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Completed

NCT Number: NCT01917292

Impact of Periodontal Intervention on Vascular Dysfunction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One-Stage Full-Mouth Disinfection

Procedure
  • 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

Periodontal care

Procedure
  • Basic oral hygiene instructions
  • Standard cycle of supragingival ultrasonic scaling and polishing

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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

    Compare the changes of traditional inflammatory biomarkers:hs-CRP and IL-6 over a 6-month follow-up period.

  3. Expression of the Long non-protein-coding RNA(lncRNA) and microRNA

    Time frame: baseline

  4. 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

  5. Change in Periodontal Inflamed Surface Area(PISA)

    Time frame: Baseline; 3 months post periodontal therapy; 6 months post periodontal therapy

    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.

  6. 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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

Periodontal Intervention Improves Vascular Function Among Chinese Prehypertensive Adults With Periodontitis

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Aug 6, 2013
Registry last updated
Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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