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Stomatitis clinical trials

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NCT ID: NCT01684566 Completed - Oral Mucositis Clinical Trials

A Comparative Investigation of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis

episil(R)
Start date: February 2013
Phase: N/A
Study type: Interventional

To compare the performance of standard of care (SOC) + episil® versus SOC alone on oral mucositis in patients receiving conditioning treatment for hematopoietic stem cell transplantation (HSCT). The primary variable will be the area under the curve (AUC) of oral mucositis scores defined by the World Health Organisation (WHO) oral toxicity scale assessed daily by the investigator over the 28-day study period.

NCT ID: NCT01668849 Completed - Clinical trials for Head and Neck Cancer

Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer

Start date: August 2, 2012
Phase: Phase 1
Study type: Interventional

This study will evaluate the ability of grape exosomes, given to the subject as grape powder, as an important anti-inflammatory agent to reduce the incidence of oral mucositis during radiation and chemotherapy treatment for head and neck tumors.

NCT ID: NCT01652625 Completed - Clinical trials for Recurrent Aphthous Stomatitis

Efficacy and Safety Study of Yunnan Baiyao on Minor Recurrent Aphthous Stomatitis

Start date: March 2010
Phase: Phase 2
Study type: Interventional

Recurrent aphthous stomatitis (RAS) is a common recurrent oral disorder with no curative treatment available to date. The challenge remains in patients that do develop drug resistance and/or secondary infection, although topical corticosteroids and antimicrobials are the first therapeutic choice. The aim of the study was to evaluate the efficacy and safety of an herbal extract of Yunnan Baiyao formulated in toothpaste as an alternative therapy for minor RAS. Yunnan Baiyao is a well-known traditional Chinese medicine, formulated in a powder or capsule form. It was initially and widely used in wounds for its anti-hemorrhagic hemostatic function, and further in gastrointestinal bleeding. Yunnan Baiyao powder has been generally applied on RAS among Chinese population. In this study, a randomized, double-blind, placebo-controlled clinical trial (from March 2010 to March 2011) was conducted on a cohort of 227 minor RAS patients. The toothpaste containing Yunnan Baiyao was used twice daily as part of the patient's routine oral hygiene for 5 days. An assessment of ulcerative size and pain was recorded on Day 0 (baseline), Day 3 and Day 5. Any noted adverse reactions were recorded.

NCT ID: NCT01643876 Completed - Denture Stomatitis Clinical Trials

The Effect of Palatal Brushing on Denture Stomatitis

Start date: July 2012
Phase: Phase 1
Study type: Interventional

Palatal brushing has several advantages including removal of debris and stimulation of blood flow and saliva, which may help to prevent or treat oral diseases, such as denture-related stomatitis in complete denture wearers. However, there is no previous clinical trial testing this effect. Therefore, the investigators goal is to evaluate whether palatal brushing may change the severity of denture stomatitis and counts of microbes on denture and palatal mucosa. After an initial exam and data collection, participants will receive instructions about palatal brushing and they will be assessed after 1 and 3 months. Collection of data will include patient-reported information, intraoral photographs and swabbing (for counting microbes). Tested Hypotheses: - There is no difference in the extent of palatal inflammation in edentulous patients with denture stomatitis before and after 3 months of palatal brushing. - There is no difference in the number of colony forming unit (CFU) of Candida isolated from palate and denture of patients affected by denture stomatitis before and after 3 months of palatal brushing.

NCT ID: NCT01545687 Withdrawn - Pain Clinical Trials

CD2 Lozenges in Preventing Acute Oral Mucositis in Patients With Head and Neck Cancer Receiving Radiotherapy and Chemotherapy

Start date: April 2012
Phase: Phase 3
Study type: Interventional

RATIONALE: Lactobacillus bevis CD2 lozenge may help prevent symptoms of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy. This therapy may improve the quality of life of patients with head and neck cancer. PURPOSE: This phase III trial studies how well Lactobacillus bevis CD2 lozenge prevents oral mucositis in patients with head and neck cancer who are being treated with cisplatin and radiation therapy. These results will be compared to results in patients using placebo lozenges.

NCT ID: NCT01501409 Completed - Clinical trials for Recurrent Aphthous Stomatitis

Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis

Start date: January 2010
Phase: N/A
Study type: Interventional

Sodium lauryl sulfate (SLS) is an anionic detergent that has been used as the major or sole surfactant in most dentifrices. But it is known to local irritating factor to oral mucosa and skin and results in many side effects. This study was to compare the effects of SLS-free dentifrice and SLS-containing dentifrice in patients with recurrent aphthous stomatitis (RAS).

NCT ID: NCT01480011 Completed - Oral Mucositis Clinical Trials

A Pilot Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation

Start date: November 2011
Phase: Phase 2
Study type: Interventional

Patients with various malignancies who are taken up for high dose chemotherapy followed by stem cell transplant (blood and marrow transplant) have very high chances of developing severe oral mucositis (between 95-100%). This mucositis not only causes significant morbidity but also hampers quality of life so much so that patients at times feel difficult to continue treatment. No definite treatment exists for prevention or treatment of oral mucositis in this group of patients. Though one study has suggested that use of IV palifermin (a keratinocyte growth factor) will reduce duration and severity. Palifermin is very expensive and not available in country. Recently the investigators have shown effectiveness of a probiotic Lactobacillus CD 2 in reducing incidence and severity of chemo-radiotherapy induced mucositis in head and neck squamous cell cancer patients. (Published online in European Journal of Cancer: http://dx.doi.org/10.1016/j.ejca.2011.06.010). No significant toxicity has been reported with its use. Now, the investigators want to study the efficacy of this drug to reduce severity of mucositis in patients undergoing hematopoietic stem cell transplantation. The drug will be supplied by CD Pharma India Private Limited. The investigators further give undertaking that study will be carried as per good clinical practices (GCP) and declaration of Helsinki.

NCT ID: NCT01465308 Completed - Clinical trials for Head and Neck Cancer

The Effect of Honey on Xerostomia and Oral Mucositis

AC-H
Start date: August 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the use of pure honey will help in the treatment of radiation induced xerostomia and oral mucositis (symptom management)

NCT ID: NCT01439724 Completed - Clinical trials for Squamous Cell Carcinoma of Oropharynx

Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients

Start date: June 2007
Phase: Phase 3
Study type: Interventional

Oral mucositis remains a limiting factor in in head and neck squamous cell carcinomas patients treated with chemoradiation leading to pain, dysphagia, and weight loss. Low-level laser therapy emerges as a promising, preventive therapy of chemoradiation-induced OM. This study was designed to assess the efficacy of Low Level Laser Therapy (LLLT) in reducing the incidence and/or severity of oral mucositis.

NCT ID: NCT01431729 Completed - Oral Mucositis Clinical Trials

Honey and a Mixture of Honey, Beeswax and Olive Oil-propolis Extract in Treatment of Chemotherapy-induced Oral Mucositis

Start date: June 2010
Phase: Phase 2
Study type: Observational

Although, oral mucositis has been studied for many years, no available treatment has been shown to be effective in preventing or treating mucositis. Based on the observations that honey and other products of honeybees have anti-inflammatory, anti-oxidant, anti-microbial and wound healing effects, the present study aims at evaluation of the effect of topical application of honey and a mixture of honey, beeswax and olive oil-propolis extract, as natural products, in treatment of chemotherapy-induced oral mucositis in children with acute lymphoblastic leukemia (ALL). This is a randomised controlled clinical trial in which eligible patients were randomly assigned into three equal treatment groups. Group 1 received 15 gm honey applied topically to the affected oral mucosa three times daily. Group 2 received 5 gm of a mixture of honey, olive oil-propolis extract and bees wax (HOPE) applied topically to the oral mucosa three times daily. Group 3 served as control and received a 7.5% benzocaine gel applied to the areas of ulcers three times daily.