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

NCT02166450 | Unknown

• 1 other identifier: DRS-001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Denture Stomatitis

Keywords

Denture stomatitis; Dentures; Denture wearers

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

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

Interventions

Nystatin DRUG

100 000 IU every 6 h as a suspension

Also known as: Mycostatin, Stamicin, Stamycin, Fungicidin, Nilstat

Denture-related stomatitis group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dental clinic patients wearing dentures

You may qualify if:

• Patients with dental prostheses used for at least 6 months,
• Substantial portion of the oral mucosa covered by dental prosthesis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (2)

Zbigniew Żak Voivodeship Dental Clinic

Krakow, 31-135, Poland

RECRUITING

Jagiellonian University Dental Clinic

Krakow, 31-155, Poland

RECRUITING

MeSH Terms

Conditions

Stomatitis, Denture

Interventions

Nystatin

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Tomasz Guzik, MD, PhD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

• Marta Cześnikiewicz-Guzik, PhD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Cześnikiewicz-Guzik, PhD

CONTACT

+48126330003; marta.czesnikiewicz-guzik@glasgow.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 18, 2014
• Study Start: October 1, 2011
• Primary Completion: December 1, 2015
• Last Updated: June 19, 2014

Record last verified: 2014-06

Locations

PL (2)