Evidence map›Paper›PMID 38321454›Full record

Trial reportBMC oral health2024

The anti-fungal effect of miconazole and miconazole-loaded chitosan nanoparticles gels in diabetic patients with Oral candidiasis-randomized control clinical trial and microbiological analysis.

Yasmine Gamil, Mohamed G Hamed, Mahitab Elsayed, Aya Essawy, Sara Medhat, Shaimaa O Zayed, Radwa M Ismail

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC oral health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06072716 (The Anti-fungal Effect of Miconazol and Miconazol-Loaded Chitosan Nanoparticles in Diabetic Patients With Oral Candidiasis-Randomized Control Clinical Trial and Microbiological Analysis), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06072716 phase1completednot on this map

The Anti-fungal Effect of Miconazol and Miconazol-Loaded Chitosan Nanoparticles in Diabetic Patients With Oral Candidiasis-Randomized Control Clinical Trial and Microbiological Analysis

TypeinterventionalSponsorYasmine gamilRan2023 to 2023Enrolled80ConditionsOral ThrushArmsChitosan
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  3. Pharmacological assessment of drugs retained in the 1Naunyn-Schmiedeberg's archives of pharmacology · 2026
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  8. A Cross-Sectional Study to DetermineBioMed research international · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Yasmine GamilDepartment of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of oral and dental surgery, Modern University for Technology & Information, Al Gamea Al Haditha St, Cairo, 4410240, Egypt.ORCID https://orcid.org/0000-0003-3268-5043
Mohamed G HamedFaculty of medicine, Helwan University, Al Masaken Al Iqtisadeyah, Cairo, 4034572, Egypt.ORCID https://orcid.org/0000-0002-3428-3876
Mahitab ElsayedClinical Pharmacy Department, Faculty of Pharmacy, Modern University for Technology & Information, Al Gamea Al Haditha St, Cairo, 4410240, Egypt.ORCID https://orcid.org/0000-0003-1251-0537
Aya EssawyClinical Pharmacy Department, Faculty of Pharmacy, Modern University for Technology & Information, Al Gamea Al Haditha St, Cairo, 4410240, Egypt.ORCID https://orcid.org/0000-0002-5515-8230
Sara MedhatFaculty of oral and dental surgery, Modern University for Technology & Information, Al Gamea Al Haditha St, Cairo, 4410240, Egypt.ORCID https://orcid.org/0009-0002-5836-5021
Shaimaa O ZayedOral & maxillofacial Pathology Department, Faculty of Dentistry, Cairo University. Misr university for science & technology, Giza, 3236101, Egypt.ORCID https://orcid.org/0000-0002-6559-0609
Radwa M IsmailLecturer of oral medicine, periodontology and oral diagnosis, Faculty of oral and dental surgery, Misr University for Science and Technology, Giza, 3236101, Egypt. radwa.mohamed@must.edu.eg.ORCID https://orcid.org/0000-0002-0128-6042

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOral thrush is the most common occurring fungal infection in the oral cavity in uncontrolled diabetic patients, it is treated by various antifungal drugs according to each case. This study aimed to evaluate the therapeutic effects of topical application of miconazole and miconazole-loaded chitosan nanoparticles in treatment of diabetic patients with oral candidiasis.

methodsIn 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 28 days, and clinical assessments were conducted at baseline, 7, 14, 21 and 28 days. Clinical parameters, including signs and symptoms of oral candidiasis were evaluated and microbiological analysis was performed to determine the Candida species and assess their susceptibility to the antifungal agents. Statistical analysis was done to the categorical and numerical data using chi-square test and Kruskal Wallis test.

resultsThe antifungal efficacy between the miconazole and miconazole-loaded chitosan nanoparticles (CS-MCZ) groups insignificant difference (P >  0.05) was observed. Both treatment modalities exhibited comparable effectiveness in controlling oral candidiasis symptoms and reducing Candida colonization as miconazole-loaded chitosan nanoparticles group showed a significant difference in the clinical improvement in respect of both signs and symptoms from baseline (70%) until the end of study at 28 days (5%) (P <  0.05) Moreover, miconazole-loaded chitosan nanoparticles, there was a significant reduction in the number of colonies forming units of Candida albicans from baseline until the end of the study at 28-day with P value <  0.000.

conclusionsThis randomized controlled clinical trial and microbiological analysis demonstrate that both miconazole and miconazole-loaded chitosan nanoparticles are effective in the treatment of oral candidiasis in diabetic patients with no adverse reactions.

trial registrationNCT06072716 with first registration first registration in 10/10/2023.

Indexed as

Candidiasis, OralChitosanDiabetes MellitusNanoparticlesAntifungal AgentsCandidaGelsHumansMiconazoleAntifungal AgentsChitosanGelsMiconazoleChitosanDiabetic patientMiconazoleOral candidiasisOral thrush

Identifiers

PMID38321454
PMCPMC10848391

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.