Quantitative polygraphic controlled study on efficacy and safety of oral splint devices in tooth-grinding subjects.

The efficacy of occlusal splints in diminishing muscle activity and tooth-grinding damage remains controversial. The objective of this study was to compare the efficacy and safety of an occlusal splint (OS) vs. a palatal control device (PCD). Nine subjects with sleep bruxism (SB) participated in this randomized study. Sleep laboratory recordings were made on the second night to establish baseline data. Patients then wore each of the splints in the sleep laboratory for recording nights three and four, two weeks apart, according to a crossover design. A statistically significant reduction in the number of SB episodes per hour (decrease of 41%, p = 0.05) and SB bursts per hour (decrease of 40%, p < 0.05) was observed with the two devices. Both oral devices also showed 50% fewer episodes with grinding noise (p = 0.06). No difference was observed between the devices. Moreover, no changes in respiratory variables were observed. Both devices reduced muscle activity associated with SB.

RCT Entities:   Population Interventions Outcomes