Halloysite-Assisted Delivery of Cannabidiol for the Management of Temporomandibular Pain: A Pilot Study

<b>Background</b>: Bruxism and temporomandibular disorders (TMD) are commonly associated with increased masticatory muscle activity and pain. Cannabidiol (CBD) exhibits analgesic, myorelaxant, and anti-inflammatory properties, while halloysite may enhance mucosal delivery and bioavailability. <b>Methods</b>: In a randomized, double-blind pilot trial, 20 adults with TMD applied either a CBD gel or a CBD plus halloysite gel nightly for 6 weeks. Masseter muscle activity was recorded using surface electromyography (sEMG) at baseline and post-treatment. <b>Results</b>: Both formulations significantly reduced masseter sEMG activity. The mean decrease was 37.95% with CBD alone (SD = 9.37) and 37.41% with CBD plus halloysite (SD = 5.44). Minimum reductions were 20.44% and 20.02%, and maximum reductions reached 55.16% and 82.52%, respectively. Reductions were bilateral and comparable between right and left sides. Differences between formulations were not statistically significant by <i>t</i>-test (<i>t</i>(8) = 1.613, <i>p</i> = 0.145) or Mann-Whitney <i>U</i> test (<i>p</i> > 0.5). However, variability was lower with the CBD plus halloysite formulation, suggesting a more consistent response. A sex effect reached significance within one formulation (<i>t</i>(8) = 2.315, <i>p</i> = 0.049), while no sex difference was observed in the other. Treatment duration did not correlate with effect size for either gel (Spearman's rₛ = 0.213 and -0.071, both <i>p</i> > 0.5). No adverse events were reported. <b>Conclusions</b>: Nightly intraoral CBD and CBD plus halloysite gels reduced masseter sEMG in adults with TMD, with similar mean efficacy and lower response variability for CBD plus halloysite. These pilot data support further adequately powered, placebo-controlled trials to confirm efficacy, define optimal dosing, and clarify subgroup effects. The trial registration number registered prospectively is NCT05562635 (accessed on 31 August 2022).