Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk

Cardiovascular Diseases Clinical Trial

Official title:

Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk in People at Risk of Cardiovascular Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05459727
• Other study ID #: NFEC-2022-243
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jiancheng Xiu, MD
• Phone: +86-020-61648319
• Email: xiujch[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 376
• Est. completion date: December 31, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Periodontitis

Intervention

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.
• Control periodontal treatment
Control periodontal treatment includes basic oral hygiene instructions and full-mouth supragingival ultrasonic scaling.

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong
China	Stomatological Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Stomatological Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline systolic blood pressure at 1 year after enrollment.		Baseline; 1 year
Secondary	Change from baseline diastolic blood pressure at 1 year after enrollment.		Baseline; 1 year
Secondary	Change from baseline fasting blood glucose at 1 year after enrollment.		Baseline; 1 year
Secondary	Change from baseline glycosylated hemoglobin at 1 year after enrollment.		Baseline; 1 year
Secondary	Change from baseline total cholesterol at 1 year after enrollment.		Baseline; 1 year
Secondary	Change from baseline triglyceride at 1 year after enrollment.		Baseline; 1 year
Secondary	Change from baseline low-density lipoprotein cholesterol at 1 year after enrollment.		Baseline; 1 year
Secondary	Change from baseline high-density lipoprotein cholesterol at 1 year after enrollment.		Baseline; 1 year
Secondary	Change from baseline high sensitivity C-reactive protein at 1 year after enrollment.		Baseline; 1 year
Secondary	Change from baseline interleukin-6 at 1 year after enrollment.		Baseline; 1 year
Secondary	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
Secondary	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
Secondary	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;
Secondary	All-cause mortality	Defined as any death after enrollment.	Baseline; 3 months; 6 months; 9 months; 1 year; 2 years; 3 years;
Secondary	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
Secondary	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