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
About this trial
This is an interventional prevention trial for Chronic Periodontitis focused on measuring Periodontitis, Prehypertension, Periodontal Intervention
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
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
NCT ID
NCT01917292
First Posted
August 1, 2013
Last Updated
April 15, 2015
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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
derived
Learn more about this trial
Impact of Periodontal Intervention on Vascular Dysfunction
We'll reach out to this number within 24 hrs