NCT07069153

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Pavia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Oral Mucositis
• Head and Neck Neoplasms
• Hematologic Neoplasms

Interventions

Type	Name	Description
DEVICE	Laser Therapy	High-power diode laser therapy is applied to the oral mucosa using the Garda Laser LEO PLUS device with a flat-top handpiece at 660 nm wavelength. Treatment is delivered once daily over five consecutive days according to a standardized photobiomodulation protocol (energy density: 2-4 J/cm²).
DEVICE	Ozone therapy	Medical ozone gas is delivered intraorally using the Sweden \& Martina DTA device. The treatment is administered once daily over five consecutive days. A flat-tipped probe is used to apply ozone directly to the mucosal lesions at a concentration of 30-40 µg/mL, following a standardized safety protocol.

Timeline

• Start date: 2025-07-30
• Primary completion: 2025-09-15
• Completion: 2025-09-30
• First posted: 2025-07-16
• Last updated: 2025-11-17

Locations

1 site across 1 country: Italy