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

NCT ID: NCT02166450

Last Updated: 2014-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Denture Stomatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Denture wearers without clinical signs of denture-related stomatitis confirmed with negative Candida swabs.

No interventions assigned to this group

Denture-related stomatitis group

Denture wearers with clinical signs of denture-related stomatitis, confirmed with positive Candida swabs.

Treated for fungal infection, with nystatin \[100 000 IU every 6 h for 3 weeks, applied on the infected area of the mucous membrane of the palate and cheeks\].

Nystatin

Intervention Type DRUG

100 000 IU every 6 h as a suspension

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nystatin

100 000 IU every 6 h as a suspension

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mycostatin Stamicin Stamycin Fungicidin Nilstat

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tomasz Guzik

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tomasz Guzik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Marta Cześnikiewicz-Guzik, PhD

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zbigniew Żak Voivodeship Dental Clinic

Krakow, , Poland

Site Status RECRUITING

Jagiellonian University Dental Clinic

Krakow, , Poland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Poland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marta Cześnikiewicz-Guzik, PhD

Role: CONTACT

+48126330003

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DRS-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.