Extraoral photobiomodulation to prevent hyposalivation in patients treated with head and neck radiotherapy: randomized double-blind clinical trial

Abstract

Purpose To evaluate the efficacy of extraoral photobiomodulation in preventing hyposalivation in patients treated with radiotherapy for head and neck cancers. Methods 52 patients divided into an intervention group (23 patients) and a control group (29 patients). The parameters used were: 30mW, 7.5 J / cm2, 10s / point, 0.3 J / point, a wavelength of 830 nm and an area of 0.028 cm². The salivary flow at rest and the xerostomia inventory were evaluated three times from the beginning to the end of radiotherapy and one month after the end. The primary outcome was the absence of hyposalivation, with secondary outcomes showing a higher prevalence of dry mouth and hyposalivation. Results Most of the sample remained with salivary flow > 0.2 ml / min before and after radiotherapy (control 69% × 65% intervention p > 0.05). The prevalence of xerostomia was higher in the control group (21% x 17% p > 0.05) as well as the complaint of severe xerostomia at the end of radiotherapy (35% x 30% p > 0.05). Oral pain was the most frequent complication (26% vs. 20%, P > 0.05). Conclusion Extraoral photobiomodulation was not effective in preventing the reduction of salivary flow during radiotherapy, but it was responsible for higher flow values compared to the control group. This study allowed for a lower prevalence and severity of xerostomia; however, further studies should be conducted to confirm the real benefits. Trial Registration Numbe at REBEC: RBR5746z9, Dated: April 5^th 2020