Denture StomatitisPhase 2NCT07694024
Efficacy of 1% Nanochitosan Solution in the Treatment of Denture Stomatitis
A Phase 2 study testing 1% Nanochitosan Solution and Nystatin Oral Suspension in people with Denture Stomatitis and Chronic Atrophic Candidiasis, run by Kerman University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to evaluate and compare the clinical efficacy of a 1% nanochitosan solution versus a standard Nystatin oral suspension in patients diagnosed with Newton's type II denture stomatitis (chronic atrophic candidiasis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Denture Stomatitis, Chronic Atrophic Candidiasis
- What is being tested?
- 1% Nanochitosan Solution and Nystatin Oral Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 17 Jan 2016to 4 May 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
- Complete denture wearers diagnosed with Newton's type II denture stomatitis.
- Diagnosis verified by an oral medicine specialist.
- No use of antifungal agents, antibiotics, corticosteroids, or medications that reduce salivary flow in the month prior to the study.
- Willing to provide written informed consent.
Who cannot join
- Patients with Alzheimer's disease.
- Patients with diabetes mellitus.
- Patients with masticatory muscle disorders.
- Patients with immunocompromising diseases.
- Patients with psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Faculty of Dentistry, Kerman University of Medical Sciences
Kerman, Kerman, 7618868345
About this study
Official title: Evaluation of the Efficacy of 1% Nanochitosan Solution Compared to Nystatin Oral Suspension in the Treatment of Newton's Type II Denture Stomatitis: A Randomized Clinical Trial
The purpose of this study is to evaluate and compare the clinical efficacy of a 1% nanochitosan solution versus a standard Nystatin oral suspension in patients diagnosed with Newton's type II denture stomatitis (chronic atrophic candidiasis). Chitosan nanoparticles are investigated as a potential biocompatible, mucoadhesive alternative to traditional antifungal treatments to accelerate mucosal healing and reduce the erythema of the palatal mucosa.
Read the detailed description
Denture stomatitis is a common oral mucosal lesion, primarily caused by Candida species under dental prostheses. This randomized single-blind clinical trial investigates the therapeutic properties of a novel 1% nanochitosan formulation synthesized via ionic gelation technique. Eligible participants with Newton's type II denture stomatitis are randomly allocated into two parallel groups. The intervention group receives the 1% nanochitosan solution, and the active control group receives a standard Nystatin oral suspension (100,000 U/mL). Both groups apply 2 mL of their respective medications topically as an oral rinse four times a day for a total duration of 2 weeks. Prior to each application, patients are instructed to remove their dentures to maximize mucosal contact. Clinical outcomes, specifically the change in the erythematous lesion area of the palatal mucosa (measured in square millimeters), are assessed at baseline, at the end of the first week, and at the completion of the second week.
- Conditions
- Denture Stomatitis, Chronic Atrophic Candidiasis
- Being tested
- 1% Nanochitosan Solution, Nystatin Oral Suspension
- Keywords
- Chitosan, Nanoparticles, Nystatin, Oral Candidiasis
- Medical subject headings
- Stomatitis, Denture, Candidiasis, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Nanochitosan SolutionDrug
Also called Chitosan Nanoparticles
A novel topical formulation of chitosan nanoparticles synthesized from low-molecular-weight chitosan using the ionic gelation method, prepared as a 1 wt.% aqueous solution.
Nystatin Oral SuspensionDrug
Also called Nistat
Standard commercial Nystatin oral suspension (100,000 U/mL) manufactured by Jaber Ebne Hayyan Pharmaceutical Company, utilized as the reference active control.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Nanochitosan Group | Experimental | Participants in this group received a 1% nanochitosan solution prepared via the ionic gelation technique. They rinsed with 2 mL of the solution four times a day for 2 minutes over a 2-week period. Patients were instructed to remove their dentures prior to each rinse. Receives: Drug: 1% Nanochitosan Solution |
| Active Comparator: Nystatin Group | Active comparator | Participants in this group received a standard Nystatin oral suspension (100,000 U/mL). They rinsed with 2 mL of the suspension four times a day for 2 minutes over a 2-week period. Patients were instructed to remove their dentures prior to each rinse. Receives: Drug: Nystatin Oral Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in erythematous palatal mucosa lesion area
The total surface area of the erythematous lesion on the palatal mucosa is measured and calculated in square millimeters (mm²) to determine the reduction in denture stomatitis inflammation and evaluate clinical efficacy.
Measured: Baseline, 1 week, and 2 weeks
Secondary outcomes (3)
Change in burning sensation
Subjective burning sensation was assessed using a Visual Analogue 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
Microbiological findings from palatal smears
Mean count of fungal structures (mycelia and blastospores) examined via Gram-stained smears under light microscopy.
Measured: Baseline and 2 weeks
Overall clinical response rate
Percentage of participants achieving complete recovery (total elimination of erythematous lesions) or partial recovery (reduction in erythema area).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start17 Jan 2016
- Primary completion4 May 2016
- Study completion4 May 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
- Model description
- A randomized, parallel-group clinical trial to compare the efficacy of 1% nanochitosan solution with Nystatin oral suspension.
- 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
- NCT07694024
- Sponsor's protocol ID
- IR.KMU.REC.1394.723
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant privacy and maintain clinical data confidentiality, individual participant data (IPD) will not be shared publicly. However, the study protocol and de-identified data may be made available to researchers upon reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of 1% Nanochitosan Solution Compared to Nystatin Oral Suspension in the Treatment of Newton's Type II Denture Stomatitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07694024
- Acronym / sponsor ID
- IR.KMU.REC.1394.723
- Conditions
- Denture Stomatitis, Chronic Atrophic Candidiasis
- Keywords
- Chitosan, Nanoparticles, Nystatin, Oral Candidiasis
- 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
- 17 Jan 2016 (actual)
- Primary completion
- 4 May 2016 (actual)
- Study completion
- 4 May 2016 (actual)
- First posted
- 9 Jul 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.
The purpose of this study is to evaluate and compare the clinical efficacy of a 1% nanochitosan solution versus a standard Nystatin oral suspension in patients diagnosed with Newton's type II denture stomatitis (chronic atrophic candidiasis). Chitosan nanoparticles are investigated as a potential biocompatible, mucoadhesive alternative to traditional antifungal treatments to accelerate mucosal healing and reduce the erythema of the palatal mucosa.
Detailed description
Denture stomatitis is a common oral mucosal lesion, primarily caused by Candida species under dental prostheses. This randomized single-blind clinical trial investigates the therapeutic properties of a novel 1% nanochitosan formulation synthesized via ionic gelation technique. Eligible participants with Newton's type II denture stomatitis are randomly allocated into two parallel groups. The intervention group receives the 1% nanochitosan solution, and the active control group receives a standard Nystatin oral suspension (100,000 U/mL). Both groups apply 2 mL of their respective medications topically as an oral rinse four times a day for a total duration of 2 weeks. Prior to each application, patients are instructed to remove their dentures to maximize mucosal contact. Clinical outcomes, specifically the change in the erythematous lesion area of the palatal mucosa (measured in square millimeters), are assessed at baseline, at the end of the first week, and at the completion of the second week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized, parallel-group clinical trial to compare the efficacy of 1% nanochitosan solution with Nystatin oral suspension.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Nanochitosan Group | Experimental | Drug: 1% Nanochitosan SolutionParticipants in this group received a 1% nanochitosan solution prepared via the ionic gelation technique. They rinsed with 2 mL of the solution four times a day for 2 minutes over a 2-week period. Patients were instructed to remove their dentures prior to each rinse. |
| Active Comparator: Nystatin Group | Active comparator | Drug: Nystatin Oral SuspensionParticipants in this group received a standard Nystatin oral suspension (100,000 U/mL). They rinsed with 2 mL of the suspension four times a day for 2 minutes over a 2-week period. Patients were instructed to remove their dentures prior to each rinse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Complete denture wearers diagnosed with Newton's type II denture stomatitis.
- Diagnosis verified by an oral medicine specialist.
- No use of antifungal agents, antibiotics, corticosteroids, or medications that reduce salivary flow in the month prior to the study.
- Willing to provide written informed consent.
Key exclusion criteria (5 listed)
- Patients with Alzheimer's disease.
- Patients with diabetes mellitus.
- Patients with masticatory muscle disorders.
- Patients with immunocompromising diseases.
- Patients with psychiatric disorders.
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 |
|---|---|---|
| 1% Nanochitosan SolutionAlso: Chitosan NanoparticlesA novel topical formulation of chitosan nanoparticles synthesized from low-molecular-weight chitosan using the ionic gelation method, prepared as a 1 wt.% aqueous solution. | Drug | Experimental: Nanochitosan Group |
| Nystatin Oral SuspensionAlso: NistatStandard commercial Nystatin oral suspension (100,000 U/mL) manufactured by Jaber Ebne Hayyan Pharmaceutical Company, utilized as the reference active control. | Drug | Active Comparator: Nystatin Group |
Primary outcome
Change in erythematous palatal mucosa lesion area
Time frame: Baseline, 1 week, and 2 weeks
The total surface area of the erythematous lesion on the palatal mucosa is measured and calculated in square millimeters (mm²) to determine the reduction in denture stomatitis inflammation and evaluate clinical efficacy.
3 secondary outcomes
Change in burning sensation
Time frame: Baseline, 1 week, and 2 weeks
Microbiological findings from palatal smears
Time frame: Baseline and 2 weeks
Overall clinical response rate
Time frame: 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 13 Jul 2026.
- Individual participant dataSharing planned: No. To protect participant privacy and maintain clinical data confidentiality, individual participant data (IPD) will not be shared publicly. However, the study protocol and de-identified data may be made available to researchers upon reasonable request to the corresponding author.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1% Nanochitosan Solution and Nystatin Oral Suspension in people with Denture Stomatitis and Chronic Atrophic Candidiasis, run by Kerman University of Medical Sciences at 1 site in Iran.
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 5 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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.
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 palatal mucosa lesion 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 13 Jul 2026.