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NCT02977351 Clinical Trial

Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms

Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02977351
Other study ID # IzmirKCU
Secondary ID
Status Completed
Phase N/A
First received November 15, 2016
Last updated November 29, 2016
Start date January 2014
Est. completion date January 2016

Study information
Verified date November 2016
Source Izmir Katip Celebi University
Contact n/a
Is FDA regulated No
Health authority Turkey: Drug and Medical Device Institution
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date January 2016
Est. primary completion date January 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Non-surgical periodontal treatment

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Izmir Katip Celebi University

Outcome
Type Measure Description Time frame Safety issue
Primary Periodontopathogenic microorganism levels 1 year Yes
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