Non-surgical Peridontal Treatment on Cardiovascular Risk Markers

• Sponsor: Kırıkkale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04540328
• Collaborator: (none)
• Enrollment: 80
• Arm: 1
• Actual Duration (Months): 24

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Risk Markers; Chronic Periodontitis	Other: Non-surgical periodontal treatment	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Non-surgical Peridontal Treatment on Cardiovascular Risk Markers in Patients With Severe Chronic Periodontitis
• Actual Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Asymmetric dimethylarginine (ADMA) [At the 3rd months after non-surgical periodontal treatment]

   Serum Concentration (pg/mL)

2. Endothelial nitric oxide synthase (eNOS) [At the 3rd months after non-surgical periodontal treatment]

   Serum Concentration (pg/mL)

3. Homocysteine (Hcy) [At the 3rd months after non-surgical periodontal treatment]

   Serum Concentration (nmol/mL)

4. Monocyte chemoattractant protein-1 (MCP-1) [At the 3rd months after non-surgical periodontal treatment]

   Serum Concentration (ng/mL)

Secondary Outcome Measures

1. Clinical periodontal parameter [At the 3rd months after non-surgical periodontal treatment]

   Clinical attachment level (mm)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 54 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Kırıkkale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Meltem Karsiyaka Hendek, Assistant Professor, Kırıkkale University
• ClinicalTrials.gov Identifier: NCT04540328
• Other Study ID Numbers: 2015 / 029
• First Posted: Sep 7, 2020
• Last Update Posted: Sep 7, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Meltem Karsiyaka Hendek, Assistant Professor, Kırıkkale University: asymmetric dimethylarginine; endothelial nitric oxide synthase; homocysteine; monocyte chemoattractant protein-1
• Additional relevant MeSH terms: Periodontitis; Chronic Periodontitis

Study Results

No Results Posted as of Sep 7, 2020