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

Denture Stomatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02166450
• Other study ID #: DRS-001
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2014
• Last updated: June 18, 2014
• Start date: October 2011

Study information

• Verified date: June 2014
• Source: Jagiellonian University
• Contact: Marta Czesnikiewicz-Guzik, PhD
• Phone: +48126330003
• Email: marta.czesnikiewicz-guzik[@]glasgow.ac.uk
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Denture Stomatitis
• Stomatitis
• Stomatitis, Denture

Intervention

Drug:
• Nystatin
100 000 IU every 6 h as a suspension

Locations

Country	Name	City	State
Poland	Jagiellonian University Dental Clinic	Krakow
Poland	Zbigniew Zak Voivodeship Dental Clinic	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No