Impact of Periodontal Intervention on Vascular Dysfunction

Phase 3

Completed

• Conditions: Prehypertension; Chronic Periodontitis
• Interventions: Procedure: One-Stage Full-Mouth Disinfection; Procedure: Periodontal care

• Registration Number: NCT01917292
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-08-01
• Study First Submitted QC: 2013-08-04
• Study First Posted: 2013-08-06
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One-Stage Full-Mouth Disinfection	One-Stage Full-Mouth Disinfection	-
Periodontal care	Periodontal care	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the Blood Pressure at 6 months	Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
Change from Baseline in the Number of Endothelial Microparticle at 6 months	Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy

Secondary Outcome Measures

Name	Time	Method
Changes in Malondialdehyde(MDA) and Superoxide Dismutase(SOD)	Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
Changes in high-sensitivity C-Reactive Protein(hs-CRP) and Interleukin-6(IL-6)	Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy	Compare the changes of traditional inflammatory biomarkers：hs-CRP and IL-6 over a 6-month follow-up period.
Change in Periodontal Inflamed Surface Area(PISA)	Baseline; 3 months post periodontal therapy; 6 months post periodontal therapy	Bleeding on probing(BOP), clinical attachment loss (CAL) and gingival recession(GR) are measured to calculate the PISA.The PISA reflects the surface area of bleeding pocket epithelium in square millimetres.
Change in Brachia-ankle Pulse Wave Velocity(baPWV)	Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
Change in Endothelium-dependent Brachial Artery Flow-mediated Dilation(FMD)	Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
Expression of the Long non-protein-coding RNA(lncRNA) and microRNA	baseline

Trial Locations

Locations (1)

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China