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Mucositis clinical trials

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NCT ID: NCT03400475 Completed - Clinical trials for Peri-implant Mucositis

Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis

Start date: April 23, 2015
Phase: Phase 2
Study type: Interventional

This study seeks to test the recently discovered anti-inflammatory action of statins on inflamed mucosa surrounding dental implants. Hypothesis: The application of 1.2% simvastatin gel will decrease peri-implant inflammation. The pilot study will involve 44 subjects divided into a test and control group. The test group shall receive topical simvastatin gel administered around the implant with a blunt tipped needle. The control group will receive a placebo. Inflammatory state shall be determined at baseline as well as follow up visits at 24 hours, 1 week, and 1 month by clinical indices of inflammation as well as biochemical markers of inflammation gathered from around the implants.

NCT ID: NCT03399331 Recruiting - Leukemia Clinical Trials

Honey or Olive Oil for Treating Oral Mucositis in Children and Adults With Leukemia Receiving Intensive Chemotherapy

Start date: July 10, 2017
Phase: Phase 1
Study type: Interventional

Background: Oral mucositis (OM) is a significant complication occurring in approximately 40% of patients on chemotherapy regimens. Ulcerative lesions of OM can be very painful, with negative impact on diet, oral hygiene, and quality of life. Although a wide variety of agents have been tested to prevent OM or reduce its severity, none have provided conclusive evidence. Objectives of this study will be: to determine the efficacy of honey or olive oil on the severity and pain of OM compared to placebo (standard care) and, (2) to assess which of the two interventions is more beneficial. Research Questions: 1. Children/adults who receive honey (group 1) or olive oil (group 2) will have less severe OM compared to the control group (Severity is measured by recovery time from OM and is the primary outcome) 2. Children/adults who receive honey (group 1) OR Olive oil (group 2) will have less pain than the control group. (Severity of pain is the secondary outcome Methods: A randomized controlled study (RCT) will be used to evaluate the effect of topical application of honey or olive oil, in the treatment of chemotherapy-related OM in 60 participants with OM. The primary outcome will be the severity of mucositis, assessed by four trained nurses blinded to the study group using the scale presented by the World Health Organization (WHO). The secondary outcome will be pain also assessed by the four trained nurses on the visual analogue scale ort eh Wong Faces scale. The relevance of this study lies in the possibility of challenging nurses in regard to the problem of OM and in proving a possible herbal cure that may influence clinical practice. Data analysis: The characteristics of the three groups will be described using mean and SD, frequencies and percentages. Baseline differences between the two groups will be tested using ANOVA for continuous data, and the Chi-square for categorical data. Kruskall-Wallis (chi square) test will be used to find the association group assignment and WHO grades of OM and ANOVA and RANOVA tests will be used to find the association between group assignment and the pain scores. Bonferroni tests will be conducted to explore which of the three groups has the better outcomes.

NCT ID: NCT03387774 Not yet recruiting - Clinical trials for Oral Mucositis (Ulcerative) Due to Radiation

Safety and Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients

UTI-RTOM-NPC
Start date: January 1, 2018
Phase: Phase 3
Study type: Interventional

This is a phase 3, open-label, multicenter, randomized controlled phase III clinical trial. The purpose of this study is to evaluate the efficacy and safety of ulinastatin, a kind of protease inhibitor, in the treatment of radiation-induced acute oral mucositis in nasopharyngeal carcinoma(NPC) patients treated with concurrent chemoradiotherapy(CCRT). To Explore a new and efficient way to reduce the incidence and severity of radiation-induced acute oral mucositis.

NCT ID: NCT03359187 Recruiting - Clinical trials for Head and Neck Cancer

Prevention of Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy

Start date: February 2016
Phase: N/A
Study type: Interventional

Prevention of radiation-induced mucositis in patients with head and neck cancer treated with radiotherapy : A Double-blind Randomized Controlled Trial

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 Not yet recruiting - Mucositis Clinical Trials

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

PERIFLOW
Start date: December 31, 2017
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 Recruiting - Mucositis Clinical Trials

Impact of Oral Hygiene Gels on Peri-implant Mucositis

Start date: August 22, 2017
Phase: Phase 4
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 Recruiting - 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: July 25, 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 Recruiting - Oral Mucositis Clinical Trials

Determination of 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 radiation therapy (RT) 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.