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.

BACKGROUND: Oral 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. 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 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. RESULTS: The 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. CONCLUSIONS: This 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 REGISTRATION: NCT06072716 with first registration first registration in 10/10/2023.

The Influence of Low-Level Laser Therapy on CBCT Radiographic and Biochemical Profiles of Type II Controlled Diabetic Patients After Dental Implant Insertion: A Randomized Case-Control Study.

Background Low-level laser treatment (LLLT) was thought to increase bone quality during osseointegration when combined with dental implants. However, there is no sufficient information on its impact on dental implants in diabetics. Osteoprotegerin (OPG) has been described as a marker for bone turnover to determine implant prognosis. The current research aims to evaluate the effect of low-level laser therapy (LLLT) on bone density (BD) and osteoprotegerin levels in peri-implant crevicular fluid (PICF) in type II diabetic patients. Methods This study comprised 40 individuals with type II diabetes mellitus (T2DM). Implants were randomly placed in 20 non-lasered T2DM patients (control) and 20 lasered T2DM patients (LLLT group). At the follow-up stages, BD and OPG levels in the PICF were evaluated in both groups. Results Significant variations were shown among control and LLLT groups concerning OPG level and BD (p≤0.001). OPG was significantly decreasing with follow-up points (p≤0.001). There was a significant decrease in OPG with time in both groups with a higher decrease in the control group. Conclusion LLLT is promising in controlled T2DM patients due to its outstanding influence on BD and estimated crevicular levels of OPG. Regarding its clinical significance, LLLT significantly improved bone quality during osseointegration on dental implants in T2DM. LLLT is considered potentially important for T2DM patients during implant placement. Trial registration The study was registered on ClinicalTrial.gov under registration number NCT05279911 (registration date: March 15, 2022) (https://clinicaltrials.gov/ct2/show/NCT05279911).

Syringeable atorvastatin loaded eugenol enriched PEGylated cubosomes in-situ gel for the intra-pocket treatment of periodontitis: statistical optimization and clinical assessment.

Atorvastatin calcium (ATV) is a well-known anti-hyperlipidemic drug currently being recognized for possessing an anti-inflammatory effect. Introducing it as a novel remedy for periodontitis treatment necessitates developing a syringeable modified delivery system capable of targeting inflammation within the periodontal pockets. Thus, a 33 Box-Behnken design was used to generate eugenol enriched PEGylated cubosomes. Based on the desirability function, the optimized formulation (OEEPC) was selected exhibiting a solubilization efficiency (SE%) of 97.71 ± 0.49%, particle size (PS) of 135.20 ± 1.11 nm, polydispersity index (PDI) of 0.09 ± 0.006, zeta potential (ZP) of -28.30 ± 1.84 mV and showing a sustained drug release over 12 h. It displayed a cubic structure under the transmission electron microscope, furthermore, it was stable upon storage for up to 30 days. Hence, it was loaded into an optimum syringeable in-situ gel (ISG) which displayed the desired periodontal gelation temperature (34 ± 0.70 °C) and an adequate gelation time (46 ± 2.82 sec), it also released approximately 75% of the drug within 72 h. Clinical evaluation of the ISG showed a promising percentage reduction of about 58.33% in probing depth, 90% in the bleeding index, 81.81% in the plaque index, and 70.21% in gingival levels of transforming growth factor-ß1. This proved that the formulated syringeable intra-pocket delivery system of ATV is an efficient candidate for diminishing inflammation in periodontitis.