Role of suPAR in Periodontitis and CVD

Periodontal Diseases Clinical Trial

Official title:

Evaluation of Plasma and Salivary suPAR in Periodontitis and CVD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04335344
• Other study ID #: 11-18-18
• Status: Completed
• Start date: February 15, 2015
• Est. completion date: February 25, 2020

Study information

• Verified date: April 2020
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: February 25, 2020
• Est. primary completion date: September 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Disturbance
• Periodontal Diseases
• Periodontitis

Intervention

Other:
• Observation of suPAR plasma and salivary levels
Evaluation of suPAR plasma level and correlation of plasma suPAR levels with periodontal and cardiovascular disease

Locations

Country	Name	City	State
Italy	University of Messina	Messina

Sponsors (2)

Lead Sponsor	Collaborator
University of Messina	University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level	evaluation of changes in clinical attachment level	1-year