Back to resultsNon-surgical Peridontal Treatment on Cardiovascular Risk Markers
Primary Purpose
Cardiovascular Risk Markers, Chronic Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-surgical periodontal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Risk Markers focused on measuring asymmetric dimethylarginine, endothelial nitric oxide synthase, homocysteine, monocyte chemoattractant protein-1
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Non-surgical peridontal treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
Asymmetric dimethylarginine (ADMA)
Serum Concentration (pg/mL)
Endothelial nitric oxide synthase (eNOS)
Serum Concentration (pg/mL)
Homocysteine (Hcy)
Serum Concentration (nmol/mL)
Monocyte chemoattractant protein-1 (MCP-1)
Serum Concentration (ng/mL)
Secondary Outcome Measures
Clinical periodontal parameter
Clinical attachment level (mm)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04540328
Brief Title
Non-surgical Peridontal Treatment on Cardiovascular Risk Markers
Official Title
Effect of Non-surgical Peridontal Treatment on Cardiovascular Risk Markers in Patients With Severe Chronic Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırıkkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Markers, Chronic Periodontitis
Keywords
asymmetric dimethylarginine, endothelial nitric oxide synthase, homocysteine, monocyte chemoattractant protein-1
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-surgical peridontal treatment
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Non-surgical periodontal treatment
Primary Outcome Measure Information:
Title
Asymmetric dimethylarginine (ADMA)
Description
Serum Concentration (pg/mL)
Time Frame
At the 3rd months after non-surgical periodontal treatment
Title
Endothelial nitric oxide synthase (eNOS)
Description
Serum Concentration (pg/mL)
Time Frame
At the 3rd months after non-surgical periodontal treatment
Title
Homocysteine (Hcy)
Description
Serum Concentration (nmol/mL)
Time Frame
At the 3rd months after non-surgical periodontal treatment
Title
Monocyte chemoattractant protein-1 (MCP-1)
Description
Serum Concentration (ng/mL)
Time Frame
At the 3rd months after non-surgical periodontal treatment
Secondary Outcome Measure Information:
Title
Clinical periodontal parameter
Description
Clinical attachment level (mm)
Time Frame
At the 3rd months after non-surgical periodontal treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Non-surgical Peridontal Treatment on Cardiovascular Risk Markers
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