Role of suPAR in Periodontitis and CVD

April 3, 2020 updated by: Gaetano Isola, DDS, PhD, University of Messina

Evaluation of Plasma and Salivary suPAR in Periodontitis and CVD Patients

soluble urokinase-type plasminogen activator receptor (suPAR) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and cardiovascular disease (CVD). The investigators compared the impact of gingival health, periodontitis (CP), CHD or of both diseases (CP+CHD) on saliva and serum suPAR levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study was to evaluate a possible association between both saliva and serum suPAR levels in patients with CP and with CVD and if the serum suPAR levels are mediated by serum CRP.

Study Type

Observational

Enrollment (Actual)

326

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy subjects (n=33) and patients with periodontitis (n=35), CVD (n=34), and a combination of periodontitis + CVD (n=34) were enrolled in the present study.

Description

Inclusion Criteria:

  • Presence of at least 15 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Healthy patients
Other: Observation of suPAR plasma and salivary levels
Evaluation of suPAR plasma level and correlation of plasma suPAR levels with periodontal and cardiovascular disease
Periodontitis
Patients with periodontitis
Other: Observation of suPAR plasma and salivary levels
Evaluation of suPAR plasma level and correlation of plasma suPAR levels with periodontal and cardiovascular disease
Cardiovascular disease
Patients with cardiovascular disease
Other: Observation of suPAR plasma and salivary levels
Evaluation of suPAR plasma level and correlation of plasma suPAR levels with periodontal and cardiovascular disease
Periodontitis + cardiovascular disease
Patients with Periodontitis + cardiovascular disease
Other: Observation of suPAR plasma and salivary levels
Evaluation of suPAR plasma level and correlation of plasma suPAR levels with periodontal and cardiovascular disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment level
Time Frame: 1-year
evaluation of changes in clinical attachment level
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Messina

Collaborators

University of Catania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2015

Primary Completion (ACTUAL)

September 21, 2018

Study Completion (ACTUAL)

February 25, 2020

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (ACTUAL)

April 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-18-18

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

10 years at least

IPD Sharing Access Criteria

Pubmed

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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