Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk

Not Applicable

Not yet recruiting

• Conditions: Cardiovascular Diseases; Periodontitis
• Interventions: Procedure: Non-surgical periodontal therapy; Procedure: Control periodontal treatment

• Registration Number: NCT05459727
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-12
• Last Update Submitted: 2022-07-12
• Study First Posted: 2022-07-15
• Last Update Posted: 2022-07-15
• Study Start: 2022-08-01
• Primary Completion: 2025-08-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 376

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Non-surgical periodontal therapy	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.
Control arm	Control periodontal treatment	1. Basic oral hygiene instructions. 2. Full-mouth supragingival ultrasonic scaling.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Cardiovascular risk (Framingham risk score (FRS)) at 1 year.	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline fasting blood glucose at 1 year after enrollment.	Baseline; 1 year
Change from baseline triglyceride at 1 year after enrollment.	Baseline; 1 year
Change from baseline diastolic blood pressure at 1 year after enrollment.	Baseline; 1 year
Change from baseline low-density lipoprotein cholesterol at 1 year after enrollment.	Baseline; 1 year
Change from baseline high sensitivity C-reactive protein at 1 year after enrollment.	Baseline; 1 year
Change from baseline interleukin-6 at 1 year after enrollment.	Baseline; 1 year
Major adverse cardiovascular event	Baseline; 3 months; 6 months; 9 months; 1 year; 2 years; 3 years;	The major adverse cardiovascular event includes acute myocardial infarction, stroke, heart failure, peripheral artery disease, and coronary heart disease.
All-cause mortality	Baseline; 3 months; 6 months; 9 months; 1 year; 2 years; 3 years;	Defined as any death after enrollment.
Change from baseline glycosylated hemoglobin at 1 year after enrollment.	Baseline; 1 year
Change from baseline pain at 1 year after enrollment.	Baseline; 1 year	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.
Change from baseline systolic blood pressure at 1 year after enrollment.	Baseline; 1 year
Change from baseline high-density lipoprotein cholesterol at 1 year after enrollment.	Baseline; 1 year
Change from baseline community periodontal index at 1 year after enrollment.	Baseline; 1 year	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.
Change from baseline anxiety at 1 year after enrollment.	Baseline; 1 year	Anxiety will be assessed through "Self-Rating Anxiety Scale (SAS)". The SAS score range from 20 - 80 points. Higher points mean more serious anxiety.
Change from baseline total cholesterol at 1 year after enrollment.	Baseline; 1 year
Change from baseline cardiovascular risk (CHINA-PAR) at 1 year after enrollment.	Baseline; 1 year	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.

Trial Locations

Locations (2)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Stomatological Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China