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

NCT07247799 | Completed

• 1 other identifier: 2025-OZONEMUCOSITIS
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Mucositis; Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual Analogue Scale

  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

  At baseline (T0) and at day fifteen (T6)

Study Arms (2)

Patients undergoing radio and chemotherapy for head and neck cancer

Device: Ozone treatment

Patients undergoing radio and chemotherapy for cancers in other districts

Device: Ozone treatment

Interventions

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).

Patients undergoing radio and chemotherapy for cancers in other districts; Patients undergoing radio and chemotherapy for head and neck cancer

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients under orthodontic care at the Section of Dentistry

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Andrea Scribante: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Stomatitis; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 25, 2025
• Study Start: September 1, 2025
• Primary Completion: January 10, 2026
• Study Completion: January 20, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

IT (1)