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

• Conditions: Denture Stomatitis
• Interventions: Drug: Nystatin

• Registration Number: NCT02166450
• Lead Sponsor: Jagiellonian University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Status Verified: 2014-06
• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-18
• Last Update Submitted: 2014-06-18
• Last Update Posted: 2014-06-19
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Denture-related stomatitis group	Nystatin	Denture wearers with clinical signs of denture-related stomatitis, confirmed with positive Candida swabs. Treated for fungal infection, with nystatin \[100 000 IU every 6 h for 3 weeks, applied on the infected area of the mucous membrane of the palate and cheeks\].

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Zbigniew Żak Voivodeship Dental Clinic; 🇵🇱 Krakow, Poland

Jagiellonian University Dental Clinic; 🇵🇱 Krakow, Poland