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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02166450
Recruitment Status : Unknown
Verified June 2014 by Tomasz Guzik, Jagiellonian University.
Recruitment status was:  Recruiting
First Posted : June 18, 2014
Last Update Posted : June 19, 2014
Sponsor:
Information provided by (Responsible Party):
Tomasz Guzik, 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.

Condition or disease Intervention/treatment
Denture Stomatitis Drug: Nystatin

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Study Type : Observational
Estimated 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 : October 2011
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures
Drug Information available for: Nystatin

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




Primary Outcome Measures :
  1. Change from baseline in blood pressure [ Time Frame: 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 :
  1. Change from baseline in endothelial function [ Time Frame: 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

  2. Changes in immune cell subset populations from baseline [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Dental clinic patients wearing dentures
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166450


Contacts
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Contact: Marta Cześnikiewicz-Guzik, PhD +48126330003 marta.czesnikiewicz-guzik@glasgow.ac.uk

Locations
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Poland
Zbigniew Żak Voivodeship Dental Clinic Recruiting
Krakow, Poland, 31-135
Jagiellonian University Dental Clinic Recruiting
Krakow, Poland, 31-155
Sponsors and Collaborators
Jagiellonian University
Investigators
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Principal Investigator: Tomasz Guzik, MD, PhD Jagiellonian University
Principal Investigator: Marta Cześnikiewicz-Guzik, PhD Jagiellonian University
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Responsible Party: Tomasz Guzik, MD, PhD, Jagiellonian University
ClinicalTrials.gov Identifier: NCT02166450    
Other Study ID Numbers: DRS-001
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: June 19, 2014
Last Verified: June 2014
Keywords provided by Tomasz Guzik, Jagiellonian University:
Denture stomatitis
Dentures
Denture wearers
Additional relevant MeSH terms:
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Stomatitis
Stomatitis, Denture
Mouth Diseases
Stomatognathic Diseases
Nystatin
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action