Occlusal splint therapy performed during the day and at night in addition to usual care does not result in greater reductions in headache symptoms compared with usual care alone in patients with migraine and/or tension-type headache (TTH) comorbid with temporomandibular disorder (TMD), study results published in Medicine (Baltimore) suggests.

In this randomized trial, patients with migraine and/or TTH and comorbid TMD were assigned to either individualized occlusal splint therapy applied during the day and at night in addition to usual care (n=30) or usual care alone (n=30). The change in current pain intensity based on a 100-mm visual analogue scale from week 1 to week 12 comprised the primary outcome. Secondary outcomes were changes in headache days and headache hours over a 2-week period (assessed by self-reported headache diaries), health-related quality of life (SF-36), and adverse events (AEs) from week 1 to week 12. The change in the rate of AEs was also assessed up to week 24 in the combined intervention group.

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From week 1 to week 12, there were no group differences in changes in headache intensity (group difference, −12.2; 95% CI, −29.1 to 4.8; P =.283), headache days (group difference, 0.5; 95% CI, −2.7 to 3.7; P =.757), or headache hours (group difference, 14.7; −41.0 to 70.5; P =.558). A larger significant decrease in mental quality of life was observed in the usual care alone group (P =.022). Conversely, there was a significantly greater increase in physical quality of life from week 1 to week 12 and to week 24 in the occlusal splint plus usual care group (P <.001). None of the patients reported any AEs during the study.

Study limitations included the small sample size, the high drop-out rate, the short duration, and the lack of placebo or sham splints as a comparator intervention.

Although the findings are promising, the study’s inherent limitations suggest no current “clear implications for clinical practice can be drawn,” the investigators wrote.


Saha FJ, Pulla A, Ostermann T, et al. Effects of occlusal splint therapy in patients with migraine or tension-type headache and comorbid temporomandibular disorder: a randomized controlled trial. Medicine (Baltimore). 2019;98(33):e16805.