Clinical trial NCT01917292: Impact of Periodontal Intervention on Vascular Dysfunction
Official title: Periodontal Intervention Improves Vascular Function Among Chinese Prehypertensive Adults With Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Periodontitis
Prehypertension
Keywords: Periodontitis
Prehypertension
Periodontal Intervention
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in the Number of Endothelial Microparticle at 6 months
timeFrame: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
measure: Change from Baseline in the Blood Pressure at 6 months
timeFrame: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
Secondary outcomes:
measure: Change in Brachia-ankle Pulse Wave Velocity(baPWV)
timeFrame: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
measure: Changes in high-sensitivity C-Reactive Protein(hs-CRP) and Interleukin-6(IL-6)
timeFrame: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
measure: Expression of the Long non-protein-coding RNA(lncRNA) and microRNA
timeFrame: baseline
measure: Changes in Malondialdehyde(MDA) and Superoxide Dismutase(SOD)
timeFrame: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
measure: Change in Periodontal Inflamed Surface Area(PISA)
timeFrame: Baseline; 3 months post periodontal therapy; 6 months post periodontal therapy
measure: Change in Endothelium-dependent Brachial Artery Flow-mediated Dilation(FMD)
timeFrame: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Jun Ying Yang, Master
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Jun Tao, M.D.,phD.
role: STUDY_CHAIR
References:
citation: 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.