Dry Mouth (Xerostomia)

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjögren's Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Researchers are studying the safety, tolerability, how the body processes, and immune response to XmAb657 in healthy adults and adults with autoimmune diseases such as Idiopathic Inflammatory Myopathies, Systemic Sclerosis, and Sjogren's Disease. This is a Phase 1, first-in-human, open-label clinical trial evaluating the effects of XmAb657 given by injection under the skin. The study aims to better understand the potential effects of XmAb657 in these populations. Participants will receive XmAb657 as a subcutaneous injection in a dose-escalation format. The study includes healthy adults and adults diagnosed with specific autoimmune diseases based on established classification criteria. The treatment is administered under medical supervision, and dosing levels may increase over time to monitor safety and immune responses. During the study, participants will be monitored for any side effects or adverse reactions, including serious or treatment-emergent events, through week 52. Blood samples will be collected to measure the levels of XmAb657 and assess its effects on the immune system. The study involves regular visits for safety assessments and pharmacokinetic and pharmacodynamic evaluations. Participants may be involved for up to a year to ensure thorough monitoring.

This research aims to evaluate the safety and effectiveness of a topical treatment called recombinant human proteoglycan 4 (rhPRG4) in people with Sjögren's related Dry Eye Disease. The study is a phase II, prospective, randomized, and double-masked trial conducted across multiple centers in Australia. It focuses on improving symptoms and healing the eye surface in adults diagnosed with Sjögren's Syndrome who experience dry eye symptoms. Participants will be randomly assigned to receive either rhPRG4 at a concentration of 450 micrograms per milliliter or a placebo vehicle control. The treatment is applied topically to the eyes, and the study lasts 28 days. The trial compares the effects of rhPRG4 with the placebo to assess its impact on corneal damage and dry eye symptoms. During the study, participants will attend scheduled clinic visits where researchers will examine their eyes using fluorescein staining to measure corneal healing and perform other eye assessments such as slit lamp examination and intraocular pressure checks. Symptoms like dryness, burning, itching, and blurred vision will be recorded using questionnaires and visual scales. Safety will be closely monitored by observing any adverse events and changes in vision. The total study duration for each participant is 28 days from baseline to end of treatment.

This research aims to evaluate the effects of a commercially available oil rinse product called PerioPull™ on dental health markers in adults. The study focuses on people with dental health issues, such as deeper-than-normal gum pockets that may harbor infection and cause inflammation leading to periodontal disease. The trial is a 12-week pilot study designed to assess whether PerioPull™ can improve common, validated dental health measures used in clinical practice. Participants will use PerioPull™, a natural oil rinse containing ingredients like Medium Chain Triglycerides from coconut oil, Bixa orellana seed extract, natural mint flavor, bromelain, ubiquinone, and delta tocotrienols. They will swish approximately one teaspoon (5 mL) of the oil in their mouth for at least five minutes daily after brushing, then spit it out without rinsing. This routine will be maintained daily for 12 weeks. Throughout the study, participants will attend three dental visits at baseline, six weeks, and 12 weeks. During these visits, dental health will be assessed using measurements such as plaque index, gingival index, and pocket depth. Oral samples will be collected and analyzed in a laboratory to further evaluate outcomes. Additional assessments include intraoral photos and MyPerioPath® testing. These procedures align with standard dental exams and will help researchers monitor changes in dental health over the study period.

Researchers are evaluating spermidine as a potential way to prevent radiation-induced dry mouth (xerostomia) in patients undergoing radiotherapy for head and neck tumors, including nasopharyngeal carcinoma. This single-center, double-blind, randomized controlled trial compares spermidine capsules to placebo capsules to understand if spermidine can reduce this common side effect during treatment. Participants will take spermidine capsules or matching placebo capsules twice daily with meals, starting one week before radiotherapy or concurrent chemoradiotherapy and continuing until one week after completing radiotherapy. Both groups also receive routine health education, nursing care, and treatment as usual. The study maintains a quadruple-blind design to keep treatment assignments unknown. During the trial, radiation-induced xerostomia will be assessed weekly from the start of radiotherapy through three months after its completion, about 18 to 19 weeks in total. Additional measures include unstimulated salivary flow rates and quality of life questionnaires at several key time points. Participants will be monitored closely for treatment adherence and safety throughout the study period.

Researchers are evaluating CLN-978, a subcutaneously administered CD19-directed T cell engager, in patients with active, moderate to severe Sjogren's Disease. This phase 1b, open-label study aims to assess the safety and tolerability of CLN-978 as well as its effects on B lymphocyte levels in peripheral blood over a 48-week period. Participants will receive CLN-978 in dose escalation cohorts during the initial phase, followed by further evaluation of the treatment. The drug is administered at specified doses on specified days, with no placebo group. The study consists of two parts: Part A for dose escalation and Part B for further dose evaluation. Throughout the 48 weeks of the study, participants will undergo safety monitoring, pharmacokinetic assessments, and tests for anti-drug antibodies. Blood tests will measure changes in lymphocyte counts and B cell numbers. The study involves regular visits for these evaluations and monitoring of tolerability and immune response.

Researchers are evaluating the effects of RSLV-132 in adult females with Primary Sjögren Syndrome (pSS), a condition characterized by symptoms like fatigue, dryness, and pain. This Phase 2 clinical trial aims to determine if RSLV-132 improves these key symptoms, assess its safety, and study immune responses and blood levels of the drug over time. The study compares RSLV-132 to a placebo to understand its impact on symptom relief and safety in participants with moderate to severe symptom burden. Participants receive intravenous infusions of either 10 mg/kg RSLV-132 or a placebo solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155, covering a total of 22 weeks of treatment. This double-blind, randomized study includes regular clinic visits weekly for the first two weeks, then every two weeks until the end of treatment, with a final follow-up visit at Day 211. Each infusion and visit involves monitoring and assessments to track progress and responses. During the study, participants will record their symptoms daily using an electronic device and attend scheduled clinic visits for check-ups, tests, and questionnaires. Researchers will assess fatigue and tiredness, measure drug levels and immune responses in blood samples, and monitor for any adverse events throughout and after treatment. The main outcome focuses on the evaluation of key symptoms of Sjögren's disease, with safety and immune response also closely observed until Day 211.

Delirium is a clinical syndrome marked by sudden attention problems, changes in consciousness, and fluctuating thinking abilities. It often occurs in hospitalized elderly patients after surgery, especially in intensive care units, leading to worse recovery, higher death rates, longer hospital stays, and increased healthcare costs. This research investigates how oral health, particularly a condition called oral frailty, may be linked to postoperative delirium and cognitive decline in surgical patients. The study observes surgical patients who have or do not have oral frailty before elective cardiac or thoracic surgery requiring endotracheal intubation. Oral frailty is assessed using a specific scale before surgery. Participants are grouped based on the presence or absence of oral frailty to explore its relationship with delirium and other postoperative outcomes. Participants will be monitored for delirium within one week after surgery. Other evaluations include swallowing ability, appetite, and blood protein levels measured within 48 hours after removing the breathing tube, as well as routine postoperative blood tests during the first week. The study aims to understand connections between oral health and cognitive changes after surgery, potentially guiding future prevention strategies. Participation lasts throughout the perioperative and early postoperative period.

Researchers are investigating oral disorders in extremely premature infants born before 29 weeks, focusing on the age at which these infants achieve full oral feeding without the need for tube feeding. The study aims to understand the development of oral skills in this population, as oral disorders can lead to delayed feeding autonomy and longer hospital stays, impacting psychomotor and cognitive development. It also seeks to identify risk factors for delayed oral feeding and calculate the incidence of oral feeding disorders up to 24 months of age. The study monitors infants admitted to a neonatal unit where a daily tactile stimulation protocol of orality is applied by nurses and physiotherapists to support the development of oral skills. This protocol involves stroking cheeks and peri-oral and intra-oral areas to encourage oral feeding autonomy. The study is observational and focuses on infants born between 2018 and 2021 who received this care approach during their hospital stay. Participants will be followed from birth until they reach full oral feeding autonomy, with the main measurement being the corrected gestational age at this time, observed up to two months. Researchers will also analyze risk factors for delayed oral feeding and track oral feeding disorders over a longer term. Data collection includes monitoring feeding progress and hospital discharge details, with participant involvement ending when oral feeding autonomy is achieved or after 24 months for disorder incidence assessment.

Researchers are evaluating the effects of self-administered acupressure on xerostomia, or dry mouth, in patients with head and neck cancer. This randomized controlled trial aims to compare acupressure with oral health education to see which better relieves dry mouth symptoms. The study also looks at quality of life, symptom severity, patient expectations of acupressure, and how acceptable this therapy is for patients. Xerostomia is common and often underrecognized among these patients, usually caused by radiation and chemotherapy treatments affecting salivary glands.