Ozone Therapy for Oral Mucositis in Patients Receiving Head and Neck Cancer Radio- and Chemotherapy

NCT07199712 | Completed

• 1 other identifier: 2025-OMUC-O3
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Oral Mucositis; Oral Stomatitis; Head and Neck Cancer Squamous Cell Carcinoma; Radiotherapy Induced Mucositis; Chemotherapy Induced Mucositis

Keywords

Ozone Therapy; Oral Mucositis; Head and Neck Cancer; Chemotherapy-Induced Mucositis; Radiotherapy-Induced Mucositis; Supportive Care; Pain Management; WHO Oral Toxicity Scale; Visual Analogue Scale (VAS)

Outcome Measures

Primary Outcomes (1)

• Time to Clinical Response of Oral Mucositis (WHO ≤ 1)

  Clinical response is defined as the first assessment at which oral mucositis improves to WHO grade ≤ 1. Evaluations are performed at baseline (day 0) and during follow-up visits at 48 hours, day 5, day 8, day 12, and day 15. Participants who do not achieve WHO ≤ 1 by day 15 are censored at their last evaluation.

  Baseline (initial evaluation) (T0); First treatment session (T1); 48 hours (T2; Day 5 (T3); Day 8 (T4); Day 12 (T5); Day 15 (T6).

Study Arms (1)

Ozonotherapy Protocol (Professional and Home-Based)

EXPERIMENTAL

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.

Other: Ozone Therapy (In-Office and Home-Based Treatment)

Interventions

Ozone Therapy (In-Office and Home-Based Treatment) OTHER

The intervention consists of professional in-office ozone therapy delivered with the Ozono DTA device (Sweden-Martina) applied to oral mucosal lesions. The first treatment is administered at baseline and additional sessions are performed at 48 hours, day 5, day 8, day 12, and day 15, if clinically required. Alongside in-office therapy, participants perform a 15-day domiciliary regimen with ozonated oral care products, including toothpaste with 2% ozonated sunflower oil, a mouthrinse with 4% ozonated sunflower oil solution, and a topical gel with 15% ozonated sunflower oil, each used twice daily. Clinical outcomes are assessed at each visit from baseline to day 15 with the WHO oral mucositis scale and the Visual Analogue Scale for pain.

Ozonotherapy Protocol (Professional and Home-Based)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women.
• Patients with Down syndrome.
• Patients with epilepsy.
• Patients with cardiac pacemakers.
• Patients with marked sensitivity to electrical current.
• Non-cooperative patients.

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Stomatitis; Head and Neck Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea Scribante, Associate Professor

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Model Details: All enrolled patients receive the same intervention, consisting of professional in-office ozone therapy sessions combined with domiciliary use of ozonated toothpaste, mouthrinse, and gel. No control or comparator group is included.

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: October 1, 2025
• Primary Completion: November 15, 2025
• Study Completion: November 20, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)