Doxycycline hydrochloride-metronidazole solid lipid microparticles gels for treatment of periodontitis: development, in-vitro and in-vivo clinical evaluation.

OBJECTIVE: To formulate solid lipid microparticles (SLMs) encapsulating doxycycline hydrochloride (DH) and metronidazole (MT) for the treatment of periodontal diseases. METHODS: SLMs were prepared applying hot homogenization method, using different types of lipids and stabilized with various types and concentrations of surfactants. The optimized formula was subjected to freeze-drying followed by incorporation into poloxamer gel. Microbiological and clinical evaluation of the selected SLMs on patients suffering from periodontal diseases was performed. RESULTS: SLMs could entrap high percentage of both drugs (81.14% and 68.75 % for doxycycline hydrochloride and metronidazole respectively). Transmission electron microscopy images of SLMs showed nearly spherical particles. Freeze-dried SLMs showed satisfactory stability for three months. Combined drugs were molecularly dispersed in SLMs. Incorporation of the freeze-dried SLMs powder in poloxamer gel could control the drugs release for 72 h. In-vivo study revealed effective and safe use of SLMs gel for periodontitis treatment. Significant improvement in both microbiological and clinical parameters was observed as compared to scaling and root planing alone. CONCLUSION: The formulated SLMs gel offers an applicable dosage form that can be injected directly into the periodontal pocket as adjunctive to scaling and root planing.

Vesicular powder as carrier for doxycycline hydrochloride and metronidazole combination therapy.

In this study, vesicular proniosomal powder encapsulating doxycycline hydrochloride (DH) and metronidazole (MT) combination therapy was developed using different types of spans, cholesterol (CH) and maltodextrin as a carrier. Proniosomal powder was free flowing and spherical in shape. The surfactant structure affected the entrapment efficiency of both drugs with highest value of Sp 60 proniosomes of 45.16% and 42.64% for DH and MT, respectively. Incorporation of CH influenced vesicle stability and permeability with optimum concentration of 10 mole%. Increasing the surfactant loading from 1 mM to 3 mM resulted in a significant decrease in the amount of drugs (mg) entrapped per mM lipid (from 9.95 to 1.13 and from 8.88 to 1.22 for DH and MT, respectively). Longer chain length surfactants produced larger vesicles. Surfactant hydrophilicity affected zeta potential. Both drugs were molecularly dispersed in the proniosomal powder with no chemical interaction with other components. Proniosomal powder was stable at 2-8 °C for three months.

CD4+CD25+ T regulatory cells and MMP-9 as diagnostic salivary biomarkers in oral lichen planus.

Oral lichen planus (OLP) is a chronic inflammatory disease characterized by a dense subepithelial lymphocytic infiltrate, degeneration of basal keratinocytes and basement membrane disruption. Non-specific mechanisms include mast cell degranulation and matrix metalloproteinase (MMP) activation in OLP lesions. These mechanisms may combine to cause T-cell accumulation in the superficial lamina propria, basement membrane disruption, intra-epithelial T-cell migration, and keratinocyte apoptosis in OLP. Obviously, abnormality of immunological regulation may contribute to its pathogenesis. This study aimed at evaluating the role of salivary CD4+CD25+ T regulatory cells & Matrix Metalloproteinase-9 (MMP.9) as salivary biomarkers in patients with OLP. Twenty patients with various forms of OLP were investigated: 8 with bullous erosive form, 7 with atrophic and 5 with reticular forms. From each patient saliva was collected, and used for assessment of salivary T regulatory cells by immunoflourescent and MMP9 expression by quantitative RT-PCR. Nine out of the twenty patients showed CD4+CD25+ Tregs in saliva by immunoflourescent staining with sensitivity (90%), specificity (83.3%) and diagnostic accuracy (87.5%). molecular detection of salivary MMP-9 levels in CD4+CD25+ Tregs +ve cases showed a significant increase in CD4+CD25+ Tregs +ve cases. In conclusion, salivary CD4+CD25+ T regs and MMP-9 could be considered as sensitive and specific diagnostic & prognostic biomarkers in the detection of OLP.

Knowledge, Awareness, and Attitudes about Research Ethics among Dental Faculty in the Middle East: A Pilot Study.

Objective. To assess the knowledge, awareness, and attitudes of dental faculty regarding research ethics and research ethics committees (RECs). Design. Through convenience sampling, we distributed a survey to academics at dental faculties at two universities in the Middle East. We used descriptive, chi-square, and logistic regression statistics to analyze the data. Results. Our response rate was 62.5%. A large majority (>90%) held positive attitudes towards RECs; however, almost half (44.0%) thought that RECs would delay research. Less than half (36.8%) had received prior training in research ethics, and the average score they achieved on the questions on research ethics was only 40.2%. Most (>90%), however, were favorable towards research ethics education. Finally, some faculty held attitudes regarding certain research ethics practices that were not optimal. Conclusions. We conclude that among the dental faculties participating in our study, there is broad-based acceptance of RECs and training in research ethics, while there are knowledge gaps in research ethics. We recommend further studies to determine the generalizability of our findings to other institutions.

Curriculum guide for research ethics workshops for countries in the Middle East.

To help ensure the ethical conduct of research, many have recommended educational efforts in research ethics to investigators and members of research ethics committees (RECs). One type of education activity involves multi-day workshops in research ethics. To be effective, such workshops should contain the appropriate content and teaching techniques geared towards the learning styles of the targeted audiences. To ensure consistency in content and quality, we describe the development of a curriculum guide, core competencies and associated learning objectives and activities to help educators organize research ethics workshops in their respective institutions. The curriculum guide is divided into modular units to enable planners to develop workshops of different lengths and choose content materials that match the needs, abilities, and prior experiences of the target audiences. The content material in the curriculum guide is relevant for audiences in the Middle East, because individuals from the Middle East who participated in a Certificate Program in research ethics selected and developed the training materials (e.g., articles, PowerPoint slides, case studies, protocols). Also, many of the activities incorporate active-learning methods, consisting of group work activities analyzing case studies and reviewing protocols. The development of such a workshop training curriculum guide represents a sustainable educational resource to enhance research ethics capacity in the Middle East.

A novel formulation for mebeverine hydrochloride.

The antispasmodic drug mebeverine hydrochloride was formulated into a film-forming gel to be used as a topical local anesthetic. A mixture of cellulose derivatives was used as a base. Additives were used to enhance the release as well as the residence time. Formulations were characterized in terms of drug release, mucoadhesion and rheology. Clinically, the selected formula has shown faster onset (p = 0.0156), longer duration (p = 0.0313), better film residence (p = 0.0313), and no foreign body sensation (p = 0.0313) in comparison to Solcoseryl dental paste. Histopathological examination showed no change in inflammatory cells count, concluding that this topical anesthetic is efficacious and safe orally.