Validation of a new diagnostic method for quantification of sleep bruxism activity

Abstract

Abstract Objectives To validate a new diagnostic method (DIABRUX) for quantifying sleep bruxism (SB) activity using the current gold standard, polysomnography (PSG), as a criterion in an adequate sample size investigation. Materials and methods For SB diagnosis, each participant received a two-night ambulatory PSG including audio–video recordings. The 0.5-mm-thick sheet is produced in a thermoforming process. After diagnosis via PSG, each subject wore the diagnostic sheet for five consecutive nights. The resulting total abrasion on the surface was automatically quantified in pixels by a software specially designed for this purpose. Results Forty-five participants (10 SB and 35 non-SB subjects) were included. The difference of the mean pixel score between the SB (M = 1,306, SD = 913) and the non-SB group (M = 381, SD = 483; 3.4 times higher for SB) was statistically significant (p < 0.001). The receiver operator characteristic (ROC) analysis revealed a value of 507 pixels as the most appropriate cut-off criterion with a sensitivity of 1.0, a specificity to 0.8, and an area under the curve (AUC) of 0.88. The positive and negative predictive value accounted for 0.59 and 1.0. Conclusions The present data confirm that the new diagnostic method is valid and user-friendly that may be used for therapeutic evaluation, and for the acquisition of larger sample sizes within sophisticated study designs. Clinical relevance The verified properties of the new diagnostic method allow estimating SB activity before damages occur due to long-standing bruxism activity. Therefore, it might be utilized for preventive dentistry. Trial registration number NC T03325920 (September 22, 2017).