A randomized clinical trial of intraoral soft splints and palliative treatment for masticatory muscle pain.

Thirty subjects seeking treatment for masticatory muscle pain at a university-based TMJ clinic were randomly assigned to soft-splint, palliative-treatment, and no-treatment groups. After 4 to 11 weeks of treatment, subjects were evaluated for changes from their baseline levels of symptoms, maximum pain-free opening, pain thresholds measured by a pressure algometer, and occlusal contacts. With the use of the multivariate analysis of variance and analysis of covariance, the results suggest that the soft-splint group had statistically significant improvement (P < .01), the palliative-treatment group had improvement that was not statistically significant, and the no-treatment group had a slight aggravation of symptoms. The soft-splint group had fewer occlusal contact changes assessed with shimstock compared to the palliative-treatment and no-treatment groups. The findings of this study suggest that the soft splint is an effective short-term treatment for reducing the signs and symptoms of masticatory muscle pain in patients, and the soft splint does not cause occlusal changes.