Head and Neck Neoplasms, Oral Mucositis
Conditions
Brief 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. 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.
Interventions
DEVICEOzone treatment
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).
Sponsors
Andrea Scribante
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Inclusion criteria
* patients undergoing radio and chemotherapy for head and neck cancer and cancers in other districts
Exclusion criteria
* syndromic patients * pregnant women * patients with cardiac pacemakers * epileptic patients * patients with high sensitivity to electric current
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WHO scale for oral mucositis | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | 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) | Evaluation of self-perceived pain from 0 (no pain) to 10 (worst pain ever) |
| Questionnaire | At baseline (T0) and at day fifteen (T6) | 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 |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORAndrea Scribante, DDS, PhD
University of Pavia
Outcome results
None listed