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Stomatitis clinical trials

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NCT ID: NCT04915599 Completed - Oral Mucositis Clinical Trials

Feasibility and Patient Reported Tolerance of Cryotherapy With the Cooral ® Mouth Cooling Device [MCD) in Patients Undergoing Radiation Therapy

CooRay
Start date: June 22, 2021
Phase: N/A
Study type: Interventional

This study is to investigate the use of the Cooral ® standardized CyT device to achieve a constant and reproducible cooling of the oral mucosa to prevent OM in patients undergoing RT in the head and neck region.

NCT ID: NCT04911335 Completed - Oral Mucositis Clinical Trials

Propolis-based Product (FARINGEL PLUS) for Oral Mucositis in Palliative Care

FARINGEL-CP
Start date: July 13, 2021
Phase: Phase 2
Study type: Interventional

Oral health is crucial for palliative patients' quality of life. The evidence on effective interventions and measures of oral mucositis in palliative care is sparse. This is a single-center, prospective, uncontrolled open label Phase 2 non-profit study, aimed at evaluating a propolis-based product (FARINGEL PLUS) added to basic oral hygiene safety, acceptability and activity in preventing and treating oral mucositis in patients in palliative care. A two-step design was adopted according to Simon's Optimum approach, with an overall sample of 77 evaluable cases (step1_26 cases; step2_51 cases).

NCT ID: NCT04886011 Completed - Clinical trials for Antioxidative Stress

Camel Whey Protein Gel for the Treatment of Aphthous Ulcer

Start date: May 15, 2021
Phase: N/A
Study type: Interventional

Higher prevalence of recurrent aphthous ulcer in young adults and the severity decreased with increasing age. The etiology of aphthous ulcer remains unclear. Other possible factors include trauma, drug use, deficiency in vitamin B12, folic acid, iron, stress, hormonal changes and metabolic diseases. Many topical agents such as local and systemic an- tibiotics, local antiseptics, topical NSAIDs, and topical corticosteroids are generally prescribed for symptomatic relief. Several approved drug for- mulations such as pills, mouthwash, sprays and paste such as vitamin B12, chlorhexidine mouthwash, steroid lozenges and local anesthetics are primarily suggested for the treatment of aphthous ulcer. Camel whey protein gel was fabricated to get benefits of its antiinflammatory, immunomodulator, Antibacterial and antioxidant effects.

NCT ID: NCT04884464 Completed - Aphthous Stomatitis Clinical Trials

Hyaluronic Acid in Counteracting Aphthous Stomatitis

Start date: September 1, 2018
Phase:
Study type: Observational

Oral mucosal ulcers can determine a real worsening of the quality of life. Conventional therapy usually lasts not less than 2-3 weeks, and carries a high risk of serious side effects; furthermore, ulcers often recur. The use of hyaluronic acid applied as an adhesive gel over the lesions seems to have potential in terms of efficacy and the avoidance of side effects. Of course, hyaluronic acid-based formulations show different effects and tolerability. In this retrospective observational study, the results obtained using a hyaluronic-acid based medical device applied for 14 days to counteract ulcers in adults will be reported.

NCT ID: NCT04870060 Completed - Clinical trials for Oral Mucositis (Ulcerative)

Ability of Curcumin to Decrease Cytokines Involved in Mucositis in the Autologous Transplant

Start date: October 6, 2010
Phase: Phase 2
Study type: Interventional

Mucositis is a very common complication in bone marrow transplant setting. It is a result of injury to the gut caused by high dose chemotherapy. Currently there are no universal protocols that have been accepted as a standard to prevent and treat mucositis in the transplant setting. Post transplant upto 80% of patients suffer from a severe mucositis. Proinflammatory cytokines play a major role in the development of mucositis. Interventions that decrease the levels of these cytokines may be beneficial in preventing mucositis. This study is aimed at evaluating the role of curcumin in reducing cytokine levels and the incidence and duration of mucositis in patients undergoing autologous stem cell transplantation.

NCT ID: NCT04800549 Completed - Oral Mucositis Clinical Trials

Effect of Black Mulberry Lollipop on Prevention of Oral Mucositis in Children

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

THE EFFECT OF BLACK MULBERRY LOLLIPOP AND SODIUM BICARBONATE USED IN ORAL CARE ON PREVENTION OF ORAL MUCOSITIS AMONG CHILDREN RECEIVING CHEMOTHERAPY DUE TO CANCER

NCT ID: NCT04717765 Completed - Clinical trials for Head and Neck Cancer

Photobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention

Start date: February 10, 2021
Phase: N/A
Study type: Interventional

Introduction: There are several manifestations in the oral mucosa resulting from antineoplastic treatments by chemo (QT) or radiotherapy (RT). In this study we will collect the variables referring to oral mucositis (OM), radiodermatitis, osteonecrosis of the jaws (ONJ), hyposalivation and xerostomia, dysgeusia, pain, oral candidiasis (opportunistic infection), trismus, quality of life, oral hygiene. MO and hyposalivation, which are related to damage to the salivary glands, are the most common manifestations, and ONJ is the most difficult to treat. The dentist can play an important role in prevention and treatment these oral lesions, directly influencing the patient's quality of life and adherence to antineoplastic treatment. Objectives: The main objective is to evaluate the efficacy of the intervention, using LLL phototherapy and topical Vit E, in the OM. And the intervention through LLL phototherapy and LPRP in the ONJ. These interventions will be performed by dentists during antineoplastic medical treatment. Material and methods: clinical trial, randomized, with balanced randomization, single-blind (for the evaluator of the results) with 2 experimental arms and a control group, carried out in a single center. Group 1, intervention with LLL phototherapy, Group 2, intervention with application of topical Vit E and Group 3, mouthwash with 0.12% chlorhexidine (usual clinical information). 360 patients will participate in this study from the Units of Oncology Medicine, Radiotetaphic Medicine and Oral Medicine, Oral Surgery and Implantology at the University of Santiago de Compostela. The segment of the patients will be given, an initial visit and returns every day that hears the application of antineoplastic treatment for the group of LLL phototherapy, returns of 15 days, one month, three months, six months, nine months and one year. In these return visits, evaluations and questionnaires will be carried out regarding all the variables that we will collect. Predictable results: If the application of laser phototherapy or topical Vit E contributes to the cessation, reduction or improvement of the clinical evolution of the manifestation of oral lesions, these treatments could be immediately implemented in our Oral Medicine unit and could lay the foundations for its implementation in different public centers and private.

NCT ID: NCT04699487 Completed - Clinical trials for Head and Neck Cancer

Efficacy and Safety of CareMin650 for Prevention of Oral Mucositis in HNC Patients Starting Radiotherapy

PrOMiSE
Start date: May 10, 2021
Phase: N/A
Study type: Interventional

Oral mucositis (OM) can affect up to 90% of head and neck cancer (HNC) patients treated with radiation therapy (RT). The Mucositis Study Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) recommends the use of photobiomodulation (PBM) in the prevention of OM. PBM is the application of lasers or non-coherent light sources such as LEDs, to beneficially influence cellular metabolism. Even though PBM has proved its efficacy, this therapeutic option is currently limited by lack of standardization, accuracy and reproducibility. CareMin650 has been developed to overcome these issues, since it allows a reproducible delivery of light, independently of the operator. Additionally, it is easy to use and user-friendly. PrOMiSE is a prospective, interventional, one-group, open-label, multicentric, international study conducted in European sites, specialized in radio-oncology. Patients with head and neck cancer (HNC) starting RT and with no oral mucositis (OM) lesion at the time of inclusion, will be eligible. They will be treated by PBM using CareMin650 during the whole period of radiotherapy.

NCT ID: NCT04677062 Completed - Aphthous Stomatitis Clinical Trials

Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis

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

The aim of the study was to assess the safety, acceptability, and efficacy of product GV-328 for the treatment of childhood oral aphthous lesion.

NCT ID: NCT04595838 Completed - Oral Mucositis Clinical Trials

A Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis

Start date: August 31, 2020
Phase: N/A
Study type: Interventional

This study will compare the use of the Chemo MouthpieceTM device along with best supportive oral care to best supportive oral care alone to rate the effectiveness of Chemo MouthpieceTM in lessening symptoms associated with chemotherapy regimen known to place patients at risk for symptomatic mucositis and, of those, chemotherapy regimens for which ice-based cryotherapy has been demonstrated to have a favorable impact on oral mucositis symptom management. Subjects who are receiving standard chemotherapy regimens will be randomly assigned to receive either study device and oral care ingredients or oral care ingredients only. All subjects will complete daily diaries for the first 14 days of chemotherapy Cycles 1 and 2. Subjects who are assigned to the study device arm will use the device during their chemotherapy infusion in clinic and will continue to use the device at home ,at least twice daily, for the first six (6) days of chemotherapy Cycles 1 and 2. Prior to the first chemotherapy infusion in Cycle 3, all subjects in the study regardless of treatment assignment will have the option of using the Chemo MouthpieceTM for subsequent cycles.