Clinical Efficacy of a Mouth-Exercising Device Adjunct to Local Ointment, Intra-Lesional Injections and Surgical Treatment for Oral Submucous Fibrosis: a Randomized Controlled Trial

Background: Oral physiotherapy or mouth exercise is considered to be an adjunct but mandatory treatment modality for oral submucous fibrosis (OSMF). This study planned to evaluate the clinical efficacy of a newly designed mouth exercising device (MED) in OSMF patients receiving local ointment, intra-lesional drugs and surgical treatment. Materials and Methods: A total of 231 OSMF patients were selected and treated with basic regime including topical corticosteroids, oral antioxidants and the icecream-stick exercise regime and allotted randomly to two equal groups A and B. Group-A patients were additionally given MED. Subgroups A1 and B1 patients with an inter-incisal distance (IID) 20-35mm were not given any additional therapy; subgroup A2 and B2 patients (IID 20-35mm) were treated additionally with intra-lesional injections. Subgroups A3 and B3 with IID<20mm were managed surgically. IID was measured at baseline and at 6 months recall. The change in IID measurements was calculated and statistically analyzed using 2-way ANOVA and Tukeys multiple post hoc analysis. Results: Average improvement in IID after six months of recall visits was observed to be 8.4 mm in subgroup-A1 (n-53) compared to 5.5 mm in B1(n-50) (p<0.01). The IID improvement in subgroup-A2 was found to be 9.3mm (n-46) compared to 5.1 mm in B2 (n-48) (p<0.01). In the surgery group, mouth opening improvement was observed to be 9.6 mm in subgroup A3 (n-18) compared to 4.8 mm for B3 (n-16) (p<0.01). Conclusions: Use of the MED appears to be effective for increasing oral opening in OMSF patients in conjunction with local, injection and/or surgical treatment.