Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Periodontitis
• Intervention / Treatment: Procedure: Non-surgical periodontal therapy; Procedure: Control periodontal treatment

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 Type: Interventional
• Enrollment (Anticipated): 376
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital, Southern Medical University
    • Guangzhou, Guangdong, China, 510280
      • Stomatological Hospital, Southern Medical University
      • Contact: Jia Ni, MD; Email: 441569008@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Basic oral hygiene instructions.; Full-mouth subgingival scaling and root planing under local anesthesia.; Additional full-mouth subgingival scaling and root planing under local anesthesia every 3 months during the follow-up period if necessary.	Procedure: Non-surgical periodontal therapy; Non-surgical periodontal therapy includes basic oral hygiene instructions and full-mouth subgingival scaling and root planing under local anesthesia.
Placebo Comparator: Control arm; Basic oral hygiene instructions.; Full-mouth supragingival ultrasonic scaling.	Procedure: Control periodontal treatment; Control periodontal treatment includes basic oral hygiene instructions and full-mouth supragingival ultrasonic scaling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline; 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline systolic blood pressure 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 fasting blood glucose at 1 year after enrollment.		Baseline; 1 year
Change from baseline glycosylated hemoglobin at 1 year after enrollment.		Baseline; 1 year
Change from baseline total cholesterol at 1 year after enrollment.		Baseline; 1 year
Change from baseline triglyceride 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-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
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.	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.	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.	Baseline; 3 months; 6 months; 9 months; 1 year; 2 years; 3 years;
All-cause mortality	Defined as any death after enrollment.	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.	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.	Baseline; 1 year

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Stomatological Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): August 31, 2025
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Periodontitis; Cardiovascular risk; Non-surgical Periodontal Therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Cardiovascular Diseases; Periodontitis
• Other Study ID Numbers: NFEC-2022-243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No