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

ABSTRACT

BACKGROUND: Severe oral mucositis associated with cancer therapy is a frequent complication that may affect a patient's systemic condition, resulting in interruption and/or prolongation of cancer therapy. Dentoxol® is a medical solution in the form of a mouthwash that has been shown to result in statistically significant improvement in the prevention of severe oral mucositis. However, knowing the measures of the clinical significance of this therapy is important for accurate decision-making. AIM: To describe the clinical impact of Dentoxol® use in severe oral mucositis. METHODS: Clinical significance was measured using the results obtained in a randomized controlled clinical trial previously conducted by the same group of researchers. The measures of clinical significance evaluated were the absolute risk or incidence, relative risk, absolute risk reduction, relative risk reduction, number needed to treat, and odds ratio. RESULTS: The data obtained show that the impact of Dentoxol® on reducing the severity of oral mucositis has important clinical relevance. CONCLUSION: The results of this study justify the incorporation of Dentoxol® mouth rinse into clinical protocols as a complement to cancer therapy to prevent and/or treat oral mucositis secondary to radiotherapy.