Ozone gas plus biomimetic toothpaste and mouthwash to treat cancer therapy mouth sores
Combined Gas Ozone Therapy and Biomimetic Oral Care in the Management of Radio- and Chemotherapy-Induced Oral Mucositis: A Randomized Controlled Clinical Trial
This trial will test whether adding a biomimetic toothpaste and mouthwash to ozone gas therapy helps adults with chemo- or radiotherapy-induced mouth sores heal faster and have less pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pavia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT07491536 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) undergoing oncologic treatment for solid tumors, especially head and neck cancers, who have WHO grade 1–3 radio- or chemotherapy-induced oral mucositis and can comply with clinic visits and home oral care are the ideal candidates.
Not a fit: Patients with grade 4 mucositis, active oral infections, non-oncologic mucosal diseases, very recent high-dose head and neck radiotherapy, or who cannot perform domiciliary care are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined approach could reduce mucositis severity and pain, improve eating and oral function, and lower the risk of cancer treatment interruptions.
How similar studies have performed: Small dental and experimental studies suggest ozone can have antimicrobial and wound-healing effects, but robust randomized data specifically for cancer therapy-induced oral mucositis are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pavia, Lombardy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.