Randomized Controlled Clinical Trials Research Articles

Efficacy of ultrasound guided caudal epidural steroid injection with or without ozone in patients with lumbosacral canal stenosis; a randomized clinical controlled trial

BackgroundLumbosacral canal stenosis is known as the most common cause of back surgery with several complications. Selecting a minimally invasive treatment with high efficacy in such patients is necessary. This study was designed to evaluate the effectiveness of ozone therapy in combination with caudal epidural steroid in patients with lumbar spinal stenosis.MethodsA double-blind randomized clinical trial was conducted on 50 patients with lumbar spinal stenosis allocated into two study groups. Under ultrasound guidance, the first group received 80 mg of triamcinolone hexavalent with 4 mL of Marcaine 0.5% and 6 mL of distilled water to the caudal epidural space. The second group received an injection similar to the first group, combined with 10 mL of ozone (O2-O3) gas at a concentration of 10 µg/cc. The patients were followed at baseline, one, and six months after injection with clinical outcomes measures using Visual Analog Scale (VAS), Walking Distance (WD) and Oswestry Disability Index (ODI).ResultsThe mean age of subjects, 30 males (60%) and 20 females (40%), was reported as 64.51 ± 7.19 years old. Reduction of pain intensity based on VAS score was statistically significant in both groups at follow-up periods (P < 0.001). The VAS changes in the first month and sixth months showed no significant difference between the two groups (P = 0.28 and P = 0.33, respectively). The improvement in disability index (ODI) in both types of treatment during follow-up was significant (P < 0.0001), and there was no difference between the two treatment groups in one month and six months (P = 0.48 and P = 0.88, respectively). As for walking distance, the improvement process with both types of treatment during follow-up periods was significant (P < 0.001). However, after one and six months of treatment, the rate of improvement in patients’ walking distance in the caudal epidural steroid injection plus ozone group was significantly higher than in the epidural steroid group (p = 0.026 and p = 0.017, respectively).ConclusionsIn this study, the results of VAS and ODI outcomes showed that caudal epidural steroid injection combined with ozone has no advantage over caudal epidural steroid injection alone. Interestingly, our results demonstrated that the group receiving caudal epidural steroid injection plus ozone scored significantly higher on the walking distance index than the group receiving caudal epidural steroid alone.Trial RegistrationIRCT IRCT20090704002117N2 (registration date: 07/08/2019).

Behavioral economics-based counseling and mobile phone text educational messages to strengthen family planning services in Jordan: a randomized control clinical trial

Behavioral economics-based counseling and mobile phone text educational messages to strengthen family planning services in Jordan: a randomized control clinical trial

Comparative Evaluation of the Effects of Low-Level Laser Therapy and Ozone Application on Wound Healing After Gingivectomy and Gingivoplasty: A Randomized Control Clinical Trial

AIM: The aim of this randomized controlled clinical trial was to clinically evaluate and compare the effect of ozonated water and Low level laser therapy (LLLT) on the early wound healing period of gingivectomy and gingivoplasty wounds by clinical analysis. Materials &amp; Methods: Forty-five patients were randomly allocated into 3 groups, test group 1 (ozone therapy n=15), test group 2 (LLLT application n=14) and control group (no treatment n=15). Ozone irrigation was done on the surgical site with a concentration of 4ppm for 5-10 minutes, LLLT application was performed with diode LASER (810 nm) immediately after the surgical therapy and on day 3, day 7, day 21. Wound surface area, wound healing index, quality of life, plaque index, sulcus bleeding index were investigated. Results: At day 21 statistically significant smaller wounds were observed in both ozone and LLLT groups compared to control group. However, intergroup comparison between the ozone and LLLT group did not show statistically significant difference in wound surface area evaluated by staining technique and image J analysis. The wound healing index, VAS score OHIP -14 questionnaire, analgesics consumed, plaque index, sulcus bleeding index showed a statistically significant reduction from baseline to day 21in all groups. Conclusion: Ozone therapy is safe and effective in promoting wound healing during the 1st 3 weeks post-surgery. Ozone therapy and LLLT application enhanced wound healing after gingivectomy and gingivoplasty procedures, accompanied by better quality of life and reduced pain .

Tapentadol Nasal Spray is an Effective Way of Pain Management after Tooth Extraction: A Randomized Control Clinical Trial

Background: Tapentadol nasal spray (Tapease NS) application is a novel method of pain management attributable to its action on higher centers for pain management in contrast to non-steroidal analgesics. The study aims to compare the efficacy of post-extraction pain control between Tapentadol nasal spray and oral administration of Diclofenac (50mg tablet).&#x0D; Methodology: Fifteen subjects (30 sides) between the age group of 18-50 years with bilateral extraction of teeth were randomly selected for the study. Tapentadol nasal spray [22.5mg x 2=45mg] was administered on the right side every 8 hourly. The second extraction was done after 7 days on the left side and administered Diclofenac tablet at eight hourly intervals. Both groups received the therapy drugs for 3 days and the pain was assessed using the pain analog scale in both cases.&#x0D; Results: The subjects administered with Tapentadol nasal spray did not experience any pain and controlled group receiving the Diclofenac tablet experienced pain and were administered with rescue analgesics.&#x0D; Conclusion: Tapentadol nasal spray demonstrated a favorable outcome compared to the Diclofenac tablet in managing post-extraction pain. Hence, the proposed Tapentadol nasal spray is an optimal choice of analgesia recommended over other forms of oral analgesia post-extraction determined through thorough evaluations and approved questionnaires received from patients.

Hellenic Headache Society Recommendations for the Use of Monoclonal Antibodies Targeting the Calcitonin Gene-Related Peptide Pathway for the Prevention of Migraine and Cluster Headache—2023 Update

The confirmed involvement of the neuropeptide calcitonin gene-related peptide (CGRP) in the pathophysiology of migraine has led to the development of treatments, which for the first time are specific to migraine and mechanism based, in contrast to repurposed traditional prophylactic anti-migraine medications. Thus, in the last 5 years, the European Medicines Agency (EMA) approved four monoclonal antibodies that target either the CGRP ligand (eptinezumab, fremanezumab, and galcanezumab) or the CGRP receptor (erenumab). These anti-CGRP therapies are indicated for use in people with migraine who have more than 4 migraine days per month. In this consensus article, the Hellenic Headache Society highlights the indications and treatment protocols of these novel anti-migraine therapies, aiming to assist Greek neurologists in the optimal management of people with migraine. The recommendations are based on data from phase 3 randomized-controlled clinical trials, the recent European Headache Federation (EHF) recommendations, a consensus article under the auspices of both the EHF and the European Academy of Neurology (EAN), recent real-world evidence studies, and the authors’ acquired clinical experience.

Efficacy of High Dilution Medicines in combination with physiotherapy in trauma induced low back pain- A Randomized Control Clinical Trial

Background: Lower back pain can refer to a wide range of back injuries or conditions and is one of the most common musculoskeletal disorders which necessitating health care and one of the reason for which many seek a family physician which is cause for limited range of motion. Homoeopathic medicines can offer long term relief from the backache. Methods: This is a three arm randomized controlled trial. Total 30 patients with trauma-induced low backache were chosen at random and divided equally into three study groups. Group A (n=10) was given Arnica 200 twice a day for the first 15 days, after 15 days, another evaluation was performed, and the dose was repeated as needed. Group B (n=10) received constitutional medicine. The dose of constitutional medicine was repeated as needed. After careful case taking, case working, and repertorisation, Bryonia Alba Linn., Rhus Toxicodendron Linn., Nux Vomica Linn. were administered on a constitutional basis. Group C (n=10) received a placebo. All the three groups received physiotherapy to strengthen back muscles in order to reduce the likelihood of recurrenceData was anlaysed using STATA software using Chi square test, ANOVA and post-hoc Bonferroni Multiple comparison test. Results- Significant improvement in pain scores (VAS) was observed in both between the group and within the group comparisons and the effect was more pronounced in Group B. Conclusion: Hence we conclude that an individualized approach is more effective in the management of patients with trauma-induced low back pain.

Cryoanesthesia with ethyl chloride spray versus 5% lidocaine gel in alleviating oral local anesthetic injection pain for buccal anaesthesia: A randomized clinical (controlled) trial.

Numbing the area of oral mucosa with cold application prior to administration of regional anesthesia has been widely used by various dentists in alleviating pain caused by needle prick. Cryoanesthesia using Endo-ice as topical anesthesia has been studied as a replacement to prevail the fallibility of topical anaesthetics. This study aimed to evaluate and compare effectiveness of ethyl chloride spray with 5% lidocaine gel in alleviating buccal anesthesia injection pain. Total of 90 outpatients were randomly divided into 3 groups as follows: Group 1 - cryotherapy with ethyl chloride at the anesthetic site preceding before administration of local anesthesia; Group 2 - topical application of 5% LIDOCAINE GEL preceding before administration of local anesthesia; and group 3 - control that did not receive any topical agent preceding before administration of local anesthesia. Visual analogue scale (VAS) was used to document pain immediately after injection prick. About comparison of pain scores, significant difference was found between group 1 (ethyl chloride) and group 2 (topical lidocaine) patients (P=0.001). For group 1, about 15 (50%) patients suffered from mild pain, followed by 14 (46.67%) patients suffering from moderate pain. However, majority of the 21 (70%) patients in group 2 suffered from moderate pain. All the patients in group 3 suffered from severe pain. Importance of alleviating fear of needle injection phobia amongst patients is of paramount importance. Ethyl chloride was found to be more effective than topical lidocaine in alleviating needle injection pain before administration of local anesthetic injection.

Topical administration of tacrolimus and systemic corticosteroids in treatment of oral and nasal mucous membrane pemphigoid in a sample of Egyptian population: A randomized control Clinical trial

Topical administration of tacrolimus and systemic corticosteroids in treatment of oral and nasal mucous membrane pemphigoid in a sample of Egyptian population: A randomized control Clinical trial

Comparative evaluation of conventional and diode laser-assisted gingival curettage in shallow suprabony periodontal pocket – Three months follow-up of a randomized clinical trial

Background: Chronic periodontitis is one of the most common forms of periodontal disease in adults. The primary goal of periodontal therapy is to remove dental plaque and bacteria to restore and maintain gingival tissue health. Subgingival scaling, root planning, and curettages are aimed at removing dental plaque, calculus, and necrotic cementum. Aim and Objectives: The main aim of our present randomized control clinical trial was to evaluate the clinical effectiveness of diode lasers compared to conventional curettage using hand instruments in patients with chronic periodontitis having shallow suprabony pockets. In addition, the pain sensation during conventional and laser-assisted curettage was compared during the procedure using Visual Analog Scale. Materials and method: Subjects with shallow pockets were divided into two groups and treated with either conventional curettage (Control group) with hand instrument or with diode laser (Test group). The data obtained were fed into Microsoft Excel 2000 package, and statistical analysis was carried out using SPSS software version 20.0 for Windows. Results: The control group elicited a reduction in probing pocket depth (PPD) from baseline to 1 month after treatment (6.60 ± 0.99 vs. 3.87 ± 0.64, respectively), which was statistically significant (P &lt; 0.05). The 3-month postoperative scores had been reduced to 2.43 ± 0.50, which was also statistically significant (P &lt; 0.05). The reduction between the 1 and 3 months after treatment (3.87 ± 0.64 vs. 2.43 ± 0.46, respectively), was also statistically significant (P &lt; 0.05). The test group elicited a reduction in PPD from baseline to 1 month after treatment (6.80 ± 0.86 vs. 4.00 ± 0.76, respectively), which was statistically significant (P &lt; 0.05). The 3-month postoperative scores had been reduced to 3.53 ± 0.48, which was also statistically significant (P &lt; 0.05). There was a marginal reduction of postoperative scores between the 1 and 3 months after treatment (4.00 ± 0.76 vs. 3.53 ± 0.48, respectively), which was nonsignificant (P = 0.53). The mean PPD at baseline between Control group versus Test group (6.60 ± 0.99 vs. 6.80 ± 0.86, respectively) was nonsignificant (P = 0.56). The PPD at 1 month also revealed nonsignificant reduction, i.e. Control group versus Test group (3.87 ± 0.64 vs. 4.00 ± 0.76, P = 0.60). The postoperative reduction of PPD at 3 months was statistically significant (P &lt; 0.05), i.e. Control group versus Test group (2.43 ± 0.46 vs. 3.53 ± 0.48). Conclusion: Within the limit of our study, it can be proved that both hand instrument-guided curettage and laser-assisted curettage can effectively reduce shallow pockets to a healthy gingival sulcus.

MP13-07 AQUABLATION THERAPY ® VS TRANSURETHRAL RESECTION OF THE PROSTATE: 5-YEAR OUTCOMES OF THE WATER RANDOMIZED CLINICAL TRIAL FOR MEDIUM-SIZED PROSTATES

You have accessJournal of UrologyCME1 Apr 2023MP13-07 AQUABLATION THERAPY® VS TRANSURETHRAL RESECTION OF THE PROSTATE: 5-YEAR OUTCOMES OF THE WATER RANDOMIZED CLINICAL TRIAL FOR MEDIUM-SIZED PROSTATES Kussil Oumedjbeur, Ahmed Ibrahim, Imad Matta, David-Dan Nguyen, Adel Arezki, Iman Sadri, David Bouhadana, Tawfik Elsherbini, Peter Gilling, Neil Barber, Mihir Desai, Alexis E. Te, Claus G. Roehrborn, and Kevin C. Zorn Kussil OumedjbeurKussil Oumedjbeur More articles by this author , Ahmed IbrahimAhmed Ibrahim More articles by this author , Imad MattaImad Matta More articles by this author , David-Dan NguyenDavid-Dan Nguyen More articles by this author , Adel ArezkiAdel Arezki More articles by this author , Iman SadriIman Sadri More articles by this author , David BouhadanaDavid Bouhadana More articles by this author , Tawfik ElsherbiniTawfik Elsherbini More articles by this author , Peter GillingPeter Gilling More articles by this author , Neil BarberNeil Barber More articles by this author , Mihir DesaiMihir Desai More articles by this author , Alexis E. TeAlexis E. Te More articles by this author , Claus G. RoehrbornClaus G. Roehrborn More articles by this author , and Kevin C. ZornKevin C. Zorn More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003233.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The WATER trial previously introduced Aquablation® as a safe and effective TURP alternative in the management of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) for prostates <80 mL. To date, no long-term superiority endpoints have been reported for medium-sized prostates. In this subset analysis of the WATER cohort, we aim to compare the 5-year efficacy and safety of Aquablation® vs. TURP for the management of 50-80 mL prostates. METHODS: WATER is a double-blinded, multicenter and prospective randomized-controlled clinical trial for prostates 30-80 mL. 96 men with prostates 50-80 mL randomized to either Aquablation Therapy® or TURP from the initial cohort were retained for the subset analysis. Men received follow-up at 1, 3, 6 and 12 months, then annually up to 5 years. The primary efficacy endpoint was reduction of IPSS at 5-year follow-up. The primary safety endpoint was the occurrence of Clavien-Dindo postoperative complications grade 1 persistent (CD1P) and grade 2 (CD2) or higher at 6 months. Other measures included QoL, Qmax, PVR and MSHQ-EjD. RESULTS: Both study groups had comparable baseline voiding parameters and clinical demographics. Overall reduction in IPSS score was significantly higher in the Aquablation group across 5 years of follow-up (-14.1 vs. -10.8, p=0.02). Changes in QoL, Qmax and PVR were similar across groups (p>0.05). The Aquablation group displayed no changes in MSHQ-EjD score, while TURP yielded poorer questionnaire scores across all follow-ups (0.6 vs -2.1, p=0.01). The Aquablation group achieved a significantly lower rate of CD1P and CD2 or higher events at 6 months (RD=-23.1%; 95% CI [-29.9, -15.5], p=0.018). Among complications, post-operative ejaculatory dysfunction was notably lower in Aquablation® (RD=-21.9%; 95% CI [-32.5, -10.7], p=0.0005), while risk of bleeding was similar. The surgical and medical retreatment rate was also lower in Aquablation® (RD=-14.4%, 95% CI [-2.29, -30.4], p=0.015). CONCLUSIONS: Aquablation Therapy® yields better long-term efficacy and safety outcomes than TURP in the management of LUTS for prostate volumes of 50-80 mL within the WATER trial. This further supports adoption of Aquablation Therapy® over TURP for men with medium-sized prostates. Source of Funding: The trial is funded by PROCEPT BioRobotics. No funding was provided for the abstract creation © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e175 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kussil Oumedjbeur More articles by this author Ahmed Ibrahim More articles by this author Imad Matta More articles by this author David-Dan Nguyen More articles by this author Adel Arezki More articles by this author Iman Sadri More articles by this author David Bouhadana More articles by this author Tawfik Elsherbini More articles by this author Peter Gilling More articles by this author Neil Barber More articles by this author Mihir Desai More articles by this author Alexis E. Te More articles by this author Claus G. Roehrborn More articles by this author Kevin C. Zorn More articles by this author Expand All Advertisement PDF downloadLoading ...

Adverse cardiovascular effect following gonadotropin-releasing hormone antagonist versus GnRH agonist for prostate cancer treatment: A systematic review and meta-analysis.

Androgen deprivation therapy is the mainstay of medical treatment for prostate cancer (Pca); however, it is associated with an increased risk of adverse cardiovascular (CV) events and death. To date, CV death has been the leading noncancer cause of death in Pca patients. Both GnRH antagonists (an emerging class of drugs) and GnRH agonists (most frequently prescribed) are efficacious against Pca. However, the adverse effects, especially the adverse CV effect between them remain unclear. Through a literature search using MEDLINE, EMBASE and the Cochrane Library, all available studies comparing the safety of CV risk between GnRH antagonists and GnRH agonists in Pca patients were extracted. Comparisons of outcomes of interest between these two classes of drugs were calculated using the risk ratio (RR). Subgroup analyses were performed depending on the study design and preexisting CV disease at baseline. Nine randomized controlled clinical trials (RCTs) and five real-world observational studies comprising 62160 Pca patients were included in our meta-analysis. Patients receiving GnRH antagonists experienced fewer CV events (RR: 0.66, 95% CI:0.53-0.82, P<0.001), CV death (RR:0.4, 95% CI: 0.24-0.67, P<0.001) and myocardial infarctions (RR: 0.71, 95% CI: 0.52-0.96, P=0.03). No difference was found in the incidence of stroke and heart failure. Moreover, GnRH antagonists were associated with fewer CV events in patients with preexisting CV disease but not in those without preexisting CV disease in the RCT series. GnRH antagonists appear to offer favorable safety in terms of adverse CV events and CV death compared with GnRH agonists among men diagnosed with Pca, especially those who had established CV disease at baseline. https://inplasy.com/inplasy-2023-2-0009/, identifier INPLASY202320009.

Endovascular Treatment for Acute Basilar Artery Occlusion: A Fragility Index Meta-Analysis

High-quality evidence regarding the use of endovascular treatment (EVT) in patients with acute basilar artery occlusion (BAO) has been provided by recently completed randomized controlled clinical trials (RCTs). We conducted a systematic review and meta-analysis including all available RCTs that investigated efficacy and safety of EVT in addition to best medical treatment (BMT) versus BMT alone for BAO. The random-effects model was used, while the fragility index (FI) was calculated for dichotomous outcomes of interest. Four RCTs were included comprising a total of 988 patients with acute BAO (mean age: 65.6 years, 70% men, median NIHSS: 24, 39% pretreatment with intravenous thrombolysis). EVT was related to higher likelihood of good functional outcome (RR: 1.54; 95% CI: 1.16-2.05; I2 = 60%), functional independence (RR: 1.83; 95% CI: 1.08-3.08; I2 = 79%) and reduced disability at 3 months (adjusted common OR: 1.96; 95% CI: 1.26-3.05; I2 = 59%) compared to BMT alone. Despite that EVT was associated with a higher risk for symptomatic intracranial hemorrhage (RR: 7.78; 95% CI: 2.36-25.61; I2 = 0%) and any intracranial hemorrhage (RR: 2.85; 95% CI: 1.50-5.44; I2 = 16%), mortality at 3 months was lower among patients that received EVT plus BMT versus BMT alone (RR: 0.76; 95% CI: 0.65-0.89; I2 = 0%). However, sufficient robustness was not evident in any of the reported associations (FI < 10) including the overall effect regarding the primary outcome. The former associations were predominantly driven by RCTs with recruitment limited in China. EVT combined with BMT is associated with a higher likelihood of achieving good functional outcomes and a lower risk of death at 3 months compared to BMT alone, despite the higher risk of sICH. An individual-patient data meta-analysis is warranted to uncover and adjust for potential sources of heterogeneity and to provide further insight.

Compare the Effect of Zinc–Probiotic versus Zinc Therapy in Acute Watery Diarrhea in Children

Background: Acute watery diarrhea still remains a major health problem among under 5 children worldwide. Apart from oral rehydration solution, continued feeding and oral zinc therapy the administration of adequate amounts of probiotics seems beneficial for acute diarrheal episodes in children in the developing world. Objective: To compare the efficacy of zinc-probiotic combination therapy versus zinc-only therapy in children with acute watery diarrhea. Materials and Methods: This was a hospital based randomized controlled clinical trial (RCT) conducted from July 2019 to June 2021 in the Department of Pediatrics, Khwaja Yunus Ali Medical College &amp; Hospital. Total 70 children aged 6 months to 5 years admitted in hospital with acute watery diarrhea (AWD) with severe dehydration or some dehydration with intractable vomiting were included in this study. Patients were equally divided into 2 groups. Group A received oral zinc sulfate 20 mg/day for 10 days combined with oral Bacillus clausii probiotic 4million spores/day for 5 days. Group B received only oral zinc sulfate at the same dosage as group A. We also studied the relationship between mother`s education, knowledge of ORS preparation and child’s feeding practices and nutritional status with the occurrence of diarrhea in children. Results: Frequency of diarrhoea was significantly higher in group B (Zinc only) in comparison to group A (Zinc and probiotic). Mean frequency of diarrhea, Mean duration of diarrhea and Mean length of hospital stay was significantly higher in group B (Zinc) than group A (Zinc+Probiotic). Conclusion: Compared to oral Zinc therapy only; the combination of oral zinc and probiotic therapy is clinically more effective in reducing the frequency of acute watery diarrhea in under 5 years children. KYAMC Journal Vol. 13, No. 04, January 2023: 218-222

Prevention of relapse in drug sensitive pulmonary tuberculosis patients with and without vitamin D3 supplementation: A double blinded randomized control clinical trial.

The immunomodulatory effects of vitamin D are widely recognized and a few studies have been conducted to determine its utility in the treatment of tuberculosis, with mixed results. This study was conducted to see if vitamin D supplementation in patients with active pulmonary tuberculosis (PTB) in the Indian population contributed to sputum smear and culture conversion as well as the prevention of relapse. This randomized double-blind placebo-controlled trial was conducted in three sites in India. HIV negative participants aged 15-60 years with sputum smear positive PTB were recruited according to the Revised National Tuberculosis Control Program guidelines and were randomly assigned (1:1) to receive standard anti-tubercular treatment (ATT) with either supplemental dose of oral vitamin D3 (60,000 IU/sachet weekly for first two months, fortnightly for next four months followed by monthly for the next 18 months) or placebo with same schedule. The primary outcome was relapse of PTB and secondary outcomes were time to conversion of sputum smear and sputum culture. A total of 846 participants were enrolled between February 1, 2017 to February 27, 2021, and randomly assigned to receive either 60,000 IU vitamin D3 (n = 424) or placebo (n = 422) along with standard ATT. Among the 697 who were cured of PTB, relapse occurred in 14 participants from the vitamin D group and 19 participants from the placebo group (hazard risk ratio 0.68, 95%CI 0.34 to 1.37, log rank p value 0.29). Similarly, no statistically significant difference was seen in time to sputum smear and sputum culture conversion between both groups. Five patients died each in vitamin D and placebo groups, but none of the deaths were attributable to the study intervention. Serum levels of vitamin D were significantly raised in the vitamin D group as compared to the placebo group, with other blood parameters not showing any significant difference between groups. The study reveals that vitamin D supplementation does not seem to have any beneficial effect in the treatment of PTB in terms to the prevention of relapse and time to sputum smear and culture conversion. CTRI/2021/02/030977 (ICMR, Clinical trial registry-India).

Comparative assessment of treatment efficiency and patient experience between Dental Monitoring and conventional monitoring of clear aligner therapy: A single-center randomized controlled trial

This 2-arm randomized controlled clinical trial (RCT) aimed to assess the effect of Dental Monitoring (DM) on the efficiency of clear aligner therapy (CAT) and patient experience compared with conventional monitoring (CM) used for regularly scheduled clinical appointments. Fifty-six patients with full permanent dentition treated with CAT participated in this RCT. Patients were recruited from a single private practice and treated by 1 experienced orthodontist. Randomization was performed with permutated blocks of 8 patients assigned to either a CM or DM group with allocations concealed in opaque, sealed envelopes. It was not feasible to blind subjects or investigators. The primary treatment efficiency outcome assessed was the number of appointments. Secondary outcomes included the time to reach the first refinement, the number of refinements, the total number of aligners, and treatment duration. The patient experience was assessed using a visual analog scale questionnaire administered at the end of CAT. No patients were lost to follow-up. There was no significant difference in the number of refinements (mean= 0.1; 95% confidence interval [CI], -0.2 to 0.5; P= 0.43) and the number of total aligners (median= 5; 95% CI, -1 to 13; P= 0.09). There was a significant difference in the number of appointments, with the DM group requiring 1.5 fewer visits (95% CI, -3.3, -0.7; p= 0.02) as well as overall treatment duration, with the DM group taking 1.9 months longer (95% CI, 0.0-3.6; P= 0.04). There was a difference between study groups regarding the importance of face-to-face appointments, with the DM group not perceiving face-to-face appointments as important (P= 0.03). DM with CAT resulted in 1.5 fewer clinical appointments and a longer treatment duration of 1.9 months. There were no significant intergroup differences in the number of refinements or total aligners. CM and DM groups had similarly high levels of satisfaction with CAT. The trial was registered at Australian New Zealand Clinical Trials Registry (ACTRN12620000475943). The protocol was published before trial commencement. This research did not receive any grant from funding agencies.

Effect of group education and person-centered support in primary health care on mental health and quality of life in women aged 45–60 years with symptoms commonly associated with stress: a randomized controlled trial

BackgroundMental illness and somatic symptoms are common causes of long-term sick leave for women during menopause, which usually occurs between the ages of 45 and 55. Many women experience a lack of knowledge about menopause and its associated symptoms. This study evaluates the effect of group education and person-centered individual support in primary health care (PHC) on mental health and quality of life for women in menopause with symptoms that are usually associated with stress.MethodsThe randomized controlled clinical trial (RCT) with a two-factor design was conducted in PHC in southwestern Sweden, from 2018 to 2019. A total of 370 women aged 45–60 were allocated in four groups: 1, group education (GE) 2, GE and person-centered individual support (PCS) 3, PCS and 4, control group. GE comprised four weekly sessions and PCS included five sessions with topics related to menopause. The effect of the interventions were followed up at 6 and 12 months. Linear and ordinal regression were used to analyse the effect of the intervention, either group education or person-centred individual support.ResultsThe main findings: Improved quality of life and physical, psychological, and urogenital symptoms. GE and PCS resulted in improvement of the quality of life at six months. At the 12-month follow-up these results were significantly strengthened for PCS and improved health-related quality of life, and reduced mental, urogenital, and stress-related symptoms with an effect lasting at least 12 months. These results suggest that this intervention could be an effective intervention in PHC for improving women’s health in menopause.ConclusionsPCS can be an effective intervention in PHC for improving women’s health in menopause and possibly also prevent the development of exhaustion syndrome.Trial registration: Universal trial number is U1111-1219-6542 and the registration number in ClinicalTrials.gov is NCT03663075, date of registration 10/09/2018.

Dietary and Nutraceutical Interventions as an Adjunct to Non-Surgical Periodontal Therapy-A Systematic Review.

The aim of this study was to conduct a systematic literature review on the influence of dietary and nutraceutical interventions as an adjunct to non-surgical periodontal therapy (NSPT). A literature search for randomized, controlled clinical trials (RCTs) was performed in PubMed, the Cochrane Library, and the Web of Science. Trial inclusion criteria included the application of a defined nutritional intervention (food, beverages, or supplements) adjunctive to NSPT compared to NSPT alone with at least one measured periodontal parameter (pocket probing depths (PPD) or clinical attachment level (CAL)). Of 462 search results, 20 clinical trials relating to periodontitis and nutritional interventions were identified, of which, in total, 14 studies could be included. Eleven studies examined supplements containing lycopene, folate, chicory extract, juice powder, micronutrients and plant extracts, omega-3 fatty acids, vitamin E, or vitamin D. Three studies examined food-based interventions (kiwifruit, green or oolong tea). Due to limited information on within-group differences in the studies, results were descriptively analyzed. A significant positive effect on periodontal parameters (PPD, bleeding on probing) was found for vitamin E, chicory extract, juice powder, green tea, and oolong tea. Heterogeneous effects were found for lycopene, folate, omega-3 fatty acids, and vitamin D. No effects on PPD were found for adjunct kiwifruit (in combination with NSPT). Risk of bias via RoB2 revealed a low risk of bias with some concerns. There was a high heterogeneity in the type of nutritional interventions. The adjunctive use of various supplements and green/oolong tea led to positive and significant effects of the nutritional interventions on clinical periodontal outcome parameters. In the context of non-surgical periodontal therapy, an adjunctive intake of micronutrients, omega-3 fatty acids, green/oolong tea, and polyphenols and flavonoids could be beneficial. Long-term clinical studies with full data reports (especially within-group differences) are needed for conducting a meta-analysis.

One-Year Review in Cardiac Arrest: The 2022 Randomized Controlled Trials.

Cardiac arrest, one of the leading causes of death, accounts for numerous clinical studies published each year. This review summarizes the findings of all the randomized controlled clinical trials (RCT) on cardiac arrest published in the year 2022. The RCTs are presented according to the following categories: out-of- and in-hospital cardiac arrest (OHCA, IHCA) and post-cardiac arrest care. Interestingly, more than 80% of the RCTs encompassed advanced life support and post-cardiac arrest care, while no studies focused on the treatment of IHCA, except for one that, however, explored the temperature control after resuscitation in this population. Surprisingly, 9 out of 11 RCTs led to neutral results demonstrating equivalency between the newly tested interventions compared to current practice. One trial was negative, showing that oxygen titration in the immediate pre-hospital post-resuscitation period decreased survival compared to a more liberal approach. One RCT was positive and introduced new defibrillation strategies for refractory cardiac arrest. Overall, data from the 2022 RCTs discussed here provide a solid basis to generate new hypotheses to be tested in future clinical studies.

Effects of tocopherol supplementation on endometrial thickness in subfertility patients

Background and Aim: Tocopherol is a vital nutrient for women during pregnancy, and multiple investigations revealed that a lack of tocopherol can cause preeclampsia, miscarriage, intrauterine growth restriction, and premature birth. There is scarcity of data regarding the effect of tocopherol on endometrial thickness. Therefore, the purpose of the present study was to assess the effect of tocopherol supplement on endometrial thickness. Methods: This randomized control clinical trial was conducted on 120 women with subfertility age group of 18 years to 37 years who visited the Obstetrics and Gynecology Department of Dr fida Painless Hospital Peshawar from January 2022 to June 2022. Patients were categorized into two groups: Group-I received Vit E supplements (800 IU) (n=60) and Group-II received placebo (n=60) for 12 weeks. The number of follicles and thickness of the endometrium were evaluated on ultrasound at day 2 and day 14. SPSS version 27 was used for data analysis. Results: The overall mean age of group I and II was 30.4±2.6 and 29.8±2.5 respectively. A significant difference was observed in mean endometrial thickness between groups I and II on day 2 (4.6 mm versus 3.3 mm) and day 14 (8.4 mm versus 5.8 mm) (P&lt;0.001).

The efficacy of implant surface decontamination using chemicals during surgical treatment of peri-implantitis: A systematic review and meta-analysis.

To answer the following PICOS question: "In adult patients with peri-implantitis, what is the efficacy of surgical therapy with chemical surface decontamination of implant surfaces in comparison with surgical therapy alone or surgery with placebo decontamination, on probing pocket depth (PD) reduction and bleeding on probing (BoP)/suppuration on probing (SoP), in randomized controlled clinical trials (RCTs) and non-RCTs with at least 6months of follow-up?" Six databases were searched from their inception up to 20 May 2022. Data on clinical outcome variables were pooled and analysed using mean differences (MDs), risk ratios (RRs), or risk differences (RDs) as appropriate, 95% confidence intervals (CIs), and prediction intervals (PIs) in the case of significant heterogeneity. Primary outcomes were determined as changes in PD and BoP/SoP. Secondary outcomes were radiographic marginal bone loss (MBL), implant loss, and disease resolution. PROSPERO registration number: CRD42022325603. Six RCTs-two with moderate, three with high, and one with low risk of bias (RoB)-were included. These studies test the adjunctive effect of photodynamic therapy (PDT), chlorhexidine (CHX), and administration of local antibiotics (LAbs) during surgery on the clinical outcome. In a single 12-month study, the adjunctive use of local antibiotics showed a clinically relevant reduction of PD [MD=1.44; 95%CI (0.40 to -2.48)] and MBL [MD=1.21; 95%CI (0.44-1.98); one trial, 32 participants]. PDT showed a small but significant reduction in BoP [MD=7.41%; 95%CI (0.81-14.00); p= 0.028; two trials; 42 participants]. Treatment with CHX resulted in no significant changes in PD, BoP, or MBL compared to placebo (saline solution). None of the interventions affected disease resolution and implant loss. Certainty of the evidence was very low for all outcome measures assessed. Within the limitations of this systematic review and the meta-analysis, adjunctive use of chemicals such as PDT, CHX, and LAbs for surface decontamination during surgery of peri-implantitis cannot be recommended as superior to standard debridement procedures (mechanical debridement with or without saline).