Role of suPAR in Periodontitis and CVD

NCT04335344 | Completed DMC

• 1 other identifier: 11-18-18
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Disturbance; Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level

  evaluation of changes in clinical attachment level

  1-year

Study Arms (4)

Control

Healthy patients

Other: Observation of suPAR plasma and salivary levels

Periodontitis

Patients with periodontitis

Other: Observation of suPAR plasma and salivary levels

Cardiovascular disease

Patients with cardiovascular disease

Other: Observation of suPAR plasma and salivary levels

Periodontitis + cardiovascular disease

Patients with Periodontitis + cardiovascular disease

Other: Observation of suPAR plasma and salivary levels

Interventions

Observation of suPAR plasma and salivary levels OTHER

Evaluation of suPAR plasma level and correlation of plasma suPAR levels with periodontal and cardiovascular disease

Cardiovascular disease; Control; Periodontitis; Periodontitis + cardiovascular disease

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

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
• University of Catania: collaborator

Study Sites (1)

University of Messina

Messina, 98125, Italy

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Giovanni Matarese

  University of Messina

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: February 15, 2015
• Primary Completion: September 21, 2018
• Study Completion: February 25, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 10 years at least
• Access Criteria: Pubmed

Locations

IT (1)