Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Induced Mucositis | — | UNRESOLVED | — |
| Head and Neck Cancer Squamous Cell Carcinoma | — | UNRESOLVED | — |
| Oral Mucositis | — | UNRESOLVED | — |
| Oral Stomatitis | — | UNRESOLVED | — |
| Radiotherapy Induced Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ozone Therapy (In-Office and Home-Based Treatment) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ozonotherapy Protocol (Professional and Home-Based)
- description
- All participants receive professional in-office ozone therapy with the Ozono DTA device (Sweden-Martina). The first treatment is administered at baseline (T0/T1), followed by additional applications at 48 hours (T2), day 5 (T3), day 8 (T4), day 12 (T5), and day 15 (T6), if clinically indicated. In parallel, participants perform domiciliary treatment for the entire 15-day study period, consisting of daily use of an ozonated toothpaste (DentoO3, 2% ozonated sunflower oil), an ozonated mouthrinse (CollutO3, 4% ozonated sunflower oil solution), and a topical ozonated gel (Ozoral Gel, 15% ozonated sunflower oil), each applied twice daily. Clinical assessments with the WHO oral mucositis scale and the Visual Analogue Scale for pain are performed at all study visits from baseline to day 15.
- interventionNames
- Other: Ozone Therapy (In-Office and Home-Based Treatment)
Primary outcomes (1)
- measure
- Time to Clinical Response of Oral Mucositis (WHO ≤ 1)
- timeFrame
- Baseline (initial evaluation) (T0); First treatment session (T1); 48 hours (T2; Day 5 (T3); Day 8 (T4); Day 12 (T5); Day 15 (T6).
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Pregnant women. * Patients with Down syndrome. * Patients with epilepsy. * Patients with cardiac pacemakers. * Patients with marked sensitivity to electrical current. * Non-cooperative patients.
References
Publications (0)
Data not yet available