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Oral MucositisLOMUCNCT07069153

Laser vs Ozone Therapy for Oral Mucositis in Cancer Patients

A study testing Laser Therapy and Ozone therapy in people with Oral Mucositis and Head and Neck Neoplasms, run by University of Pavia at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laser Therapy and Ozone therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteItaly
Study dates
30 Jul 2025to 30 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

    Pavia, Lombardy, 27100

Other trials in Italy

About this study

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

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.

Being tested
Laser Therapy, Ozone therapy
Keywords
Oral Mucositis, Cancer Pain, Laser Therapy, Ozone Therapy, Photobiomodulation, Head and Neck Cancer, Hematologic Malignancies, Chemotherapy, Radiotherapy, Supportive Care in Oncology
Medical subject headings
Stomatitis, Head and Neck Neoplasms, Hematologic Neoplasms, Cancer Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laser TherapyDevice

    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 therapyDevice

    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.

Study groups in NCT07069153
Study groupRoleWhat they receive
Laser Therapy for Oral MucositisExperimentalPatients 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.
Receives: Device: Laser Therapy
Ozone Therapy for Oral MucositisActive comparatorPatients 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.
Receives: Device: Ozone therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

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

    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).

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

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2025
  2. Study start30 Jul 2025
  3. Primary completion15 Sep 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07069153
Sponsor's protocol ID
2025-LOMUC
Acronym
LOMUC
Status last verified
Nov 2025
First submitted
5 Jul 2025
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be available upon motivated request to the corresponding authors.

Questions about this trial

What is this clinical trial studying?

A study testing Laser Therapy and Ozone therapy in people with Oral Mucositis and Head and Neck Neoplasms, run by University of Pavia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07069153.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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