Trial reportJournal of medical Internet research2025
Evaluating the Efficacy of a Digital Therapeutic Intervention for Temporomandibular Disorders: Multicenter, Randomized, Sham-Controlled Trial.
Trial report in Journal of medical Internet research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Advanced, pharmacological and complementary interventions for chronic or recurrent orofacial pain conditions: a systematic evidence map with selective meta-analyses.The journal of headache and pain · 2026Pooled it
- Behavioral Modification as a Putative Mediator of Digital Therapeutic Response in Temporomandibular Disorders: Secondary Analysis of a Multicenter Sham-Controlled Randomized Trial.JMIR mHealth and uHealth · 2026Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTemporomandibular 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.
objectiveThis 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.
methodsWe 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.
resultsA 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.
conclusionsThis 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.
trial registrationClinical Research Information Service KCT0009493; https://tinyurl.com/567fexbj.
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