Efficacy of Prednisolone Mouthwash in Management of Grade III Oral Submucous Fibrosis: A Newer Drug Regimen

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ORIGINAL ARTICLE

Efficacy of Prednisolone Mouthwash in Management of Grade III Oral Submucous Fibrosis: A Newer Drug Regimen Abhay Datarkar1 • Abhishek Akare1 • Shikha Tayal1

Received: 18 December 2018 / Accepted: 21 May 2019 Ó The Association of Oral and Maxillofacial Surgeons of India 2019

Abstract Introduction This clinical randomized controlled trial evaluates the effectiveness of prednisolone mouthwash as a treatment modality for moderately advanced cases of oral submucous fibrosis. Materials and Method Sixty-four patients were enrolled for the study and randomized into two groups (n = 32 in each group). The experimental group was treated with prednisolone mouthwash and antioxidant capsule as per GDCH Nagpur protocol, and control group was treated with antioxidant capsule only. The primary outcome variables were interincisal mouth opening, burning sensation, and recurrent ulceration. Clinical responses were obtained at the time of the allocation, at 1, 3, 6, and 9 months into the intervention, and 6 months thereafter. Results The average increased mouth opening achieved was 10.46 mm (p \ 0.5) in group A (experimental group) and only 1.04 mm (p \ 0.5) mm in group B (control group). In addition, there was a significant difference in relief of burning sensation and recurrent ulceration. Relief of burning sensation and recurrent ulceration was within 12.81 and 10.93 days, respectively, in group A when compared to group B which was within 21.56 and 20.06 days, respectively.

& Shikha Tayal [email protected] Abhay Datarkar [email protected] Abhishek Akare [email protected] 1

Department of Oral and Maxillofacial Surgery, Government Dental College & Hospital, Medical Campus, Medical Square, Nagpur, Maharashtra 440003, India

Conclusion We conclude that in our trial, prednisolone mouthwash with antioxidants was seen to be efficacious, safe, and reliable in the management of oral submucous fibrosis. Keywords Oral submucous fibrosis  Prednisolone  Mouthwash  Antioxidant  Interincisal mouth opening  Advanced cases  Prednisone  OSF  osmf

Introduction Oral submucous fibrosis (OSF) is a chronic slowly progressive disease of oral cavity which is most prevalent in India and East Asia. According to J. J. Pindborg, submucous fibrosis may be defined as an insidious, chronic disease affecting any part of the oral cavity and sometimes the pharynx. Although occasionally preceded by, and/or associated with vesicle formation, it is always associated with a juxta-epithelial inflammatory reaction followed by a fibroelastic change of the lamina propria, with epithelial atrophy leading to stiffness of the oral mucosa and causing trismus and inability to eat [1]. The WHO definition for an oral precancerous condition—’’a generalized pathological state of the oral mucosa associated with a significantly increased risk of cancer’’—elaborates the characteristics of OSF [2]. The symptoms start from burning sensation in mouth specially while eating spicy food that progresses to recurrent oral ulcerations, pain and stomati