Ozone gas plus biomimetic toothpaste and mouthwash to treat cancer therapy mouth sores

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a monocentric, randomized, controlled, parallel-group trial at the University of Pavia comparing gas ozone therapy alone versus gas ozone therapy combined with a structured biomimetic oral care regimen (toothpaste and mouthwash) in adults with radio- or chemotherapy-induced oral mucositis. Eligible patients with WHO grade 1–3 mucositis are randomly assigned to one of the two arms and receive outpatient ozone applications plus home oral care as assigned. Outcomes include changes in mucositis severity, pain, oral function, and need for oncologic treatment modification. The protocol emphasizes standardized ozone delivery and a domiciliary biomimetic regimen to measure any added clinical benefit.

Why it matters

Who can join: the full rules

Inclusion 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

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/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

Where it's running

• Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
  Pavia, Lombardy, Italy Recruiting

Study contacts

• Principal investigator: Andrea Scribante, Associate Professor — University of Pavia
• Study coordinator: Andrea Scribante, Associate Professor
• Email: andrea.scribante@unipv.it
• Phone: +39 0382516223

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.