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

Open label randomized controlled trial of a digital therapeutics in temporomandibular disorder (TMD) patients: A preliminary study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Open label randomized controlled trial of a digital therapeutics in temporomandibular disorder (TMD) patients: A preliminary study Young-Kyun Kim, Sang-Yoon Park, Daehyun Kim, Bongju Kim, Jong-Ho Lee This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-2756192/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version 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. Health sciences/Health care/Therapeutics/Pain management Health sciences/Medical research/Clinical trial design/Randomized controlled trials Temporomandibular disorder Digital therapeutics Digital medicine Medical device as software Full Text Additional Declarations (Not answered) Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-2756192","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":193772385,"identity":"131af137-4411-4601-8376-497360893970","order_by":0,"name":"Young-Kyun 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therapeutics, Digital medicine, Medical device as software","lastPublishedDoi":"10.21203/rs.3.rs-2756192/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-2756192/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: 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. 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The patients were followed up in 3-4 weeks for both groups, and the outcome data were collected and analyzed.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResult\u003c/strong\u003e: 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. 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