will receive supragingival ultrasonic scaling. All patients were given instructions on basic oral hygiene.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Procedure: Non-surgical periodontal therapy1. Basic oral hygiene instructions. 2. Full-mouth subgingival scaling and root planing under local anesthesia. 3. Additional full-mouth subgingival scaling and root planing under local anesthesia every 3 months during the follow-up period if necessary. |
| Control arm | Placebo comparator | Procedure: Control periodontal treatment1. Basic oral hygiene instructions. 2. Full-mouth supragingival ultrasonic scaling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- At risk of cardiovascular disease (defined as "Framingham Score" predicted 10-year risk of cardiovascular disease ≥ 20%);
- Moderate//severe periodontitis;
Key exclusion criteria (8 listed)
- Cardiovascular diseases at baseline (coronary heart disease, stroke and peripheral artery disease);
- Received periodontal treatment within the past 6 months;
- Pregnant or lactating females;
- Non residents of Guangzhou and its surrounding cities or expected to leave Guangzhou or its surrounding cities within 1 year;
- Malignant tumors or other end-stage diseases with life expectancy less than 1 year;
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 |
|---|---|---|
| Non-surgical periodontal therapyNon-surgical periodontal therapy includes basic oral hygiene instructions and full-mouth subgingival scaling and root planing under local anesthesia. | Procedure or surgery | Intervention arm |
| Control periodontal treatmentControl periodontal treatment includes basic oral hygiene instructions and full-mouth supragingival ultrasonic scaling. | Procedure or surgery | Control arm |
Primary outcome
Change from Baseline Cardiovascular risk (Framingham risk score (FRS)) at 1 year.
Time frame: Baseline; 1 year
Cardiovascular risk is assessed by "Framingham risk score (FRS)". (Circulation, 2008,117(6): 743-753.) Generally, the "Framingham risk score (FRS)" ranges from -4 to 33 for men and -5 to 33 for women. A higher "Framingham risk score (FRS)" means a higher risk of developing cardiovascular disease.
16 secondary outcomes
Change from baseline systolic blood pressure at 1 year after enrollment.
Time frame: Baseline; 1 year
Change from baseline diastolic blood pressure at 1 year after enrollment.
Time frame: Baseline; 1 year
Change from baseline fasting blood glucose at 1 year after enrollment.
Time frame: Baseline; 1 year
Change from baseline glycosylated hemoglobin at 1 year after enrollment.
Time frame: Baseline; 1 year
Change from baseline total cholesterol at 1 year after enrollment.
Time frame: Baseline; 1 year
Change from baseline triglyceride at 1 year after enrollment.
Time frame: Baseline; 1 year
Change from baseline low-density lipoprotein cholesterol at 1 year after enrollment.
Time frame: Baseline; 1 year
Change from baseline high-density lipoprotein cholesterol at 1 year after enrollment.
Time frame: Baseline; 1 year
Change from baseline high sensitivity C-reactive protein at 1 year after enrollment.
Time frame: Baseline; 1 year
Change from baseline interleukin-6 at 1 year after enrollment.
Time frame: Baseline; 1 year
Change from baseline cardiovascular risk (CHINA-PAR) at 1 year after enrollment.
Time frame: Baseline; 1 year
Change from baseline community periodontal index at 1 year after enrollment.
Time frame: Baseline; 1 year
Major adverse cardiovascular event
Time frame: Baseline; 3 months; 6 months; 9 months; 1 year; 2 years; 3 years;
All-cause mortality
Time frame: Baseline; 3 months; 6 months; 9 months; 1 year; 2 years; 3 years;
Change from baseline anxiety at 1 year after enrollment.
Time frame: Baseline; 1 year
Change from baseline pain at 1 year after enrollment.
Time frame: Baseline; 1 year
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 15 Jul 2022.
- 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.
Jiancheng Xiu, MD principal investigator
Nanfang Hospital, Southern Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal therapy in people with Cardiovascular Diseases and Periodontitis, run by Nanfang Hospital, Southern Medical University at 2 sites 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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Jiancheng Xiu, MD (+86-020-61648319, xiujch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Cardiovascular risk (Framingham risk score (FRS)) at 1 year. (time frame: Baseline; 1 year). 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 15 Jul 2022.