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

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).