There is limited evidence supporting the role of occlusal splints in Temporomandibular disorder (TMD) therapy. The aim of this randomized controlled clinical trial was to assess the efficacy of stabilization splint therapy on TMD related facial pain and mandibular mobility. The sample of study consisted of eighty consecutive patients diagnosed with TMD. Patients were randomly assigned into two groups: a splint group (n = 40) comprising of patients treated with stabilization splint, councelling and masticatory muscle exercises, and a control group (n = 40), comprising of patients treated with councelling and masticatory muscle exercises alone. Data from both the groups were collected at the beginning of the study and after a 6-month follow up. The outcome variables were visual analogue scale on facial pain intensity and clinical findings for TMD (anterior maximal opening, mandibular right laterotrusion, mandibular left laterotrusion, mandibular protrusion, and number of painful muscle sites). Changes within the splint and control groups (before treatment and 6 months after treatment) were analyzed using paired samples t test. Differences in change between the splint and control groups were analyzed using independent samples t-test. The level of significance was set at p < 0.05. Facial pain and number of painful muscle sites decreased, and the mandibular mobility increased significantly in both groups after treatment; however the differences in changes in VAS or clinical TMD findings between the two groups were not statistically significant. The findings of this study show that stabilization splint treatment in combination with counselling and masticatory muscle exercises has no additional benefit in relieving facial pain and increasing the mobility of the mandible than counselling and masticatory muscle exercises alone over a 6-months' time interval.
Keywords: Facial pain; Mandibular mobility; Randomized clinical trials; Stabilization splint; Temporomandibular disorders.