Evaluation of clinical efficacy of a new mouth-exercising device in association with local ointment application, intra-lesional drug administration and surgical treatment for oral submucous fibrosis

Background: Oral submucous fibrosis (OSMF) is a chronic, insidious oral mucosal condition that affects predominantly Indians and other Asians. OSMF is the most prevalent premalignant condition found in all parts of India. The hallmark of the disease is progressive juxtaepithelial fibrosis of the oral soft tissues resulting in burning sensation, blanching, and stiffening of oral mucosa and oropharynx leading to restricted mouth opening. Improved oral opening is an important objective of OSMF treatment. Often physiotherapy alone can modify tissue remodeling in oral submucous fibrosis to increase oral opening. We have planned to test the hypothesis whether or not physiotherapy with new MED in association with local ointment application, intra-lesional drug administration and surgical treatment can modify tissue remodeling in OSMF. The purpose of this study is to describe fabrication and use of the new mouth exercising device (MED) and to evaluate its clinical efficacy in OSMF patients.

Aims and objectives: 1) To describe fabrication and use of a new MED for OSMF. 2) To evaluate and compare the clinical efficacy of the MED among the OSMF patients using MED with local ointment application, intra-lesional drugs administration and surgical treatment.  3) To evaluate subjective perception of improvement in burning sensation and in eating, swallowing and speech habits.

Methodology: We have designed a new Mouth Exercising Device (MED) which is non-tooth-borne, simple, handy and easy to use by the patients. The device is made with the help of heat and self-polymerized acrylic resin and Stainless steel orthodontic wire. No special equipments or materials are required for fabrication of the MED. The MED can be used in patients with poor dental conditions and allows rehabilitation to start immediately after trismus release.Total 225 OSMF patients will be selected randomly.  All patients will be treated with topical corticosteroid, oral antioxidant and Ice-cream-stick exercise regime. All patients will be allotted randomly to two groups: Group A, and B. Each group will be again divided into three subgroups namely A1, A2 A3 and B1, B2, B3. SubGroup A1 and B1: Inter-incisal distance (IID): 20-35 mm, to be managed without any additional therapy; SubGroup A2, B2: IID: 20-35 mm, to be managed with intra-lesional injections; SubGroup A3, B3: IID<20 mm to be managed surgically. Subgroup-A1,A2,A3 patients will be given MED (Subgroup-1A, 2A and 3A) and subgroup-B patients will not given MED for exercise. Improvement in mouth opening with a caliper and burning sensation on Visual Analogue Scale will be measured and analyzed. All treated patient will be followed bimonthly for 6 months and at each follow-up visit patients will be evaluated for 1) Improvement in interincisal distance on maximum opening with the help of digital Vernier caliper. 2) Visual Analogue Scale (VAS) measurements for burning sensation. 3) Visual Analogue Scale (VAS) measurements for difficulty in eating, swallowing, speech.

Collection of the data and Statistical Analysis: Data will be analysed statistically and will be interpreted to evaluate the clinical efficacy of the MED in all subgroups. The results will be discussed in regards to efficacy of the MED based upon the clinical findings and the statistical analysis.