Impact of Periodontal Intervention on Vascular Dysfunction

Chronic Periodontitis Clinical Trial

Official title:

Periodontal Intervention Improves Vascular Function Among Chinese Prehypertensive Adults With Periodontitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917292
• Other study ID #: 20130718emp
• Secondary ID: 31270992
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2013
• Last updated: April 15, 2015
• Start date: December 2012
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis
• Prehypertension

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Change in Brachia-ankle Pulse Wave Velocity(baPWV)		Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy	No
Secondary	Changes in high-sensitivity C-Reactive Protein(hs-CRP) and Interleukin-6(IL-6)	Compare the changes of traditional inflammatory biomarkers:hs-CRP and IL-6 over a 6-month follow-up period.	Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy	No
Secondary	Expression of the Long non-protein-coding RNA(lncRNA) and microRNA		baseline	No
Secondary	Changes in Malondialdehyde(MDA) and Superoxide Dismutase(SOD)		Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy	No
Secondary	Change in Periodontal Inflamed Surface Area(PISA)	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.	Baseline; 3 months post periodontal therapy; 6 months post periodontal therapy	No
Secondary	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	No