Laser vs Ozone Therapy for Oral Mucositis in Cancer Patients

NCT07069153 | Completed

• 1 other identifier: 2025-LOMUC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Oral Mucositis; Cancer Pain; Laser Therapy; Ozone Therapy; Photobiomodulation; Head and Neck Cancer; Hematologic Malignancies; Chemotherapy; Radiotherapy; Supportive Care in Oncology

Outcome Measures

Primary Outcomes (1)

• Change in Oral Mucositis Severity Assessed by WHO Oral Mucositis Scale

  Oral mucositis severity will be evaluated using the World Health Organization (WHO) Oral Mucositis Scale, a standardized clinical tool that grades mucosal toxicity on a scale from 0 to 4. Grade 0 indicates no mucositis, grade 1 indicates soreness and erythema, grade 2 denotes erythema and ulcers but the patient can eat solid food, grade 3 represents ulcers with a liquid diet only, and grade 4 corresponds to severe mucositis with alimentation not possible. Scores will be recorded at baseline (T0), after 5 days of treatment (T1), and at follow-up visits on day 15 (T3) and day 30 (T5). The primary endpoint is the change in WHO score from baseline to day 30.

  Baseline (T0), Day 5 (T1), Day 15 (T3), and Day 30 (T5)

Secondary Outcomes (2)

• Change in Pain Intensity Assessed by Visual Analogue Scale (VAS)

  Baseline (T0), Day 5 (T1), Day 15 (T3), and Day 30 (T5)

• Change in Quality of Life Assessed by Oral Mucositis Weekly Questionnaire - Head and Neck (OMWQ-HN)

  Baseline (T0), Day 5 (T1), Day 15 (T3), and Day 30 (T5)

Study Arms (2)

Laser Therapy for Oral Mucositis

EXPERIMENTAL

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.

Device: Laser Therapy

Ozone Therapy for Oral Mucositis

ACTIVE COMPARATOR

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.

Device: Ozone therapy

Interventions

Laser Therapy 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).

Laser Therapy for Oral Mucositis

Ozone therapy 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.

Ozone Therapy for Oral Mucositis

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Stomatitis; Head and Neck Neoplasms; Hematologic Neoplasms; Cancer Pain

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Andrea Scribante, Associate Professor

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 16, 2025
• Study Start: July 30, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 30, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)