NCT01917292

Impact of Periodontal Intervention on Vascular Dysfunction

Periodontal Intervention Improves Vascular Function Among Chinese Prehypertensive Adults With Periodontitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Periodontitis
• Prehypertension

Interventions

Type	Name	Description
PROCEDURE	One-Stage Full-Mouth Disinfection	1. Basic oral hygiene instructions 2. Dental extractions will be performed (only in cases of teeth that could not be saved) 3. Standard cycle of supragingival ultrasonic scaling and polishing 4. Scaling and root planning after the administration of local anesthesia, four quadrants in one session 5. Minocycline Hydrochloride Ointment (Periocline, OraPharma) were delivered locally into the periodontal pockets
PROCEDURE	Periodontal care	1. Basic oral hygiene instructions 2. Standard cycle of supragingival ultrasonic scaling and polishing

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-12-01
• Completion: 2014-06-01
• First posted: 2013-08-06
• Last updated: 2015-04-17

Locations

1 site across 1 country: China