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Development and Evaluation of Buccal Mucoadhesive Polymer Formulations Containing Antifungal Drugs of the Management of Denture-Stomatitis

Development and Evaluation of Buccal Mucoadhesive Polymer Formulations Containing Antifungal Drugs of the Management of Denture-Stomatitis.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202210598505787
Enrollment
48
Registered
2022-10-04
Start date
2020-01-20
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Oral Health

Interventions

HPMC film F1
HPMC and SCMC film F2
MN Nanoparticles loaded in mucoadhesive film F3
Miconazol oral gel

Sponsors

Department of Oral Medicine Periodontology Oral diagnosis and Radiology Faculty of Dentistry Alexandria University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Providing consent prior to participation in the study Wearing a maxillary complete acrylic denture Clinically diagnosed with grade II denture stomatitis Cytologically diagnosed with denture stomatitis

Exclusion criteria

Exclusion criteria: Patients with systemic disease and conditions which predispose to Candida spp. (e.g.: diabetes, cardiovascular disease and viral hepatitis). Smoking patients. Having a history of chemotherapy/radiotherapy or under warfarin therapy Patients with previous history of antifungal treatment. Patients with history of corticosteroids (systemic or local buccal) within last 3 months. Contact allergy. Patient with history of antibiotics (systemic or local buccal) within one month from study. Having oral mucosal lesions other than from denture stomatitis Being scheduled to replace existing dentures with new ones during the period of the study

Design outcomes

Primary

MeasureTime frame
Colony counting (Candida albicans Colony count)

Secondary

MeasureTime frame
Visual Analogue Scale for Pain (VAS)

Countries

Egypt

Contacts

Public ContactElsayedamr Basma

Patient Information Manager

elsayedamr@yahoo.com00201223106023

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026