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Mucositis clinical trials

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NCT ID: NCT03348241 Completed - Clinical trials for Chemotherapy-induced Oral Mucositis

Using Gum Arabic for Cancer Patients to Protect From Oral Mucositis Caused by Chemotherapy: ِِِAn Experimental Study

Start date: October 26, 2015
Phase: Phase 2
Study type: Interventional

This study was designed to investigate the effect of Gum Arabic (GA) on cancer patients to prevent chemotherapy-induced oral mucositis. Cancer patients who will receive chemotherapy were divided into two groups; study "Gum Arabic" group (which received GA with chemotherapy) and control group (chemotherapy alone); and the participants were recruited to reach 190 patients in the study group and 184 patients in control group. This clinical trial was conducted in outpatient chemotherapy sections at Radiation and Isotopes Center of Khartoum. This study was designed to test the theory that say the chemotherapy-induced oral mucositis will significantly decrease after ingestion 30 grams as daily dose of Gum Arabic in a form of solution for six weeks during therapy.

NCT ID: NCT03348111 Withdrawn - Peri-Implantitis Clinical Trials

Establishing a New Protocol for Early Mucositis and Peri-implantitis Treatment Using an Air-polishing Device

PERIFLOW
Start date: June 2019
Phase: N/A
Study type: Interventional

Considering the frequent occurence of peri-implantitis and mucositis, a multiple of treatment alternatives have been proposed including non-surgical and surgical procedures. However, it seems that the most effective treatment remains prevention of these diseases. The aim of this study is to emphasize on mucositis and peri-implantitis prevention using an air abrasion device the Air-Flow Master Piezon® with erythritol and chlorhexidine powder in order to eliminate and / or disorganize the biofilm responsible for peri-implant mucosa inflammation.

NCT ID: NCT03243591 Completed - Mucositis Clinical Trials

Impact of Oral Hygiene Gels on Peri-implant Mucositis

Start date: August 22, 2017
Phase: N/A
Study type: Interventional

Peri-implant mucositis is abnormal inflammation occurring around dental implants, increasing the risk of loss of bone support. The purpose of this study is to evaluate the impact of brushing the bacterial biofilm at the implant-mucosa interface with one of two, commercially-available dental gels over a 30-day period on amounts of biofilm and indices of mucosal inflammation. Adult subjects (> 19 years old) will be invited to consent if they have at least one dental implant displaying mucositis defined as Gingivitis Index of 2 or greater, no dental treatment in the previous 30 days, capable of normal toothbrushing, and no Sjogrens disease, immunodeficiency, pregnancy, poorly-controlled diabetes, or regular systemic antibiotics, anti-inflammatory drugs or immune suppressants. Ten patients in each tooth gel group will be instructed to apply a pea size amount of dentifrice brushing the implant and mucosa 2 times daily for 30 days. Baseline and 30-day examinations will be conducted to record Gingivitis Index, Plaque Index, probing depths, clinical photo, crevicular fluid, and adverse events.

NCT ID: NCT03241407 Completed - Cigarette Smoking Clinical Trials

Triclosan Toothpaste as a Preventive Strategy of Mucositis in Smokers

Start date: July 1, 2013
Phase: N/A
Study type: Interventional

The purpose of this trial was to determine the effect of a triclosan-containing toothpaste in the clinical parameters and in the profile of osteo-immunoinflammatory mediators in the peri-implant crevicular fluid (PICF) as a preventive therapy of peri-implant experimental mucositis in cigarette smokers

NCT ID: NCT03237325 Completed - Oral Mucositis Clinical Trials

DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer

Start date: December 4, 2017
Phase: Phase 3
Study type: Interventional

To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer

NCT ID: NCT03234465 Terminated - Oral Mucositis Clinical Trials

Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day

Start date: July 18, 2017
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy, safety and tolerability of topically administered AG013 compared to placebo for reducing Oral Mucositis (OM) in patients undergoing chemoradiation for the treatment of head and neck cancer, as measured by the duration, time to development, and overall incidence of OM during the active treatment phase, beginning from the start of chemoradiation therapy (CRT) until 2 weeks following its completion. The effect of AG013 on patient-reported symptoms and analgesic use during the active treatment phase, and on the cumulative radiation dose administered before the onset of OM will also be evaluated, as will biomarkers and, in a subset of subjects, the PK (pharmacokinetic) profile of AG013.

NCT ID: NCT03233776 Completed - Multiple Myeloma Clinical Trials

Anakinra: Safety and Efficacy in the Management of Fever During Neutropenia and Mucositis in ASCT

AFFECT-1
Start date: August 21, 2017
Phase: Phase 2
Study type: Interventional

Oral and intestinal mucositis are major risk factors for the occurrence of fever during neutropenia and bloodstream infections after intensive chemo- and radiotherapy. These complications often require dose reductions or cause delay of treatment, and thereby interfere with optimal anticancer treatment. Currently, there are no effective strategies to prevent or treat mucositis and the related complications. The pro-inflammatory cytokine interleukin-1β (IL-1β) has shown pivotal in the pathogenesis of mucositis and recently, it has been established in murine models that IL-1 inhibition significantly ameliorates chemotherapy-induced intestinal mucositis. In this phase IIa study the safety, maximum tolerated dose and efficacy of anakinra, a recombinant human IL-1 receptor antagonist, will be determined in adult patients with multiple myeloma who receive high-dose melphalan (HDM) in the preparation for an autologous hematopoietic stem cell transplantation (ASCT) and are at high risk for experiencing mucositis and fever during neutropenia (FN). After establishing the optimal dose, a pivotal double-blind randomized placebo-controlled multicenter phase IIb trial will be planned to establish efficacy.

NCT ID: NCT03228147 Completed - Malignant Neoplasm Clinical Trials

Sensory Evaluation of Oral Nutrition Supplements in Patients at Risk for Mucositis Undergoing Cancer Treatment

Start date: July 25, 2017
Phase: N/A
Study type: Interventional

This pilot clinical trial studies sensory evaluation of oral nutrition supplements in patients at risk for mucositis undergoing cancer treatment. Sensory evaluation may help to obtain input about new oral nutritional supplements that may increase nutrient intake and maintain or improve nutritional status, functional capacity, and quality of life in cancer patients.

NCT ID: NCT03221790 Not yet recruiting - Clinical trials for Irritable Bowel Syndrome With Diarrhea

Effect of FODMAPs on Mucosal Inflammation in IBS Patients

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

OBJECTIVE: To gain mechanistic insights, we will compare effects of low fermentable oligosaccharides, disaccharides and monosaccharides and polyols (FODMAP) and high FODMAP diets on symptoms and colonic protease expression in patients with diarrhea predominant irritable bowel syndrome (IBS-D). We will measure how protease changes affect excitability of pain sensing neurons and correlate this with measurements of the metabolome and the microbiome. DESIGN: We aim to perform a single blind prospective study of patients with diarrhea predominant IBS (Rome IV criteria) who will sequentially consume a high and low FODMAP diets, each for 3 weeks. Symptoms will be assessed using the IBS symptom severity scoring (IBS-SSS). Electrophysiological studies of changes in mouse dorsal root ganglia neurons in response to colonic mucosal/lamina propria supernatants will be carried out. Protease antagonist will be used to specifically assess protease expression. The metabolome will be evaluated using metabolic profiling in urine using mass spectrometry. Stool microbiota composition will be analysed by 16S rRNA gene profiling. All the above testing will be performed at 4 time points: at baseline, 3 weeks following a run-in period, after a 3-week-long high FODMAP diet, and after a 3-week-long low FODMAP diet period. HYPOTHESIS: We anticipate that colonic tissue protease effects on the excitability of dorsal root ganglia (DRG) neurons will increase with a high FODMAP diet and decrease with a low FODMAP diet, but that this may not be found in all patients. The magnitude of the effect may vary and this variation could be due to differences in the individual patients microbiome.

NCT ID: NCT03203733 Completed - Cryotherapy Effect Clinical Trials

Cryoprotection of Chemotherapy-induced Oral Mucositis After Autologous Stem Cell Transplantation, a Randomized Study

Start date: June 12, 2017
Phase: N/A
Study type: Interventional

This study evaluates, among study patients with lymphoma or myeloma undergoing autologous SCT, whether cooling oral mucosa with a cooling device compared with ice cubes/crushed ice or ice pop succeeds in reducing the degree of oral mucositis (OM) according to the Oral Mucositis Assessment Scale (OMAS) total,degree of OM according to World Health Organisation (WHO), tolerability of either cooling method. The study is also aiming to , patients subjective experience of OM, rating of general quality of life and oral pain, number of days with total parenteral nutrition (TPN), number of hospital days, total dose of opioids, and C reactive protein during time in care. Finally, the study aims to evaluate weight loss, Leukocyte particle concentration, number of days until bone marrow response, S-albumin, and body temperature.