Proof of Concept Study of an Oral Orthotic in Reducing Tic Severity in Tourette Syndrome.

The use of an oral orthotic, called an occlusal splint, has gained recognition for the potential to reduce the frequency of tics for individuals with Persistent Tic Disorders. The purpose of this study was to assess the feasibility of a fully blinded, randomized controlled trial (RCT) to assess the safety, tolerability and initial efficacy of the oral orthotic in youth with chronic tics. Thirteen youth were randomly assigned to wear an active or sham orthotic in a two week double-blind RCT, with a 4-6 week unblinded follow up period. A statistically significant difference was found for change in tic severity between participants wearing the active and sham orthotic. However, this difference was not replicated during the follow up period. The oral orthotic is a promising intervention for the reduction of tics in youth with Tourette's Syndrome and is worthy of continued study to establish intervention efficacy and mechanism of action.