Laser Therapy Versus Ozone Therapy for Oral Mucositis in Patients With Cancer

NCT07724444 | Completed

• 1 other identifier: 2026-LOMUC-RETRO
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective observational study will compare laser therapy and ozone therapy for the management of oral mucositis in adults with head and neck cancer. Oral mucositis is a painful inflammation of the mouth that may develop during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and can cause redness, ulceration, difficulty eating or swallowing, and reduced quality of life. The study will review existing clinical records of patients who previously received either laser therapy or ozone therapy as part of routine clinical care. Patients were not assigned to treatment by the study protocol, and no additional treatment or study procedures will be performed. The main outcome will be the change in oral mucositis severity measured using the World Health Organization oral mucositis scale. Secondary outcomes will include changes in oral pain measured using a visual analogue scale and changes in oral mucositis-related quality of life, when questionnaire data are available. The aim is to determine whether the clinical course of oral mucositis differs between patients treated with laser therapy and those treated with ozone therapy.

Conditions

Oral Mucositis

Keywords

Oral Mucositis; Laser Therapy; Photobiomodulation; Ozone Therapy; Cancer Patients; Chemotherapy; Radiotherapy; Pain; World Health Organization Oral Mucositis Scale; Visual Analogue Scale

Outcome Measures

Primary Outcomes (1)

• Change in Oral Mucositis Severity Assessed Using the World Health Organization Scale

  Change in oral mucositis severity from baseline to the last available follow-up assessment will be evaluated using the World Health Organization Oral Toxicity Scale. The scale ranges from grade 0 to grade 4, where grade 0 indicates no oral mucositis and grade 4 indicates severe mucositis with inability to eat or drink. Scores documented in the clinical records will be compared between patients who received laser therapy and those who received ozone therapy. A reduction in the WHO grade indicates clinical improvement.

  At baseline before the first treatment session (T0), 24 hours after T0 (T1), 48 hours after T0 (T2), 5 days after T0 (T3), 15 days after T0 (T4), and 30 days after T0 (T5).

Secondary Outcomes (2)

• Change in Oral Pain Intensity Assessed Using the Visual Analogue Scale

  At baseline before the first treatment session (T0), 24 hours after T0 (T1), 48 hours after T0 (T2), 5 days after T0 (T3), 15 days after T0 (T4), and 30 days after T0 (T5).

• Change in Oral Mucositis-Related Quality of Life Assessed Using the OMWQ-HN

  At baseline before the first treatment session (T0) and 30 days after T0 (T5).

Study Arms (2)

Laser Therapy Cohort

Adult patients with histologically confirmed head and neck cancer who developed oral mucositis during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and previously received laser therapy as part of routine clinical care. Laser therapy was delivered to the affected oral mucosa according to the treating clinician's routine practice. Clinical records will be reviewed retrospectively to assess oral mucositis severity, pain intensity, and oral mucositis-related quality of life, when available. No treatment will be assigned or administered as part of this study.

Device: Laser Therapy

Ozone Therapy Cohort

Adult patients with histologically confirmed head and neck cancer who developed oral mucositis during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and previously received ozone therapy as part of routine clinical care. Ozone therapy was applied topically to the affected oral mucosa using an intraoral ozone-generating device according to the treating clinician's routine practice. Clinical records will be reviewed retrospectively to assess oral mucositis severity, pain intensity, and oral mucositis-related quality of life, when available. No treatment will be assigned or administered as part of this study.

Device: Ozone therapy

Interventions

Laser Therapy DEVICE

Adult patients in this cohort previously received diode laser therapy for oral mucositis as part of routine clinical care. Treatment was delivered to the affected oral mucosa using a diode laser device. Available medical records will be reviewed to retrieve treatment parameters, including wavelength, power, energy, application time, number of treated sites, treatment frequency, and number of sessions, when documented. No laser treatment will be assigned or administered as part of this retrospective study.

Also known as: Photobiomodulation

Laser Therapy Cohort

Ozone therapy DEVICE

Adult patients in this cohort previously received topical gaseous ozone therapy for oral mucositis as part of routine clinical care. Ozone was applied to the affected oral mucosa using an intraoral ozone-generating device and a dedicated probe. Available medical records will be reviewed to retrieve treatment parameters, including device settings, application duration, treated sites, treatment frequency, and number of sessions, when documented. No ozone treatment will be assigned or administered as part of this retrospective study.

Ozone Therapy Cohort

Eligibility Criteria

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

Study Population

Adult patients with histologically confirmed head and neck cancer who developed oral mucositis during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and who previously received either laser therapy or ozone therapy as part of routine clinical care. Participants will be identified retrospectively from existing clinical records. Eligible patients must have documented oral mucositis of World Health Organization grade 1 or higher, a baseline assessment, and at least one post-treatment evaluation. No treatment will be assigned or administered for research purposes.

You may qualify if:

• Adults aged 18 years or older.
• Histologically confirmed diagnosis of a malignant neoplasm of the head and neck region.
• Receipt of radiotherapy, chemotherapy, or concurrent chemoradiotherapy for head and neck cancer.
• Clinically documented oral mucositis of World Health Organization grade 1 or higher.
• Previous treatment of oral mucositis with either laser therapy or ozone therapy as part of routine clinical care.
• Availability of baseline oral mucositis severity assessment and at least one post-treatment assessment.
• Availability of sufficient clinical records to determine eligibility and evaluate the study outcomes.

You may not qualify if:

• Active oral infection at the time of oral mucositis assessment, including oral candidiasis or herpes simplex infection.
• Use of another specific treatment for oral mucositis within the 2 weeks before initiation of laser therapy or ozone therapy, when documented.
• Medical conditions contraindicating laser therapy or ozone therapy, including photosensitivity disorders or severe respiratory disease.
• Concurrent participation in another interventional clinical study that could have affected oral mucositis outcomes.
• Pregnancy or breastfeeding at the time of treatment, when documented.
• Neurological, psychiatric, or cognitive conditions that could have impaired reliable pain assessment or questionnaire completion.
• Previous treatment with both laser therapy and ozone therapy during the same episode of oral mucositis.
• Incomplete or insufficient clinical records for assessment of the primary outcome.

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Stomatitis; Pain

Interventions

Laser Therapy; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Phototherapy

Study Design

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

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 24, 2026
• Study Start: September 25, 2024
• Primary Completion: September 15, 2025
• Study Completion: September 29, 2025
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)