Laser vs Ozone Therapy for Oral Mucositis in Cancer Patients

NCT ID: NCT07069153

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2025-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser Therapy for Oral Mucositis

Patients in this arm will undergo high-power diode laser therapy using the Garda Laser LEO PLUS device with a flat-top handpiece at a wavelength of 660 nm. The laser is applied intraorally on the mucosal lesions following a standardized photobiomodulation protocol. The treatment is administered once daily for five consecutive days. Mucositis severity (WHO scale), pain intensity (VAS), and quality of life (OMWQ-HN) will be monitored from baseline through 30 days of follow-up.

Group Type: EXPERIMENTAL

Laser Therapy

Intervention Type: DEVICE

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).

Ozone Therapy for Oral Mucositis

Patients in this arm will receive medical ozone therapy for the treatment of chemotherapy- or radiotherapy-induced oral mucositis. Ozone is administered intraorally in gaseous form using a Sweden \& Martina DTA device and a flat probe specifically designed for mucosal application. The treatment is delivered once daily for five consecutive days, following a standardized therapeutic protocol. Clinical parameters including mucositis severity (WHO scale), pain (VAS), and quality of life (OMWQ-HN) will be assessed at baseline and during follow-up.

Group Type: ACTIVE_COMPARATOR

Ozone therapy

Intervention Type: DEVICE

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Previous treatment with ozone or laser therapy for oral mucositis in the past 3 months
• Pregnancy or breastfeeding
• Cognitive impairment or psychiatric disorders preventing full cooperation
• Known allergy or intolerance to ozone or laser exposure
• Use of investigational drugs or participation in other clinical trials within 30 days prior to enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Scribante, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, Italy

Countries

Italy

Other Identifiers

2025-LOMUC

Identifier Type: -

Identifier Source: org_study_id