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Nevin Manimala Statistics

Optimization of a solidified micelle formulation for enhanced oral bioavailability of atorvastatin calcium using statistical experimental design

Pharm Dev Technol. 2023 Apr 26:1-35. doi: 10.1080/10837450.2023.2208206. Online ahead of print.

ABSTRACT

To enhance the oral bioavailability of atorvastatin calcium (ATV), a novel solidified micelle (S-micelle) was developed. Two surfactants, Gelucire 48/16 (G48) and Tween 20 (T20), were employed for micelle formation, and two solid carriers (SC), Florite PS-10 (FLO) and Vivapur 105 (VP105), were selected as solid carriers. The S-micelle was optimized using a Box-Behnken design with three independent variables, including G48:T20 (X1, 1.8:1), SC:G48 + T20 (X2, 0.65:1), and FLO:VP105 (X3, 1.4:0.6), resulting in a droplet size (Y1) of 198.4 nm, dissolution efficiency at 15 min in the pH 1.2 medium (Y2) of 47.6%, Carr’s index (Y3) of 16.9, and total quantity (Y4) of 562.5 mg. The optimized S-micelle resulted in good correlation showing percentage prediction values less than 10%. The optimized S-micelle formed a nanosized dispersion in the aqueous phase, with a higher dissolution rate than raw ATV and crushed Lipitor®. The optimized S-micelle improved the relative bioavailability of oral ATV (25 mg equivalent/kg) in rats by approximately 509% and 271% compared to raw ATV and crushed Lipitor®, respectively. In conclusion, the optimized S-micelle possesses great potential for the development of solidified formulations for improved oral absorption of poorly water-soluble drugs.

PMID:37099663 | DOI:10.1080/10837450.2023.2208206

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Nevin Manimala Statistics

Executive Functioning, Language, and Behavioral Abilities Related to Obstructive Sleep Apnea in Down Syndrome

J Dev Behav Pediatr. 2023 Apr 26. doi: 10.1097/DBP.0000000000001189. Online ahead of print.

ABSTRACT

OBJECTIVES: Obstructive sleep apnea (OSA) is highly prevalent among individuals with Down syndrome (DS), and the nonphysiological consequences of OSA require examination to inform treatment planning. This study aimed to investigate the association between OSA and aspects of language, executive functioning, behavioral, social abilities, and sleep problems in youth with DS aged 6 to 17 years.

METHODS: Multivariate analysis of covariance was used to compare 3 groups adjusted for age, participants with DS with untreated OSA (n = 28), participants with DS without OSA (n = 38), and participants with DS with treated OSA (n = 34). To be eligible for the study, participants had to have an estimated mental age of 3 years. No children were excluded based on estimated mental age.

RESULTS: After adjusting for age, participants with untreated OSA showed a common pattern of lower estimated marginal mean scores than those with treated OSA and those with no OSA in expressive and receptive vocabulary and higher estimated marginal mean scores with executive functions, everyday memory, attention, internalizing and externalizing behavior, social behavior, and sleep problems. However, only the group differences for executive function (emotional regulation) and internalizing behavior were statistically significant.

CONCLUSION: Study findings corroborate and extend prior findings related to OSA and clinical outcomes for youth with DS. The study highlights the importance of OSA treatment in youth with DS and provides clinical recommendations for this population. Additional studies are necessary to control the effects of health and demographic variables.

PMID:37099648 | DOI:10.1097/DBP.0000000000001189

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Nevin Manimala Statistics

Descriptive Analysis of Documentation Time for the National Developmental-Behavioral Pediatric Physician Workforce Using a Commercial Electronic Health Record System

J Dev Behav Pediatr. 2023 Apr 26. doi: 10.1097/DBP.0000000000001185. Online ahead of print.

ABSTRACT

OBJECTIVE: The national developmental-behavioral pediatric (DBP) workforce struggles to meet current service demands because of several factors. Lengthy and inefficient documentation processes are likely to contribute to service demand challenges, but DBP documentation patterns have not been sufficiently studied. Identifying clinical practice patterns may inform strategies to address documentation burden in DBP practice.

METHODS: Nearly 500 DBP physicians in the United States use a single commercial electronic health record (EHR) system (EpicCare Ambulatory, Epic Systems Corporation, Verona WI). We evaluated descriptive statistics using the US Epic DBP provider data set. We then compared DBP documentation metrics against those of pediatric primary care and selected pediatric subspecialty providers who provide similar types of care. One-way analyses of variance (ANOVAs) were conducted to determine whether outcomes differed among provider specialties.

RESULTS: We identified 4 groups for analysis from November 2019 through February 2020: DBP (n = 483), primary care (n = 76,423), pediatric psychiatry (n = 783), and child neurology (n = 8589). Post hoc pairwise comparisons revealed statistically significant differences between multiple outcome-specialty combinations. Time in notes per appointment and progress note length demonstrated the strongest evidence of an increased burden on DBP providers compared with other similar provider groups.

CONCLUSION: DBP providers spend a significant amount of time documenting progress notes both during and outside of normal clinic hours. This preliminary analysis highlights the utility of using EHR user activity data to quantitatively measure documentation burden.

PMID:37099647 | DOI:10.1097/DBP.0000000000001185

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Nevin Manimala Statistics

Evaluation of Glove Performance after Decontamination

Biomed Instrum Technol. 2023;57(1):31-39. doi: 10.2345/0899-8205-57.1.31. Epub 2023 Apr 26.

ABSTRACT

Studies of healthcare providers doffing personal protective equipment, especially gloves, indicate that self-contamination does occur. Although generally this is not hazardous, working with particularly pathogenic organisms, such as Ebola virus and Clostridium difficile, can present a serious health risk. Decontaminating medical gloves before removal can reduce self-contamination and mitigate the spread of these types of pathogens. Also, in cases of extreme shortage, the Centers for Disease Control and Prevention (CDC) has specific recommendations for decontaminating gloves for extended use. Reuse of medical gloves is strongly discouraged by both the CDC and Food and Drug Administration. This work seeks to lay a foundation of testing to evaluate whether a decontamination method is compatible for a given glove type and material. Four potential methods of decontamination (commercial hand soap, alcohol-based hand sanitizer, commercial bleach, and quaternary ammonium solution) were tested on a variety of surgical and patient examination gloves. The method of barrier performance evaluation was ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. Our results indicated that the performance of the gloves after treatment was highly dependent on the composition of the medical gloves. In general, the surgical gloves in this study performed better than the patient examination gloves, regardless of the material from which they were made. Specifically, vinyl examination gloves tended to have poorer performance. In this study, the number of gloves available to test were limited and therefore statistical significance is beyond the scope of this project.

PMID:37099598 | DOI:10.2345/0899-8205-57.1.31

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Nevin Manimala Statistics

Preventive Antibiotic Therapy in Sinus Elevation Procedures: A Systematic Review

Int J Oral Maxillofac Implants. 2023 Jan-Feb;38(1):19-28. doi: 10.11607/jomi.9930.

ABSTRACT

Purpose: To study whether the use of preventive antibiotic therapy reduces the sinus graft infection and/or dental implant failure rates in maxillary sinus elevation surgeries (primary outcome), and to identify the associated best protocol (secondary outcome). Materials and Methods: The MEDLINE (via PubMed), Web of Science, Scopus, LILACS, and OpenGrey databases were searched between December 2006 and December 2021. Prospective and retrospective comparative clinical studies with at least 50 patients and published in English were included. Animal studies, systematic reviews and meta-analyses, narrative literature reviews, books, case reports, letters to the editor, and commentaries were excluded. Assessment of the identified studies, data extraction, and risk of bias were performed independently by two reviewers. Authors were contacted if required. Collected data were reported by descriptive methods. Results: A total of 12 studies fulfilled the inclusion criteria. The only retrospective study comparing the use of antibiotics vs no use of them showed no statistically significant differences for implant failure; however, no data were reported for sinus infection rates. The only randomized clinical trial comparing different courses of antibiotics (only the day of surgery vs 7 additional postoperative days) reported no statistically significant differences between groups in terms of sinus infection rate. Conclusion: Not enough evidence is available to support either the use or nonuse of preventive antibiotic therapy for sinus elevation surgeries or to support the superiority of any protocol over others.

PMID:37099582 | DOI:10.11607/jomi.9930

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Nevin Manimala Statistics

Matrix Metalloproteinase-8 Levels in Peri-Miniscrew Crevicular Fluid During Immediate and Delayed Orthodontic Loading–A Split-Mouth Study

Int J Oral Maxillofac Implants. 2023 Jan-Feb;38(1):130-135. doi: 10.11607/jomi.9705.

ABSTRACT

Purpose: To compare the matrix metalloproteinase-8 (MMP-8) levels in the peri-miniscrew implant crevicular fluid (PMCF) of immediate-loaded and delayed-loaded miniscrew implants at different time intervals. Materials and Methods: Titanium orthodontic miniscrews were placed bilaterally in the attached gingiva of 15 patients between the maxillary second premolar and maxillary first molar for en masse retraction. This split-mouth study was designed to have an immediate-loaded miniscrew on one side and a delayed-loaded miniscrew on the other side that was loaded 8 days after miniscrew placement. PMCF was collected from the mesiobuccal aspects of the immediate-loaded implants at 24 hours, 8 days, and 28 days after loading, and from the delayed-loaded miniscrew implants at 24 hours and 8 days before loading and 24 hours and 28 days after loading. An enzyme-linked immunosorbent assay kit was used to assess MMP-8 levels in the PMCF samples. Unpaired t test, ANOVA F-test, and Tukey post hoc test were used to evaluate data at the P < .05 level. Results: Although there were slight alterations in the MMP-8 levels in the PMCF over time, there was no statistically significant difference in the MMP-8 levels between groups. There was a statistically significant decrease in the levels of MMP-8 between 24 hours after miniscrew placement and 28 days after loading on the delayed-loaded side (P < .05). Conclusion: The MMP-8 levels did not vary much between immediate-loaded and delayed-loaded miniscrew implants as a result of the force application. However, there was no significant difference between immediate loading and delayed loading in terms of biologic response to mechanical stress. The increase in MMP-8 levels after 24 hours post-miniscrew insertion, as well as the subsequent gradual reduction over the course of the study period in both immediate and delayed groups after loading, is probably due to the bone adapting to stimuli.

PMID:37099575 | DOI:10.11607/jomi.9705

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Nevin Manimala Statistics

Is Incisive Papilla a Good Landmark to Predict Clinical Outcomes and the Esthetic Perceptions of Edentulous Patients Treated with Implant-Supported Fixed Prostheses on Maxillae?

Int J Oral Maxillofac Implants. 2023 Jan-Feb;38(1):71-76. doi: 10.11607/jomi.9829.

ABSTRACT

Purpose: To investigate the effect of incisive papilla on esthetic ratings and lip support for patients who are treated with implant-supported fixed prostheses on edentulous maxillae. Materials and Methods: A study population of 118 patients with maxillomandibular edentulism was identified. A self-administered questionnaire was used to evaluate treatment outcomes through a patient perspective. Also, clinical factors such as smile line, maxillary resorption, incisive papilla position, and lip support were evaluated. Results: Lip support has a significant effect on the facial esthetic scores of patients, while smile line and incisive papilla localization have not had a proven statistically significant effect on esthetic and facial esthestic scores of patients treated with implant-supported fixed prostheses on maxillae. Conclusion: Although the patients were diagnosed with disadvantageous clinical factors such as crestally localized incisive papilla, they still noted higher esthetic scores with their fixed prostheses. Factors that affect the esthetic perception of patients or their priorities should be investigated more to understand the reasons for patient satisfaction with prostheses.

PMID:37099573 | DOI:10.11607/jomi.9829

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Nevin Manimala Statistics

The Effects of Clockwise and Counterclockwise Conventional and Osseodensification Drilling on the Dimensions, Density, and Biomechanical Properties of Bone

Int J Oral Maxillofac Implants. 2023 Jan-Feb;38(1):77-83. doi: 10.11607/jomi.9555.

ABSTRACT

Purpose: To compare the effects of regular implant drills to osseodensifying drills used in clockwise and counterclockwise motions on bone dimension change and primary implant stability. Materials and Methods: A total of 40 bone models were made (20 × 15 × 4 mm) from porcine tibia to represent implants placed in soft bone. Implant osteotomies were prepared in the bone models using one of the following techniques: (1) regular implant drills in a clockwise direction (group A), (2) regular implant drills in a counterclockwise direction (group B), (3) osseodensifying drills in a clockwise direction (group C), and (4) osseodensifying drills in a counterclockwise direction (group D). Bone-level tapered titanium alloy implants (4.1 × 10 mm) were placed following osteotomy creation. The implant stability quotient (ISQ) was measured after implant placement. Each bone model was scanned with an optical scanner to convert to Standard Tessellation Language (STL) files before and after the osteotomy creation. Presurgical and postsurgical STL files were superimposed, and the dimensional changes were measured at 1, 3, and 7 mm from the crestal bone. Histomorphometric analysis was done, and bone-to-implant contact percentage (BIC%) was calculated. Results: There were no significant differences in ISQ values (P = .239) between any of the groups. Histomorphometric analysis showed implants in group D had significantly higher BIC% than groups A (P = .020) and B (P = .009). The amount of bone expansion decreased with distance from the crest (P < .001). Groups B (P = .039) and D (P = .001) showed significant expansions at all levels compared with group A. No other statistically significant differences in dimensional change were found between groups. Conclusion: Both regular and osseodensification burs used in a counterclockwise motion contribute to expansion of bone dimension compared to conventional drilling methods.

PMID:37099572 | DOI:10.11607/jomi.9555

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Nevin Manimala Statistics

Influence of Splint Support on the Precision of Static Totally Guided Dental Implant Surgery: A Systematic Review and Network Meta-analysis

Int J Oral Maxillofac Implants. 2023 Jan-Feb;38(1):157-168. doi: 10.11607/jomi.9796.

ABSTRACT

Purpose: To assess the accuracy of totally guided implant placement with static surgical splints in relation to the different types of supporting tissues (tooth, mucosa, or bone). Materials and Methods: This review was carried out following the PRISMA guidelines. An electronic search was done of the MEDLINE (PubMed), Embase, and Cochrane Library databases, without publication year or language restrictions. Results: The literature search yielded a total of 877 articles; 18 were included in the qualitative synthesis, and 16 of these articles were included in the quantitative analysis. The included studies presented a high risk of bias, except for one randomized clinical trial. The strength of the recommendations is therefore weak. In the angular deviation treatment, statistically significant differences were observed in the accuracy of the implants with tooth vs bone support: Bone support yielded 1.31 degrees greater deviation vs tooth support (SD = 0.43; 95% CI: 0.47, 2.15, P = .002). No significant differences were observed in the linear deviations. Conclusion: Tooth support proved to be significantly more precise than bone support splints. There were no differences referring to horizontal coronal deviation, horizontal apical deviation, or vertical deviation according to the type of splint support used.

PMID:37099571 | DOI:10.11607/jomi.9796

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Nevin Manimala Statistics

The 3′ UTR polymorphisms rs3742330 in DICER1 and rs10719 in DROSHA genes are not associated with primary open-angle and angle-closure glaucoma: As case-control study

PLoS One. 2023 Apr 26;18(4):e0284852. doi: 10.1371/journal.pone.0284852. eCollection 2023.

ABSTRACT

AIM: In a retrospective and exploratory case-control study, we examined the genetic association of two common polymorphisms in the 3′ untranslated region (UTR) of DICER1 (rs3742330) and DROSHA (rs10719) genes in primary open-angle glaucoma (POAG) and primary angle-closure glaucoma (PACG), and its related clinical phenotypes in a Saudi cohort.

METHODS: DNA genotyping was performed using TaqMan real-time PCR assays in 500 participants, including 152 POAG, 102 PACG, and 246 non-glaucomatous controls. Statistical analyses were performed to examine the association(s).

RESULTS: Allele and genotype frequency of rs3742330 and rs10719 did not vary significantly in POAG and PACG compared to controls. No significant deviation was observed from Hardy-Weinberg Equilibrium (p > 0.05). Gender stratification revealed no significant allelic/genotype association with glaucoma types. Also, these polymorphisms showed no significant genotype effect on clinical markers such as intraocular pressure, cup/disc ratio, and the number of antiglaucoma medications. Logistic regression showed no effect of age, sex, rs3742330, and rs10719 genotypes on the risk of disease outcome. We also examined a combined allelic effect of rs3742330 (A>G) and rs10719 (A>G). However, none of the allelic combinations significantly affected POAG and PACG.

CONCLUSIONS: The 3′ UTR polymorphisms rs3742330 and rs10719 of DICER1 and DROSHA genes are not associated with POAG and PACG or its related glaucoma indices in this Middle-Eastern cohort of Saudi Arab ethnicity. However, there is a need to validate the results on a broader population and other ethnicities.

PMID:37099569 | DOI:10.1371/journal.pone.0284852