Endothelin Concentrations in a Population With Cardiovascular Disease and Periodonitis

Sponsor

University of Messina (Other)

Overall Status

Completed

CT.gov ID

NCT04152005

Collaborator

(none)

165

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Serum; Disease	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 Design

Study Type:

Observational

Actual Enrollment :

165 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Sep 25, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Evaluation of ET-1 levels [1 year]
Correlation of ET-1 levels with periodontal and cardiovascular disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 71 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Messina	Messina		Italy	98125

Sponsors and Collaborators

University of Messina

Investigators

Study Director: Giovanni Matarese, University of Messina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gaetano Isola, DDS, PhD, Assistant Professor, University of Messina

ClinicalTrials.gov Identifier:

NCT04152005

Other Study ID Numbers:

10-918-10

First Posted:

Nov 5, 2019

Last Update Posted:

Nov 6, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Nov 6, 2019