NCT07199712Completed
Ozone Therapy for Oral Mucositis in Patients Receiving Head and Neck Cancer Radio- and Chemotherapy
Ozone Therapy for the Treatment of Oral Mucositis and/or Stomatitis in Patients Undergoing Radio- and Chemotherapy in the Head and Neck District: A Prospective Clinical Trial
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
Oral mucositis is a frequent and painful side effect of radio- and chemotherapy, especially in patients with head and neck cancer. It can cause severe discomfort, difficulty eating and swallowing, infections, and interruptions of cancer treatment. This study evaluates the effectiveness of ozone therapy, delivered both professionally in the dental clinic and at home with ozone-based toothpaste, mouthrinse, and gel, in reducing symptoms of oral mucositis and stomatitis. Fifty-eight adult cancer patients with oral mucositis of at least WHO grade 1 are included. Professional ozone therapy sessions are performed in-office, combined with daily home use of ozonated products. The main goal is to determine how many days are needed for lesions to heal (WHO ≤ 1). A secondary goal is to measure pain reduction using a visual analogue scale (VAS). This research aims to provide evidence for a supportive care protocol that may improve quality of life, reduce treatment complications, and support cancer patients during therapy.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 22 Sept 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 15 Nov 2025
- Lead sponsor
- University of Pavia
- Diseases
- Head and neck cancer
- NCT number
- NCT07199712
What you commit to
- Study type: Interventional
- Participants enrolled: 58
- From 1 Oct 2025 to the primary completion date, 15 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with Down syndrome.
- Patients with epilepsy.
- Patients with cardiac pacemakers.
Other
- Pregnant women.
- Patients with marked sensitivity to electrical current.
- Non-cooperative patients.
Who the study is looking for
- Age ≥ 18 years.
- Currently undergoing oncologic therapy (radiotherapy, chemotherapy, or combined treatment).
- Presence of oral mucositis or stomatitis of at least WHO grade 1 at baseline evaluation.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.