Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-surgical periodontal therapy, Control periodontal treatment.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases, Periodontitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk in People at Risk of Cardiovascular Disease
Overview
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.
Interventions
- 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. - Procedure Control periodontal treatment
Control periodontal treatment includes basic oral hygiene instructions and full-mouth supragingival ultrasonic scaling.
Primary outcome measures
- Change from Baseline Cardiovascular risk (Framingham risk score (FRS)) at 1 year. [Time frame: Baseline; 1 year]
Secondary outcome measures (12)
- Change from baseline systolic blood pressure at 1 year after enrollment. [Time frame: Baseline; 1 year]
- Change from baseline diastolic blood pressure at 1 year after enrollment. [Time frame: Baseline; 1 year]
- Change from baseline fasting blood glucose at 1 year after enrollment. [Time frame: Baseline; 1 year]
- Change from baseline glycosylated hemoglobin at 1 year after enrollment. [Time frame: Baseline; 1 year]
- Change from baseline total cholesterol at 1 year after enrollment. [Time frame: Baseline; 1 year]
- Change from baseline triglyceride at 1 year after enrollment. [Time frame: Baseline; 1 year]
- Change from baseline low-density lipoprotein cholesterol at 1 year after enrollment. [Time frame: Baseline; 1 year]
- Change from baseline high-density lipoprotein cholesterol at 1 year after enrollment. [Time frame: Baseline; 1 year]
- Change from baseline high sensitivity C-reactive protein at 1 year after enrollment. [Time frame: Baseline; 1 year]
- Change from baseline interleukin-6 at 1 year after enrollment. [Time frame: Baseline; 1 year]
- Change from baseline cardiovascular risk (CHINA-PAR) at 1 year after enrollment. [Time frame: Baseline; 1 year]
- Change from baseline community periodontal index at 1 year after enrollment. [Time frame: Baseline; 1 year]
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 2 centers
- Stomatological Hospital, Southern Medical University — Guangzhou
- Nanfang Hospital, Southern Medical University — Guangzhou
Identifiers
NCT: NCT05459727 · NFEC-2022-243