Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cardiovascular Diseases Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Due to the characteristics of the intervention in this trial, it would be impossible to blind the enrolled participants. However, the investigators and outcomes assessors will be blinded. Allocation to arms will be concealed in an envelope and revealed to the stomatologist and patient before delivering the first treatment. Other investigators like outcomes assessors and staff involved in the data collection and analyses will be masked.

Study Groups

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Intervention arm

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.

Group Type EXPERIMENTAL

Non-surgical periodontal therapy

Intervention Type PROCEDURE

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

Control arm

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

Group Type PLACEBO_COMPARATOR

Control periodontal treatment

Intervention Type PROCEDURE

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

Interventions

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Non-surgical periodontal therapy

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

Intervention Type PROCEDURE

Control periodontal treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No