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Denture liner material with special antifungal medications in the treatment of Oral Candidiasis

Tissue conditioner containing Nystatin Complexed with Beta-Cylodextrin for the treatment of denture stomatitis: a randomized clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-46ykd6t
Enrollment
Unknown
Registered
2024-08-14
Start date
2023-02-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Stomatitis Denture

Interventions

The sample of this study will involve patients using conventional upper completure dentures with denture stomatitis on the palatal denture-bearing mucosa, attended in the Prosthodontics Clinic of the
D04.345.103.333

Sponsors

Faculdade de Odontologia de Bauru - Universidade de São Paulo
Lead Sponsor
Unisagrado
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Volunteer users of conventional removable upper denture; clinical diagnosis for denture stomatitis in the palatal mucosa supporting the complete denture, both genders, any age, regardless of the condition of the mandibular arch and the use and status of the lower denture.

Exclusion criteria

Exclusion criteria: Volunteers with anemia; immunocompromised; with uncontrolled endocrinopathologies; in a therapeutic regimen with antibiotics, steroids or antifungals in the last three months; under antineoplastic treatment by radio or chemotherapy; users of the same upper complete denture for over 30 years

Design outcomes

Primary

MeasureTime frame
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.;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. ;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

MeasureTime frame
Assess whether the main general and local factors associated with Candida proliferation (patient's age and sex, age and nighttime use of current dentures, smoking, the type of denture stomatitis according to Newton, the use of xerostomia-inducing drugs, presence of xerostomia and poor oral and prosthesis hygiene habits) were present in most volunteers, through anamnesis, clinical examination and examination of the prosthesis, to verify their influence as predisposing factors to denture stomatitis.

Countries

Brazil

Contacts

Public ContactKarin Neppelenbroek

Faculdade de Odontologia de Bauru - Universidade de São Paulo

khnepp@yahoo.com.br+55 (14) 32358245

Outcome results

None listed

Source: REBEC (via WHO ICTRP)