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

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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.

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.

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Authors and Affiliations

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

    Abhay Datarkar, Abhishek Akare & Shikha Tayal

Authors
  1. Abhay Datarkar
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  2. Abhishek Akare
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  3. Shikha Tayal
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Correspondence to Shikha Tayal.

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“All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards”. This article does not contain any studies with animals performed by any of the authors.

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Informed consent was obtained from all individual participants included in the study.

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Datarkar, A., Akare, A. & Tayal, S. Efficacy of Prednisolone Mouthwash in Management of Grade III Oral Submucous Fibrosis: A Newer Drug Regimen. J. Maxillofac. Oral Surg. 19, 532–538 (2020). https://doi.org/10.1007/s12663-019-01248-3

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  • DOI: https://doi.org/10.1007/s12663-019-01248-3

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