Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk

Nanfang Hospital, Southern Medical University

Status: Not yet enrolling

Conditions: Periodontitis; Cardiovascular Diseases

Treatments: Procedure: Control periodontal treatment; Procedure: Non-surgical periodontal therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05459727

NFEC-2022-243

Details and patient eligibility

About

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.

Full 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.

Enrollment: 376 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

376 participants in 2 patient groups, including a placebo group

Intervention arm

Experimental group

Description:

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.

Treatment:

Procedure: Non-surgical periodontal therapy

Control arm

Placebo Comparator group

Description:

1. Basic oral hygiene instructions. 2. Full-mouth supragingival ultrasonic scaling.

Treatment:

Procedure: Control periodontal treatment