Ozone Therapy for the Treatment of Oral Mucositis in Patients Undergoing Radio and Chemotherapy in the Head and Neck Region

Andrea Scribante38 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Oral Mucositis Head and Neck Neoplasms

Interventions

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).

Outcomes

Primary Outcomes

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

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)

Secondary Outcomes

Visual Analogue Scale

Evaluation of self-perceived pain from 0 (no pain) to 10 (worst pain ever)

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

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

Time frame: At baseline (T0) and at day fifteen (T6)