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Chronic PeriodontitisPhase 3NCT01917292

Impact of Periodontal Intervention on Vascular Dysfunction

A Phase 3 study testing One-Stage Full-Mouth Disinfection and Periodontal care in people with Chronic Periodontitis and Prehypertension, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Periodontitis, Prehypertension
What is being tested?
One-Stage Full-Mouth Disinfection and Periodontal care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
1 siteChina
Study dates
Dec 2012to Jun 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: Periodontal Intervention Improves Vascular Function Among Chinese Prehypertensive Adults With Periodontitis

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.

Read the 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.

Being tested
One-Stage Full-Mouth Disinfection, Periodontal care
Keywords
Periodontitis, Prehypertension, Periodontal Intervention
Medical subject headings
Chronic Periodontitis, Prehypertension, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • One-Stage Full-Mouth DisinfectionProcedure or surgery

    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

  • Periodontal careProcedure or surgery

    1. Basic oral hygiene instructions
    2. Standard cycle of supragingival ultrasonic scaling and polishing
Study groups in NCT01917292
Study groupRoleWhat they receive
Periodontal careOtherNot described
Receives: Procedure: Periodontal care
One-Stage Full-Mouth DisinfectionExperimentalNot described
Receives: Procedure: One-Stage Full-Mouth Disinfection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in the Number of Endothelial Microparticle at 6 months

    Measured: 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

    Measured: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy

Secondary outcomes (6)

  1. Change in Brachia-ankle Pulse Wave Velocity(baPWV)

    Measured: 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)

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

    Measured: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy

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

    Measured: baseline

  4. Changes in Malondialdehyde(MDA) and Superoxide Dismutase(SOD)

    Measured: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy

  5. 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.

    Measured: Baseline; 3 months post periodontal therapy; 6 months post periodontal therapy

  6. Change in Endothelium-dependent Brachial Artery Flow-mediated Dilation(FMD)

    Measured: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionDec 2013
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01917292
Sponsor's protocol ID
20130718emp
Other IDs
31270992
Status last verified
Apr 2015
First submitted
1 Aug 2013
Last updated
17 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28452620

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing One-Stage Full-Mouth Disinfection and Periodontal care in people with Chronic Periodontitis and Prehypertension, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01917292, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015.

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