NCT07069153Completed
Laser vs Ozone Therapy for Oral Mucositis in Cancer Patients
Efficacy of Laser Therapy and Ozone Therapy for the Treatment of Oral Mucositis in Cancer Patients: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
This randomized clinical trial aims to compare the efficacy of laser therapy and ozone therapy in the treatment of oral mucositis in adult cancer patients undergoing chemotherapy or radiotherapy, particularly those with head and neck tumors or hematologic malignancies. Oral mucositis is a frequent and debilitating complication of cancer treatment, characterized by painful ulcerations that impair nutrition, speech, and oral hygiene, often requiring opioid analgesics and supportive care. Forty eligible patients will be randomly assigned to two parallel groups. The trial group will receive high-power diode laser therapy using a flat-top handpiece at 660 nm wavelength, following a standardized photobiomodulation protocol. The control group will be treated with medical ozone gas administered via an intraoral device, using a standardized ozone therapy protocol. Both treatments will be applied once daily over five consecutive days. Patients will be followed up at 15 and 30 days after treatment initiation. The primary outcome is the reduction in mucositis severity, measured using the World Health Organization (WHO) Oral Toxicity Scale. Secondary outcomes include pain intensity assessed with the Visual Analogue Scale (VAS), and quality of life evaluated through the Oral Mucositis Weekly Questionnaire - Head and Neck (OMWQ-HN). The study seeks to determine whether laser therapy offers superior clinical benefits compared to ozone therapy in reducing lesion severity, alleviating pain, and improving patient well-being during cancer treatment.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 5 Jul 2025
- Start date
- 30 Jul 2025
- Primary completion date
- 15 Sept 2025
- Lead sponsor
- University of Pavia
- Diseases
- Head and neck cancer
- NCT number
- NCT07069153
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 30 Jul 2025 to the primary completion date, 15 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with ozone or laser therapy for oral mucositis in the past 3 months
- Use of investigational drugs or participation in other clinical trials within 30 days prior to enrollment
Other illness
- Presence of autoimmune or systemic diseases affecting the oral mucosa (e.g., lichen planus, pemphigus, pemphigoid)
- Presence of active oral infections unrelated to mucositis (e.g., candidiasis, herpes simplex)
- Cognitive impairment or psychiatric disorders preventing full cooperation
- Known allergy or intolerance to ozone or laser exposure
Other
- Pregnancy or breastfeeding
Who the study is looking for
- Age ≥18 years
- Diagnosis of head and neck cancer or hematologic malignancy
- Currently undergoing chemotherapy and/or radiotherapy
- Presence of oral mucositis of grade 2 or higher (WHO Oral Mucositis Scale)
- Ability to provide written informed consent
- Willingness to comply with study procedures and follow-up schedule
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.