A protocol for Comparative Evaluation of Efficacy of Ksheerabala Oil and Steroid mouthwash In Management of Oral Submucous Fibrosis- an in vivo study
European Journal of Molecular & Clinical Medicine,
2020, Volume 7, Issue 2, Pages 2119-2127
AbstractAbstract: 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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