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โ† Trials
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Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis

RecruitingNAAges 18 Years - anyAllUniversity of Pavia
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In plain words

What the trial is, and whether it could suit you

Oral mucositis is a frequent and often debilitating complication of radiotherapy and chemotherapy, particularly in patients treated for head and neck cancers. It is characterized by inflammation and ulceration of the oral mucosa, leading to pain, difficulty swallowing, taste disturbances, dry mouth, and impairment of daily activities. In more severe cases, oral mucositis may require modification or temporary interruption of cancer treatment. This randomized controlled clinical trial is designed to assess the clinical effectiveness of gas ozone therapy in patients with radio- and chemotherapy-induced oral mucositis. In addition, the study will evaluate whether combining ozone therapy with a structured biomimetic oral care regimen, including toothpaste and mouthwash, provides additional clinical benefit compared with ozone therapy alone. Eligible participants will be randomly assigned to

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 18 years * Confirmed diagnosis of radio- and/or chemotherapy-induced oral mucositis, grade 1-3 according to the WHO Oral Toxicity Scale * Undergoing oncologic treatment for solid malignancies, particularly head and neck cancers * Clinically stable general health condition (ASA physical status I-III) * Ability to understand and comply with study procedures, including domiciliary treatment and questionnaire completion * Written informed consent provided Exclusion Criteria: * Oral mucositis grade 4 according to the WHO Oral Toxicity Scale * Active fungal or bacterial oral infections (e.g., candidiasis, ulcerative stomatitis) * Traumatic ulcers, non-oncologic mucositis, or concomitant oral mucosal diseases (e.g., lichen planus, pemphigus, graft-versus-host disease) * Ongoing head and neck radiotherapy with cumulative dose \>70 Gy or completion within 7 days prior to enrollment * Use within 14 days prior to enrollment of mouthwashes, sprays, or gels containing hyaluronic acid, ozone, aloe vera, or similar bioactive agents * Systemic or topical therapies known to interfere with salivary function or mucosal healing (e.g., anticholinergics, tricyclic antidepressants, diuretics) * Known allergy or hypersensitivity to components of the oral care products or materials used during ozone therapy * Severe or uncontrolled systemic diseases (including hepatic, renal, respiratory, or cardiac insufficiency) * Severe immunosuppression or neutropenia (neutrophils \<1,000/mmยณ) * Pregnancy or breastfeeding * Alcohol or substance abuse, or any condition that may compromise adherence to the protocol * Inability to attend scheduled follow-up visits through Day 30
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What it tests

  • Gas Ozone Therapy
  • Biomimetic Oral Care Regimen
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Where

1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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