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Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms

Primary Purpose

Atherosclerosis, Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-surgical periodontal treatment
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring Periodontopathogenic microorganisms, Non-surgical periodontal treatment

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • had no systemic disease,
  • had not used any antibiotics
  • had not used medications with an impact on the immune system,
  • had not received any periodontal and/or medical treatment within the last 6 months.

Exclusion Criteria:

  • smokers of cigarettes or other tobacco products,
  • pregnant or breastfeeding,
  • non-stable cardiovascular condition.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Atherosclerosis

    Systemically healthy

    Arm Description

    Patients with atherosclerosis and chronic periodontitis

    Patients with Systemically healthy and chronic periodontitis.

    Outcomes

    Primary Outcome Measures

    Periodontopathogenic microorganism levels

    Secondary Outcome Measures

    Full Information

    First Posted
    November 15, 2016
    Last Updated
    November 29, 2016
    Sponsor
    Izmir Katip Celebi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02977351
    Brief Title
    Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms
    Official Title
    Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms in Chronic Periodontitis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Izmir Katip Celebi University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Determine the relationship between the systemic indications of atherosclerosis by means of the change in the ratio of periodontopathogenic microorganisms following periodontal treatment of individuals who have been diagnosed with chronic periodontitis-atherosclerosis and for individuals who have been diagnosed with systemically healthy-chronic periodontitis.
    Detailed Description
    It has been aimed in this study to compare 1) the change in periodontal status; 2) the change of the periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T. forsythia, T. denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E. nodatum, E. corrodens, and C. gingivalis/ochracea/sputigena) in dental plaque samples, 3) the changes of the amounts of HDL, LDL, hs-CRP white blood cell levels (WBC), platelet levels (PLT), creatinine, and fibrinogen in serum samples; and 4) the correlation between periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T. forsythia, T. denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E. nodatum, E. corrodens, and C. gingivalis/ochracea/sputigena) and HDL, LDL, hs-CRP WBC, PLT, creatinine, and fibrinogen in patients that have been diagnosed with atherosclerosis-chronic periodontitis and systemic healthy patients and patients diagnosed with chronic periodontitis, following non surgical periodontal treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atherosclerosis, Chronic Periodontitis
    Keywords
    Periodontopathogenic microorganisms, Non-surgical periodontal treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Atherosclerosis
    Arm Type
    Experimental
    Arm Description
    Patients with atherosclerosis and chronic periodontitis
    Arm Title
    Systemically healthy
    Arm Type
    Active Comparator
    Arm Description
    Patients with Systemically healthy and chronic periodontitis.
    Intervention Type
    Procedure
    Intervention Name(s)
    Non-surgical periodontal treatment
    Primary Outcome Measure Information:
    Title
    Periodontopathogenic microorganism levels
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: had no systemic disease, had not used any antibiotics had not used medications with an impact on the immune system, had not received any periodontal and/or medical treatment within the last 6 months. Exclusion Criteria: smokers of cigarettes or other tobacco products, pregnant or breastfeeding, non-stable cardiovascular condition.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms

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