Non-surgical periodontal therapy
ProcedureNon-surgical periodontal therapy includes basic oral hygiene instructions and full-mouth subgingival scaling and root planing under local anesthesia.
NCT Number: NCT05459727
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-surgical periodontal therapy includes basic oral hygiene instructions and full-mouth subgingival scaling and root planing under local anesthesia.
Control periodontal treatment includes basic oral hygiene instructions and full-mouth supragingival ultrasonic scaling.
Time frame: 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.
Time frame: Baseline; 1 year
Time frame: Baseline; 1 year
Time frame: Baseline; 1 year
Time frame: Baseline; 1 year
Time frame: Baseline; 1 year
Time frame: Baseline; 1 year
Time frame: Baseline; 1 year
Time frame: Baseline; 1 year
Time frame: Baseline; 1 year
Time frame: Baseline; 1 year
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline; 3 months; 6 months; 9 months; 1 year; 2 years; 3 years;
Defined as any death after enrollment.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Nanfang Hospital, Southern Medical University
Other
Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk in People at Risk of Cardiovascular Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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