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NCT04540328 Clinical Trial

Non-surgical Peridontal Treatment on Cardiovascular Risk Markers

Chronic Periodontitis Clinical Trial

Official title:
Effect of Non-surgical Peridontal Treatment on Cardiovascular Risk Markers in Patients With Severe Chronic Periodontitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04540328
Other study ID # 2015 / 029
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date August 2017

Study information
Verified date September 2020
Source Kirikkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study evaluates the influence of non-surgical mechanical periodontal treatment in patients with severe chronic periodontitis on inflammatory markers related to risk for cardiovascular diseases

Description:

A total of 80 non-smokers with systemically healthy, including 40 patients with severe chronic periodontitis and 40 periodontally health subjects were included into the present study. The probing depth, clinical attachment level, plaque index, gingival index and blood samples were collected at baseline and at the 3rd months after treatment and the serum levels of asymmetric dimethylarginine (ADMA), endothelial nitric oxide synthase (eNOS), homocysteine (Hcy), monocyte chemoattractant protein-1 (MCP-1) were determined with enzyme-linked immunosorbent assay (ELISA).

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date August 2017
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 54 Years
Eligibility Inclusion Criteria:

Clinical diagnosis of severe chronic periodontitis

Clinical diagnosis of periodontal health

Exclusion Criteria:

Systemic diseases such as diabetes, cardiovascular disease

Periodontal treatment within the previous year

Drugs such as systemic steroids, non-steroidal anti-inflammatory drugs, immunosuppressants, hormone drugs, contraceptives, anticoagulants, cholesterol regulating drugs, systemic antibiotics, antioxidants within the previous 3 months

Pregnant or lactating

Consumed alcohol

Smoker

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-surgical periodontal treatment

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kirikkale University

Outcome
Type Measure Description Time frame Safety issue
Primary Asymmetric dimethylarginine (ADMA) Serum Concentration (pg/mL) At the 3rd months after non-surgical periodontal treatment
Primary Endothelial nitric oxide synthase (eNOS) Serum Concentration (pg/mL) At the 3rd months after non-surgical periodontal treatment
Primary Homocysteine (Hcy) Serum Concentration (nmol/mL) At the 3rd months after non-surgical periodontal treatment
Primary Monocyte chemoattractant protein-1 (MCP-1) Serum Concentration (ng/mL) At the 3rd months after non-surgical periodontal treatment
Secondary Clinical periodontal parameter Clinical attachment level (mm) At the 3rd months after non-surgical periodontal treatment
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