Efficacy of botulinum toxin type a in the targeted treatment of sleep bruxism: a double-blind, randomised, placebo-controlled, cross-over study

Abstract

BackgroundIntramuscular 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.MethodsThis 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.Results41 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.DiscussionTargeted 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 numberACTRN12618001430224.

Effect of botulinum toxin type A on muscular temporomandibular disorder: A systematic review and meta‐analysis of randomized controlled trials

“…1 week in three RCTs, 14,23,24 2 weeks in one RCT, 14 1 month in seven RCTs, 8,14,22,23,[27][28][29] 2 months in two RCTs, 14,26 3 months in four RCTs, 8,14,22,24 6 months in four RCTs, 9,14,23,24 and 6 years in one RCT. 10…”

“…Twelve studies involving 158 participants reported adverse eve nts. 8,14,16,17,22,23,[25][26][27][28][29][30] There was no significant difference in the risk of any adverse effects between BTX-A and placebo (RR 2.68, 95% CI 0.86 to 8.35, p = .09, I 2 = 47%) (Figure 5). Subgroup analyses based on dosage and injection sites showed no difference compared to placebo and between subgroups (Figure S6).…”

“…Of these, 19 publications on 15 RCTs involving 504 participants met the inclusion criteria and were included in this systematic review and meta-analysis. [8][9][10][11][12][13][14][15][16][17]22,23,[24][25][26][27][28][29][30]…”

“…15 The maximum total dose was 100 U per side in three RCTs. 9,27,30 BTX-A was administered to the masseter in all but one RCT, 15 temporalis in 12 RCTs, [8][9][10]14,17,[23][24][25][26][27][28][29] medial pterygoid in three RCTs, 8,14,29 and lateral pterygoid in three RCTS. 14,15,28 In one RCT, 8 the sites of injection depended on the intervention group to which the participants were assigned.…”

“…Another review suggested a slight decrease in pain in the BTX-A group after 1 month and emphasized the need for further high quality studies. 5 Recently, several new randomized controlled trials (RCTs) [8][9][10][11][12][13][14][15][16][17] have been published, allowing for a more comprehensive evaluation of the changes in pain intensity, muscle activity and mandibular movement range following BTX-A injection, across different follow-up intervals and injection protocols. This systematic review and meta-analysis of randomized controlled trials aimed to assess the effectiveness, safety and optimal dose of BTX-A for the treatment of muscular TMD.…”