Clinical evaluation of a nystatin-containing gel for the treatment of denture-associated candidiasis

Mucoadhesive containing nystatin complexed with ß-cyclodextrin for the treatmente of Denture Stomatitis: a randomized clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-8pzmt86

Enrollment

Registered

2026-02-13

Start date

2025-12-04

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomatitis Denture

Interventions

This is a randomized, controlled, parallel-group clinical trial with three arms, which will include 45 patients who are users of conventional removable maxillary complete dentures and have a diagnosis

Eligibility

Inclusion criteria

Inclusion criteria: Individuals who are users of conventional removable maxillary complete dentures; with a clinical diagnosis of denture stomatitis on the palatal mucosa supporting the denture; of both sexes, without age restrictiont; who present a positive smear for Candida on the palatal mucosa and/or on the internal surface of the maxillary complete denture; who agree to participate in the study and sign the Informed Consent Form

Exclusion criteria

Exclusion criteria: Individuals with anemia or uncontrolled endocrine disorders; undergoing antineoplastic treatment with radiotherapy and/or chemotherapy; who have used antibiotics, steroids, or antifungal agents within the last three months; users of the same maxillary complete denture for a period longer than 30 years

Design outcomes

Primary

Measure	Time frame
It’s expected to observe reduction of mycelial forms of Candida species both on the palatal mucosa affected by denture stomatitis and on the inner surface of the upper complete denture, verified by cytological examinations by smears obtained from these areas, from the observation, at the end of the treatment (14 days) and at the end of the experimental period (60 days of treatment discontinuation), of at least a 30% improvement in palatal smears as well as a large (greater or equal to 0.8) or very large (greater or equal to 1.20) effect size of treatment on the prosthetic smears.;It’s expected to observe reduction in the values of colony forming units per milliliter of Candida species both on the palatal mucosa affected by denture stomatitis and on the inner surface of the upper complete denture, verified by means of quantitative mycological cultures, from the observation, at the end of the treatment (14 days) and at the end of the experimental period (60 days of suspension of the treatment) of a large (greater or equal to 0.8) or very large (greater or equal to 1.20) effect size of treatment in cultures of both palate and prosthesis areas. ;It’s expected to observe reduction of clinical severity of denture stomatitis, verified by means of standardized photographs of the palatal mucosa affected by the lesion, from the observation, at the end of treatment (14 days) and at the end of the experimental period (60 days after suspension of treatment), of a large (greater or equal to 0.8) or very large (greater or equal to 1.20) effect size of the treatment.	—

Measure

Time frame

It’s expected to observe reduction of mycelial forms of Candida species both on the palatal mucosa affected by denture stomatitis and on the inner surface of the upper complete denture, verified by cytological examinations by smears obtained from these areas, from the observation, at the end of the treatment (14 days) and at the end of the experimental period (60 days of treatment discontinuation), of at least a 30% improvement in palatal smears as well as a large (greater or equal to 0.8) or very large (greater or equal to 1.20) effect size of treatment on the prosthetic smears.;It’s expected to observe reduction in the values of colony forming units per milliliter of Candida species both on the palatal mucosa affected by denture stomatitis and on the inner surface of the upper complete denture, verified by means of quantitative mycological cultures, from the observation, at the end of the treatment (14 days) and at the end of the experimental period (60 days of suspension of the treatment) of a large (greater or equal to 0.8) or very large (greater or equal to 1.20) effect size of treatment in cultures of both palate and prosthesis areas. ;It’s expected to observe reduction of clinical severity of denture stomatitis, verified by means of standardized photographs of the palatal mucosa affected by the lesion, from the observation, at the end of treatment (14 days) and at the end of the experimental period (60 days after suspension of treatment), of a large (greater or equal to 0.8) or very large (greater or equal to 1.20) effect size of the treatment.

—

Secondary

Measure	Time frame
Secondary outcomes are expected to include good acceptability of the proposed experimental therapy, as well as increased satisfaction with the maxillary complete denture and improvement in oral health–related quality of life at the end of treatment and during the follow-up periods compared with baseline.	—

Countries

Brazil

Contacts

Public ContactKarin Neppelenbroek

Faculdade de Odontologia de Bauru - Universidade de São Paulo

khnepp@yahoo.com.br+551432358245

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 14, 2026