Impact of Periodontal Intervention on Vascular Dysfunction

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Prehypertension; Chronic Periodontitis

Treatments: Procedure: Periodontal care; Procedure: One-Stage Full-Mouth Disinfection

Study type: Interventional

Funder types: Other

Identifiers

NCT01917292

31270992 (Registry Identifier)

20130718emp

Details and patient eligibility

About

The purpose of this study is to determine the effect of periodontal intervention on vascular dysfunction among Chinese prehypertensive adults with moderate to severe periodontal disease.

Full description

Periodontitis is one of the low-grade chronic diseases, and it is the principal cause of tooth loss among middle-aged and elderly. Recently, epidemiological data indicate that patients with periodontitis are associated with increases in blood pressure levels and hypertension prevalence. Furthermore, studies from cross-sectional investigations demonstrate that hypertensive patients with periodontitis may enhance the risk and degree of vascular damage. Therefore, periodontal therapy is a novel therapeutic strategy to prevent the occurrence of BP elevation and retard the development vascular injury.

The term "prehypertension" indicates those with BPs ranging from 120 to 139 mm Hg systolic and/or 80 to 89 mm Hg diastolic blood pressure. Accumulating evidence suggests that subjects with prehypertension is associated with higher incidence of atherosclerotic vascular disease. However, until now there are no available data to investigate the influence of periodontitis on prehypertension and whether periodontal intervention may reduce the BP rise in subjects with prehypertension and improve the vascular function. We hypothesized that periodontitis leads to elevation in BP and periodontal therapy improves vascular function in subjects with prehypertension. To address these assumptions, The present study is designed to study the effect of periodontal intervention on blood pressure and vascular function and inflammatory biomarkers among Chinese prehypertensive adults with moderate to severe periodontal disease, and determine whether intensive periodontal therapy improves these measures over a 6-month follow-up period.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects must be 18 years of age or older
2. Moderate to severe generalized periodontitis(probing pocket depths of >6 mm and Marginal alveolar bone loss of >30%) with 50% or more of their teeth affected
3. Have at least 16 natural teeth excluding third molars
4. BPs ranging from 120 to 139 mm Hg systolic and/or 80 to 89 mm Hg diastolic blood pressure
5. Provide informed consent and willingness to cooperate with the study protocol

Exclusion criteria

1. History of antibiotic use in the previous three months
2. Pregnant or lactating females
3. Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases
4. Medical history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular blockade, peripheral vascular disease, cerebrovascular accident, hypertension
5. Patients who received periodontal treatment within the last 6 months
6. Patients who require antibiotic prophylaxis before examination or treatment
7. Patients with mental retardation and dementia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 2 patient groups

Periodontal care

Other group

Treatment:

Procedure: Periodontal care

One-Stage Full-Mouth Disinfection

Experimental group

Treatment:

Procedure: One-Stage Full-Mouth Disinfection