TY - JOUR T1 - Efficacy of botulinum toxin type a in the targeted treatment of sleep bruxism: a double-blind, randomised, placebo-controlled, cross-over study JF - BMJ Neurology Open JO - BMJ Neurol Open DO - 10.1136/bmjno-2022-000328 VL - 4 IS - 2 SP - e000328 AU - Belinda Cruse AU - Thanuja Dharmadasa AU - Elise White AU - Callum Hollis AU - Andrew Evans AU - Sifat Sharmin AU - Tomas Kalincik AU - Lynette Kiers Y1 - 2022/09/01 UR - http://neurologyopen.bmj.com/content/4/2/e000328.abstract N2 - Background Intramuscular injections of botulinum toxin A (BTX-A) have been used in the treatment of sleep bruxism (SB) however controlled trials are limited and the optimal injection strategy and dose is not known.Methods This double-blind, randomised, placebo-controlled, cross-over study evaluated the efficacy and safety of BTX-A in participants with SB. Average bruxism events per hour of sleep (Bruxism Index, BI) was calculated using surface electromyography. Participants with BI >5 were included and randomised by order of injection (active or placebo with the opposite 20 weeks later) and into one of three differing treatment groups: bilateral masseter (60 units(U)), bilateral masseter and temporalis (90U) and bilateral masseter, temporalis and medial pterygoid muscles (120U). Change in BI and subjective measures of headache, pain, and bruxism at 4 and 12 weeks was calculated following intervention, and differences between treatment groups analysed.Results 41 participants were recruited, 35 randomised and data from 22 participants (14 female) were analysed. BI was significantly lower at 4 weeks after active treatment when compared with placebo (mean=−1.66, p=0.003), not sustained at 12 weeks. The difference was greater with higher doses injected and among those with greater baseline BI. There was no difference in subjective measures at any time point. Five participants injected had mild, transient side effects.Discussion Targeted BTX-A injection is a safe and effective treatment for SB. A greater benefit may be achieved by administering BTX-A into more muscles and at higher total doses and among those with higher baseline BI.Trial registration number ACTRN12618001430224.Data are available on reasonable request. ER -