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

Sponsor

Jagiellonian University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02166450

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Denture Stomatitis	Drug: Nystatin

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.