Ozone Therapy for the Treatment of Oral Mucositis in Patients Undergoing Radio and Chemotherapy in the Head and Neck Region

Ozone Therapy for the Treatment of Oral Mucositis in Patients Undergoing Radio and Chemotherapy in the Head and Neck Region: Retrospective Observational Study

The present study aims to evaluate the effectiveness of a combined protocol of professional and at-home ozone therapy in the treatment of oral mucositis in patients undergoing radio- and/or chemotherapy.

In-office treatment was performed using a medical ozone generator, while at-home therapy involved the daily application of high-concentration ozonated oil products. The study assessed the reduction in mucositis severity (WHO scale), decrease in pain (VAS scale), and improvement in patient-reported quality of life, with specific attention to nutrition, oral hygiene, and treatment adherence.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms; Oral Mucositis
• Intervention / Treatment: Device: Ozone treatment

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients under orthodontic care at the Section of Dentistry

Description

Inclusion Criteria:

• patients undergoing radio and chemotherapy for head and neck cancer and cancers in other districts

Exclusion Criteria:

• syndromic patients
• pregnant women
• patients with cardiac pacemakers
• epileptic patients
• patients with high sensitivity to electric current

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing radio and chemotherapy for head and neck cancer	Device: Ozone treatment; Ozone DTA (Sweden & Martina SpA, 35020 Due Carrare, PD, Italy) for clinical application; home oral care with DentO3® toothpaste, CollutO3®, Ozoral® Gel (Innovares, Sant'Ilario d'Enza (RE) - Italy).
Patients undergoing radio and chemotherapy for cancers in other districts	Device: Ozone treatment; Ozone DTA (Sweden & Martina SpA, 35020 Due Carrare, PD, Italy) for clinical application; home oral care with DentO3® toothpaste, CollutO3®, Ozoral® Gel (Innovares, Sant'Ilario d'Enza (RE) - Italy).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WHO scale for oral mucositis	Scoring criteria: 0 None; 1 Oral soreness, erythema; 2 Oral erythema, ulcers, solid diet tolerated; 3 Oral ulcers, liquid diet only	At baseline (T0), baseline after treatment (T1), after 48 hours (T2), at day five (T3), at day eight (T4), at day twelve (T5), at day fifteen (T6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	Evaluation of self-perceived pain from 0 (no pain) to 10 (worst pain ever)	At baseline (T0), baseline after treatment (T1), after 48 hours (T2), at day five (T3), at day eight (T4), at day twelve (T5), at day fifteen (T6)
Questionnaire	Score from 0=best outcome to 10= worst outcome for the following items: On a scale from 1 to 10, how much discomfort do certain foods and beverages cause you?; On a scale from 1 to 10, to what extent does your oral condition make you limit the intake of certain foods and beverages?; On a scale from 1 to 10, how much do certain food textures (e.g., crunchy foods) bother you?; On a scale from 1 to 10, to what extent does your oral condition lead you to limit the texture of the foods you consume?; On a scale from 1 to 10, how much discomfort does the temperature of certain foods and beverages cause you?; On a scale from 1 to 10, to what extent does your oral condition make you limit the temperature of the foods and beverages you consume?; On a scale from 1 to 10, how much does your oral condition cause discomfort during your daily oral activities?; On a scale from 1 to 10, how much discomfort does your oral condition cause during daily oral hygiene (brushin	At baseline (T0) and at day fifteen (T6)

Collaborators and Investigators

• Sponsor: Andrea Scribante
• Investigators: Principal Investigator: Andrea Scribante, DDS, PhD, University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Actual): January 10, 2026
• Study Completion (Actual): January 20, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Stomatitis
• Other Study ID Numbers: 2025-OZONEMUCOSITIS