Online ISSN: 2515-8260

A protocol for Comparative Evaluation of Efficacy of Ksheerabala Oil and Steroid mouthwash In Management of Oral Submucous Fibrosis- an in vivo study

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Abstract: Background: OSMF, apre-malignant condition is a very common and chronic condition occurring mostly due to habit of tobacco consumption and various other factors which affects the oral cavity characterized by mucosal burning on consuming hot & spicy food, oral ulcerations, fibrosis leading to difficulty in mouth opening. There are vast treatment options for this condition including pharmacotherapy, physiotherapy, surgical approaches but in our study we used an ayurvedic preparation called ksheerabala oil which has least side effects and is having holistic approach for treatment. It will also be compared with effectiveness of steroid mouthwash in the treatment of OSMF. Objectives: To evaluate efficacy of steroid mouthwash, ksheerabala oil and the combination of ksheerabala oil and steroid mouthwash in improvement and management of mouth opening, burning sensation of the mouth and cheek flexibility. Method: This study targets 90 patients clinically diagnosed to have OSMF which will be divided in three groups: Group A, B & C with 30 subjects in each group. Group A will be instructed to gargle with 10 ml of 0.1% Dexamethasone for 10 min. three times daily for 1 month. Group B will be instructed to to gargle initially with 10 ml of 0.1% Dexamethasone for 10 min& then with 10 ml of ksheerabala oil for 10 min three times daily for 1 month & Group C to gargle with 10 ml of ksheerabala oil for 10min three times daily for 1 month. Patients will be recalled after every 7 days for a period of 1 month and on each visit, mouth opening, burning sensation and cheek flexibility will be recorded. Results: The primary outcome of the study will be increase in degree of mouth opening and secondary outcome will be decrease in burning sensation and improvement in cheek flexibility after treatment in OSMF patients. The severity of burning sensation will reduce after using ksheerabala oil and steroid mouthwash both while combination of both may or may not be effective but ksheerabala oil will be more effective in improvement of mouth opening and cheek flexibility compared to steroid.

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