Laser Therapy Versus Ozone Therapy for Oral Mucositis in Patients With Cancer | NCT07724444

NCT07724444

Overview

NCT ID: NCT07724444
Lead Sponsor: University of PaviaOTHER
Official Title: Clinical Outcomes of Laser Therapy Versus Ozone Therapy for Oral Mucositis in Patients With Cancer: A Retrospective Cohort Study
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.

Status and Timeline

Status: Completed
Last Update Posted: Jul 24, 2026Actual
Start Date: Sep 25, 2024Actual
Primary Completion Date: Sep 15, 2025Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 40Actual
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: No data available
Locations: Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Similar Studies

Participant Group/Arms

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