Oral MucositisOZOMUCNCT07491536
Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis
A study testing Gas Ozone Therapy and Biomimetic Oral Care Regimen in people with Oral Mucositis and Chemotherapy-induced Oral Mucositis, run by University of Pavia at 1 site in Italy.
Trial summary
Oral mucositis is a frequent and often debilitating complication of radiotherapy and chemotherapy, particularly in patients treated for head and neck cancers. It is characterized by inflammation and ulceration of the oral mucosa, leading to pain, difficulty swallowing, taste disturbances, dry mouth, and impairment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis, Chemotherapy-induced Oral Mucositis, Head and Neck Neoplasms
- What is being tested?
- Gas Ozone Therapy and Biomimetic Oral Care Regimen
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Confirmed diagnosis of radio- and/or chemotherapy-induced oral mucositis, grade 1-3 according to the WHO Oral Toxicity Scale
- Undergoing oncologic treatment for solid malignancies, particularly head and neck cancers
- Clinically stable general health condition (ASA physical status I-III)
- Ability to understand and comply with study procedures, including domiciliary treatment and questionnaire completion
- Written informed consent provided
Who cannot join
- Oral mucositis grade 4 according to the WHO Oral Toxicity Scale
- Active fungal or bacterial oral infections (e.g., candidiasis, ulcerative stomatitis)
- Traumatic ulcers, non-oncologic mucositis, or concomitant oral mucosal diseases (e.g., lichen planus, pemphigus, graft-versus-host disease)
- Ongoing head and neck radiotherapy with cumulative dose >70 Gy or completion within 7 days prior to enrollment
- Use within 14 days prior to enrollment of mouthwashes, sprays, or gels containing hyaluronic acid, ozone, aloe vera, or similar bioactive agents
- Systemic or topical therapies known to interfere with salivary function or mucosal healing (e.g., anticholinergics, tricyclic antidepressants, diuretics)
Show all 12Show fewer
- Known allergy or hypersensitivity to components of the oral care products or materials used during ozone therapy
- Severe or uncontrolled systemic diseases (including hepatic, renal, respiratory, or cardiac insufficiency)
- Severe immunosuppression or neutropenia (neutrophils <1,000/mm³)
- Pregnancy or breastfeeding
- Alcohol or substance abuse, or any condition that may compromise adherence to the protocol
- Inability to attend scheduled follow-up visits through Day 30
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
Andrea Scribante, Associate Professor, +39 0382516223, andrea.scribante@unipv.it
About this study
Official title: Combined Gas Ozone Therapy and Biomimetic Oral Care in the Management of Radio- and Chemotherapy-Induced Oral Mucositis: A Randomized Controlled Clinical Trial
Oral mucositis is a frequent and often debilitating complication of radiotherapy and chemotherapy, particularly in patients treated for head and neck cancers. It is characterized by inflammation and ulceration of the oral mucosa, leading to pain, difficulty swallowing, taste disturbances, dry mouth, and impairment of daily activities. In more severe cases, oral mucositis may require modification or temporary interruption of cancer treatment.
This randomized controlled clinical trial is designed to assess the clinical effectiveness of gas ozone therapy in patients with radio- and chemotherapy-induced oral mucositis. In addition, the study will evaluate whether combining ozone therapy with a structured biomimetic oral care regimen, including toothpaste and mouthwash, provides additional clinical benefit compared with ozone therapy alone.
Read more
Eligible participants will be randomly assigned to one of two parallel groups. The control group will receive gas ozone therapy administered in an outpatient setting according to a standardized protocol. The experimental group will receive the same ozone therapy combined with a defined home oral care regimen. Each participant will be followed for 30 days.
The primary outcome is the change in oral mucositis severity, assessed using the World Health Organization Oral Toxicity Scale. Secondary outcomes include oral pain intensity, salivary flow rates, perceived dry mouth, taste alterations, swallowing function, oral pH, overall oral health-related quality of life, and treatment tolerability.
The findings of this study are expected to clarify the role of ozone-based supportive care strategies in the management of cancer therapy-related oral mucositis and to contribute to the development of standardized non-pharmacological treatment protocols.
Read the detailed description
Oral mucositis represents a clinically relevant toxicity associated with radiotherapy and chemotherapy, particularly in patients undergoing treatment for head and neck malignancies. The condition arises from a multifactorial biological process that includes epithelial injury, inflammatory cascade activation, oxidative stress imbalance, and subsequent disruption of mucosal integrity. The resulting ulcerative lesions are frequently associated with pain, impaired oral intake, dysphagia, taste alterations, and deterioration in oral health-related quality of life. In more severe cases, mucositis may interfere with adherence to oncologic treatment schedules.
Although several supportive approaches have been proposed, there is currently no universally accepted non-pharmacological protocol capable of consistently reducing mucositis severity and improving functional outcomes.
Medical ozone has been investigated in dentistry for its antimicrobial, anti-inflammatory, and tissue-regenerative properties. Experimental evidence suggests that controlled topical ozone exposure may enhance local oxygen metabolism, modulate inflammatory mediators, and promote mucosal repair. However, robust randomized clinical data evaluating standardized gas ozone protocols in patients with cancer therapy-induced oral mucositis remain limited.
The present study is a monocentric, randomized, controlled, parallel-group clinical trial designed to assess the clinical effectiveness of gas ozone therapy administered using a certified medical device. The trial also aims to investigate whether the association of ozone therapy with a structured biomimetic oral care regimen provides additional benefit compared with ozone therapy alone.
Eligible participants diagnosed with grade 1-3 oral mucositis will be randomized in a 1:1 ratio to receive either ozone therapy alone or ozone therapy combined with a defined home oral care protocol. Ozone applications will be performed in an outpatient clinical setting according to standardized parameters over a 30-day period. Participants allocated to the combined treatment arm will follow a structured domiciliary oral hygiene regimen throughout the study duration.
Clinical evaluations and patient-reported outcome measures will be collected at predefined follow-up visits to monitor mucosal status, symptom progression, functional changes, and treatment tolerability. The study is designed to generate clinically applicable data regarding the role of ozone-based supportive care strategies in the management of radio- and chemotherapy-induced oral mucositis.
- Being tested
- Gas Ozone Therapy, Biomimetic Oral Care Regimen
- Keywords
- Ozone Therapy, Cancer Treatment-Induced Oral Mucositis, Supportive Oncology, Non-Pharmacological Treatment, Head and Neck Cancer, Oral Toxicity, Salivary Function, Xerostomia, Randomized Controlled Trial
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gas Ozone TherapyDevice
Medical gas ozone will be administered in an outpatient clinical setting using a certified ozone delivery system. Prior to application, the affected oral mucosal areas will be gently dried. Ozone will be applied locally using a dedicated silicone applicator, with an exposure time of 60 seconds per cm² and a maximum of four sites treated per session at predefined device settings. Treatment sessions will be performed three times weekly during the first two weeks (days 1, 3, and 5), followed by twice-weekly sessions until day 30. All participants will receive standardized oral hygiene instructions and will use the same biomimetic toothpaste throughout the study period.
Biomimetic Oral Care RegimenOther
Participants allocated to the experimental arm will use a biomimetic mouthwash in addition to the standardized gas ozone therapy protocol. The mouthwash will be applied twice daily, in the morning and evening, after routine oral hygiene procedures for 30 consecutive days. Adherence to the domiciliary regimen will be monitored using a structured patient diary.
| Study group | Role | What they receive |
|---|---|---|
| Gas Ozone Therapy | Active comparator | Participants assigned to this arm will receive gas ozone therapy administered in an outpatient clinical setting using a certified medical device. The oral mucosa will be gently dried prior to treatment, and ozone will be applied locally to affected areas using a dedicated silicone applicator. Each site will receive 60 seconds of exposure per cm² at predefined device settings, with a maximum of four sites treated per session. Treatment will be performed three times weekly during the first two weeks (days 1, 3, and 5), followed by twice-weekly sessions until day 30. All participants will receive standardized oral hygiene instructions and will use the same biomimetic toothpaste throughout the study period. Receives: Device: Gas Ozone Therapy |
| Gas Ozone Therapy Plus Biomimetic Oral Care | Experimental | Participants assigned to this arm will receive the same standardized gas ozone therapy protocol described for the control group. In addition, they will use a biomimetic mouthwash twice daily (morning and evening) after routine oral hygiene procedures for 30 consecutive days. All participants will receive standardized oral hygiene instructions and will use the same biomimetic toothpaste during the study period. Adherence to the domiciliary mouthwash regimen will be monitored through a structured patient diary. Receives: Other: Biomimetic Oral Care Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Mucositis Severity Assessed by WHO Oral Toxicity Scale
The primary outcome is the change in oral mucositis severity measured using the World Health Organization (WHO) Oral Toxicity Scale. The scale ranges from 0 (no mucositis) to 4 (severe mucositis preventing oral intake), with higher scores indicating greater mucosal damage severity. Changes in WHO grade from baseline will be compared between study groups to evaluate the clinical effectiveness of the interventions.
Measured: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Secondary outcomes (10)
Change in Oral Pain Intensity Assessed by Visual Analogue Scale (VAS)
Oral pain intensity will be measured using a 100-mm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate greater pain intensity. Changes in VAS scores over time will be compared between study groups to assess treatment-related differences in symptom reduction.
Measured: Baseline (T0), end of first treatment session (T1), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Unstimulated Salivary Flow Rate (UWS)
Salivary flow will be quantified by measuring unstimulated whole saliva (UWS), expressed in mL/min, with values ranging from 0 to theoretically unlimited positive values depending on salivary output. Lower values indicate reduced salivary gland function. Measurements will be performed under standardized conditions to evaluate changes in salivary gland function over time.
Measured: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Stimulated Salivary Flow Rate (SWS)
Salivary flow will be quantified by measuring stimulated whole saliva (SWS), expressed in mL/min, with values ranging from 0 to theoretically unlimited positive values depending on salivary output. Lower values indicate reduced salivary gland function. Measurements will be performed under standardized conditions to evaluate changes in salivary gland function over time. SWS will be collected following gustatory stimulation using fresh lemon juice (approximately two drops, ~0.1 mL, applied to the dorsal surface of the tongue).
Measured: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Xerostomia Severity Assessed by Xerostomia Inventory-11 (XI-11)
Subjective xerostomia will be assessed using the Xerostomia Inventory-11 (XI-11), an 11-item questionnaire scored on a 5-point Likert scale. The total score ranges from 11 to 55, with higher scores indicating greater perceived dry mouth severity.
Measured: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Taste Alterations Assessed by Chemotherapy-Induced Taste Alteration Scale (CiTAS)
Taste disturbances will be evaluated using the Chemotherapy-Induced Taste Alteration Scale (CiTAS), an 18-item questionnaire with each item scored from 1 to 5. The total score ranges from 18 to 90, with higher scores indicating greater taste impairment.
Measured: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Swallowing-Related Quality of Life Assessed by MDADI
Swallowing-related quality of life will be assessed using the M.D. Anderson Dysphagia Inventory (MDADI). The composite score ranges from 20 to 100, with higher scores indicating better swallowing-related quality of life. Changes in MDADI scores over time will be analyzed between study groups.
Measured: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Functional Oral Intake Assessed by FOIS
Functional oral intake will be evaluated using the Functional Oral Intake Scale (FOIS), which ranges from 1 (no oral intake) to 7 (full oral intake without restrictions). Higher scores indicate better functional oral intake.
Measured: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Oral Health-Related Quality of Life Assessed by OHIP-14
Oral health-related quality of life will be measured using the 14-item Oral Health Impact Profile (OHIP-14). Total scores range from 0 to 56, with higher scores indicating worse oral health-related quality of life.
Measured: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Patient's Global Impression of Change (PGIC)
Global patient-perceived improvement will be assessed using the 7-point Patient's Global Impression of Change (PGIC) scale, ranging from 1 (very much improved) to 7 (very much worse). Lower scores indicate greater perceived improvement.
Measured: 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Oral pH
Oral pH will be measured using standardized pH indicator strips. The pH scale ranges from 0 to 14, where lower values indicate higher acidity, 7 indicates neutrality, and higher values indicate alkalinity. Changes in oral pH over time will be evaluated between study groups.
Measured: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, Associate Professor, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491536
- Sponsor's protocol ID
- 2026-OZONEOM
- Acronym
- OZOMUC
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 24 Mar 2026
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Gas Ozone Therapy and Biomimetic Oral Care in the Management of Radio- and Chemotherapy-Induced Oral Mucositis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07491536
- Acronym / sponsor ID
- OZOMUC / 2026-OZONEOM
- Keywords
- Ozone Therapy, Cancer Treatment-Induced Oral Mucositis, Supportive Oncology, Non-Pharmacological Treatment, Head and Neck Cancer, Oral Toxicity, Salivary Function, Xerostomia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 24 Mar 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.
Oral mucositis is a frequent and often debilitating complication of radiotherapy and chemotherapy, particularly in patients treated for head and neck cancers. It is characterized by inflammation and ulceration of the oral mucosa, leading to pain, difficulty swallowing, taste disturbances, dry mouth, and impairment of daily activities. In more severe cases, oral mucositis may require modification or temporary interruption of cancer treatment.
This randomized controlled clinical trial is designed to assess the clinical effectiveness of gas ozone therapy in patients with radio- and chemotherapy-induced oral mucositis. In addition, the study will evaluate whether combining ozone therapy with a structured biomimetic oral care regimen, including toothpaste and mouthwash, provides additional clinical benefit compared with ozone therapy alone.
Eligible participants will be randomly assigned to one of two parallel groups. The control group will receive gas ozone therapy administered in an outpatient setting according to a standardized protocol. The experimental group will receive the same ozone therapy combined with a defined home oral care regimen. Each participant will be followed for 30 days.
The primary outcome is the change in oral mucositis severity, assessed using the World Health Organization Oral Toxicity Scale. Secondary outcomes include oral pain intensity, salivary flow rates, perceived dry mouth, taste alterations, swallowing function, oral pH, overall oral health-related quality of life, and treatment tolerability.
The findings of this study are expected to clarify the role of ozone-based supportive care strategies in the management of cancer therapy-related oral mucositis and to contribute to the development of standardized non-pharmacological treatment protocols.
Detailed description
Oral mucositis represents a clinically relevant toxicity associated with radiotherapy and chemotherapy, particularly in patients undergoing treatment for head and neck malignancies. The condition arises from a multifactorial biological process that includes epithelial injury, inflammatory cascade activation, oxidative stress imbalance, and subsequent disruption of mucosal integrity. The resulting ulcerative lesions are frequently associated with pain, impaired oral intake, dysphagia, taste alterations, and deterioration in oral health-related quality of life. In more severe cases, mucositis may interfere with adherence to oncologic treatment schedules.
Although several supportive approaches have been proposed, there is currently no universally accepted non-pharmacological protocol capable of consistently reducing mucositis severity and improving functional outcomes.
Medical ozone has been investigated in dentistry for its antimicrobial, anti-inflammatory, and tissue-regenerative properties. Experimental evidence suggests that controlled topical ozone exposure may enhance local oxygen metabolism, modulate inflammatory mediators, and promote mucosal repair. However, robust randomized clinical data evaluating standardized gas ozone protocols in patients with cancer therapy-induced oral mucositis remain limited.
The present study is a monocentric, randomized, controlled, parallel-group clinical trial designed to assess the clinical effectiveness of gas ozone therapy administered using a certified medical device. The trial also aims to investigate whether the association of ozone therapy with a structured biomimetic oral care regimen provides additional benefit compared with ozone therapy alone.
Eligible participants diagnosed with grade 1-3 oral mucositis will be randomized in a 1:1 ratio to receive either ozone therapy alone or ozone therapy combined with a defined home oral care protocol. Ozone applications will be performed in an outpatient clinical setting according to standardized parameters over a 30-day period. Participants allocated to the combined treatment arm will follow a structured domiciliary oral hygiene regimen throughout the study duration.
Clinical evaluations and patient-reported outcome measures will be collected at predefined follow-up visits to monitor mucosal status, symptom progression, functional changes, and treatment tolerability. The study is designed to generate clinically applicable data regarding the role of ozone-based supportive care strategies in the management of radio- and chemotherapy-induced oral mucositis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gas Ozone Therapy | Active comparator | Device: Gas Ozone TherapyParticipants assigned to this arm will receive gas ozone therapy administered in an outpatient clinical setting using a certified medical device. The oral mucosa will be gently dried prior to treatment, and ozone will be applied locally to affected areas using a dedicated silicone applicator. Each site will receive 60 seconds of exposure per cm² at predefined device settings, with a maximum of four sites treated per session. Treatment will be performed three times weekly during the first two weeks (days 1, 3, and 5), followed by twice-weekly sessions until day 30. All participants will receive standardized oral hygiene instructions and will use the same biomimetic toothpaste throughout the study period. |
| Gas Ozone Therapy Plus Biomimetic Oral Care | Experimental | Other: Biomimetic Oral Care RegimenParticipants assigned to this arm will receive the same standardized gas ozone therapy protocol described for the control group. In addition, they will use a biomimetic mouthwash twice daily (morning and evening) after routine oral hygiene procedures for 30 consecutive days. All participants will receive standardized oral hygiene instructions and will use the same biomimetic toothpaste during the study period. Adherence to the domiciliary mouthwash regimen will be monitored through a structured patient diary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Confirmed diagnosis of radio- and/or chemotherapy-induced oral mucositis, grade 1-3 according to the WHO Oral Toxicity Scale
- Undergoing oncologic treatment for solid malignancies, particularly head and neck cancers
- Clinically stable general health condition (ASA physical status I-III)
- Ability to understand and comply with study procedures, including domiciliary treatment and questionnaire completion
Key exclusion criteria (12 listed)
- Oral mucositis grade 4 according to the WHO Oral Toxicity Scale
- Active fungal or bacterial oral infections (e.g., candidiasis, ulcerative stomatitis)
- Traumatic ulcers, non-oncologic mucositis, or concomitant oral mucosal diseases (e.g., lichen planus, pemphigus, graft-versus-host disease)
- Ongoing head and neck radiotherapy with cumulative dose >70 Gy or completion within 7 days prior to enrollment
- Use within 14 days prior to enrollment of mouthwashes, sprays, or gels containing hyaluronic acid, ozone, aloe vera, or similar bioactive agents
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 |
|---|---|---|
| Gas Ozone TherapyMedical gas ozone will be administered in an outpatient clinical setting using a certified ozone delivery system. Prior to application, the affected oral mucosal areas will be gently dried. Ozone will be applied locally using a dedicated silicone applicator, with an exposure time of 60 seconds per cm² and a maximum of four sites treated per session at predefined device settings. Treatment sessions will be performed three times weekly during the first two weeks (days 1, 3, and 5), followed by twice-weekly sessions until day 30. All participants will receive standardized oral hygiene instructions and will use the same biomimetic toothpaste throughout the study period. | Device | Gas Ozone Therapy |
| Biomimetic Oral Care RegimenParticipants allocated to the experimental arm will use a biomimetic mouthwash in addition to the standardized gas ozone therapy protocol. The mouthwash will be applied twice daily, in the morning and evening, after routine oral hygiene procedures for 30 consecutive days. Adherence to the domiciliary regimen will be monitored using a structured patient diary. | Other | Gas Ozone Therapy Plus Biomimetic Oral Care |
Primary outcome
Change in Oral Mucositis Severity Assessed by WHO Oral Toxicity Scale
Time frame: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
The primary outcome is the change in oral mucositis severity measured using the World Health Organization (WHO) Oral Toxicity Scale. The scale ranges from 0 (no mucositis) to 4 (severe mucositis preventing oral intake), with higher scores indicating greater mucosal damage severity. Changes in WHO grade from baseline will be compared between study groups to evaluate the clinical effectiveness of the interventions.
10 secondary outcomes
Change in Oral Pain Intensity Assessed by Visual Analogue Scale (VAS)
Time frame: Baseline (T0), end of first treatment session (T1), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Unstimulated Salivary Flow Rate (UWS)
Time frame: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Stimulated Salivary Flow Rate (SWS)
Time frame: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Xerostomia Severity Assessed by Xerostomia Inventory-11 (XI-11)
Time frame: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Taste Alterations Assessed by Chemotherapy-Induced Taste Alteration Scale (CiTAS)
Time frame: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Swallowing-Related Quality of Life Assessed by MDADI
Time frame: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Functional Oral Intake Assessed by FOIS
Time frame: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Oral Health-Related Quality of Life Assessed by OHIP-14
Time frame: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Patient's Global Impression of Change (PGIC)
Time frame: 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Change in Oral pH
Time frame: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 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.
Andrea Scribante, Associate Professor principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gas Ozone Therapy and Biomimetic Oral Care Regimen in people with Oral Mucositis and Chemotherapy-induced 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 24 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Scribante, Associate Professor (+39 0382516223, andrea.scribante@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oral Mucositis Severity Assessed by WHO Oral Toxicity Scale (time frame: Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4)). 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 Mar 2026.