Effects of clear aligners on sleep bruxism: randomized controlled trial.

The possible effects on sleep bruxism (SB) of clear aligners in orthodontics are unknown. This study was conducted to analyze the effects of clear aligners on SB. Sixty subjects needing orthodontic treatment and affected by SB (33 m, 27 f, 20±;5 years) were enrolled in the study and randomly assigned to one of the following three groups: 20 were given clear aligners (CAT) (12 m, 8 f, 19±5 years), 20 occlusal splint (MOS) (9 m, 11 f, 22±5 years) and 20 a placebo splint (PMS) (12 m, 8 f, 24±3 years). All groups were followed for 6 consecutive months and monitored for SB with a portable electromyographic-electrocardiographic (EMG-ECG) device (Bruxoff®, OT Bioelettronica, Torino, Italy). MOS subjects reduced masseter contractions after 6 months of treatment (t3) (MD=-29.11, std. error 11.74, p=0.017) but increased phasic contractions related to SB after 3 months of treatment (t2) (MD=4.73, std. error 2.36, p=0.048) and tonic contractions related to SB during all the six months of treatment (t1, t2, t3) when compared to PMS. CAT subjects increased phasic contractions related to SB during the first (t1) (MD=3.94, std. error 2.27, p=0.04) and the third month (t2) of treatment (MD=4.62, std. error 2.36, p=0.046) when compared to PMS. No significant differences were found for SB index at any time for all the three groups. Although MOS and CAT affected EMG signals during sleep time differently, they did not influence the overall SB index.