Open label randomized controlled trial of a digital therapeutics in temporomandibular disorder (TMD) patients: A preliminary study

Abstract Background : Temporomandibular disorder (TMD) is a common condition that affects the temporomandibular joint (TMJ) and the muscles of the jaw, resulting in pain and dysfunction. TMD is affected by both behavioral and psychological factors. However, the effectiveness of conservative treatments varies among patients. Digital therapeutics (DTx) is a new treatment approach where a software based medical device is used such as smartphone application. DTx can expect therapeutic effects by controlling behavioral factors through delivery of appropriate intervention and cognitive behavioral therapy. DTx have emerged as a promising alternative treatment option for various chronic conditions, but the development of DTx and the efficacy for TMD have not been fully evaluated. Objective : The aim of this study is to evaluate the efficacy of a DTx for TMD called ‘Clickless®’, which is the first DTx using a smartphone application for TMD. Methods : We recruited 40 participants diagnosed with TMD who visited the Bundang Seoul National University Hospital from March to May 2022. Participants were randomly divided into an intervention test group (DTx use) and a control group. The intervention group received the usual treatment process for TMD in addition to the use of the DTx. The control group received the usual treatments only. The patients were followed up in 3-4 weeks for both groups, and the outcome data were collected and analyzed. Result : The intervention group showed a significant reduction in pain score as measured by the numeral rating scale (NRS) (mean difference 0.82, p = 0.038). Additionally, the intervention test group showed a statistically significant increase in maximal mouth opening compared to the control group. (mean difference 1.38(mm), p = 0.040] However, there was no significant difference of improvement in jaw functional limitation scale, oral behavior checklist, and patient health questionnaire-4 between the two groups. Conclusion : DTx is an effective treatment option for TMD patients when it applied with the conventional treatments, however further research is necessary to confirm its efficacy and wider application.