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Efficacy of 1% Nanochitosan Solution in the Treatment of Denture Stomatitis

3. juli 2026 opdateret af: zahra atai, Kerman University of Medical Sciences

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Iran
    • Kerman
      • Kerman, Kerman, Iran, 7618868345
        • Faculty of Dentistry, Kerman University of Medical Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with Alzheimer's disease.
  • Patients with diabetes mellitus.
  • Patients with masticatory muscle disorders.
  • Patients with immunocompromising diseases.
  • Patients with psychiatric disorders.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental: Nanochitosan Group
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.
Medicin: 1% Nanochitosan Solution
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.
Andre navne:
  • Chitosan Nanoparticles
Aktiv komparator: Active Comparator: Nystatin Group
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.
Medicin: Nystatin Oral Suspension
Standard commercial Nystatin oral suspension (100,000 U/mL) manufactured by Jaber Ebne Hayyan Pharmaceutical Company, utilized as the reference active control.
Andre navne:
  • Nistat

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in erythematous palatal mucosa lesion area
Tidsramme: 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.
Baseline, 1 week, and 2 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in burning sensation
Tidsramme: Baseline, 1 week, and 2 weeks
Assessed using a Visual Analog Scale (VAS) to measure the level of discomfort and irritation.
Baseline, 1 week, and 2 weeks
Microbiological findings from palatal smears
Tidsramme: Baseline and 2 weeks
Mean count of fungal structures (mycelia and blastospores) examined via Gram-stained smears under light microscopy.
Baseline and 2 weeks
Overall clinical response rate
Tidsramme: 2 weeks
Percentage of participants achieving complete recovery (total elimination of erythematous lesions) or partial recovery (reduction in erythema area).
2 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kerman University of Medical Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. januar 2016

Primær færdiggørelse (Faktiske)

4. maj 2016

Studieafslutning (Faktiske)

4. maj 2016

Datoer for studieregistrering

Først indsendt

3. juli 2026

Først indsendt, der opfyldte QC-kriterier

3. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IR.KMU.REC.1394.723

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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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Kliniske forsøg med Tandprotese Stomatitis

Kliniske forsøg med 1% Nanochitosan Solution

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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