The aim of this study was to assess the impact of the use of a fluoride toothpaste (Bioxtra®, Biopharm, Milan, Italy) with salivary enzymes, essential oils, proteins and colostrum extract versus a fluoride toothpaste without menthol on the oral hygiene grade and on the quality of life (QoL) of children with oral mucositis (OM) grade 1 or 2 receiving chemotherapy for Acute Lymphoblastic Leukaemia (ALL).


Patients between 6 and 14 years with OM were randomly assigned to two groups, group A (Bioxtra® toothpaste) and group B (fluoride toothpaste without menthol). The patients were instructed to brush their teeth at least twice a day using a soft toothbrush with a small head. Oral hygiene grade was assessed using the simplified oral hygiene index (OHI-s); quality of life was assessed using the short form of the Oral Health Impact Profile (OHIP-14) questionnaires. The patients were evaluated on day 1(diagnosis of OM-T0) and on day 8 (T1). Statistical analysis was performed.


A total of 64 patients were enrolled. A significant difference (P < 0.001) between the mean of the OHI-s in group A (0.9 ± 1.2) and in group B (1.5 ± 1.3) was found; the overall OHIP-14 scores were not associated with the use of one or the other toothpaste (P = 0.33).


Although the use of Bioxtra® toothpaste does not affect the QoL of children undergoing chemotherapy, it may be recommended as clinically effective in improving the oral hygiene grade.

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