Non-surgical Peridontal Treatment on Cardiovascular Risk Markers

September 1, 2020 updated by: Meltem Karsiyaka Hendek, Kırıkkale University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

80

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

30 years to 54 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Non-surgical peridontal treatment
Patients with chronic periodontitis received non-surgical periodontal treatment, including scaling and root planing and polishing within 14 days under local anesthesia with manual and ultrasonic devices and standardized oral hygiene instructions including methods of tooth-brushing and interdental cleaning were also given to each one. A professional supragingival plaque control was applied on a regular basis every month.
Other: Non-surgical periodontal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asymmetric dimethylarginine (ADMA)
Time Frame: At the 3rd months after non-surgical periodontal treatment
Serum Concentration (pg/mL)
At the 3rd months after non-surgical periodontal treatment
Endothelial nitric oxide synthase (eNOS)
Time Frame: At the 3rd months after non-surgical periodontal treatment
Serum Concentration (pg/mL)
At the 3rd months after non-surgical periodontal treatment
Homocysteine (Hcy)
Time Frame: At the 3rd months after non-surgical periodontal treatment
Serum Concentration (nmol/mL)
At the 3rd months after non-surgical periodontal treatment
Monocyte chemoattractant protein-1 (MCP-1)
Time Frame: At the 3rd months after non-surgical periodontal treatment
Serum Concentration (ng/mL)
At the 3rd months after non-surgical periodontal treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical periodontal parameter
Time Frame: At the 3rd months after non-surgical periodontal treatment
Clinical attachment level (mm)
At the 3rd months after non-surgical periodontal treatment

Collaborators and Investigators

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

Sponsor

Kırıkkale 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 (Actual)

August 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 7, 2020

Study Record Updates

Last Update Posted (Actual)

September 7, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015 / 029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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