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NCT Number: NCT07247799

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

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.

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Key information

Conditions

Oral Mucositis Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Stomatitis Stomatognathic Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Pavia, Lombardy, 27100, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ozone treatment

Device

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).

Primary outcomes

  1. WHO scale for oral mucositis

    Time frame: 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)

    Scoring criteria:

    • 0 None
    • 1 Oral soreness, erythema
    • 2 Oral erythema, ulcers, solid diet tolerated
    • 3 Oral ulcers, liquid diet only

Secondary outcomes

  1. Visual Analogue Scale

    Time frame: 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)

    Evaluation of self-perceived pain from 0 (no pain) to 10 (worst pain ever)

  2. Questionnaire

    Time frame: At baseline (T0) and at day fifteen (T6)

    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

Sponsors and collaborators

Lead sponsor

Andrea Scribante

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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