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

NCT ID: NCT07247799

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Mucositis Head and Neck Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients undergoing radio and chemotherapy for head and neck cancer

Ozone treatment

Intervention Type 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

Ozone treatment

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Andrea Scribante

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrea Scribante, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Pavia, Lombardy, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Andrea Scribante, DDS, PhD

Role: CONTACT

+39 0382516223

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Andrea Scribante

Role: primary

+39 0382516223

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-OZONEMUCOSITIS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Omega-3 Hydrogel and Prevention of Oral Mucositis
NCT05214495 COMPLETED PHASE2/PHASE3