MATERIALS AND METHODS: Sixty-three freshly extracted human maxillary central incisors were used for the study. The teeth were instrumented with K-flex files and obturated using lateral condensation technique with GP and AH Plus sealer. The teeth were divided into three retreatment groups, each group consisting of 21 teeth. Group I: D-RaCe desobturation files (D-RaCe); group II: ProTaper Universal retreatment files (PTUR); group III: Hedstrom files (H-file). After removal of GP, the teeth were split longitudinally and divided into three equal parts: Cervical, middle, and apical third. The middle and apical thirds of all root halves were examined using scanning electron microscope (SEM). The total surface area covered by the residual debris was evaluated using Motic Image plus 2.0 software. Statistical analysis was done by one-way analysis of variance (ANOVA) test with a p-value <0.05 used to determine significance and Tukey's multiple post hoc tests used for comparison between the groups, and 't' test was done for comparison between the thirds within the same group.
RESULTS: The PTUR retreatment files showed overall better performance compared with D-RaCe files and H-files. The PTUR files performed better at middle third compared with others. The PTUR files and D-RaCe files performed equally at apical third better than H-files.
CONCLUSION: ProTaper retreatment files are better compared with D-RaCe files and H-files for the retreatment of the previously endodontically treated teeth.
CLINICAL SIGNIFICANCE: Highest efficacy for the removal of GP was shown by ProTaper Universal System followed by D-RaCe and H-file.
METHODS: The Bovine Corneal Opacity and Permeability test method (BCOP), OECD Test Guideline 437, was used as an initial step to study the inducing effect of palm-based MES on irreversible eye damage. The second assessment involved the use of reconstructed human corneal-like epithelium test method, OECD Test Guideline 492 using SkinEthic™ Human Corneal Epithelium to study the potential effect of palm-based MES on eye irritancy. The palm-based MES were prepared in 10% solution (w/v) in deionized water and tested as a liquid and surfactant test substances whereby both test conducted according to the liquid/surfactant treatment protocol.
RESULTS: The preliminary BCOP results showed that palm-based MES; C12, C14, C16, C16:18 were not classified as severe eye irritants test substances with in vitro irritancy score between 3 and the threshold level of 55. The second evaluation using SkinEthic™ HCE model showed that palm-based MES; C12, C14, C16, C16:18 and three commercial samples were potentially irritants to the eyes with mean tissue viability ≤ 60% and classified as Category 2 according to United Nations Globally Harmonized System of Classification and Labelling of Chemicals. However, there are some limitations of the proposed ocular irritation classification of palm-based MES due to insolubility of long chain MES in 10% solution (w/v) in deionized water.
CONCLUSION: Therefore, future studies to clarify the eye irritation potential of the palm-based MES will be needed, and could include; methods to improve the test substance solubility, use of test protocol for solids, and/or inclusion of a benchmark anionic surfactant, such as sodium dodecyl sulphate within the study design.
Materials and Methods: Biodegradable polymeric microneedle arrays were fabricated out of poly lactic-co-glycolic acid (PLGA) using the micromolding technique under aseptic conditions, and the morphology of the microneedles was characterized using light microscopy. Sodium dodecyl sulfate-polyacrylamide gel electrophoresis was used to rule out drug-polymer interactions. Standard procedures were used to analyze the prepared microneedle arrays for in vitro drug release and to perform a microneedle insertion test. Enzyme-linked immunosorbent assay was used to quantify rHuKGF.
Results: The PLGA polymer was safe for use in the fabrication of rHuKGF microneedles as there was no interaction between the drug and the polymer. The fabricated rHuKGF microneedle arrays had fully formed microneedles with a height of 600 µm and a base of 300 µm. The drug from the microneedle patch was released in vitro within 30 minutes. The strength of the microneedles in the patch was good, as they were able to reach a depth of 381±3.56 µm into parafilm without any structural change or fracture.
Conclusion: Microneedle transdermal patches were successfully prepared for rHuKGF, and their evaluation suggested excellent quality and uniformity of patch characteristics. This can have potential applications in the therapeutic arena, offering advantages in terms of reduced dosing frequency, improved patient compliance, and bioavailability.