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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing radio and chemotherapy for head and neck cancer |
| ||
| Patients undergoing radio and chemotherapy for cancers in other districts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozone treatment | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| WHO scale for oral mucositis | Scoring criteria:
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale | Evaluation of self-perceived pain from 0 (no pain) to 10 (worst pain ever) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients under orthodontic care at the Section of Dentistry
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Scribante, DDS, PhD | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia | Pavia | Lombardy | 27100 | Italy |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Score from 0=best outcome to 10= worst outcome for the following items:
|
| At baseline (T0) and at day fifteen (T6) |