Efficacy and safety of Dentoxol® in the prevention of radiation-induced oral mucositis in head and neck cancer patients (ESDOM): a randomized, multicenter, double-blind, placebo-controlled, phase II trial

Abstract

Purpose The aim of this study was to assess the efficacy and safety of Dentoxol mouthrinse in reducing the severity of oral mucositis (OM) secondary to radiation therapy (RT) for head and neck cancer. Methods A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial was conducted. Subjects were asked to use Dentoxol (n = 55) or control (n = 53) mouthrinse 5 times/day during RT. Twice a week, OM was assessed clinically using the WHO scale and the Oral Mucositis Daily Questionnaire (OMDQ) was completed. Results The incidence of severe OM was 40.7% in the Dentoxol group and 51% in the control group (p = 0.265). Comparing all recorded clinical assessments, severe OM was seen in 13.3% of all assessments in the Dentoxol group vs. 21.8% in the control group (p = 0.000). There was a statistically significant lower proportion of assessments showing severe OM in the Dentoxol group at weeks 4, 5, and 6 of RT. The mean duration of severe OM was 11.95 days in the Dentoxol group vs. 14.59 days in the control group (p = 0.502). There was no difference between groups in mouth pain and its impact on function. The use of Dentoxol was safe and was not linked to any serious adverse events. Conclusion The use of Dentoxol 5 times/day is safe and resulted in significantly fewer time-points with severe OM and a delay in the onset of severe OM, compared with a control rinse. A phase III clinical trial is warranted to confirm efficacy and address the limitations of this study.

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

“…A descriptive study was conducted on the clinical significance of Dentoxol ® in treating oral mucositis based on results obtained in a randomized controlled clinical trial with a parallel arm design (1:1) evaluating the effect of Dentoxol ® mouthwash (test group) versus a placebo mouthwash (control group) on the incidence of severe oral mucositis associated with cancer therapy. The full methodology of the clinical trial was previously published by Lalla et al [ 21 ].…”

“…As a result, Dentoxol ® can prevent oral mucositis by physically moisturizing and lubricating the oral mucosa to provide flexibility and resistance. Accordingly, it affects several pathways that influence the severity of oral mucositis[ 21 ].…”

“…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[ 21 ]. Many clinical studies present their results based on statistical significance.…”

Effect of Dentoxol® in the treatment of recurrent mild aphthous ulcers. A prospective observational pilot study.

“…Its primary mode of action is through cleaning, moisturizing and lubricating the mouth and mechanical stimulation of the epithelium, generating optimal conditions for natural cell turnover. Some of the components (eugenol, camphor, parachlorophenol, hydrogen peroxide, purified water, xylitol, sodium bicarbonate, sucralose, and peppermint essence) may have calming and antimicrobial activity (8,9) . Recently, a double-blind randomized clinical trial was conducted with the objective of evaluating the efficacy of Dentoxol ® in radiation-induced oral mucositis (OM) in patients with head and neck cancer (8) .…”

Mucositis Oral: Actualización en el Diagnóstico, Prevención y Tratamiento

“…Mientras que en pacientes tratados con RT, afectará principalmente las superficies mucosas expuestas en forma directa a la radiación de cabeza y cuello. Las lesiones iniciales establecidas en ambos casos sufren una decoloración blanquecina debido a la falta de descamación de queratina, la cual posteriormente se desprende y es reemplazada por mucosa atrófica, edematosa, eritematosa y friable, la que finalmente progresa a múltiples erosiones y úlceras, de gran tamaño, poca profundidad, fondo necrótico y halos eritematoso en su periferia (Mallick et al, 2016;Lalla et al, 2020).…”