Impact of Periodontal Intervention on Vascular Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Junying Yang, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01917292
First received: August 1, 2013
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Chronic Periodontitis
Prehypertension
Procedure: One-Stage Full-Mouth Disinfection
Procedure: Periodontal care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Periodontal Intervention Improves Vascular Function Among Chinese Prehypertensive Adults With Periodontitis

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Changes in high-sensitivity C-Reactive Protein(hs-CRP) and Interleukin-6(IL-6) [ Time Frame: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in Periodontal Inflamed Surface Area(PISA) [ Time Frame: Baseline; 3 months post periodontal therapy; 6 months post periodontal therapy ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: December 2012
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Periodontal care Procedure: Periodontal care
  1. Basic oral hygiene instructions
  2. Standard cycle of supragingival ultrasonic scaling and polishing
Experimental: One-Stage Full-Mouth Disinfection Procedure: One-Stage Full-Mouth Disinfection
  1. Basic oral hygiene instructions
  2. Dental extractions will be performed (only in cases of teeth that could not be saved)
  3. Standard cycle of supragingival ultrasonic scaling and polishing
  4. Scaling and root planning after the administration of local anesthesia, four quadrants in one session
  5. Minocycline Hydrochloride Ointment (Periocline, OraPharma) were delivered locally into the periodontal pockets

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917292

Locations
China, Guangdong
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Junying Yang, professor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01917292     History of Changes
Other Study ID Numbers: 20130718emp, 31270992
Study First Received: August 1, 2013
Last Updated: June 10, 2014
Health Authority: China: Ministry of Health

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
Periodontitis
Prehypertension
Periodontal Intervention

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Prehypertension
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014