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New treatment option for Oral Mucositis
Official title Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis
ClinicalTrials.gov ID: NCT07491536
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 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
You likely can't join if
- 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...
See the full eligibility criteria
- Age ≥ 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
- 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/mm³)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Pavia, Lombardy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pavia, Lombardy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.