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Impact of Periodontal Intervention on Vascular Dysfunction

Primary Purpose

Chronic Periodontitis, Prehypertension

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
One-Stage Full-Mouth Disinfection
Periodontal care
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Periodontitis focused on measuring Periodontitis, Prehypertension, Periodontal Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The First Affiliated Hospital, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Periodontal care

One-Stage Full-Mouth Disinfection

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in the Number of Endothelial Microparticle at 6 months
Change from Baseline in the Blood Pressure at 6 months

Secondary Outcome Measures

Change in Brachia-ankle Pulse Wave Velocity(baPWV)
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.
Expression of the Long non-protein-coding RNA(lncRNA) and microRNA
Changes in Malondialdehyde(MDA) and Superoxide Dismutase(SOD)
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.
Change in Endothelium-dependent Brachial Artery Flow-mediated Dilation(FMD)

Full Information

First Posted
August 1, 2013
Last Updated
April 15, 2015
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01917292
Brief Title
Impact of Periodontal Intervention on Vascular Dysfunction
Official Title
Periodontal Intervention Improves Vascular Function Among Chinese Prehypertensive Adults With Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Prehypertension
Keywords
Periodontitis, Prehypertension, Periodontal Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Periodontal care
Arm Type
Other
Arm Title
One-Stage Full-Mouth Disinfection
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
One-Stage Full-Mouth Disinfection
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Periodontal care
Intervention Description
Basic oral hygiene instructions Standard cycle of supragingival ultrasonic scaling and polishing
Primary Outcome Measure Information:
Title
Change from Baseline in the Number of Endothelial Microparticle at 6 months
Time Frame
Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
Title
Change from Baseline in the Blood Pressure at 6 months
Time Frame
Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
Secondary Outcome Measure Information:
Title
Change in Brachia-ankle Pulse Wave Velocity(baPWV)
Time Frame
Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
Title
Changes in high-sensitivity C-Reactive Protein(hs-CRP) and Interleukin-6(IL-6)
Description
Compare the changes of traditional inflammatory biomarkers:hs-CRP and IL-6 over a 6-month follow-up period.
Time Frame
Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
Title
Expression of the Long non-protein-coding RNA(lncRNA) and microRNA
Time Frame
baseline
Title
Changes in Malondialdehyde(MDA) and Superoxide Dismutase(SOD)
Time Frame
Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy
Title
Change in Periodontal Inflamed Surface Area(PISA)
Description
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.
Time Frame
Baseline; 3 months post periodontal therapy; 6 months post periodontal therapy
Title
Change in Endothelium-dependent Brachial Artery Flow-mediated Dilation(FMD)
Time Frame
Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects must be 18 years of age or older 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 Have at least 16 natural teeth excluding third molars BPs ranging from 120 to 139 mm Hg systolic and/or 80 to 89 mm Hg diastolic blood pressure Provide informed consent and willingness to cooperate with the study protocol Exclusion Criteria: History of antibiotic use in the previous three months Pregnant or lactating females Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases Medical history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular blockade, peripheral vascular disease, cerebrovascular accident, hypertension Patients who received periodontal treatment within the last 6 months Patients who require antibiotic prophylaxis before examination or treatment Patients with mental retardation and dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Ying Yang, Master
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jun Tao, M.D.,phD.
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
28452620
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.
Results Reference
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Impact of Periodontal Intervention on Vascular Dysfunction

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