Effects of Denture-Related Stomatitis on Blood Pressure in Denture Wearers

Effects of Denture-Related Stomatitis on Blood Pressure, Endothelial Function and Systemic Immune Response in Patients With Dentures

The aim of this study is to evaluate the influence of presence of oral fungal infection, which leads to denture-related stomatitis, on blood pressure, endothelial function and immune cell phenotype in patients wearing dentures.

Study Overview

• Status: Unknown
• Conditions: Denture Stomatitis
• Intervention / Treatment: Drug: Nystatin

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Marta Cześnikiewicz-Guzik, PhD; Phone Number: +48126330003; Email: marta.czesnikiewicz-guzik@glasgow.ac.uk

Study Locations

• Poland
  • Krakow, Poland, 31-135
    • Recruiting
    • Zbigniew Żak Voivodeship Dental Clinic
  • Krakow, Poland, 31-155
    • Recruiting
    • Jagiellonian University Dental Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Dental clinic patients wearing dentures

Description

Inclusion Criteria:

• Patients with dental prostheses used for at least 6 months,
• Substantial portion of the oral mucosa covered by dental prosthesis.

Exclusion Criteria:

• acute inflammatory disorders other than denture-related stomatitis, neoplastic disease relapses or chemotherapy courses less than 5 years before the enrolment,
• antibiotics in less than 4 weeks before the enrolment,
• anti-inflammatory drugs (steroids and non-steroidal, excluding aspirin in doses less than 80 mg) in less than 2 months before the enrolment,
• history of myocardial infarction, acute coronary incident or vascular inflammation in 5 weeks or less before the enrolment,
• chronic haematological disorders and immunodeficiencies less than 5 weeks before the enrolment,
• major medication changes less than 5 weeks before the enrolment or during study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Denture wearers without clinical signs of denture-related stomatitis confirmed with negative Candida swabs.
Denture-related stomatitis group; Denture wearers with clinical signs of denture-related stomatitis, confirmed with positive Candida swabs. Treated for fungal infection, with nystatin [100 000 IU every 6 h for 3 weeks, applied on the infected area of the mucous membrane of the palate and cheeks].	Drug: Nystatin; 100 000 IU every 6 h as a suspension; Other Names: Mycostatin; Stamicin; Stamycin; Fungicidin; Nilstat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in blood pressure	Ambulatory Blood Pressure Monitoring System	Within 48h Prior to denture-related stomatitis treatment; 48h after recovery from denture-related stomatitis; 2 months after recovery from denture-related stomatitis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in endothelial function	Flow Mediated Dilatation	Within 48h Prior to denture-related stomatitis treatment; 48h after recovery from denture-related stomatitis; 2 months after recovery from denture-related stomatitis
Changes in immune cell subset populations from baseline	Determination of cell subsets, activation markers and intracellular cytokine production	Within 48h Prior to denture-related stomatitis treatment; 48h after recovery from denture-related stomatitis; 2 months after recovery from denture-related stomatitis

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Investigators: Principal Investigator: Tomasz Guzik, MD, PhD, Jagiellonian University; Principal Investigator: Marta Cześnikiewicz-Guzik, PhD, Jagiellonian University

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Estimate): June 19, 2014
• Last Update Submitted That Met QC Criteria: June 18, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Denture stomatitis; Dentures; Denture wearers
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Stomatitis; Stomatitis, Denture; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Anti-Bacterial Agents; Membrane Transport Modulators; Antifungal Agents; Ionophores; Nystatin
• Other Study ID Numbers: DRS-001