In clinical practice, it is commonly assumed that occlusal splints have therapeutic value in the treatment of temporomandibular disorders CTMD), but the evidence based on randomized controlled trials is scarce. This study evaluated the short-term (10-week) efficacy of a stabilization splint in subjects with recurrent secondary otalgia and active TMD treatment need using a randomized, controlled, double-blind design. Thirty-six subjects were randomly allocated to the two treatment groups: the stabilization splint and the control splint group. After 10 weeks' treatment, the intensity of secondary otalgia, measured on a VAS scale (from 0 to 100 mm), decreased statistically significantly in the stabilization splint group (t 2.12; P 0.006), but not in the control group. Improvement in active TMD treatment need in subjects showing moderate or severe signs and symptoms of TMD was reported significantly more often in the stabilization splint group than in the control splint group (chi2 5.71; P.017). A statistically significant decrease in the Helkimo clinical dysfunction index was seen in the subjects with stabilization splint (Z-2.63; P.009), but not in the subjects with control splint. The results indicate that the use of a stabilization splint is beneficial with regard to secondary otalgia and active TMD treatment need.
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