Clinical relevance of the use of Dentoxol® for oral mucositis induced by radiotherapy: A phase II clinical trial

ARTICLE HIGHLIGHTS

Research background

Oral mucositis is a complication that arises from cancer treatment (chemotherapy and/or radiotherapy) and manifests as erythematous and ulcerative lesions of the oral mucosa. The pathogenesis of oral mucositis is complex and involves different pathways. One of the events involved in the development of mucositis is the inflammatory response of tissues to cancer therapy The complex nature of oral mucositis requires a comprehensive preventive and therapeutic approach that can address the different pathways involved to achieve a successful outcome. Managing only inflammation or overinfection is not sufficient for efficient and adequate control. In this context, Dentoxol^®, an aqueous solution used as a mouthwash, whose main mode of action is mechanical sloughing of the superficial epithelial cell layer of the oral mucosa, thus stimulating local regeneration of the epithelium, was developed. Recently, a randomized controlled clinical trial conducted by this research team evaluated the effect of Dentoxol^® mouthwash on the prevalence of severe oral mucositis and found statistically significant results regarding the prevention and reduction in the severity of oral mucositis.

Research motivation

Many clinical studies present their results based on statistical significance. However, clinical measures of significance are essential for evaluating the relevance and usefulness of a therapy in daily clinical practice.

Research objectives

The aim of the present study is to objectively and clearly present the clinical impact of Dentoxol^® on affected tissues based on statistical results obtained in a previously conducted clinical trial, with the aim of providing a clearer picture of the impact that clinicians responsible for managing this pathology should expect in their daily work when using this preventive and therapeutic tool to manage and control oral mucositis.

Research methods

Once the statistical results of the clinical trial were obtained, clinical significance measures such as the absolute risk (AR), relative risk (RR), absolute risk reduction (ARR), relative risk reduction, number necessary to treat (NNT), and odds ratio were calculated using a contingency table.

Research results

The ARs of severe oral mucositis in the Dentoxol^® group were 0.04 and 0.09 or 4% and 9% for weeks 3 and 4, respectively, versus 0.23 and 0.29 or 23% and 29%, respectively, in the control group. Additionally, from week 2 onward, the relative risk of severe oral mucositis in the Dentoxol^® group was less than 1, indicating that Dentoxol^® use acted as a protective factor. Dentoxol^® use was positively associated with a reduction in severe oral mucositis from week 2 onward, showing ARR values greater than 0. The values at weeks 3 and 4, ARR = 0.19 or 19% and 0.21 or 21%, respectively, indicate that if 100 patients were treated with Dentoxol^®, 19 and 21, respectively, fewer cases of severe mucositis would occur compared to the control group. Likewise, during weeks 3 and 4, when statistically significant differences between the groups were noted, 5 patients (NNT) would need to be treated with Dentoxol^® to prevent 1 additional case of severe oral mucositis.

Research conclusions

In this study, the effects of Dentoxol^® were clinically evident and detectable in a small number of treated patients; therefore, the inclusion of Dentoxol^® in clinical protocols is highly recommended for the management and control of the side effects of cancer treatments, which is as important as the other components of the therapeutic arsenal for cancer.