Endothelin Concentrations in a Population With Cardiovascular Disease and Periodonitis

NCT04152005 | Completed DMC

• 1 other identifier: 10-918-10
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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

Conditions

Serum; Disease

Outcome Measures

Primary Outcomes (1)

• Evaluation of ET-1 levels

  Correlation of ET-1 levels with periodontal and cardiovascular disease

  1 year

Study Arms (4)

Control

Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease

Other: Observation

Periodontitis

Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease

Other: Observation

Cardiovascular

Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease

Other: Observation

Periodontitis+Cardiovascular

Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease

Other: Observation

Interventions

Observation OTHER

Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease

Cardiovascular; Control; Periodontitis; Periodontitis+Cardiovascular

Eligibility Criteria

• Age: 21 Years - 71 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Messina: lead

Study Sites (1)

University of Messina

Messina, 98125, Italy

Location

MeSH Terms

Conditions

Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Giovanni Matarese

  University of Messina

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 5, 2019
• Study Start: January 1, 2016
• Primary Completion: September 25, 2018
• Study Completion: September 30, 2018
• Last Updated: November 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 5 years
• Access Criteria: IRB university of messina

Locations

IT (1)