A randomized control trial measuring the effectiveness of a mouth-exercising device for mucosal burning in oral submucous fibrosis.

Objectives To evaluate effect of ice-cream stick exercise regimen with or without a mouth-exercising device (MED) on mucosal burning sensation in oral submucous fibrosis. Study Design In total, 282 patients with oral submucous fibrosis were treated with topical corticosteroid and oral antioxidant and the ice-cream stick exercise regimen. Patients in subgroups A1, A2, and A3 were additionally given a new MED. Patients in subgroups A1 and B1 patients with interincisal distance (IID) of 20 to 35 mm were managed without any additional therapy; patients in subgroups A2 and B2 with IID of 20 to 35 mm were additionally managed with intralesional injections; and those in subgroups A3 and B3 with IID less than 20 mm were managed surgically. Subjective evaluation of decrease in the oral mucosal burning was measured on a visual analogue scale (VAS). Analysis of variance and Tukey's multiple post hoc analysis were carried out to present the results. Results Patients using the MED, that is, subgroups A1, A2, and A3, showed reduction in burning sensation in the range of 64.8% to 71.1% and 27.8% to 30.9%, whereas in subgroups B1, B2, and B3, reduction in burning sensation ranged from 64.7% to 69.9% and from 29.3% to 38.6% after 6 months. The wo-way analysis of variance indicated statistically significant results in changes in initial VAS scores to 6-monthly VAS scores between MED users and non-MED users. Conclusions The MED helps to enhance the rate of reduction of mucosal burning sensation, in addition to the conventional ice-cream stick regimen, as an adjunct to local and surgical treatment.