Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms

November 29, 2016 updated by: Dr. A. Seckin ERTUGRUL, Izmir Katip Celebi University

Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms in Chronic Periodontitis Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atherosclerosis
Patients with atherosclerosis and chronic periodontitis
Procedure: Non-surgical periodontal treatment
Active Comparator: Systemically healthy
Patients with Systemically healthy and chronic periodontitis.
Procedure: Non-surgical periodontal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Periodontopathogenic microorganism levels
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

November 30, 2016

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IzmirKCU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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