Oral MucositisNCT07247799
Ozone Therapy for the Treatment of Oral Mucositis in Patients Undergoing Radio and Chemotherapy in the Head and Neck Region
An observational study of Oral Mucositis and Head and Neck Neoplasms, run by Andrea Scribante at 1 site in Italy.
Trial summary
The present study aims to evaluate the effectiveness of a combined protocol of professional and at-home ozone therapy in the treatment of oral mucositis in patients undergoing radio- and/or chemotherapy. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Oral Mucositis, Head and Neck Neoplasms
- What is being tested?
- Ozone treatment
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 20 Jan 2026
- 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 40 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients under orthodontic care at the Section of Dentistry
Who may be able to join
- patients undergoing radio and chemotherapy for head and neck cancer and cancers in other districts
Who cannot join
- syndromic patients
- pregnant women
- patients with cardiac pacemakers
- epileptic patients
- patients with high sensitivity to electric current
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Ozone Therapy for the Treatment of Oral Mucositis in Patients Undergoing Radio and Chemotherapy in the Head and Neck Region: Retrospective Observational Study
The present study aims to evaluate the effectiveness of a combined protocol of professional and at-home ozone therapy in the treatment of oral mucositis in patients undergoing radio- and/or chemotherapy.
In-office treatment was performed using a medical ozone generator, while at-home therapy involved the daily application of high-concentration ozonated oil products. The study assessed the reduction in mucositis severity (WHO scale), decrease in pain (VAS scale), and improvement in patient-reported quality of life, with specific attention to nutrition, oral hygiene, and treatment adherence.
- Conditions
- Oral Mucositis, Head and Neck Neoplasms
- Being tested
- Ozone treatment
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone treatmentDevice
Ozone DTA (Sweden \& Martina SpA, 35020 Due Carrare, PD, Italy) for clinical application; home oral care with DentO3® toothpaste, CollutO3®, Ozoral® Gel (Innovares, Sant'Ilario d'Enza (RE) - Italy).
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing radio and chemotherapy for head and neck cancer | Not described Receives: Device: Ozone treatment | |
| Patients undergoing radio and chemotherapy for cancers in other districts | Not described Receives: Device: Ozone treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHO scale for oral mucositis
Scoring criteria:
- 0 None
- 1 Oral soreness, erythema
- 2 Oral erythema, ulcers, solid diet tolerated
- 3 Oral ulcers, liquid diet only
Measured: At baseline (T0), baseline after treatment (T1), after 48 hours (T2), at day five (T3), at day eight (T4), at day twelve (T5), at day fifteen (T6)
Secondary outcomes (2)
Visual Analogue Scale
Evaluation of self-perceived pain from 0 (no pain) to 10 (worst pain ever)
Measured: At baseline (T0), baseline after treatment (T1), after 48 hours (T2), at day five (T3), at day eight (T4), at day twelve (T5), at day fifteen (T6)
Questionnaire
Score from 0=best outcome to 10= worst outcome for the following items:
- On a scale from 1 to 10, how much discomfort do certain foods and beverages cause you?
- On a scale from 1 to 10, to what extent does your oral condition make you limit the intake of certain foods and beverages?
- On a scale from 1 to 10, how much do certain food textures (e.g., crunchy foods) bother you?
- On a scale from 1 to 10, to what extent does your oral condition lead you to limit the texture of the foods you consume?
- On a scale from 1 to 10, how much discomfort does the temperature of certain foods and beverages cause you?
- On a scale from 1 to 10, to what extent does your oral condition make you limit the temperature of the foods and beverages you consume?
- On a scale from 1 to 10, how much does your oral condition cause discomfort during your daily oral activities?
- On a scale from 1 to 10, how much discomfort does your oral condition cause during daily oral hygiene (brushin
Measured: At baseline (T0) and at day fifteen (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Sep 2025
- Primary completion10 Jan 2026
- Study completion20 Jan 2026
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrea Scribante
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247799
- Sponsor's protocol ID
- 2025-OZONEMUCOSITIS
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ozone Therapy for the Treatment of Oral Mucositis in Patients Undergoing Radio and Chemotherapy in the Head and Neck Region: Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07247799
- Acronym / sponsor ID
- 2025-OZONEMUCOSITIS
- Conditions
- Oral Mucositis, Head and Neck Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Andrea ScribanteUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 25 Nov 2025 (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.
The present study aims to evaluate the effectiveness of a combined protocol of professional and at-home ozone therapy in the treatment of oral mucositis in patients undergoing radio- and/or chemotherapy.
In-office treatment was performed using a medical ozone generator, while at-home therapy involved the daily application of high-concentration ozonated oil products. The study assessed the reduction in mucositis severity (WHO scale), decrease in pain (VAS scale), and improvement in patient-reported quality of life, with specific attention to nutrition, oral hygiene, and treatment adherence.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing radio and chemotherapy for head and neck cancer | – | Device: Ozone treatment |
| Patients undergoing radio and chemotherapy for cancers in other districts | – | Device: Ozone treatment |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients under orthodontic care at the Section of Dentistry
Key inclusion criteria (1 listed)
- patients undergoing radio and chemotherapy for head and neck cancer and cancers in other districts
Key exclusion criteria (5 listed)
- syndromic patients
- pregnant women
- patients with cardiac pacemakers
- epileptic patients
- patients with high sensitivity to electric current
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 |
|---|---|---|
| Ozone treatmentOzone DTA (Sweden \& Martina SpA, 35020 Due Carrare, PD, Italy) for clinical application; home oral care with DentO3® toothpaste, CollutO3®, Ozoral® Gel (Innovares, Sant'Ilario d'Enza (RE) - Italy). | Device | Patients undergoing radio and chemotherapy for cancers in other districts, Patients undergoing radio and chemotherapy for head and neck cancer |
Primary outcome
WHO scale for oral mucositis
Time frame: At baseline (T0), baseline after treatment (T1), after 48 hours (T2), at day five (T3), at day eight (T4), at day twelve (T5), at day fifteen (T6)
Scoring criteria: * 0 None * 1 Oral soreness, erythema * 2 Oral erythema, ulcers, solid diet tolerated * 3 Oral ulcers, liquid diet only
2 secondary outcomes
Visual Analogue Scale
Time frame: At baseline (T0), baseline after treatment (T1), after 48 hours (T2), at day five (T3), at day eight (T4), at day twelve (T5), at day fifteen (T6)
Questionnaire
Time frame: At baseline (T0) and at day fifteen (T6)
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 27 Jan 2026.
Related trials for Oral Mucositis
Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
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.
Andrea Scribante, DDS, PhD 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?
An observational study of Oral Mucositis and Head and Neck Neoplasms, run by Andrea Scribante 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 1 inclusion and 5 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 27 Jan 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?
WHO scale for oral mucositis (time frame: At baseline (T0), baseline after treatment (T1), after 48 hours (T2), at day five (T3), at day eight (T4), at day twelve (T5), at day fifteen (T6)). 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 27 Jan 2026.