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Dental Tribune United Kingdom Edition

26 Product Spotlight T he NTI-tss appliance has gained in popular- ity over recent years thanks to its high clinical success rates in the treat- ment of migraines and other conditions associated with the Trigeminal Nerve System. Indeed in 1998 NTI-tss was officially approved by the FDA (Food & Drugs Agency USA), and is considered by many to be the most effec- tive non-drug FDA-approved method of migraine preven- tion available. Despite its growing recog- nition however, some quarters have questioned the effective- ness, and indeed the safety of the device. In response to these concerns, in 2008 Stapelmann and Türp conduct- ed a systematic review into all the available data on the NTI-tss appliance!1 Their ex- tensive review encompassed nine separate electronic databases; the NTI-tss manu- facturer’s website (and all its references); relevant text- books on topics including TMDs, occlusion and Bruxism; and the FDA’s MAUDE data- base. Given the research availa- ble, the review concluded that evidence from randomised controlled trials supports the use of the NTI-tss appli- ance for the management of TMDs and bruxism. Further- more, the review supports the judicious use of the NTI- tss oral appliance for patients with acute, painful tempo- romandibular joints who may require treatment that can be implemented quick- ly, and in instances where a reduction in EMG activity of the closing muscles dur- ing tooth clenching or grind- ing is desired. To avoid complications however, the authors recommend that use be limited to patients compli- ant with follow-up appoint- ments. Aside from its findings re- lating to the effectiveness of NTI-tss, the Stapelmann and Türp review is extremely useful in helping to dispel a number of the safety ‘myths’ that have come to light since the appliance was FDA approved back in 1998. The evidence pertaining to ad- verse events for example was clear, and no incidents of ap- pliance aspiration could be identified in the FDA’s Manu- facturer and User Facility De- vice Experience (MAUDE) da- tabase. Given the importance of any concerns surrounding the safety of a product, it is worth expanding upon these issues in more depth. One of the most common concerns surrounding NTI-tss relates to supra-eruption of posterior teeth. Critics argue that due to the product’s na- ture in treating cases of Brux- ism, there is a possibility that the induced hypofunction (ie no occlusal contact at all) will lead to the supra-eruption of teeth. Research by Kinoshita et al however, found that in rats, it took at least eight full NTI-tss: reviewing the evidence ‘The Stapelmann and Türp review is extremely useful in helping to dispel a number of the safe- ty ‘myths’ that have come to light ’ March 26-April 1, 2012United Kingdom Edition