Irbid

Researchers are studying the safety and effectiveness of long-acting antibodies given alone or in combinations to adults with moderately to severely active ulcerative colitis (UC). This Phase 2, multicenter platform trial aims to find treatments that can improve symptoms and induce remission in people diagnosed with UC for at least 3 months. The study includes participants with active disease confirmed by endoscopy and histology and with moderate to severe symptoms based on a scoring system. The trial has two parts. Part A is an open-label phase testing three different monotherapy drugs to assess safety and initial effectiveness. Part B will be a randomized, placebo-controlled phase where participants receive one of six interventions (three monotherapies or three combinations) or placebo to compare outcomes. Treatments involve intravenous (IV) induction followed by subcutaneous (SC) maintenance dosing. Different treatment arms may start and finish at varying times during the study. Participants will undergo endoscopy and histology to confirm disease activity at screening, with regular monitoring throughout the study. Researchers will evaluate changes in disease severity using the Robarts Histopathology Index and measure the percentage of participants achieving clinical remission by Week 12. Safety and efficacy will be closely followed during and after treatment. The total study duration depends on treatment arm timelines and follow-up requirements.

Researchers are evaluating the pharmacokinetics, efficacy, safety, and immune response of MB12, a proposed pembrolizumab biosimilar, compared to Keytruda® in patients with advanced stage IV non-squamous non-small cell lung cancer (NSCLC). This Phase 3, randomized, double-blind study involves patients who have not received prior systemic treatment for metastatic NSCLC and includes a range of international centers. The trial focuses on patients without EGFR activating mutations or ALK translocations and measures outcomes up to 24 weeks. Participants receive either MB12, EU-sourced Keytruda®, or US-sourced Keytruda®, each given as a 200 mg intravenous infusion every 3 weeks on Day 1. These immunotherapy drugs are combined with chemotherapy agents pemetrexed (500 mg/m2 IV every 3 weeks on Day 1) and either carboplatin (area under the curve 5 IV every 3 weeks on Day 1 for 4 cycles) or cisplatin (75 mg/m2 IV every 3 weeks on Day 1 for 4 cycles). The combination treatment is administered as a first-line therapy for metastatic NSCLC. During the study, patients are monitored for drug levels in the blood, treatment effectiveness, safety, and immune response. Regular assessments include imaging to measure tumor lesions using RECIST 1.1 criteria and evaluations of overall health and organ functions. The study aims to confirm that MB12 is similar to Keytruda® in how it is processed by the body and in its treatment results. Participants are followed for at least 24 weeks to collect data on these outcomes.

This research focuses on how well different types of composite dental restorations match the color of teeth after professional whitening. It compares a single-shade composite called Omnichroma with a conventional multi-shade nanohybrid composite, specifically in patients who have at least two anterior restorations. The study aims to evaluate the shade matching ability and patient and dentist satisfaction following bleaching, addressing challenges in maintaining aesthetic harmony without unnecessary replacement of restorations. Participants will receive in-office tooth whitening using a 40% hydrogen peroxide bleaching system. The study evaluates teeth restored with either the single-shade Omnichroma composite or the conventional multi-shade nanohybrid composite (Filtek Z350Xt). Shade measurements using a digital spectrophotometer will be taken before and after bleaching. Dentists blinded to the intervention will assess the color match between restorations and natural teeth, and patient satisfaction will be recorded two weeks post-bleaching. Throughout the one-year study, color measurements, patient satisfaction, and dentist satisfaction will be monitored. Evaluations include objective color readings and subjective assessments of color matching. Follow-up visits ensure monitoring of restoration color stability, and researchers will record any need for restoration replacement due to color mismatch. The study involves 240 teeth from patients meeting specific oral health and restoration criteria, with continuous assessment to gather comprehensive data on color matching after bleaching.

Researchers are studying how well single-shade resin-based composites (RBCs) match the color of natural teeth compared to conventional multi-shade composites in front tooth restorations. The study focuses on the effect called the chameleon effect, where the composite blends with the surrounding tooth color using special particles to mimic natural light and translucency. The goal is to compare color matching and satisfaction levels between the two materials, including patient and dentist perspectives. The trial involves 240 teeth divided between two groups. One group receives restorations using single-shade nanohybrid composite (Omnichroma), and the other group receives conventional multi-shade nanohybrid composite (filtek Z350Xt). Each patient will have at least one restoration from each group for balanced comparison. Satisfaction with the color match is assessed one week after treatment using a Visual Analogue Scale. The study uses a double-blind design so that both patients and clinicians do not know which material is used for each restoration. Participants will be monitored over one year, with color measurements taken using a digital spectrophotometer (VITA Easyshade V). Researchers will also evaluate patient satisfaction and dentist satisfaction regarding the color matching of the restorations. These assessments help determine how well the composites blend with natural teeth and the overall aesthetic success of the treatments.

Researchers are comparing two treatments for white spot lesions (WSLs) on teeth, which often develop during fixed orthodontic treatment and need to be treated before worsening. The study evaluates the color masking effects and mineral content changes of two materials: the resin infiltration material ICON and the bioactive glass adhesive HI-Bond universal. These materials are studied to see if there are differences in how well they restore the appearance and mineral makeup of affected teeth. The study includes 150 teeth, with 75 treated using ICON and 75 treated with the bioactive glass adhesive HI-Bond universal. The study uses a split mouth design, meaning each participant receives both treatments on different quadrants of their mouth. Treatments are applied according to the manufacturers' instructions. Mineral content in the lesions will be measured using Quantitative Light-induced Fluorescence (QLF) at baseline and again one month after treatment. Participants will have their white spot lesions tested before treatment and one month afterward to assess color masking and mineral content. The main outcomes measured are the color masking potential of each material over six months. The study will monitor the dental condition of participants' anterior and premolar teeth without previous restorations. The total participation duration is not explicitly stated but includes baseline and follow-up assessments within six months.

Researchers are evaluating the color stability and wear resistance of highly filled injectable flowable composite materials compared to preheated conventional resin composites used for anterior aesthetic restorations. This study is the first clinical trial assessing the in vivo performance of the injectable composite technique for resin composite veneers. The trial includes patients needing at least six anterior aesthetic restorations and aims to compare two different composite materials using this technique. The study is designed as a modified split-mouth randomized clinical trial with two groups. One group receives restorations with preheated conventional composite material (Estelite Sigma Quick), while the other group receives restorations with injectable flowable composite material (Estelite Flow Quick). Both treatments use the injectable resin technique. A total of 142 restorations will be applied, split evenly between the two groups, and treatments will be evaluated at baseline, six months, and one year after restoration. Participants will undergo assessments of color stability using a Vita classical shade guide and spectrophotometer, and wear resistance will be measured by comparing 3D laser scans of gypsum replicas over time. Clinical performance will be evaluated using established dental criteria (USPHS). The study involves multiple follow-up visits over the course of one year to monitor these outcomes and the overall performance of the composite veneers.

Complications like postoperative pain and delayed healing often occur after surgical removal of lower wisdom teeth. Researchers are evaluating how topical hyaluronic acid (HA), known for its anti-inflammatory and healing properties, affects postoperative pain and bone healing in extraction sockets. This prospective, randomized, controlled clinical trial uses a split-mouth design involving 20 patients with bilateral impacted mandibular third molars, comparing HA combined with a collagen sponge to a collagen sponge alone. In this study, each patient undergoes surgical extraction of both lower wisdom teeth by an experienced surgeon using standardized procedures and local anesthesia. One extraction site receives HA gel plus a collagen sponge, while the other site receives only a collagen sponge, with both sites closed by sutures. Postoperative pain is measured at 12 hours, day 3, and day 7 using a visual analog scale. Bone healing is assessed radiographically about eight weeks after extraction and histologically six weeks after extraction through core biopsies taken from both sites. Participants will attend follow-up visits for pain assessments, suture removal, and imaging. Histological samples are processed and analyzed to determine the percentage of new bone formed in the sockets. Researchers will compare pain scores and bone healing between the treated and control sites to evaluate the effect of topical HA. The total participation includes surgical treatment, monitoring during the first postoperative week, and assessments up to eight weeks after extraction.

Researchers are evaluating the effects of a bioactive glass desensitizer on reducing tooth sensitivity caused by in-office vital tooth bleaching. This randomized controlled clinical trial aims to compare the bioactive glass desensitizer with a fluoride gel and a placebo gel without desensitizing agents. The study also investigates how these treatments affect tooth shade after bleaching, testing the hypothesis that there will be no difference in sensitivity reduction and no impact on bleaching efficacy among the treatments. Participants will undergo two bleaching sessions spaced one week apart, using a 40% hydrogen peroxide gel applied three times for 20 minutes on upper front teeth. Before bleaching, a lip and cheek retractor and a resin dam will protect the gums. Participants will be randomly assigned to receive one of three gels: the bioactive desensitizer, fluoride gel, or placebo gel. Each gel will be applied on the teeth for three minutes after bleaching. Teeth shade will be evaluated both subjectively with a shade guide and objectively with a spectrophotometer at baseline, immediately after bleaching, and on days 3, 7, and 14. A follow-up whitening for the lower arch is scheduled after 14 days. During the 14-day follow-up, participants will record their tooth sensitivity daily using a pain scale and note triggers such as hot or cold stimuli and duration of pain. Dental professionals will monitor tooth shade changes and sensitivity levels throughout the study. Protective eyewear and other safety measures will be used during bleaching. The total participation time includes the bleaching sessions and 14 days of sensitivity and shade monitoring.

Researchers are investigating diabetic foot ulcers (DFU) and related risk factors among adults with diabetes mellitus (DM) in Northern Jordan. The study aims to understand complications associated with DFU and assess how educational interventions might influence patient behavior and foot care practices. This research focuses on the impact of education on preventing and managing diabetic foot problems, a major cause of lower limb amputations in diabetic patients. The study has two phases. The first phase is a cross-sectional study involving 200 diabetic patients, including 94 with a history of diabetic foot ulcers, to collect demographic and clinical information related to DFU risks and complications. The second phase is a randomized clinical trial with 105 diabetic patients divided into two groups: one receiving standard care and the other receiving standard care plus formal educational sessions and ongoing foot care education through mobile health provided by a clinical pharmacist. Both groups' foot care behaviors and medication adherence are evaluated. Participants are assessed at the beginning and after 8 weeks of follow-up. Researchers measure the number of patients without diabetic foot ulcers, those with ulcers, and those receiving diabetic foot care education. The study also monitors changes in foot care practices and treatment adherence. Data analysis includes assessing factors linked to DFU and comparing behavioral changes between the control and intervention groups over the study period.

Researchers are evaluating the use of intraoperative ketamine to reduce shoulder pain following laparoscopic gastric sleeve surgery, a common procedure for managing obesity. Shoulder pain after laparoscopy, particularly in the left shoulder, is a frequent and often under-recognized problem caused mainly by irritation of the diaphragm and phrenic nerve during surgery. This early phase 1 study aims to compare an anesthetic plan that includes ketamine to one that does not, focusing on the incidence and severity of postoperative shoulder pain as well as other recovery outcomes. Participants will receive either an intravenous ketamine infusion during surgery at a dose of 0.3 mg/kg/hour or standard anesthetic management without ketamine. The study will monitor the effects of ketamine on shoulder pain and other postoperative factors. The treatment period is during the surgery, with follow-up assessments planned to evaluate pain and recovery over time. During the study, participants will be assessed for shoulder pain intensity using standard pain scales over six months. Researchers will also track the duration of recovery, length of hospital stay, postoperative pain medication use, side effects related to ketamine, and the occurrence of nausea and vomiting. This comprehensive monitoring will help determine the potential benefits and safety of ketamine in reducing post-laparoscopic shoulder pain in adults aged 18 to 60 years.