JMIR Publications

ABSTRACT

Background:

Temporomandibular disorders (TMD) are chronic musculoskeletal conditions influenced by behavioral and psychological factors, for which long-term symptom control remains challenging.

Objective:

To investigate the efficacy of a mobile-based DTx (Clickless DTx TMD-01) in adults with TMD (n=102).

Methods:

In this multicenter, double-blind, sham-controlled randomized clinical trial, Participants were assigned to either an active DTx group or a sham application-control group for 6 weeks. The primary outcome was pain intensity measured by visual analog scale (VAS); secondary outcomes included maximum mouth opening (MMO), jaw functional limitation scale (JFLS-20), Oral Behavior Checklist (OBC), and Patient Health Questionnaire-4 (PHQ-4).

Results:

At week 6, the DTx group showed significantly greater reductions in VAS scores compared with the sham group (−33·64 vs −9·86; between-group difference: 23.78; 95% CI: 13.41–34.15; p<0.001). Improvements were also observed in MMO (between-group difference: 4·36 mm; 95% CI: 1.92–6.81; p<0·001), JFLS-20 global scores (−1.02; 95% CI: −1.63 to −0.42; p=0.005), and OBC scores (−5.84; 95% CI: −10.18 to −1.50; p=0.009), all favoring the DTx group. No significant between-group difference was observed in PHQ-4 scores.

Conclusions:

These findings demonstrate that application-based DTx significantly reduces pain and improves functional outcomes in patients with TMD. A DTx approach may serve as an effective adjunct to standard care, particularly for behaviorally mediated chronic pain conditions. Clinical Trial: Clinical Research Information Service (CRIS), TRN: KCT0009493, Registration approval date: 30 April 2024.