Effectiveness of soft tissue manipulation on function & muscle activity of superficial masseter and anterior temporalis in patients with oral submucous fibrosis.

Oral submucous fibrosis (OSMF) is a sneaky, long-lasting, and potentially cancerous condition of the oral cavity. Submucosal fibrosis, which affects the majority of the oral cavity, and increasing trismus from tight lips, cheeks, pharynx, and upper third of esophagus that causes dysphagia and a burning feeling in the mouth are the disease’s hallmarks. Symptoms of oral submucous fibrosis include pain, ulceration, and a burning sensation in the oral mucosa. Estimates place India’s prevalence at 1.2-4.6% in women and 0.2-2.3% in men. Micronutrient deficits, an excessive consumption of areca nuts, and capsaicin in chillies are etiological variables. The purpose of current study will to determine the effect of soft tissue manipulation and to know the function and muscle activity of superficial masseter and anterior temporalis muscle. It will be the two group pre-test post-test experimental design. The patients of Oral Submucous Fibrosis will be recruited based on inclusion and exclusion criteria. The patients will be randomly allocated to two groups, group 1 and 2.  The experimental group (group 1) will receive soft tissue manipulation + intralesional medication, while the clinical group (group 2) will receive only intralesional medication. The patients of group 1 (experimental group) will be treated with intralesional medication once in a week for 6 weeks, along with soft tissue manipulation for twice a week for half an hour each session. After 2 weeks of treatment, a temporo-mandibular joint distraction and compression technique will also add which increased the treatment time to 35 min. Assessment will take at baseline, after 3 weeks and after 6 weeks. The patients of group 2 (clinical group) will be intervened by only intralesional medication. This study will help clinicians to incorporate soft tissue manipulation as a part of their treatment plan in patients with Oral Submucous Fibrosis. The estimated sample size will be calculated by conducting a pilot study. The collected data will be analyzed by using SPSS 20.0 version. Data analysis will be done with the help of Shapiro Wilk /Kolmogorov Smirnov test. Parametric/Non-parametric tests will be used accordingly. For within the group analysis, paired t-test/ Wilcoxon Signed Rank test will be used. For between group analysis, independent t-test/Mann-Whitney U test will be used.