Denture StomatitisPhase 2NCT07793331
Efficacy of 5% Nanochitosan Paste in the Treatment of Oral Candidosis
A Phase 2 study testing 5% Nanochitosan Paste and Nystatin Ointment in people with Denture Stomatitis and Oral Candidosis, run by Kerman University of Medical Sciences.
Trial summary
This study is designed to survey the therapeutic effect of a low molecular weight 5% nanochitosan paste against oral candidosis (denture stomatitis) and compare its efficacy with a standard Nystatin ointment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Denture Stomatitis, Oral Candidosis
- What is being tested?
- 5% Nanochitosan Paste and Nystatin Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Dec 2016
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients using full dentures.
- Suffering from type 2 denture stomatitis.
- Diagnosis and infection confirmed by an oral medicine specialist.
- Signed written informed consent.
Who cannot join
- History of using antifungal drugs, antibiotics, corticosteroids, and saliva-reducing drugs in the previous month.
- Patients with Alzheimer's disease.
- Patients with diabetes mellitus.
- Patients with masticatory muscle disorders.
- Patients with an immune suppressive situation.
- Patients with psychological diseases.
About this study
Official title: Antifungal Effect of Chitosan Nanoparticles Paste Against Oral Candidosis
This study is designed to survey the therapeutic effect of a low molecular weight 5% nanochitosan paste against oral candidosis (denture stomatitis) and compare its efficacy with a standard Nystatin ointment.
Read the detailed description
Denture stomatitis, also called chronic atrophic candidosis, is a common chronic disease in people who use full dentures, primarily caused by Candida albicans. This randomized single-blind clinical trial evaluates the antifungal effect of nanochitosan particles prepared by the ionic gelation method in a 5% paste formulation. Thirty patients using full dentures and suffering from type 2 denture stomatitis are randomly divided into two groups of fifteen. One group receives the 5% nanochitosan paste and the other receives Nystatin ointment. Both groups apply their respective medications to the palatal areas four times a day for two weeks. Patients are instructed to remove their dentures during application. Clinical and microbiological assessments are performed before treatment and after two weeks to evaluate changes in erythematous plaque surface area, palatal cell culture colony counts, and burning sensation.
- Conditions
- Denture Stomatitis, Oral Candidosis
- Being tested
- 5% Nanochitosan Paste, Nystatin Ointment
- Keywords
- Candida albicans, Chitosan, Nanoparticles, Oral infection, Nystatin
- Medical subject headings
- Stomatitis, Denture, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Nanochitosan PasteDrug
Also called Low molecular weight nanochitosan paste
A 5% paste of low molecular weight chitosan nanoparticles prepared via the ionic gelation method using sodium tripolyphosphate.
Nystatin OintmentDrug
Also called Nistat (100,000 U/ml)
Standard commercial antifungal Nystatin ointment utilized as the active reference treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Nanochitosan Paste Group | Experimental | Patients received 5% nanochitosan paste applied on the palatal areas four times a day for two weeks. Receives: Drug: 5% Nanochitosan Paste |
| Active Comparator: Nystatin Ointment Group | Active comparator | Patients received Nystatin ointment applied on the palatal areas four times a day for two weeks. Receives: Drug: Nystatin Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in erythematous surface area
The size of the erythematous plaques under the denture-bearing surface is measured in square millimeters (mm2) to evaluate clinical healing.
Measured: Baseline, 1 week, and 2 weeks
Secondary outcomes (2)
Microbiological palatal cell culture findings
The average number of fungal structures (mycelium and blastospore) observed in smears prepared from the palatal mucosa to quantify infection severity.
Measured: Baseline and 2 weeks
Change in burning sensation
Subjective burning sensation was assessed using a Visual Analog Scale (VAS). The scale is graded from a minimum value of 0 (no discomfort) to a maximum value of 10 (the highest rate of pain and irritation). Higher scores indicate a worse clinical outcome.
Measured: Baseline, 1 week, and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Jan 2016
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerman University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zahra atai, Kerman University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793331
- Sponsor's protocol ID
- IR.Kmu.REC.1394.722
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antifungal Effect of Chitosan Nanoparticles Paste Against Oral Candidosis
- ClinicalTrials.gov ID
- NCT07793331
- Acronym / sponsor ID
- IR.Kmu.REC.1394.722
- Conditions
- Denture Stomatitis, Oral Candidosis
- Keywords
- Candida albicans, Chitosan, Nanoparticles, Oral infection, Nystatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kerman University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 28 Aug 2026 (actual)
- 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.
This study is designed to survey the therapeutic effect of a low molecular weight 5% nanochitosan paste against oral candidosis (denture stomatitis) and compare its efficacy with a standard Nystatin ointment.
Detailed description
Denture stomatitis, also called chronic atrophic candidosis, is a common chronic disease in people who use full dentures, primarily caused by Candida albicans. This randomized single-blind clinical trial evaluates the antifungal effect of nanochitosan particles prepared by the ionic gelation method in a 5% paste formulation. Thirty patients using full dentures and suffering from type 2 denture stomatitis are randomly divided into two groups of fifteen. One group receives the 5% nanochitosan paste and the other receives Nystatin ointment. Both groups apply their respective medications to the palatal areas four times a day for two weeks. Patients are instructed to remove their dentures during application. Clinical and microbiological assessments are performed before treatment and after two weeks to evaluate changes in erythematous plaque surface area, palatal cell culture colony counts, and burning sensation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Nanochitosan Paste Group | Experimental | Drug: 5% Nanochitosan PastePatients received 5% nanochitosan paste applied on the palatal areas four times a day for two weeks. |
| Active Comparator: Nystatin Ointment Group | Active comparator | Drug: Nystatin OintmentPatients received Nystatin ointment applied on the palatal areas four times a day for two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients using full dentures.
- Suffering from type 2 denture stomatitis.
- Diagnosis and infection confirmed by an oral medicine specialist.
- Signed written informed consent.
Key exclusion criteria (6 listed)
- History of using antifungal drugs, antibiotics, corticosteroids, and saliva-reducing drugs in the previous month.
- Patients with Alzheimer's disease.
- Patients with diabetes mellitus.
- Patients with masticatory muscle disorders.
- Patients with an immune suppressive situation.
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 |
|---|---|---|
| 5% Nanochitosan PasteAlso: Low molecular weight nanochitosan pasteA 5% paste of low molecular weight chitosan nanoparticles prepared via the ionic gelation method using sodium tripolyphosphate. | Drug | Experimental: Nanochitosan Paste Group |
| Nystatin OintmentAlso: Nistat (100,000 U/ml)Standard commercial antifungal Nystatin ointment utilized as the active reference treatment. | Drug | Active Comparator: Nystatin Ointment Group |
Primary outcome
Change in erythematous surface area
Time frame: Baseline, 1 week, and 2 weeks
The size of the erythematous plaques under the denture-bearing surface is measured in square millimeters (mm2) to evaluate clinical healing.
2 secondary outcomes
Microbiological palatal cell culture findings
Time frame: Baseline and 2 weeks
Change in burning sensation
Time frame: Baseline, 1 week, and 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5% Nanochitosan Paste and Nystatin Ointment in people with Denture Stomatitis and Oral Candidosis, run by Kerman University of Medical Sciences.
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 4 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: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in erythematous surface area (time frame: Baseline, 1 week, and 2 weeks). 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 10 Sep 2026.