Denture StomatitisNCT02166450
Effects of Denture-Related Stomatitis on Blood Pressure in Denture Wearers
An observational study of Denture Stomatitis, run by Jagiellonian University at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Denture Stomatitis
- What is being tested?
- Nystatin
- How many people
- 80 participants
- Where
- 2 sitesPoland
- Study dates
- Oct 2011to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Dental clinic patients wearing dentures
Who may be able to join
- Patients with dental prostheses used for at least 6 months,
- Substantial portion of the oral mucosa covered by dental prosthesis.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
Zbigniew Żak Voivodeship Dental Clinic
Krakow, 31-135
- Recruiting
Jagiellonian University Dental Clinic
Krakow, 31-155
About this study
Official title: Effects of Denture-Related Stomatitis on Blood Pressure, Endothelial Function and Systemic Immune Response in Patients With Dentures
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
- Being tested
- Nystatin
- Keywords
- Denture stomatitis, Dentures, Denture wearers
- Medical subject headings
- Stomatitis, Denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NystatinDrug
Also called Mycostatin, Stamicin, Stamycin, Fungicidin
100 000 IU every 6 h as a suspension
| Study group | Role | What they receive |
|---|---|---|
| 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]. Receives: Drug: Nystatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood pressure
Ambulatory Blood Pressure Monitoring System
Measured: 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
Flow Mediated Dilatation
Measured: 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
Determination of cell subsets, activation markers and intracellular cytokine production
Measured: Within 48h Prior to denture-related stomatitis treatment; 48h after recovery from denture-related stomatitis; 2 months after recovery from denture-related stomatitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startOct 2011
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Guzik, Jagiellonian University
- Investigators
- Tomasz Guzik, MD, PhD, Principal investigator, Jagiellonian UniversityMarta Cześnikiewicz-Guzik, PhD, Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166450
- Sponsor's protocol ID
- DRS-001
- Status last verified
- Jun 2014
- First submitted
- 13 Jun 2014
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Denture-Related Stomatitis on Blood Pressure, Endothelial Function and Systemic Immune Response in Patients With Dentures
- ClinicalTrials.gov ID
- NCT02166450
- Acronym / sponsor ID
- DRS-001
- Conditions
- Denture Stomatitis
- Keywords
- Denture stomatitis, Dentures, Denture wearers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2015 (estimated)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Denture wearers without clinical signs of denture-related stomatitis confirmed with negative Candida swabs. |
| Denture-related stomatitis group | – | Drug: NystatinDenture 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]. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Dental clinic patients wearing dentures
Key inclusion criteria (2 listed)
- Patients with dental prostheses used for at least 6 months,
- Substantial portion of the oral mucosa covered by dental prosthesis.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NystatinAlso: Mycostatin, Stamicin, Stamycin, Fungicidin100 000 IU every 6 h as a suspension | Drug | Denture-related stomatitis group |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
Related trials for Denture Stomatitis
Not yet recruiting
Development of a Sanitizing Tablet for Removable Partial Dentures
Denture Stomatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Guzik, MD, PhD principal investigator
Jagiellonian University
Marta Cześnikiewicz-Guzik, PhD principal investigator
Jagiellonian University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Denture Stomatitis, run by Jagiellonian University at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Cześnikiewicz-Guzik, PhD (+48126330003, marta.czesnikiewicz-guzik@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2014.