Clinical trial NCT05459727: Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk
Official title: Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk in People at Risk of Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Periodontitis
Keywords: Periodontitis
Non-surgical Periodontal Therapy
Cardiovascular risk
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Southern Medical University, China
First posted: 2022-07-15
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* At risk of cardiovascular disease (defined as "Framingham Score" predicted 10-year risk of cardiovascular disease ≥ 20%);
* Moderate//severe periodontitis;

Exclusion Criteria:

* 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;

Primary outcomes:
measure: Change from Baseline Cardiovascular risk (Framingham risk score (FRS)) at 1 year.
timeFrame: Baseline; 1 year
Secondary outcomes:
measure: Change from baseline systolic blood pressure at 1 year after enrollment.
timeFrame: Baseline; 1 year
measure: Change from baseline diastolic blood pressure at 1 year after enrollment.
timeFrame: Baseline; 1 year
measure: Change from baseline fasting blood glucose at 1 year after enrollment.
timeFrame: Baseline; 1 year
measure: Change from baseline glycosylated hemoglobin at 1 year after enrollment.
timeFrame: Baseline; 1 year
measure: Change from baseline total cholesterol at 1 year after enrollment.
timeFrame: Baseline; 1 year
measure: Change from baseline triglyceride at 1 year after enrollment.
timeFrame: Baseline; 1 year
measure: Change from baseline low-density lipoprotein cholesterol at 1 year after enrollment.
timeFrame: Baseline; 1 year
measure: Change from baseline high-density lipoprotein cholesterol at 1 year after enrollment.
timeFrame: Baseline; 1 year
measure: Change from baseline high sensitivity C-reactive protein at 1 year after enrollment.
timeFrame: Baseline; 1 year
measure: Change from baseline interleukin-6 at 1 year after enrollment.
timeFrame: Baseline; 1 year
measure: Change from baseline cardiovascular risk (CHINA-PAR) at 1 year after enrollment.
timeFrame: Baseline; 1 year
measure: Change from baseline community periodontal index at 1 year after enrollment.
timeFrame: Baseline; 1 year
measure: Major adverse cardiovascular event
timeFrame: Baseline; 3 months; 6 months; 9 months; 1 year; 2 years; 3 years;
measure: All-cause mortality
timeFrame: Baseline; 3 months; 6 months; 9 months; 1 year; 2 years; 3 years;
measure: Change from baseline anxiety at 1 year after enrollment.
timeFrame: Baseline; 1 year
measure: Change from baseline pain at 1 year after enrollment.
timeFrame: Baseline; 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Stomatological Hospital, Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jiancheng Xiu, MD
role: PRINCIPAL_INVESTIGATOR
References: