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NCT Number: NCT07069153

Laser vs Ozone Therapy for Oral Mucositis in Cancer Patients

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.

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Key information

Conditions

Oral Mucositis Cancer Pain Head and Neck Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Mouth Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. Change in Oral Mucositis Severity Assessed by WHO Oral Mucositis Scale

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

    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.

Secondary outcomes

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

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

    Pain intensity will be assessed using a 10 cm Visual Analogue Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Patients will be instructed to mark the point that best represents their current level of oral pain. VAS scores will be collected at baseline (T0), after each treatment session (T1-T5), and at follow-up visits on day 15 (T3) and day 30 (T5).

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

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

    Quality of life will be assessed using the validated Oral Mucositis Weekly Questionnaire - Head and Neck (OMWQ-HN), a patient-reported outcome tool developed for individuals receiving radiotherapy or chemotherapy for head and neck cancer. The questionnaire includes 13 items covering oral pain, swallowing, speaking, eating, use of medications, and impact on daily life. Each item is scored on a 0 to 4 Likert scale, where 0 = "Not at all" and 4 = "Extremely." The overall OMWQ-HN score is calculated by summing all item scores, with total values ranging from 0 to 52. Higher scores indicate a greater negative impact on quality of life due to oral mucositis. The questionnaire will be administered at baseline (T0) and at day 30 (T5), allowing comparison of quality of life before and after treatment.

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

Efficacy of Laser Therapy and Ozone Therapy for the Treatment of Oral Mucositis in Cancer Patients: A Randomized Clinical Trial

Acronym: LOMUC

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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