Comparative Clinical Study Research Articles

P-448 Placental histopathology in frozen embryo transfer HRT induced IVF pregnancies and non-IVF pregnancies and its correlation with maternal and fetal outcomes: a prospective case-control study

Abstract Study question Is Placental histopathology altered in Frozen Embryo transfer, HRT induced IVF pregnancies when compared to non-IVF pregnancies; if yes,any implications on maternal and fetal outcome? Summary answer Pathological placental lesions and adverse maternal outcomes were found to be significantly higher in IVF pregnancies compared to non-IVF pregnancies. What is known already Studies on placental histopathology in IVF pregnancies suggest that there may be differences compared to naturally conceived pregnancies. Some research indicates an increased risk of certain placental abnormalities such as changes in vascularization and structure (Uroka Belak, et al., 2023). Additionally, alterations in gene expressions and epigenetic modifications in placenta have been observed in IVF pregnancies. However, it is essential to note that findings can vary, and more research is needed to fully understand the implications and potential long-term effects. Study design, size, duration Prospective, single centre, comparative clinical study, including 100 pregnancies between November, 2022 and November, 2023; 50 FET HRT induced IVF pregnancies, 50 non-IVF pregnancies. Participants/materials, setting, methods Patients aged 32-45 years, >34 weeks gestation, with no associated maternal and obstetrical complications were recruited after proper screening and informed consent. Among 100 pregnancies, we compared placental HPE using the Amsterdam Placental Workshop Group Consensus and feto-maternal outcomes between FET HRT induced IVF pregnancies and non-IVF pregnancies. We used Chi-square test to compare groups(p < 0.05). Main results and the role of chance Out of 100 participants, 50 were frozen embryo transfer, HRT induced IVF pregnancies and 50 were non-IVF pregnancies. Out of 50 IVF pregnancies; 27(54%) had pathological placental lesions, of which 17(63%) were noted to have adverse maternal outcomes and 6(22.2%) had adverse fetal outcomes. Out of 50 non-IVF pregnancies, 4(8%) had pathological placental lesions; of which 1(25%) were noted to have adverse maternal outcomes and 1(25%) had adverse fetal outcomes. On comparing these 2 groups, our result was found to be statistically significant(p < 0.05). Limitations, reasons for caution This study has some limitations owing to it being a single centered comparative trial, possibility of observer bias in histopathological examination and that the study is restricted to HRT induced IVF pregnancies. Wider implications of the findings This study reveals valuable insights into potential differences in placental and fetal development. Understanding these variances could influence clinical practices, patient counseling, and contribute to advancements in assisted reproductive technologies. Additionally, insights into long-term health outcomes for both mothers and babies may emerge, guiding future research and healthcare strategies. Trial registration number Not applicable

Aesthetic and Functional Evaluation of Abdominal Contouring Using Lipo-Abdominoplasty versus Lipo-Abdominoplasty with TULUA Procedure: A Comparative Clinical Study

Abstract Background Lipoabdominoplasty techniques may be followed by a wide range of complications as flap necrosis, wounddehiscence, surgical site infection, epigastric bulging, malpositioned umbilicus, high transverse scar and seroma formation. Villegas in 2014 introduced the TULUA abdominoplasty to improve the aesthetic outcome and to avoid the many associated complications mentioned. The objective of this study is to compare the aesthetic and functional outcomes between the traditional lipoabdominoplasty and TULUA abdominoplasty. Methods in this prospective comparative clinical study, sixty adult women with excess subcutaneous abdominal fat and skin laxity after repeated pregnancies with mild to moderate degree of diastasis of recti were included. The patients’ ages ranged between 28-55 years, their BMI scores were 25-35 kg/m2. Group A (30 patients) underwent lipoabdominoplasty while group B (30 patients) underwent TULUA abdominoplasty. The patients were followed up for a minimum of 6 months where the comparative study included aesthetic results as regards the abdominal contouring using clinical outcome scaling systemin addition to functional aspects assessing anatomical features, changes in anterior abdominal wall and finally the complication rate between both techniques. Results The average total liposuction aspirate volume of the abdomen was 2400 ml in group A, while in group B, the average volume was 3500 ml. The mean surface area of vertical plicature measured intraoperatively was 211.93 (±54.66) cm2 in group A, while in group (B) transverse plicature surface area was 369.47(±84.22) cm2. The increase in intra-abdominal pressure IAP after plication and skin closure in group A was 7.93±1.26 cmH2O; while for group B there was a highly significant increase by 9.87±1.01 cmH2O. Flap sloughing was seen in 4 cases(13.3%), wound dehiscence 2 cases (6.6%) seroma in 3 cases(10%) for group A,conversely no cases reported flap necrosis, wound dehiscence or seroma that need to be aspired in group B. The aesthetic outcomes were evaluated using a 5 points likert scale system through three indicators, f or group A,an overall result that was 4.50 ± 0.87, umbilical appearance 4.61±0.73, and scar quality 4.35 ± 0.82; On the other hand group B showed overall result 4.53 ± 0.71, umbilical appearance 4.52 ± 0.82, and scar quality 4.43 ± 0.87. Conclusions TULUA procedure is a safe, reproducible shift in abdominoplasty, with fewer complications to occur.

Comparison of Post-Operative Analgesia of Caudal versus Dorsal Penile Nerve Blocks for Pediatric Patients Undergoing Hypospadias Repair

Abstract Background Hypospadias is the second most common congenital disorder in males after cryptorchidism, but it is the most common penile congenital malformation. It is an abnormality of anterior urethral and penile development in which the urethral opening is ectopically located on the ventral aspect of the penis proximal to the tip of the glans penis, which, in this condition, is splayed open. The urethral opening may be located as far down as in the scrotum or perineum. The penis is more likely to have associated ventral shortening and curvature, called chordee, with more proximal urethral defects. Aim of the Work The aim of this study is to compare the effectiveness of penile block versus caudal block using bupivacaine on the quality of analgesia after hypospadias repair in pediatrics. Methodology This prospective randomized comparative clinical study was conducted in Ain Shams University Hospitals; Pediatric Surgery Unit. It included 30 male patient aged (1–8) years, ASA I or II patients undergoing hypospadias (distal penile and mid penile) repair. They were divided into two groups: Group P: Penile block (n = 15) received dorsal penile nerve block by using the subpubic approach technique. Group C: Caudal block (n = 15) received caudal epidural block using a 22-G needle in the lateral decubitus position. Results There was statistically high significant difference between the two groups in postoperative MAP and HR (p value <0.001) but no statistically significant difference between them in Spo2. FLACC pain scores were significantly lower in group C compared with group P at PACU and 3 hours postoperative (p value <0.001) but no statistically significant difference between them at 6, 9 and 12 hours postoperative. Also, The time for first rescue analgesia was significantly longer in caudal group compared with penile group (P < 0.001) and the total analgesia consumption was also significantly lower (P < 0.001) in group C compared with group P. Postoperative time of ambulation was significantly lower (P < 0.001) in group P compared with group C. Conclusion The current study revealed that Caudal block provided significantly prolonged postoperative analgesia, reduced the postoperative analgesic requirements and prolonged time of ambulation as compared with Penile block in pediatric patients undergoing hypospadias repair.

P-435 Superiority of modified natural cycle vs hormonal replacement therapy in non-menopausal egg recipients of advanced maternal age: clinical outcomes from 1273 single blastocyst transfer cycles

Abstract Study question Is the modified natural cycle (mNC) better than hormonal replacement therapy (HRT) for endometrial preparation in non-menopausal egg recipients of advanced maternal age? Summary answer In women above 40 years, mNC shows better reproductive and obstetrical outcomes compared to hormonal replacement therapy, especially in the subgroup 45-50 years old. What is known already There is extensive evidence showing the superiority of mNC over HRT in terms of live birth rates, miscarriages, and even obstetric complications. Apparently, the presence of the corpus luteum plays a major role in endometrial receptivity and embryo implantation, probably allowing for better placentation. Nevertheless, there is a general belief that the ovulatory cycle of older women is not the best choice for endometrial preparation, although paradoxically they are the group of patients who could benefit most from the reduction of obstetric complications. An increase in cancellation rates for mNC is claimed, without consistent data available. Study design, size, duration Retrospective single-centre comparative clinical study, including 1273 endometrial preparation cycles for frozen single-blastocyst transfer between January 2020 and December 2022: 892 (70,2%) on HRT protocol and 381 (29,8%) on mNC protocol. The two groups were homogeneous for donor’s age (25,7 years HRT vs 25,3 years mNC), recipient’s age (42,2 years HRT vs 42,1 years mNC), severe male factor (6% HRT vs 5% mNC), and the need for a sperm donor (28% HRT vs 26% mNC). Participants/materials, setting, methods Among 1273 started non-menopausal recipient’s cycles, we compared cancellation rates between HRT and mNC due to either medical reasons (inadequate endometrium, bleeding, premature ovulation) or other issues (no embryo survival, COVID-19, etc). We studied the outcomes of the 1096 elective frozen single-blastocyst transfers performed, comparing HRT and mNC cycles for: pregnancy, clinical pregnancy, miscarriage, live birth and <35weeks preterm birth rates. We stratified the results by age and used Chi-square test to compare groups (p < 0,05). Main results and the role of chance The overall cancellation rate was 13.9%. No significant differences in cancellation for medical reasons were found between HRT (7%) and mNC (6.8%), p = 0.93. When we analyse results stratified by age, patients aged 39 or less (270 cycles: HRT 75.9%, mNC 24.1%) showed no statistically significant differences in pregnancy (58% vs 64.6%, p = 0.35), clinical pregnancy (50.7% vs 56.9%, p = 0.34), miscarriage (18.3% vs 18.9%, p = 0.93), and live birth rates (41.5% vs 46.2%, p = 0.5). In the 40-44 age group (494 cycles: HRT 64.2%, mNC 35.8%), no statistically significant differences were found between HRT and mNC in pregnancy (58.2% vs 61.5%, p = 0.47), clinical pregnancy (50.8% vs 51.1%, p = 0.96), and live birth rates (40.4% vs 45.8%, p = 0.25). The HRT group had a significantly higher miscarriage rate (21%) compared to mNC (10%), p = 0.03. For patients aged 45-50 years (332 cycles: HRT 72%, mNC 28%), no statistically significant differences were observed in pregnancy (56.5% vs 62.4%, p = 0.33) and miscarriage rates (24.3% vs 15.1%, p = 0.18). Clinical pregnancy (44.8% Vs 57%, p = 0.04) and live birth rates (33.9% vs 48.4%, p = 0.01) were significantly higher in the mNC group compared to HRT. No significant differences were found between HRT and mNC in preterm birth rates <35 weeks (3.6% vs 4.6%, p = 0.75). Limitations, reasons for caution This study is a single-centre retrospective comparative trial. Our homogeneity study included several confounding variables, however other bias such as severe uterine factor, embryo quality or repeated implantation failure cases were not taken into account. Wider implications of the findings Modified natural cycle should be encouraged as the first option for endometrial preparation in non-menopausal egg recipients of advanced maternal age, having shown superiority over hormonal replacement therapy in patients aged 45-50 years. Moreover, modified natural cycles are more patient friendly and cost-effective, with no increase in the cancellation rates. Trial registration number not applicable

Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan

ABSTRACT Background The ‘Questions and Answers (Q&A)’ document regarding Japanese biosimilar guideline elucidated that Japanese participant enrollment in at least one comparative clinical study was required for the marketing authorization application (MAA) of biosimilars in Japan. Research design and methods To discuss the requirement of Japanese clinical study data for biosimilar development, the trend in comparative clinical studies conducted for approved biosimilars of monoclonal antibodies and fusion proteins was analyzed, and the consistency of the results between the overall population and the Japanese population according to the publicly available information was reviewed. Results The number of comparative clinical studies enrolling Japanese participants was 25 cases, and the type and percentage were 13 (52%) and 12 (48%) cases of comparative pharmacokinetic study and comparative efficacy study, respectively. In all comparative clinical studies, consistent results between the overall population and the Japanese population were shown. Conclusions Our study indicated that Japanese participant enrollment in comparative clinical studies may not always be necessary for biosimilar development when certain conditions are satisfied. This has been described in the revised Q&A document published by the Ministry of Health, Labour and Welfare in January 2024.

Comparative clinical study of attenuation of hemodynamic response to laryngoscopy and endotracheal intubation using clinical assessment guidance versus neuromuscular block monitoring guidance

Background: The hemodynamic response to the stress of laryngoscopy and endotracheal intubation does not present a problem for most patients, except in cardiovascular or cerebral disease. Various anesthetic techniques and drugs are available to control the hemodynamic response to laryngoscopy and intubation. However administration of an additional drug may adversely affect hemodynamics of the patient or unnecessarily increase the depth of anesthesia. Hence a non pharmacological measure to reduce response is preferred. The purpose of this study was to compare the hemodynamic response during laryngoscopy and intubation when choice of the moment of intubation is directed by either clinical assessment and neuromuscular monitoring with train of four. Methods: A total of 60 patients were randomised into two groups. In Group M endotracheal intubation was done after train of four count became zero in adductor pollicis muscle. In Group C timing of intubation was determined clinically by assessment of jaw muscle relaxation. Changes in heart rate (HR), systolic BP (SBP), diasolic BP (DBP), mean arterial pressure (MAP), time between the administration of neuromuscular blocking agent and endotracheal intubation was recorded. Results were analysed by the analysis of variance and chi square test. Results: Heart rate, SBP, DBP and mean arterial pressure were significantly higher in Group C as compared to Group M after laryngoscopy and endotracheal intubation (P<0.05). The mean time required for onset of intubation was significantly shorter in Group C compared to Group M. Conclusion: The objective assessment of neuromuscular relaxation prior to endotracheal intubation provides better attenuation of hemodynamic responses. Keywords: hemodynamic response; laryngoscopy; endotracheal intubation; neuromuscular block

Efficacy of Homoeopathy In PCOS- A Review

Introduction: To evaluate the usefulness of homeopathy for the treatment of PCOS through a literature review and to develop a strategy for future research. Method: A comprehensive search was done in electronic databases, including general medical databases MEDLINE, CENTRAL, Science Direct, specialised database for homeopathy CORE-Hom, CAM databases LILACS Chiro ACCESS, AYUSH Research Portal, Google Scholar, Research gate net, clinical trial registry, aimed to target the available literature of observational studies, randomized trials, controlled trials, case reports on PCOS in homeopathy and limited to the English language. The inclusion criteria are the studies with a full-text present in mentioned databases, studies with experimental or quasi-experimental designs published in peer-reviewed or partial peer-reviewed journals and studies with humans as their samples. Result: A literary search through databases helped to identify a few significant studies, such as one placebo-controlled trial, one comparative clinical study, one retrospective study, three clinical studies, and nine case reports. A retrospective study showed positive results for the role of homeopathic medicines in PCOS. The placebo-controlled trial showed a difference in outcome between the two groups. The verum group showed a positive effect in the regularization of menses. The comparative clinical study showed that both homeopathic medicines (Cal. carb, Lycopodium) appeared to be effective. Three clinical studies showed the effectiveness of homeopathic medicines in improving and curing PCOS. Nine case reports showed a positive effect of homeopathy in improving PCOS, out of which three cases showed positive outcomes also in infertility with PCOS. Conclusion: The results showed that Homoeopathy has positive effects on the management of PCOS in women. In the future, high-quality randomized controlled trials (RCT), comparative studies of homeopathy with conventional therapy, and in-vitro and animal model studies will be required to support the effectiveness of homeopathic therapeutics in PCOS.

Respiratory Viruses Co-detection on a Multiplex RT-PCR Panel: a Comparative Clinical Study.

The FilmArray Respiratory Panel RP 2.1 plus (FilmArray RP) is a point-of-care syndromic panel for respiratory pathogens. Although highly valuable in the clinical settings, the co-detection of pathogens in FilmArray RP may confound result interpretation. Nasopharyngeal swab specimens collected from patients with respiratory symptoms were analyzed by comparing co-detection results from FilmArray RP with those of Allplex Respiratory Panels (Allplex RP: Power-Chek for SARS-CoV-2). Out of 765 FilmArray RP tests, 143 (18.7%) showed co-detections (two: 122 (85.3%), three: 18 (12.6%), four: 2 (1.4%), and five viruses: 1 (0.7%). The most frequent co-detection was human rhinovirus/enterovirus (HRV/HEV) with respiratory syncytial virus (RSV) (22.3%, 32/143). The overall discordance rate between Film-Array RP and other tests was 32.9%. Notably, discordance in detecting adenovirus (AdV) was significant, with cases detected by FilmArray often not appearing in Allplex RP. Discordances were varied by virus combination. It is advisable to perform additional confirmatory testing based on clinical relevance.

Comparative Clinical Study for Uterotonic Drugs Used in Reducing Postpartum Haemorrhage for Risky Patients in Caesarean Section

Comparative Clinical Study for Uterotonic Drugs Used in Reducing Postpartum Haemorrhage for Risky Patients in Caesarean Section

Opportunity of the Effect of Injectable Platelet Rich Fibrin (I-PRF) Mixed with Bone Graft on the Correlation Between Dental Implant Stability and Alveolar Ridge Width. A Clinical Comparative Study

The potential impact of injectable platelet-rich fibrin (I-PRF) combined with bone graft as a guided bone regeneration on the relationship between dental implant stability, alveolar ridge width, and dental implant dimension. Materials and methods: The present prospective comparative study was registered at ClinicalTrials.gov (ID number: NCT05427643). A total of 13 patients aged 18-65 years (11 females and 2 males) presented with missing teeth in either the maxilla or the mandible or both and met the eligibility criteria and enrolled in this study treated with 40 dental implants. These cases were allocated into two groups, control group in which the implants were placed without I-PRF and a study group (advanced cases with narrow alveolar ridge) in which implants were installed with I-PRF mixed with synthetic bone graft at the dehiscence sites around the implants. 22 (55%) dental implants were inserted in patients with alveolar bone width of ˂ 3.5 mm and 18 (45%) dental implants were inserted in ridge with ≥ 3.5 mm. The primary stability was measured at the time of surgery and Secondary stability was measured 24 weeks after dental implant installation with Anycheck device in implant stability test (IST) values. Results: Twenty dental implants were installed in each study group. According to the results obtained in this study, there was significant difference between primary stability (69.96±8.5 vs 74.50±4.3) of both groups and secondary stability (69.96±8.5 vs 76.32±6.5) values of group A with bone width of ≥ 3.5 mm and dental implant dimension 4.1 mm. Conclusion: The addition of I-PRF with bone graft for augmentation of dehiscence and fenestration peri-implant defects with simultaneous implant placement results in 100% survival rate with statistical differences in implant secondary stability between study groups. However, the results were clinically irrelevant.

Surface Topography Has Less Influence on Peri-Implantitis than Patient Factors: A Comparative Clinical Study of Two Dental Implant Systems.

This study aims to assess the risk of peri-implantitis (PI) onset among different implant systems and evaluate the severity of the disease from a population of patients treated in a university clinic. Furthermore, this study intends to thoroughly examine the surface properties of the implant systems that have been identified and investigated. Data from a total of six hundred and 14 patients were extracted from the Institute of Clinical Dentistry, Dental Faculty, University of Oslo. Subject- and implant-based variables were collected, including the type of implant, date of implant installation, medical records, recall appointments up to 2022, periodontal measurements, information on diabetes, smoking status, sex, and age. The outcome of interest was the diagnosis of PI, defined as the occurrence of bleeding on probing (BoP), peri-implant probing depth (PD) ≥ 5 mm, and bone loss (BL). Data were analyzed using multivariate linear and logistic regression. Scanning electron microscopy, light laser profilometer, and X-ray photoelectron spectroscopy were utilized for surface and chemical analyses. Among the patients evaluated, 6.8% were diagnosed with PI. A comparison was made between two different implant systems: Dentsply Sirona, OsseospeedTM and Straumann SLActive, with mean follow-up times of 3.84 years (SE: 0.15) and 3.34 years (SE: 0.15), respectively. The surfaces have different topographies and surface chemistry. However, no significant association was found between PI and implant surface/system, including no difference in the onset or severity of the disease. Nonetheless, plaque control was associated with an increased risk of developing PI, along with the gender of the patient. Furthermore, patients suffering from PI exhibited increased BL in the anterior region. No differences were observed among the evaluated implant systems, although the surfaces have different topography and chemistry. Factors that affected the risk of developing PI were plaque index and male gender. The severity of BL in patients with PI was more pronounced in the anterior region. Consequently, our findings show that success in implantology is less contingent on selecting implant systems and more on a better understanding of patient-specific risk factors, as well as on implementing biomaterials that can more effectively debride dental implants.

Effect of Marham-i-Bāsalīqūn on Cervical Erosion (Qurūḥ al-Raḥim)): A Randomized Comparative Clinical Study

Background and Objective: Cervical erosion (Qurūḥ al-Raḥim) is one of the most frequent gynecological conditions seen in clinical practice. Therefore, the objective of the current study was to assess the impact of the topical application of Marham-i-Bāsalīqūn in Qurūḥ al- Raḥim. Material and Method: A randomized comparative clinical study was carried out at the Institute Hospital in Bengaluru. Diagnosed cases (n=40) of cervical erosion were randomly assigned to test (n=20) and control (n=20) groups. A total of 6 g ointment of Marham-i-Bāsalīqūn (test drug) and tested Unani formulation (control drug) was applied with an applicator per vaginum over the eroded area of the cervix daily once at bedtime for 14 days. A single dose of the antibiotic regimen (azithromycin-1g and cefixime-400 mg) was administered orally in both groups. Subjective parameters like vaginal discharge, pruritus vulvae, low back ache, lower abdominal pain, and postcoital bleeding were assessed during the trial. The main outcome measure was an improvement in the cervical erosion grading score. The inference was executed with appropriate statistical analysis. Result: Improvement in the cervical erosion grading score was achieved in 50% and 40% of patients in the control and test groups, respectively, after 2 weeks of treatment with P<0.0001, which was considered highly significant. A highly significant improvement in subjective parameters was observed during the trial with P<0.0001. Conclusion: Considering the high prevalence of cervical erosion among women of reproductive age group, effective treatment and safe strategies are highly recommended. Marham-i-Bāsalīqūn is cost-effective and has several therapeutic actions that can help to promote the healing of erosion and relieve the associated symptoms. The clinical trial was registered at the Clinical Trial Registry of India (CTRI) with registration number CTRI/2022/02/040419.

Effects of Body Mass Index on Hypertriglyceridemia Associated with Oral Bexarotene Therapy: A Post Hoc Analysis of an Open-Label Comparative Clinical Study of Combined Bexarotene and Phototherapy Versus Bexarotene Monotherapy for Japanese Patients with Cutaneous T-Cell Lymphoma.

Bexarotene, which has been approved for use in Japan since 2016, is an effective drug for cutaneous T-cell lymphoma; however, careful management is imperative because of its adverse events. We previously demonstrated the severity of bexarotene-associated hypertriglyceridemia and the need for bexarotene dose reduction for patients with cutaneous T-cell lymphoma and high body mass index (BMI); however, high BMI does not affect the efficacy of combined bexarotene and phototherapy treatment. This study aimed to verify the effects of BMI on hypertriglyceridemia associated with oral bexarotene therapy. We conducted a post hoc analysis of data from a previous randomized, open-label clinical study that compared combined bexarotene-phototherapy treatment with bexarotene monotherapy for cutaneous T-cell lymphoma by dividing patients into two groups based on BMI (<23 kg/m2 and ≥23 kg/m2). No statistically significant association was observed between patients with BMI ≥23 kg/m2 and severe hypertriglyceridemia; however, there was a significant association between BMI ≥23 kg/m2 and severe hypertriglyceridemia for patients who received bexarotene monotherapy, but not for those who received combined bexarotene-phototherapy treatment. The exact reasons for the discrepancies between the results of this thorough analysis and those of our past research are unclear. However, high BMI may be a risk factor for hypertriglyceridemia. Additional unidentified risk factors could also affect treatment outcomes. High BMI is the primary reason for hypertriglyceridemia-associated bexarotene dose reduction; however, unexplored risk factors other than high BMI could exist.

Biomechanical Parameters of Implants Placed with Osseodensification Versus Implants Placed with Under-drilling Osteotomy Techniques in Posterior Maxilla: A Comparative Clinical Study

BACKGROUND: To facilitate better implant survival rates in areas with clinically low bone density, osteotomy techniques that provide higher implant stability and improve bone quality are often recommended. The most widely used are under-drilling (UD) and osseodensification (OD). In the UD technique, the diameter of the final osteotomy drill is narrower that the diameter of the placed implant, whereas in the OD technique, special drills that rotate counter-clockwise to condense and densify the bone are used. AIM: The aim of this study was to evaluate the effect of two different implant osteotomy methods – UD versus osseodensification (OD) in terms of implant stability during the period of osseointegration in the posterior maxillary region. MATERIAL AND METHODS: This prospective randomized clinical study included 22 patients who received a total of 37 implants in the posterior maxillary region. They were divided into two groups: In 11 patients, 18 implants were placed using the under-drilling method (UD), while the other 11 patients received 19 implants using the osseodensification method (OD). Within the OD group, 10 implants were placed in areas with the initial height that was insufficient to accommodate implants with a minimal length of 8 mm. In these areas, crestal sinus elevation without bone graft use was performed simultaneously with implant placement, according to the osseodensification protocol proposed by the manufacturer. All implants were placed in a dual-stage manner – completely covered with soft tissue and uncovered 4 months later, at the time of second-stage surgery. The implant stability was determined by measurement of implant stability quotient (ISQ) with instrument that utilizes the method of resonance frequency analysis (RFA) to discover implant stability. The ISQ represents a value on a scale between 0 and 100, with values above 65 indicating high implant stability. ISQ values were measured at two timepoints: At the time of implant placement and at the time of their uncovery. Statistical analysis was performed with Prism 9 statistical program for Mac. The data were analyzed using one-sample t-test, Wilcoxon, and paired two-way ANOVA test. The significance level was set at p ≤ 0.05. RESULTS: The differences between the primary implant stability ISQ values in the UD and osseodensification (OD) groups were not statistically significant. The secondary implant stability was statistically significantly higher in the osseodensification group (p &lt; 0.001) There were no statistically significant differences between secondary implant stability values in implants placed with and without crestal sinus floor lift within the osseodensification group. CONCLUSION: Within the limitations of the study, the conclusion is that osseodensification method of implant osteotomy (OD) results in higher secondary implant stability values that the under-drilling method (UD), which has clinical relevance regarding long-term implant survival. It should be a preferred method of choice for osteotomy in areas with clinically low density of bone due to its predictability and effectiveness.

Value of the three-dimensional visualization ablation planning system in ultrasound-guided percutaneous microwave ablation for malignant adrenal tumors: A clinical comparative study.

We aimed to assess the efficacy and safety of the three-dimensional visualization ablation planning system (3DVAPS) in ultrasound-guided percutaneous microwave ablation (US-PMWA) for malignant adrenal tumors (MATs). A retrospective analysis was conducted on a cohort of 62 unilateral MAT cases from March 2011 to November 2022. There were a total of 62 lesions, with a mean maximum diameter of 5.4 ± 2.7 cm (range, 1.4-15.7 cm). The patients were categorized into the following, based on the pre-operative planning method: 3D planning (n = 32) and 2D planning (n = 30) groups. A comparative analysis was performed on various parameters, including ablation techniques, tumor-related prognosis, and incidence of complications. This analysis encompassed indicators, such as overall survival (OS) rate and local tumor progression (LTP), among others. The median follow-up period was 30 months (range, 3-84 months). Notably, compared with the 2D planning group, the 3D planning group exhibited significant disparities in the number of punctures (P = 0.035) and incidence of complications (P = 0.029) and had no significant difference in the OS ( P > 0.05) but had a significantly lower LTP rate (6.2% vs. 23.3%, P = 0.033). In the 3D planning group, the sub-group with a tumor diameter of < 5 cm exhibited a significantly less number of punctures ( P = 0.039), lower input energy ( P = 0.002), and a shorter ablation time ( P = 0.001), compared with the sub-group with a tumor diameter of ≥ 5 cm, but there was no significant difference in the LTP and OS rates between the two sub-groups ( P > 0.05). The use of 3DVAPS in US-PMWA of MATs was advantageous, especially in lesions with a diameter of ≥ 5 cm. It can help in developing more rational surgical plans, reducing the incidence of complications, and extending the local recurrence-free survival time of patients and can add a certain value for precise treatment and expand the indications for ablation.

Clinical comparative study of laparoscopic partial splenectomy and open partial splenectomy.

The aim of the article was too investigate and compare the feasibility, safety, and early postoperative recovery associated with laparoscopic partial splenectomy (LPS) and open partial splenectomy (OPS) in patients with benign splenic tumours and traumatic splenic rupture. A retrospective analysis was conducted on clinical data from 110 patients undergoing splenic resection at our hospital between March 2019 and May 2022. Among them, 35 patients underwent OPS, 25 underwent LPS for traumatic splenic rupture, while 50 patients with benign splenic tumours underwent either OPS (n = 20) or LPS (n = 30). Preoperative, intraoperative, and postoperative data were collected and compared. Statistical analysis was conducted using SPSS software. There was no significant difference in the general data between the 2 groups of patients with benign splenic tumours and those with splenic trauma. Among patients with traumatic splenic rupture, the OPS group had a shorter operation time (p < 0.05). Regardless of whether they had traumatic splenic rupture or benign splenic tumours, the LPS group required less postoperative analgesia and had a shorter defecation recovery time (p < 0.05). Additionally, the LPS group displayed lower white blood cell count, white blood cell/lymphocyte ratio (WLR), neutrophil/lymphocyte ratio (NLR), monocyte/lymphocyte ratio (MLR), C-reactive protein (CRP), calcitonin (PCT), and interleukin-6 (IL-6) than the OPS group on the first and third days post-surgery (p < 0.05). In comparison to OPS, LPS presents significant advantages, including minimal surgical trauma, a reduced early postoperative inflammatory response, milder wound pain, and a faster recovery of gastrointestinal function.

Clinical efficacy of a new type of Sports Rehabilitation Therapy Bed.

To prove that the "sports rehabilitation bed" is a device aimed at improving the precision of stretching, which can help to reduce the difficulty of rehabilitation therapy, cut down the manpower input of rehabilitation therapy, and shorten the therapy duration as well. This was a clinical comparative study. Twenty patients who underwent stretching therapy in Sichuan Province Orthopedic Hospital from June 2020 to August 2020 were randomly selected to carry out a control study on both lower extremities. The experimental group was given sports rehabilitation bed to assist rehabilitation therapy, while the control group was given conventional bare-handed stretching rehabilitation therapy. The stretching angle, stretching value, and the effective rate of stretching therapy between the two groups to analyze the clinical value of the new sports rehabilitation therapy bed. The stretching angle in the experimental group when using the sports rehabilitation therapy bed for stretching was lower than the conventional bare-handed stretching in the control group (T<0, P=0.05), with a statistically significant difference; the stretching values of the experimental group were lower than those of the control group(P<0.01), with a statistically significant difference. Moreover, the response rate of stretching therapy in the experimental group was lower than that in the control group(P<0.05), with a statistically significant difference. Sports rehabilitation therapy beds can results in the advantages of effectively preventing iatrogenic injury in the process of stretching, and providing a more accurate and convenient stretching therapy method than the current commonly used bare-handed stretching for sports rehabilitation and intervention.

Efficacy and safety of the combined drug (5% benzoyl peroxide / 1% clindamycin) in the treatment of acne: results of an open randomized comparative clinical study

Background. Acne is one of the most common dermatoses, the presence of which significantly reduces the quality of life of patients. For patients with inflammatory, comedonal or combined acne, the external use of fixed combinations is a first-line therapy. Aims. To study the efficacy and safety of the Zerkalin Intensive (benzoyl peroxide + clindamycin) in the treatment of acne in comparison with the Effezel (adapalene + benzoyl peroxide). Methods. An open comparative clinical study included 60 patients with acne of varying severity: group 1 — 30 patients received therapy with Zerkalin Intensive, group 2 — 30 patients received therapy with Effezel 1 time a day in the evening. The effectiveness of therapy was evaluated 2 weeks, 1, 2 and 3 months after the start of treatment. Results. After 1 month of therapy, there was a significant improvement (resolution of elements by at least 70%) in 9 (30%) patients of the group 1 and in 9 (30%) patients of the group 2 (p = 1.000); improvement (decrease in the severity of the pathological process by at least 25%) — in 12 (40%) and 18 (60%) patients, respectively (p = 0.106). After 2 months of using Zerkalin Intensive and Effezel, complete resolution of rashes was observed in 11 (36.7%) and 6 (20%), respectively (p = 0.395); significant improvement in 13 (43.3%) and 11 (36.7%) patients (p = 0.628); improvement in 6 (20%) and 13 (43.3%), respectively. After 3 months complete resolution of rashes was observed in 24 (80%) patients of the group 1 and in 12 (40%) patients of the group 2 (p = 0.088); significant improvement in 5 (16.7%) and 11 (36.6%) patients (p = 0.236); improvement in 1 (3.3%) and 7 (23.3%) patients, respectively. Against the background of the use of Effezel, 20 (66.7%) patients showed the appearance of slight dry skin and redness. No side effects were detected when using the Zerkalin Intensive. Conclusions. A comparable high efficiency of Zerkalin Intensive and Effezel in acne therapy has been established. Use of Zerkalin Intensive made it possible to achieve the onset of a full clinical effect and a significant improvement in the clinical picture in a larger number of patients and in a shorter time.

A clinical comparative study of dual LVIS devices and single flow diversion stenting for the treatment of unruptured V3-V4 vertebral artery dissection.

This study aims to compare the efficacy and safety of using overlapping low-profile visualized intraluminal support (LVIS) devices and flow diversion (FD) for the treatment of unruptured vertebral artery dissection (VAD) in the V3-V4 segments. The clinical and imaging data of 71 patients with unruptured VAD in the V3-V4 segments who underwent either dual LVIS stenting (d-LVIS group) or single FD stenting (FD group) at our center from September 2014 to December 2021 were retrospectively analyzed. Immediate postoperative angiography revealed no significant difference in the degree of occlusion between the two groups in treating vertebral artery dissecting aneurysms (with or without noncompact coiling). However, the d-LVIS group had significantly higher fluoroscopy exposure time and total radiation exposure dose compared to the FD group. During the perioperative period, two cases of pontine infarction and one case of acute thrombosis were encountered. One patient died from subarachnoid hemorrhage during the follow-up period. For dissecting the aneurysm, angiographic follow-up (8.56 ± 1.96 months) showed similar healing outcomes between the two groups (with or without noncompact coiling). However, seven patients (7/40, 17.5%) showed poor healing and one patient showed mild in-stent stenosis. For simple dissection, angiographic follow-up (8.78 ± 1.83 months) showed patent lumens in both groups, with all dissections healing well, and two patients having mild in-stent stenosis. Both methods could effectively treat unruptured VAD in V3-V4 segments. Nevertheless, simple FD implantation is relatively easier to perform and involves lower radiation exposure.

EXPLORING CYTOLOGICAL ASPECTS OF SOCKET HEALING OPTIMIZATION AFTER ATYPICALREMOVAL OF THE THIRD LOWER MOLAR

This study aims to investigate the cytological characteristics of socket healing after atypical removal of the lower third molar, utilizing osteoplastic synthetic material in conjunction with platelet-rich gel and plasma enriched with thrombocyte factors, to enhance local osteogenesis. Materials and Methods For this comparative clinical study, smears of alveolar content were collected following atypical extraction of the lower third molar. Cell elements were quantified for cytological analysis. Data collection utilized a template developed in Microsoft Excel version 16.34. Statistical processing was performed using RStudio 2023.03.1 Build 446 (Posit Software, PBC). Smears were air-dried, fixed in a 1:1 mixture of alcohol and acetone for 5 minutes, stained first with May-Grünwald’s methylene blue (15 minutes), followed by Romanowsky-Giemsa’s azure-eosin stain (30 minutes). Smear images were captured with the Leica morpho densitometric complex: DM 1000 microscope, DFC-320 camera, images were obtained in jpg format at 400x magnification. Results The study encompassed 30 patients divided into control and experimental groups. Cytological analysis was conducted on the 2nd, 5th, and 10th days of post- operation. In both groups, on the 2nd day, alveolar smears showed the presence of erythrocytes (n = 6) and neutrophils (n = 2). On the 5th day, the experimental group exhibited neutrophils (n = 3) and abundant cocci microflora (n = 6). On the 10th day, epitheliocytes (n = 8) primarily indicated proliferation. Conclusions The obtained results underscore the effectiveness of employing osteoplastic synthetic material in combination with plateletrich gel and plasma enriched with thrombocyte factors for enhancing local osteogenesis following atypical removal of the third molar. This approach demonstrates significant elevation in epithelialization activity, fibroblastic activity, and other markers of the reparative process in comparison to the control group.