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NCT Number: NCT05459727

Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Non-surgical periodontal therapy

Procedure

Non-surgical periodontal therapy includes basic oral hygiene instructions and full-mouth subgingival scaling and root planing under local anesthesia.

Control Periodontal Treatment

Procedure

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

Primary outcomes

  1. Change from Baseline Cardiovascular risk (Framingham risk score (FRS)) at 1 year.

    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.

Secondary outcomes

  1. Change from baseline systolic blood pressure at 1 year after enrollment.

    Time frame: Baseline; 1 year

  2. Change from baseline diastolic blood pressure at 1 year after enrollment.

    Time frame: Baseline; 1 year

  3. Change from baseline fasting blood glucose at 1 year after enrollment.

    Time frame: Baseline; 1 year

  4. Change from baseline glycosylated hemoglobin at 1 year after enrollment.

    Time frame: Baseline; 1 year

  5. Change from baseline total cholesterol at 1 year after enrollment.

    Time frame: Baseline; 1 year

  6. Change from baseline triglyceride at 1 year after enrollment.

    Time frame: Baseline; 1 year

  7. Change from baseline low-density lipoprotein cholesterol at 1 year after enrollment.

    Time frame: Baseline; 1 year

  8. Change from baseline high-density lipoprotein cholesterol at 1 year after enrollment.

    Time frame: Baseline; 1 year

  9. Change from baseline high sensitivity C-reactive protein at 1 year after enrollment.

    Time frame: Baseline; 1 year

  10. Change from baseline interleukin-6 at 1 year after enrollment.

    Time frame: Baseline; 1 year

  11. Change from baseline cardiovascular risk (CHINA-PAR) at 1 year after enrollment.

    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.

  12. Change from baseline community periodontal index at 1 year after enrollment.

    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.

  13. Major adverse cardiovascular event

    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.

  14. All-cause mortality

    Time frame: Baseline; 3 months; 6 months; 9 months; 1 year; 2 years; 3 years;

    Defined as any death after enrollment.

  15. Change from baseline anxiety at 1 year 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.

  16. Change from baseline pain at 1 year after enrollment.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiancheng Xiu, MD

CONTACT

[email protected]

+86-020-61648319

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Southern Medical University, China

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 15, 2022
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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