Oral MucositisLOMUC-RETRONCT07724444
Laser Therapy Versus Ozone Therapy for Oral Mucositis in Patients With Cancer
An observational study of Oral Mucositis, run by University of Pavia at 1 site in Italy.
Trial summary
This retrospective observational study will compare laser therapy and ozone therapy for the management of oral mucositis in adults with head and neck cancer. Oral mucositis is a painful inflammation of the mouth that may develop during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and can cause redness… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Laser Therapy and Ozone therapy
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 25 Sep 2024to 29 Sep 2025
- Phase
- Observational
- 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
Study population: Adult patients with histologically confirmed head and neck cancer who developed oral mucositis during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and who previously received either laser therapy or ozone therapy as part of routine clinical care. Participants will be identified retrospectively from existing clinical records. Eligible patients must have documented oral mucositis of World Health Organization grade 1 or higher, a baseline assessment, and at least one post-treatment evaluation. No treatment will be assigned or administered for research purposes.
Who may be able to join
- Adults aged 18 years or older.
- Histologically confirmed diagnosis of a malignant neoplasm of the head and neck region.
- Receipt of radiotherapy, chemotherapy, or concurrent chemoradiotherapy for head and neck cancer.
- Clinically documented oral mucositis of World Health Organization grade 1 or higher.
- Previous treatment of oral mucositis with either laser therapy or ozone therapy as part of routine clinical care.
- Availability of baseline oral mucositis severity assessment and at least one post-treatment assessment.
- Availability of sufficient clinical records to determine eligibility and evaluate the study outcomes.
Who cannot join
- Active oral infection at the time of oral mucositis assessment, including oral candidiasis or herpes simplex infection.
- Use of another specific treatment for oral mucositis within the 2 weeks before initiation of laser therapy or ozone therapy, when documented.
- Medical conditions contraindicating laser therapy or ozone therapy, including photosensitivity disorders or severe respiratory disease.
- Concurrent participation in another interventional clinical study that could have affected oral mucositis outcomes.
- Pregnancy or breastfeeding at the time of treatment, when documented.
- Neurological, psychiatric, or cognitive conditions that could have impaired reliable pain assessment or questionnaire completion.
- Previous treatment with both laser therapy and ozone therapy during the same episode of oral mucositis.
- Incomplete or insufficient clinical records for assessment of the primary outcome.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Clinical Outcomes of Laser Therapy Versus Ozone Therapy for Oral Mucositis in Patients With Cancer: A Retrospective Cohort Study
This retrospective observational study will compare laser therapy and ozone therapy for the management of oral mucositis in adults with head and neck cancer. Oral mucositis is a painful inflammation of the mouth that may develop during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and can cause redness, ulceration, difficulty eating or swallowing, and reduced quality of life.
The study will review existing clinical records of patients who previously received either laser therapy or ozone therapy as part of routine clinical care. Patients were not assigned to treatment by the study protocol, and no additional treatment or study procedures will be performed.
Read more
The main outcome will be the change in oral mucositis severity measured using the World Health Organization oral mucositis scale. Secondary outcomes will include changes in oral pain measured using a visual analogue scale and changes in oral mucositis-related quality of life, when questionnaire data are available.
The aim is to determine whether the clinical course of oral mucositis differs between patients treated with laser therapy and those treated with ozone therapy.
Read the detailed description
This single-center retrospective observational cohort study will evaluate existing clinical records of adults with histologically confirmed head and neck cancer who developed oral mucositis during radiotherapy, chemotherapy, or concurrent chemoradiotherapy.
Patients will be classified according to the treatment previously received for oral mucositis as part of routine clinical care: laser therapy or ozone therapy. Treatment selection occurred independently of the present study. No participant will be assigned to an intervention, and no additional treatment, visit, or research-specific procedure will be performed.
The study will examine the clinical course of oral mucositis using data already documented in medical records. The primary analysis will compare changes in oral mucositis severity, assessed using the World Health Organization Oral Toxicity Scale, between the two cohorts. Secondary analyses will compare changes in oral pain intensity measured using a Visual Analogue Scale and changes in oral mucositis-related quality of life using the Oral Mucositis Weekly Questionnaire-Head and Neck, when these data are available.
Demographic and clinical variables relevant to oral mucositis outcomes may also be extracted, including age, sex, cancer diagnosis, anticancer treatment, baseline mucositis severity, treatment timing, and available follow-up assessments. The analysis will account for the retrospective nature of the study and the availability and completeness of routinely collected clinical data.
- Conditions
- Oral Mucositis
- Being tested
- Laser Therapy, Ozone therapy
- Keywords
- Oral Mucositis, Laser Therapy, Photobiomodulation, Ozone Therapy, Cancer Patients, Chemotherapy, Radiotherapy, Pain, World Health Organization Oral Mucositis Scale, Visual Analogue Scale
- Medical subject headings
- Stomatitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TherapyDevice
Also called Photobiomodulation
Adult patients in this cohort previously received diode laser therapy for oral mucositis as part of routine clinical care. Treatment was delivered to the affected oral mucosa using a diode laser device. Available medical records will be reviewed to retrieve treatment parameters, including wavelength, power, energy, application time, number of treated sites, treatment frequency, and number of sessions, when documented. No laser treatment will be assigned or administered as part of this retrospective study.
Ozone therapyDevice
Adult patients in this cohort previously received topical gaseous ozone therapy for oral mucositis as part of routine clinical care. Ozone was applied to the affected oral mucosa using an intraoral ozone-generating device and a dedicated probe. Available medical records will be reviewed to retrieve treatment parameters, including device settings, application duration, treated sites, treatment frequency, and number of sessions, when documented. No ozone treatment will be assigned or administered as part of this retrospective study.
| Study group | Role | What they receive |
|---|---|---|
| Laser Therapy Cohort | Adult patients with histologically confirmed head and neck cancer who developed oral mucositis during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and previously received laser therapy as part of routine clinical care. Laser therapy was delivered to the affected oral mucosa according to the treating clinician's routine practice. Clinical records will be reviewed retrospectively to assess oral mucositis severity, pain intensity, and oral mucositis-related quality of life, when available. No treatment will be assigned or administered as part of this study. Receives: Device: Laser Therapy | |
| Ozone Therapy Cohort | Adult patients with histologically confirmed head and neck cancer who developed oral mucositis during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and previously received ozone therapy as part of routine clinical care. Ozone therapy was applied topically to the affected oral mucosa using an intraoral ozone-generating device according to the treating clinician's routine practice. Clinical records will be reviewed retrospectively to assess oral mucositis severity, pain intensity, and oral mucositis-related quality of life, when available. No treatment will be assigned or administered as part of this study. Receives: Device: Ozone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Mucositis Severity Assessed Using the World Health Organization Scale
Change in oral mucositis severity from baseline to the last available follow-up assessment will be evaluated using the World Health Organization Oral Toxicity Scale. The scale ranges from grade 0 to grade 4, where grade 0 indicates no oral mucositis and grade 4 indicates severe mucositis with inability to eat or drink. Scores documented in the clinical records will be compared between patients who received laser therapy and those who received ozone therapy. A reduction in the WHO grade indicates clinical improvement.
Measured: At baseline before the first treatment session (T0), 24 hours after T0 (T1), 48 hours after T0 (T2), 5 days after T0 (T3), 15 days after T0 (T4), and 30 days after T0 (T5).
Secondary outcomes (2)
Change in Oral Pain Intensity Assessed Using the Visual Analogue Scale
Change in oral pain intensity from baseline to each available follow-up assessment will be evaluated using the Visual Analogue Scale. Pain is scored from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores documented in the clinical records will be compared between patients who received laser therapy and those who received ozone therapy. A reduction in the Visual Analogue Scale score indicates an improvement in pain.
Measured: At baseline before the first treatment session (T0), 24 hours after T0 (T1), 48 hours after T0 (T2), 5 days after T0 (T3), 15 days after T0 (T4), and 30 days after T0 (T5).
Change in Oral Mucositis-Related Quality of Life Assessed Using the OMWQ-HN
Change in oral mucositis-related quality of life will be assessed using the Oral Mucositis Weekly Questionnaire-Head and Neck. The questionnaire evaluates the impact of oral mucositis on symptoms, oral function, eating, swallowing, and daily activities. Total scores documented in the clinical records will be compared between patients who received laser therapy and those who received ozone therapy. Lower scores indicate a lower impact of oral mucositis and an improvement in quality of life.
Measured: At baseline before the first treatment session (T0) and 30 days after T0 (T5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start25 Sep 2024
- Primary completion15 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724444
- Sponsor's protocol ID
- 2026-LOMUC-RETRO
- Acronym
- LOMUC-RETRO
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: Data will be available upon motivated request to the corresponding authors.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Laser Therapy Versus Ozone Therapy for Oral Mucositis in Patients With Cancer: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07724444
- Acronym / sponsor ID
- LOMUC-RETRO / 2026-LOMUC-RETRO
- Conditions
- Oral Mucositis
- Keywords
- Oral Mucositis, Laser Therapy, Photobiomodulation, Ozone Therapy, Cancer Patients, Chemotherapy, Radiotherapy, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective observational study will compare laser therapy and ozone therapy for the management of oral mucositis in adults with head and neck cancer. Oral mucositis is a painful inflammation of the mouth that may develop during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and can cause redness, ulceration, difficulty eating or swallowing, and reduced quality of life.
The study will review existing clinical records of patients who previously received either laser therapy or ozone therapy as part of routine clinical care. Patients were not assigned to treatment by the study protocol, and no additional treatment or study procedures will be performed.
The main outcome will be the change in oral mucositis severity measured using the World Health Organization oral mucositis scale. Secondary outcomes will include changes in oral pain measured using a visual analogue scale and changes in oral mucositis-related quality of life, when questionnaire data are available.
The aim is to determine whether the clinical course of oral mucositis differs between patients treated with laser therapy and those treated with ozone therapy.
Detailed description
This single-center retrospective observational cohort study will evaluate existing clinical records of adults with histologically confirmed head and neck cancer who developed oral mucositis during radiotherapy, chemotherapy, or concurrent chemoradiotherapy.
Patients will be classified according to the treatment previously received for oral mucositis as part of routine clinical care: laser therapy or ozone therapy. Treatment selection occurred independently of the present study. No participant will be assigned to an intervention, and no additional treatment, visit, or research-specific procedure will be performed.
The study will examine the clinical course of oral mucositis using data already documented in medical records. The primary analysis will compare changes in oral mucositis severity, assessed using the World Health Organization Oral Toxicity Scale, between the two cohorts. Secondary analyses will compare changes in oral pain intensity measured using a Visual Analogue Scale and changes in oral mucositis-related quality of life using the Oral Mucositis Weekly Questionnaire-Head and Neck, when these data are available.
Demographic and clinical variables relevant to oral mucositis outcomes may also be extracted, including age, sex, cancer diagnosis, anticancer treatment, baseline mucositis severity, treatment timing, and available follow-up assessments. The analysis will account for the retrospective nature of the study and the availability and completeness of routinely collected clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Therapy Cohort | – | Device: Laser TherapyAdult patients with histologically confirmed head and neck cancer who developed oral mucositis during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and previously received laser therapy as part of routine clinical care. Laser therapy was delivered to the affected oral mucosa according to the treating clinician's routine practice. Clinical records will be reviewed retrospectively to assess oral mucositis severity, pain intensity, and oral mucositis-related quality of life, when available. No treatment will be assigned or administered as part of this study. |
| Ozone Therapy Cohort | – | Device: Ozone therapyAdult patients with histologically confirmed head and neck cancer who developed oral mucositis during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and previously received ozone therapy as part of routine clinical care. Ozone therapy was applied topically to the affected oral mucosa using an intraoral ozone-generating device according to the treating clinician's routine practice. Clinical records will be reviewed retrospectively to assess oral mucositis severity, pain intensity, and oral mucositis-related quality of life, when available. No treatment will be assigned or administered as part of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with histologically confirmed head and neck cancer who developed oral mucositis during radiotherapy, chemotherapy, or concurrent chemoradiotherapy and who previously received either laser therapy or ozone therapy as part of routine clinical care. Participants will be identified retrospectively from existing clinical records. Eligible patients must have documented oral mucositis of World Health Organization grade 1 or higher, a baseline assessment, and at least one post-treatment evaluation. No treatment will be assigned or administered for research purposes.
Key inclusion criteria (7 listed)
- Adults aged 18 years or older.
- Histologically confirmed diagnosis of a malignant neoplasm of the head and neck region.
- Receipt of radiotherapy, chemotherapy, or concurrent chemoradiotherapy for head and neck cancer.
- Clinically documented oral mucositis of World Health Organization grade 1 or higher.
- Previous treatment of oral mucositis with either laser therapy or ozone therapy as part of routine clinical care.
Key exclusion criteria (8 listed)
- Active oral infection at the time of oral mucositis assessment, including oral candidiasis or herpes simplex infection.
- Use of another specific treatment for oral mucositis within the 2 weeks before initiation of laser therapy or ozone therapy, when documented.
- Medical conditions contraindicating laser therapy or ozone therapy, including photosensitivity disorders or severe respiratory disease.
- Concurrent participation in another interventional clinical study that could have affected oral mucositis outcomes.
- Pregnancy or breastfeeding at the time of treatment, when documented.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser TherapyAlso: PhotobiomodulationAdult patients in this cohort previously received diode laser therapy for oral mucositis as part of routine clinical care. Treatment was delivered to the affected oral mucosa using a diode laser device. Available medical records will be reviewed to retrieve treatment parameters, including wavelength, power, energy, application time, number of treated sites, treatment frequency, and number of sessions, when documented. No laser treatment will be assigned or administered as part of this retrospective study. | Device | Laser Therapy Cohort |
| Ozone therapyAdult patients in this cohort previously received topical gaseous ozone therapy for oral mucositis as part of routine clinical care. Ozone was applied to the affected oral mucosa using an intraoral ozone-generating device and a dedicated probe. Available medical records will be reviewed to retrieve treatment parameters, including device settings, application duration, treated sites, treatment frequency, and number of sessions, when documented. No ozone treatment will be assigned or administered as part of this retrospective study. | Device | Ozone Therapy Cohort |
Primary outcome
Change in Oral Mucositis Severity Assessed Using the World Health Organization Scale
Time frame: At baseline before the first treatment session (T0), 24 hours after T0 (T1), 48 hours after T0 (T2), 5 days after T0 (T3), 15 days after T0 (T4), and 30 days after T0 (T5).
Change in oral mucositis severity from baseline to the last available follow-up assessment will be evaluated using the World Health Organization Oral Toxicity Scale. The scale ranges from grade 0 to grade 4, where grade 0 indicates no oral mucositis and grade 4 indicates severe mucositis with inability to eat or drink. Scores documented in the clinical records will be compared between patients who received laser therapy and those who received ozone therapy. A reduction in the WHO grade indicates clinical improvement.
2 secondary outcomes
Change in Oral Pain Intensity Assessed Using the Visual Analogue Scale
Time frame: At baseline before the first treatment session (T0), 24 hours after T0 (T1), 48 hours after T0 (T2), 5 days after T0 (T3), 15 days after T0 (T4), and 30 days after T0 (T5).
Change in Oral Mucositis-Related Quality of Life Assessed Using the OMWQ-HN
Time frame: At baseline before the first treatment session (T0) and 30 days after T0 (T5).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the corresponding authors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Mucositis, 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 7 inclusion and 8 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 24 Jul 2026. 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 Using the World Health Organization Scale (time frame: At baseline before the first treatment session (T0), 24 hours after T0 (T1), 48 hours after T0 (T2), 5 days after T0 (T3), 15 days after T0 (T4), and 30 days after T0 (T5).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.