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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite 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
PaviaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.