Impact of Periodontal Intervention on Vascular Dysfunction

Periodontal Intervention Improves Vascular Function Among Chinese Prehypertensive Adults With Periodontitis

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.

Study Overview

• Status: Completed
• Conditions: Prehypertension; Chronic Periodontitis
• Intervention / Treatment: Procedure: Periodontal care; Procedure: One-Stage Full-Mouth Disinfection

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 Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Periodontal care	Procedure: Periodontal care; Basic oral hygiene instructions; Standard cycle of supragingival ultrasonic scaling and polishing
Experimental: One-Stage Full-Mouth Disinfection	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Brachia-ankle Pulse Wave Velocity(baPWV)		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)	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
Expression of the Long non-protein-coding RNA(lncRNA) and microRNA		baseline
Changes in Malondialdehyde(MDA) and Superoxide Dismutase(SOD)		Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
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
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Study Director: Jun Ying Yang, Master, First Affiliated Hospital, Sun Yat-Sen University; Study Chair: Jun Tao, M.D.,phD., First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

General Publications

• Zhou QB, Xia WH, Ren J, Yu BB, Tong XZ, Chen YB, Chen S, Feng L, Dai J, Tao J, Yang JY. Effect of Intensive Periodontal Therapy on Blood Pressure and Endothelial Microparticles in Patients With Prehypertension and Periodontitis: A Randomized Controlled Trial. J Periodontol. 2017 Aug;88(8):711-722. doi: 10.1902/jop.2017.160447. Epub 2017 Apr 28.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: August 1, 2013
• First Submitted That Met QC Criteria: August 4, 2013
• First Posted (Estimate): August 6, 2013

Study Record Updates

• Last Update Posted (Estimate): April 17, 2015
• Last Update Submitted That Met QC Criteria: April 15, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Prehypertension; Periodontitis; Periodontal Intervention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Prehypertension; Chronic Periodontitis
• Other Study ID Numbers: 20130718emp; 31270992 (Registry Identifier: National Natural Science Foundation of China)