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

J

Jagiellonian University

Status

Unknown

Conditions

Denture Stomatitis

Treatments

Drug: Nystatin

Study type

Observational

Funder types

Other

Identifiers

NCT02166450
DRS-001

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Volunteers

No 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.

Trial design

80 participants in 2 patient groups

Control group
Description:
Denture wearers without clinical signs of denture-related stomatitis confirmed with negative Candida swabs.
Denture-related stomatitis group
Description:
Denture wearers with clinical signs of denture-related stomatitis, confirmed with positive Candida swabs. Treated for fungal infection, with nystatin \[100 000 IU every 6 h for 3 weeks, applied on the infected area of the mucous membrane of the palate and cheeks\].
Treatment:
Drug: Nystatin

Trial contacts and locations

2

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Central trial contact

Marta Cześnikiewicz-Guzik, PhD

Data sourced from clinicaltrials.gov

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