Role of suPAR in Periodontitis and CVD

Sponsor

University of Messina (Other)

Overall Status

Completed

CT.gov ID

NCT04335344

Collaborator

University of Catania (Other)

326

Enrollment

Location

60.3

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Disturbance Periodontal Diseases	Other: Observation of suPAR plasma and salivary levels

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 Design

Study Type:

Observational

Actual Enrollment :

326 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Evaluation of Plasma and Salivary suPAR in Periodontitis and CVD Patients

Actual Study Start Date :

Feb 15, 2015

Actual Primary Completion Date :

Sep 21, 2018

Actual Study Completion Date :

Feb 25, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Clinical attachment level [1-year]
evaluation of changes in clinical attachment level

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

University of Messina
University of Catania

Investigators

Study Chair: Giovanni Matarese, University of Messina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gaetano Isola, DDS, PhD, Researcher, University of Messina

ClinicalTrials.gov Identifier:

NCT04335344

Other Study ID Numbers:

11-18-18

First Posted:

Apr 6, 2020

Last Update Posted:

Apr 7, 2020

Last Verified:

Apr 1, 2020

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:

Periodontitis

Periodontal Diseases

Study Results

No Results Posted as of Apr 7, 2020