Actively Recruiting
Combined Gas Ozone Therapy and Biomimetic Oral Care for Radio- and Chemotherapy-Induced Oral Mucositis: A Randomized Controlled Clinical Trial
Led by University of Pavia · Updated on 2026-03-24
50
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Oral mucositis is a common and often painful side effect experienced by patients undergoing radiotherapy and chemotherapy, especially those treated for head and neck cancers. This condition causes inflammation and sores in the mouth, leading to pain, swallowing difficulties, taste changes, dry mouth, and challenges in daily activities. This trial aims to evaluate the effectiveness of gas ozone therapy, alone and combined with a special oral care routine, in managing oral mucositis caused by cancer treatments. Participants will be randomly assigned to one of two groups. One group will receive gas ozone therapy applied in a clinical outpatient setting using a certified device, with treatments three times a week for the first two weeks and twice weekly until day 30. The other group will receive the same ozone therapy plus a home oral care regimen that includes using a biomimetic mouthwash twice daily for 30 days. Both groups will use the same biomimetic toothpaste and receive oral hygiene guidance. Throughout the 30-day study, participants will attend follow-up visits where researchers will assess mucositis severity, pain levels, saliva flow, dry mouth symptoms, taste changes, swallowing ability, oral pH, and overall oral health quality of life. They will also monitor how well participants tolerate the treatments. Data collected will help clarify the role of ozone therapy and oral care in supporting patients with cancer therapy-related oral mucositis.
CONDITIONS
Brief Title
Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of radio- and/or chemotherapy-induced oral mucositis grade 1-3 according to WHO Oral Toxicity Scale
- Undergoing cancer treatment for solid tumors, especially head and neck cancers
- Clinically stable health status (ASA physical status I-III)
- Ability to understand and follow study procedures including home treatment and questionnaires
- Provided written informed consent
You will not qualify if you...
- Oral mucositis grade 4 according to WHO Oral Toxicity Scale
- Active fungal or bacterial infections in the mouth, such as candidiasis or ulcerative stomatitis
- Traumatic ulcers or non-cancer related oral mucositis
- Other oral diseases like lichen planus, pemphigus, or graft-versus-host disease
- Current head and neck radiotherapy with total dose over 70 Gy or completed within 7 days before enrollment
- Use of mouthwashes, sprays, or gels with hyaluronic acid, ozone, aloe vera, or similar agents within 14 days before enrollment
- Use of systemic or topical treatments that affect saliva or mucosal healing
- Known allergy to oral care products or materials used in ozone therapy
- Severe or uncontrolled systemic diseases like liver, kidney, lung, or heart failure
- Severe immune suppression or low white blood cell counts
- Pregnancy or breastfeeding
- Alcohol or substance abuse or any condition affecting study adherence
- Unable to attend follow-up visits through day 30
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 days
Participants receive gas ozone therapy applied to affected oral mucosal areas in an outpatient clinical setting. Treatments occur three times weekly for the first two weeks, then twice weekly until day 30. Participants in the combined treatment group also follow a twice-daily biomimetic oral care regimen at home during this period.
3 visits per week for 2 weeks, then 2 visits per week until day 30
Duration - Up to 30 days after treatment starts
Participants attend follow-up visits for clinical evaluations and patient-reported outcome measures assessing oral mucositis severity, symptoms, and functional changes.
Visits on day 7, day 15, and day 30
Trial Site Locations
Total: 1 location
1
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, Italy, 27100
Actively Recruiting
Research Team
A
Andrea Scribante, Associate Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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