Endothelin Concentrations in a Population With Cardiovascular Disease and Periodonitis

Analysis of Endothelin Concentrations in a Population With Cardiovascular Disease and Periodontitis

Recently, a key role played in the ethiology of periodontitis has been highlighted by a Endothelin (ET-1). ET1 possess the ability to express surface antigens of endothelial and hematopoietic stem cells and to assist in maintaining vascular integrity and the repair mechanism of the endothelium. ET originate from bone marrow

Study Overview

• Status: Completed
• Conditions: Serum; Disease
• Intervention / Treatment: Other: Observation

Detailed Description

The aim of the present study was to investigate the association between ET-1 in patients with periodontitis. Furthermore, the objective was to determine if the periodontal status influenced ET-1 levels.

• Study Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• Italy
  • Messina, Italy, 98125
    • University of Messina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

34 patients with CP, 34 patients with CHD, 34 patients with CP+CHD, and 34 healthy subjects were finally enrolled

Description

Inclusion Criteria:

• Presence of at least 16 teeth

• CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;

• Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
• Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

• Intake of contraceptives
• Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
• Status of pregnancy or lactation
• Previous history of excessive drinking
• Allergy to local anaesthetic
• Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease	Other: Observation; Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease
Periodontitis; Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease	Other: Observation; Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease
Cardiovascular; Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease	Other: Observation; Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease
Periodontitis+Cardiovascular; Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease	Other: Observation; Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of ET-1 levels	Correlation of ET-1 levels with periodontal and cardiovascular disease	1 year

Collaborators and Investigators

• Sponsor: University of Messina
• Investigators: Study Director: Giovanni Matarese, University of Messina

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): September 25, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 10-918-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all collected IPD, all IPD that underlie results in a publication
• IPD Sharing Time Frame: 5 years
• IPD Sharing Access Criteria: IRB university of messina
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No