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Clinical Trial NCT07491536 (OZOMUC) for Oral Mucositis, Chemotherapy-induced Oral Mucositis, Head and Neck Neoplasms is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis (OZOMUC) 50 Randomized
Clinical Trial NCT07491536 (OZOMUC) is an interventional study for Oral Mucositis, Chemotherapy-induced Oral Mucositis, Head and Neck Neoplasms that is recruiting. It started on 1 March 2026 with plans to enroll 50 participants. Led by University of Pavia, it is expected to complete by 15 December 2026. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
Brief 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 daily activities. In more severe cases, oral mucositis may require modification or temporary interrup...Show More
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 a...Show More
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
Conditions
Oral MucositisChemotherapy-induced Oral MucositisHead and Neck NeoplasmsOther Study IDs
- OZOMUC
- 2026-OZONEOM
NCT ID Number
Start Date (Actual)
2026-03-01
Last Update Posted
2026-03-24
Completion Date (Estimated)
2026-12-15
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
N/A
Status
Recruiting
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
Cancer Treatment-Induced Oral Mucositis
Supportive Oncology
Non-Pharmacological Treatment
Head and Neck Cancer
Oral Toxicity
Salivary Function
Xerostomia
Randomized Controlled Trial
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorGas Ozone Therapy 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 ...Show More | Gas Ozone Therapy 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 t...Show More |
ExperimentalGas Ozone Therapy Plus Biomimetic Oral Care 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. Adhere...Show More | Biomimetic Oral Care Regimen 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline (T0), 7-day follow-up (T2), 15-day follow-up (T3), and 30-day follow-up (T4) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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)
- 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
University of PaviaStudy Responsible Party
Andrea Scribante, Principal Investigator, Associate Professor, Principal Investigator, University of Pavia
Study Central Contact
Contact: Andrea Scribante, Associate Professor, +39 0382516223, [email protected]
1 Study Locations in 1 Countries
Lombardy
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia, Pavia, Lombardy, 27100, Italy
Andrea Scribante, Associate Professor, Contact, +39 0382516223, [email protected]
Recruiting