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Xerostomia clinical trials

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NCT ID: NCT06392711 Not yet recruiting - Xerostomia Clinical Trials

Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia

Start date: May 2024
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to evaluate the safety and tolerability of injecting certain cells that you produce in your bone marrow called mesenchymal stromal cells (MSCs) into your salivary glands. The main question it aims to answer is whether injection of MSCs into your salivary glands results in any improvement in dry mouth. Participants will: - have bone marrow collected using a needle - undergo a salivary gland ultrasound - complete questionnaires - receive an injection of the bone marrow cells into a salivary gland

NCT ID: NCT06365047 Not yet recruiting - Xerostomia Clinical Trials

Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine

Start date: June 1, 2024
Phase: Phase 3
Study type: Interventional

This is a clinical investigation to measure the changes in the oral environment resulting from a 3 month exposure to an arginine containing toothpaste. This study is a double blind, randomized controlled, parallel design. Seventy (70) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following oral health evaluations, subjects will be assigned to the treatment schedule and receive their assigned study product.

NCT ID: NCT06313905 Not yet recruiting - Sjogren's Syndrome Clinical Trials

EVADRY® in the Treatment of Xerostomia in Sjögren's Syndrome

DRYLESS
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Xerostomia is a common and very bothersome manifestation that impairs the quality of life in Sjogren's syndrome. Symptomatic therapeutic alternatives for this syndrome are limited in Tunisia. We resort to bromhexine off-label with low efficacy. The aim of this work is to demonstrate the superiority of a treatment based on dietary supplements (EVADRY) vs placebo in the treatment of xerostomia. This is a double-blind randomized clinical trial with 2 arms: an EVADRY arm (n=90) and a placebo arm (n=90). The primary outcome measure is a 35% increase in salivary flow after 3 months. Secondary outcome measures were based on the Oral Health Impact Profile questionnaire, Xerostomia Inventory, the HAD depression scale, and the buccal Schirmer test.

NCT ID: NCT06276946 Not yet recruiting - Clinical trials for Head and Neck Cancer

Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia

Start date: May 8, 2024
Phase: N/A
Study type: Interventional

Radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment. This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering.

NCT ID: NCT06201923 Not yet recruiting - Xerostomia Clinical Trials

The Efficacy of Thyme Honey Mouth Rinse on Polypharmacy-induced Xerostomia

Start date: January 2024
Phase: Phase 4
Study type: Interventional

The study is designed to evaluate the clinical efficacy of thyme honey as a mouth rinse in the management of polypharmacy-induced xerostomia concerning the unstimulated whole salivary flow rate and quality of life of patients along with a biochemical assessment of salivary nitric oxide levels.

NCT ID: NCT06012604 Not yet recruiting - Clinical trials for Xerostomia Following Radiotherapy

Treatment of Post-radiation Xerostomia With Allogeneic Mesenchymal Stromal Stem Cells

Start date: September 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to learn about toxicity of allogeneic mesenchymal stromal stem cells (MSC, derived from umbilical cord tissue) treatment in head and neck cancer patients with for post-radiation xerostomia. The main question it aims to answer is the toxicity of intervention and the secondary objective is to assess preliminary efficacy. Participants will receive MSC in both parotid and submandibular glands: the toxicity of the intervention will be assessed using CTCAE v5.0 and its effect will be evaluated through measuring salivary flow and composition, radiologically (ultrasonography, magnetic resonance imaging), with scintigraphy and questionnaires. In the control group, salivary gland function (salivary flow and saliva composition) will be assessed for comparison with the intervention group.

NCT ID: NCT05872464 Not yet recruiting - Xerostomia Clinical Trials

Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

The objectives of this study are to evaluate efficacy and safety of artificial saliva containing cumin and ginger extract in head and neck cancer patients with xerostomia.

NCT ID: NCT05857358 Not yet recruiting - Xerostomia Clinical Trials

Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia

XEROCELL
Start date: January 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The main objective of this study is to evaluate the tolerance and safety of autologous adipose-derived stromal vascular fraction injected in accessory salivary glands for treatment of autoimmune xerostomia in terms of adverse reactions through day 14 (D14).

NCT ID: NCT05506137 Not yet recruiting - Xerostomia Clinical Trials

Xerostomia in Patients With a Life-limiting Condition or Frailty

Start date: January 2023
Phase: Phase 3
Study type: Interventional

Xerostomia, the subjective feeling of dry mouth, is a common symptom during the last year of life in patients with a life-limiting condition or frailty. Xerostomia leads to functional alterations (such as burning sensations, an altered taste perception, and difficulties with chewing, swallowing, and speaking), has disabling social consequences and significantly downgrades the perceived quality of life. It is an under-exposed and under-treated symptom often caused by alterations in the quality and quantity of saliva. Locally administered pilocarpine could be a promising drug in this regard as it alleviates xerostomia by increasing the production of saliva.

NCT ID: NCT05289375 Not yet recruiting - Clinical trials for Microbial Colonization

Efficacy of the Vacucis Candida® Autovaccine

Start date: April 30, 2024
Phase: N/A
Study type: Interventional

Introduction: Oral candidiasis is an infectious disease caused by the growth of Candida colonies and their penetration into oral tissues when physical barriers and host defenses are weakened. It constitutes one of the most common pathologies within the field covered by Dentistry. Candida infections are found in at least 80% of AIDS patients and in a third of HIV infection cases. Systemic diseases such as diabetes and a wide pharmacological arsenal to which the general population is subjected, are other causes of the increase in the prevalence of this disease. In addition, the high prevalence of oral sequelae (hyposialia) in the population over 65 years of age, due to the specific characteristics of this age group, such as multiple pathologies and drug use, explains the presence of this disease in this segment. of the population One of the great difficulties for the study of this disease is the diversity of predisposing factors, which do nothing but throw greater confusion into the results of the different works. Objective: To evaluate the reduction/suppression of signs and symptoms of oral candidiasis in patients treated with head and neck RT, users of Vacucis or Placebo. Material and method: Patients will receive information regarding the trial and, if they meet the inclusion criteria and agree to participate in it, they will sign the informed consent. All patients will be informed following the usual care practice of the characteristics of their candidiasis infection as well as the possibilities and alternatives of treatment and their respective efficacy. A descriptive analysis of the sample in terms of prevalence will be carried out. Categorical variables will be described as frequency and percentage and continuous variables as mean and standard deviation or median and interquartile range depending on their adjustment to normality, which will be calculated with the Kolmogorov-Smirnov test. To study the effect of the vaccine on the evolution of candidiasis, the Chi-square test, Student's t test or the non-parametric Mann-Whitney test will be used. The association of prevalence with CFU in both groups will be analyzed using the ANOVA test. Those values of p < 0.05 will be considered significant.