Oral Thrush
Conditions
Keywords
diabetic patients or oral candidiasis or oral thrush
Brief summary
Objective: this study aimed to evaluate the therapeutic effects of topical application of miconazole and miconazole-loaded chitosan nanoparticles in treatment diabetic patients with oral candidiasis.
Detailed description
Abstract: Objective: this study aimed to evaluate the therapeutic effects of topical application of miconazole and miconazole-loaded chitosan nanoparticles in treatment diabetic patients with oral candidiasis. Subjective and methods: In this randomized controlled clinical trial,. A total of 80 diabetic patients presenting with symptomatic oral candidiasis were randomly assigned into two treatment groups: miconazole and miconazole-loaded chitosan nanoparticles. The patients were treated for a duration 28days , and clinical assessments were conducted at baseline, 7, 14, 21 and 28 days. Microbiological analysis was performed to determine the Candida species and assess their susceptibility to the antifungal agents. Clinical parameters, including signs and symptoms of oral candidiasis, were also evaluated. .
Interventions
DRUGChitosan
chitosan loaded with miconazole nanoparticles gel
Sponsors
Yasmine gamil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
1:1 parallel arms
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. uncontrolled diabetes patients with oral candidiasis and their uncontrolled diabetes were confirmed by doing glycated hemoglobin test and their range is \>7.0%, 2. age ranged from 30-65 years 3. patients were willing to participate in this study
Exclusion criteria
1. immunocompromised and patients with systemic diseases that can cause muscle weakness as Parkinson's disease, or others that can limit their cognitive functioning such as dementia 2. pregnant 3. nursing women 4. smokers 5. alcoholic patients were also excluded from the study. 6. should not have a history of use of any drugs that can cause hyposalivation or broad spectrum antibiotics, within the last month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical assessment of erythematous/psuedomembranous oral candidiasis resolution | 28 days | by Pain analogue scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| microbiological count of candida | 28 days | candidal count by taking swap |
Countries
Egypt
Outcome results
None listed