Evaluating the Efficacy of a Digital Therapeutic Intervention for Temporomandibular Disorders: Multicenter,...

Temporomandibular disorders (TMDs) are common chronic musculoskeletal conditions associated with pain, jaw dysfunction, and impaired quality of life and influenced by behavioral and psychological factors. Digital therapeutics (DTx) may improve access to standardized behavioral interventions, but their clinical efficacy for TMD has not been adequately established.

This study aimed to investigate the efficacy of a mobile-based DTx intervention (Clickless DTx TMD-01) compared with a sham app in reducing pain and improving functional and psychological outcomes in patients with TMD.

We conducted a multicenter, double-blind, randomized, sham-controlled trial at 2 university hospitals in South Korea. Adults aged between 19 and 65 years with a diagnosis of TMD according to the diagnostic criteria for TMD were randomly assigned (1:1) to the intervention group or sham control. The intervention was delivered via the DTx mobile app and included TMD-related disease education, guided jaw exercises, behavioral habit tracking, psychoeducational content, guided meditation, and data-driven feedback. The sham app provided only symptom recording without therapeutic content. Participants were instructed to use the assigned app daily for 6 weeks. The primary outcome was change in pain intensity measured by a 100-mm visual analog scale. Secondary outcomes included maximum mouth opening and scores on the Jaw Functional Limitation Scale-20, Oral Behaviors Checklist, and Patient Health Questionnaire-4.

A total of 102 participants were randomly assigned (DTx group: n=50, 49%; sham group: n=52, 51%). For the per-protocol analysis, 44 (88%) of the 50 participants in the DTx group and 49 (94%) of the 52 participants in the sham group were included. At 6 weeks, the DTx group showed a significantly greater reduction in pain on the visual analog scale compared with the sham group (-33.64 vs -9.86; between-group difference -23.78, 95% CI -34.15 to -13.41; P<.001). Secondary outcomes also favored the DTx group, with improvements in maximum mouth opening (between-group difference 4.36 mm, 95% CI 1.92-6.81 mm; P<.001), Jaw Functional Limitation Scale-20 scores (-1.02, 95% CI -1.63 to -0.42; P=.005), and Oral Behaviors Checklist scores (-5.84, 95% CI -10.18 to -1.50; P=.009). No significant between-group difference was observed in Patient Health Questionnaire-4 scores. Adherence was acceptable, as all participants included in the final analysis met the use threshold of at least 66.7%. No serious adverse events were reported.

This randomized, sham-controlled trial demonstrated that a mobile-based DTx intervention led to significant improvement in pain at 6 weeks compared with sham control, with additional benefits in jaw function and oral behaviors, although no significant between-group difference was observed in psychological distress. These findings suggest that DTx interventions may serve as a promising and scalable adjunct to conventional care for patients with TMD.

Clinical Research Information Service KCT0009493; https://tinyurl.com/567fexbj.