Treatment of myogenic temporomandibular disorder: A prospective randomized clinical trial, comparing a mechanical stretching device (TheraBite®) with standard physical therapy exercise

Aims: To compare in a randomized controlled clinical trial (RCT) the application of the TheraBiteH (TB) Jaw Motion Rehabilitation System with a standard physical therapy (PT) exercise regimen for the treatment of myogenic temporomandibular disorder (TMD). Methodology: Myogenic TMD patients were randomized for the use of the TB device or for standard PT. Mandibular function was assessed with the mandibular function impairment questionnaire (MFIQ). Pain was evaluated using a visual analog scale, and maximum inter-incisor (mouth) opening (MIO) was measured using the disposable TB range of motion scale. Results: Of the 96 patients randomized (46 TB, 50 standard PT exercises), 38 actually started with the TB device and 41 with the standard PT exercises. After six-week follow-up, patients using the TB device reported a significantly greater functional improvement (MFIQ score) than the patients receiving regular PT exercises (P50.0050). At 6 weeks, no significant differences in pain, and active or passive MIO were found between the two groups. At 3 months, patients in both treatment groups did equally well, and showed a significant improvement in all parameters assessed. Conclusions: This RCT on myogenic TMD treatment, comparing standard PT with passive jaw mobilization using the TheraBite Jaw Motion Rehabilitation System®, shows that both treatment modalities are equally effective in relieving myogenic TMD symptoms, but that the use of the TB device has the benefit of achieving a significantly greater functional improvement within the first week of treatment.