Effects of occlusal splint therapy in patients with migraine or tension-type headache and comorbid temporomandibular disorder: A randomized controlled trial.

Background: Migraine and tension-type headache often occur comorbid with temporomandibular disorder; occlusal splint therapy is the most common treatment for temporomandibular disorder. The aim of this study was to assess the effects of occlusal splint therapy on headache symptoms in patients with migraine and/or tension-type headache comorbid with temporomandibular disorder. Methods: Sixty adult patients with migraine and/or tension-type headache and comorbid temporomandibular disorder were randomly assigned to individualized occlusal splint therapy applied during day-and nighttime plus usual care (n=30) or usual care alone (n=30). Primary outcome was the change in current pain intensity on a 100 mm visual analogue scale from week 1 to week 12. Secondary outcomes included changes in headache days and headache hours assessed by headache diaries over a 2-week period, health-related quality of life (SF-36), and adverse events from week 1 to week 12 and (in the occlusal splint plus usual care group only) to week 24. Results: No group differences in changes in pain intensity from week 1 to week 12 were found. The number needed to treat was 3.8. Physical quality of life reduced stronger in the usual care group than in the occlusal splint plus usual care group. In the occlusal splint plus usual care group, headache intensity significantly decreased and physical quality of life significantly increased from week 1 to week 12 and to week 24 (all P<.001). No adverse events were reported. Conclusions: A day- and night-time occlusal splint therapy in addition to usual care was not superior to usual care alone in patients with chronic headache and comorbid TMD. Four patients need to be treated to induce a minimal clinically relevant improvement in one patient. The small sample size and lack of power limit these findings.